Sooner or later, every man in Australia runs into problems with impotency levitra australia like other bodily functions, must be in order.

Ontario drug benefit formulary edition 42

Ministry of Health and Long-Term Care Ontario Drug Benefit
Drug Index

Edition 42


Drug Programs Policy and Strategy Branch
Ontario Public Drug Programs Ministry of Health and Long-Term Care Effective August 30, 2016 Table of Contents

Part I: Introduction
A. About the Formulary

The Ministry of Health and Long-Term Care (MOHLTC) issued the first Comparative Drug Index (CDI) in 1970 and Edition 1 of the Ontario Drug Benefit (ODB) Formulary was published in 1971. The integrated Formulary/CDI was first produced in 1974, to list the benefits available to eligible persons under the Ontario Drug Benefit Act (ODBA). The Formulary/CDI was developed in consultation with the ministry's external expert drug advisory committee, the Drug Quality and Therapeutics Committee (DQTC), now known as the Committee to Evaluate Drugs (CED). For many years, the Formulary/CDI has set the provincial standard for price, quality and interchangeability of drug products. The MOHLTC has liaised with the Ontario Medical Association (OMA), the Ontario Pharmacists Association (OPA), the Ontario College of Pharmacists (OCP), pharmaceutical manufacturers and other professional and patient groups as required on the content and policies embodied in this publication. The ODB program is one of the most generous drug benefit programs in Canada, providing coverage for over 4,300 drugs and other substances, including some nutrition products and diabetic testing agents. With funding provided by the MOHLTC and the Ministry of Community and Social Services, the ODB program covers most of the cost of prescription drug products listed in the Formulary. As well, drugs that are not listed in the Formulary may be considered for coverage, on a case-by-case basis, through the ministry's Exceptional Access Program (EAP). 1. Purpose The Formulary/CDI serves as a: • Guide to prescribers and pharmacists regarding drug products which are eligible for coverage under the ODB program • Guide for pharmacists regarding conditions for payment • Guide to professional committees in hospitals and institutions in the selection of • Guide to drug product interchangeability in respect of drug products that have been designated interchangeable under the Drug Interchangeability and Dispensing Fee Act (DIDFA) • Comparative pricing guide for drug products 2. Recipient Eligibility The ODB program provides community-based, out-patient drug benefits to the following groups of Ontario residents who are eligible for Ontario Health Insurance Plan (OHIP) coverage under the Health Insurance Act: Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.1 • People 65 years of age and older • People receiving benefits under the Ontario Disability Support Program or • People residing in Homes for Special Care or long-term care homes • People receiving professional services under the Home Care Program • Registrants in the Trillium Drug Program Al residents of Ontario who are covered under OHIP wil qualify for drug benefits under the ODB program on the first day of the month following their 65th birthday. For example, if a resident's 65th birthday is April 15th, he/she wil become eligible for the ODB program on May 1st. People who do not initially meet the residency requirements for OHIP coverage but who later become eligible after the specified waiting period (e.g., new or returning permanent residents, landed immigrants) will qualify for ODB program coverage provided that they fall into one of the categories listed above. To help make the ODB program sustainable and affordable for the future and to allow the government to continue to add new drugs as benefits, a cost sharing scheme was introduced in July 1996. Al ODB recipients are required to pay a portion of their prescriptions. For more details about co-payments and deductibles, please refer to Section C.4 of Part I, entitled "Cost Sharing." 3. Interchangeable Products The Drug Interchangeability and Dispensing Fee Act (DIDFA) gives the Executive Officer (EO) of the Ontario Public Drug Programs (the "Executive Officer") the authority to designate a product as interchangeable with one or more other products where the EO considers it advisable in the public interest to do so and certain requirements and conditions set out in the DIDFA and Regulation 935 made under the DIDFA are met. For example, a product can only be designated as interchangeable with another product if the product has the same amount of the same or similar active ingredient(s) in the same or similar dosage form as the other product. The onus is on the manufacturer to provide evidence of interchangeability. The reimbursement of products on the current Formulary is based on a "lowest cost" policy, meaning that dispensers wil only be reimbursed the lowest cost product listed in a category of drugs (there are some exceptions to this policy). This mandatory substitution, or interchangeability process, is set out in the DIDFA. Off-Formulary Interchangeability Off-Formulary Interchangeability (OFI) is the application of interchangeable designations to drug products that are not listed as ODB benefits in the Formulary/CDI. OFI became effective April 1, 2007 when changes to Regulation 935 made under the DIDFA came into force. OFI drug products are reviewed by the CED or by the ministry, and upon approval of the EO, are determined to be interchangeable with an original Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.2 Please note that OFI products may be covered under the ODB program through the Notice to Dispensers There are occasions when a drug product that is the subject of an ongoing patent dispute in the courts is designated as interchangeable in the Formulary/CDI. The designation of such a drug product is not meant to be, and does not act as, a certification that the drug product is non-infringing under federal patent laws. Dispensers should seek their own advice in that regard. If a court finds a drug product to be patent infringing, the EO may, depending on the relief ordered, reconsider the listing status of the drug product. 4. The Commit ee to Evaluate Drugs (CED) The Committee to Evaluate Drugs (CED) is the ministry's independent expert advisory committee on drug-related issues and is established by Order-in-Council under the authority of section 9 of the Ministry of Health and Long-Term Care Act. The CED provides an essential service to the ministry by evaluating the clinical value of drug products, interchangeability of generic drug products and cost-effectiveness of drugs through its rigorous and evidence-based reviews. These reviews result in recommendations being made to the EO regarding the designation of these products as benefits under the ODB program, and as interchangeable under the DIDFA. The EO makes the final decision regarding designations, taking into consideration the recommendations of the CED and public interest. The CED also provides the ministry with advice on a broad range of policy issues relating to the use of drugs. The CED is comprised of a chair and 16 members appointed by the Lieutenant Governor in Council. Two of the 16 CED members are patient representatives. The remaining CED members include an economist, and practicing physicians and pharmacists, who have expertise in a wide range of specialties including geriatrics, infectious disease, family medicine, pharmacology, health economics, epidemiology and other disciplines. Additional information on the CED membership and its terms of reference can be accessed through the Ontario Public Appointments' website at: To support improved transparency and accountability, the CED's recommendations and the EO's decisions are publicly available on the MOHTLC website at: For drug products to be eligible for listing in the Formulary, a drug manufacturer must provide a complete submission in accordance with the prescribed conditions set out in: • O. Reg. 201/96 made under the ODBA; and • Regulation 935 made under the DIDFA. Interpretive guidelines have been published to assist manufacturers in making their submissions and are available on the ministry's website at: Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.3 Each complete submission undergoes a thorough review by the CED. Following its review, the CED makes recommendations to the EO as to whether a drug product should be designated as a benefit under the ODB program and/or as interchangeable under the DIDFA. As well, the CED makes recommendations as to drug products that should be available through the EAP. More information on how drugs are approved can be found on the ministry's website at: B. How to Use the Formulary
The Formulary/CDI identifies over 4,300 drug products designated as benefits under the ODB program, as well as drug products that are considered to be interchangeable, and serves as a reimbursement guide for prescribers and pharmacists. The Formulary/CDI consists of a compilation of pharmaceutical products arranged in comparative categories and groupings according to the name, strength and dosage form of the active therapeutic ingredients. This information requires knowledgeable interpretation and is intended primarily
for health care professionals, pharmacies, hospitals and organizations
associated with the manufacture, distribution and use of pharmaceutical
preparations.
Part III-A ODB Formulary/Comparative Drug Index
Part III-A of the ODB formulary is available through the searchable electronic formulary
(e-Formulary) online at: Classification Drugs are indexed by pharmacologic-therapeutic classification based on the classification system of the American Hospital Formulary Service (AHFS) of the American Society of Health-System Pharmacists. Permission to use this classification system has been granted by the Society, which is not responsible for the accuracy of any reproduced content. The pharmacologic-therapeutic classification under which any drug is listed may be found by consulting the index in Part V of the Formulary/CDI. Drugs with multiple indications are listed under only one of the common uses. Interchangeable Categories Where there is more than one drug product listed in a specific category, the products have been designated as interchangeable under the DIDFA, unless otherwise noted. The Drug Benefit Price (DBP) is listed for each drug product as well as the lowest DBP
for an interchangeable category. The ODB program wil reimburse dispensing physicians and pharmacies the lowest DBP within an interchangeable category. If a pharmacy dispenses an interchangeable product to a patient who does not receive benefits under the ODB program, the pharmacy cannot charge more than the lowest Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.4 DBP for the interchangeable category when dispensing the product (see subsection 7(2) of the DIDFA). Drug Identification Number (DIN) For each drug product, the Formulary/CDI lists the eight-digit drug identification number (DIN) assigned by Health Canada's Therapeutic Products Directorate*. The DIN uniquely identifies each drug product as to its manufacturer, active ingredient(s), strength of active ingredient(s), route of administration and pharmaceutical dosage form. Please note that only products with DINs or Product Identification Numbers (PINs) that are listed as benefits in the Formulary/CDI are eligible for reimbursement under the *A small number of products, including drugs, nutrition products and diabetic test strips, have been assigned a product identification number (PIN) with leading digits 098 for the purposes of ODB claims. Ministry assigned PINs may differ from those shown on the manufacturer's label but must be used when submitting claims to the ODB program. Natural Product Number (NPN) For natural health products, the Formulary/CDI lists the eight-digit Natural Product Number (NPN) assigned by Health Canada. Natural health products, as defined in the Natural Health Products Regulations made under the federal Food and Drugs Act are excluded from the definition of "drug" in Ontario's Drug and Pharmacies Regulation Act (DPRA), unless the natural health product contains pseudoephedrine or its salts, ephedrine or its salts, or any combination of them (see clause 1(1)(f) of the DPRA and subsection 3(7) of O. Reg. 58/11 made under the DPRA). Please note that only natural health products with NPNs listed as benefits in the Formulary/CDI are eligible for reimbursement under the ODB program. Limited Use Products Limited Use (LU) products are listed in the Formulary/CDI with specific clinical criteria/conditions for use and wil be reimbursed under the ODB program only when those criteria/conditions have been met (see section 23 of the ODBA). LU products wil be reimbursed under the ODB program only when prescribed for an ODB-eligible recipient in accordance with the applicable LU criteria and only if the prescriber has provided the Reason for Use Code, either verbally, electronically or in written
format with the prescription.
For more details about the LU reimbursement process, please refer to Section C.9 of Part I, entitled "Limited Use Products" as well as to Part XII of the Formulary/CDI. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.5 Therapeutic Notes Many therapeutic notes contain specific clinical criteria that apply to some general benefit products as listed in the ODB Formulary. The therapeutic notes provide guidance to prescribers on where the product can be used in the most cost-effective manner as advised by the ministry's expert advisory committee, the CED. Therapeutic notes define appropriate therapy; and therefore, the expectation is that both prescribers and dispensers should follow them. Product Listing Agreements A Product Listing Agreement (PLA) refers to a negotiated agreement between a pharmaceutical manufacturer and the EO. These agreements support reimbursement of some products in the Formulary and other Ontario public drug programs, such as the EAP and the New Drug Funding Program. Agreements are intended to provide access to new and existing drugs according to certain conditions, and are based on a number of factors including the CED's recommendations, clinical evidence, therapeutic need and cost-effectiveness. Listing agreements may include multiple components: • Commitment to promote appropriate use • Requirement to collect outcomes data • Requirement to gather further evidence related to clinical or economic information for future consideration by the CED • Cost and utilization considerations Part III-B Off-Formulary Interchangeable Drugs Off-Formulary Interchangeable (OFI) drug products are listed by a pharmacologic- therapeutic classification based on the same classification system as applied to products in Part III-A of the Formulary/CDI. Al drug products listed in Part III-B of the Formulary/CDI are NOT benefits. Drug product prices, as reported by the respective manufacturers to the ministry, have been listed for each product for information purposes only. In accordance with paragraph 7 of subsection 8(1) Regulation 935 made under the DIDFA, manufacturers of these drug products shall give the EO notice of every change in the manufacturer's list price for their drug products. Part IV Consolidated Alphabetical Index of Drugs Products in Part I I-B Drugs in Part III-B listed by alphabetical order by name. Part V Index of Pharmacologic-Therapeutic Classification An index of the pharmacologic-therapeutic classification is provided in this section in ascending order. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.6 Part VI Facilitated Access Drug Products This part lists specific products that are reimbursed through the Facilitated Access mechanism under the ODB program for treatment of ODB recipients with HIV/AIDS or patients receiving palliative (end-of-life) care. Part VI has been divided into Part VI-A (HIV/AIDS) and Part VI-B (Palliative Care) to distinguish the differing categories of drug products available under this mechanism. Products listed in this section are available to these specific patient populations through the EAP, without the need for the submission of an individual patient request. Prescribers must be identified on the Facilitated Access Physician List that is appropriate for the patient and product being prescribed. Part VI Tril ium Drug Benefit Program The ministry provides benefits through the Tril ium Drug Program to help individuals and families who have high prescription drug expenses in relation to their incomes. Part VII explains how the Tril ium Drug Benefit Program works and provides a list of allowable Part VII Exceptional Access Program (EAP) The ministry may consider requests for coverage of drug products not listed in the Formulary/CDI for ODB-eligible persons. Part VIII provides an overview of the EAP. Part IX Additional Benefits Nutrition Products This section includes a maximum allowable reimbursement mechanism for Nutrition Products (NP) covered under the ODB program. Physicians must complete a Nutrition Products form and forward a copy with the prescription to the pharmacy for each NP prescribed. Claims for NPs are reimbursed only for patients who are eligible for ODB coverage and who also meet the eligibility criteria described in Part IX of the ODB Formulary. The ODB program does not provide coverage for NPs for residents of long- term care homes. Long-term care homes are responsible for providing NPs to their residents when required. Reimbursement of NPs is not considered through the EAP. Diabetic Testing Agents Blood glucose test strips covered by the ODB program are listed in Part IX of the ODB Formulary. These products are available to ODB-eligible recipients with a valid prescription from a physician. Blood glucose test strips are listed with a maximum price that wil be reimbursed under the ODB program. Please see section on diabetic testing Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.7 agents in Part IX for more information, including the maximum reimbursement limits on diabetic testing agents. Part X Abbreviations This part contains a list of abbreviations for the names of manufacturers whose products are listed in the Formulary/CDI and a list of abbreviations for dosage forms. Part XI Section Currently Not In Use Part XI Limited Use This section contains a guide for prescribers and pharmacists on how to complete an LU prescription. C. Dispensary Reimbursement/Procedure
1. Health Network System
The Health Network System (HNS) links all Ontario dispensaries to the ministry
computer system and allows online claims processing and adjudication in real-time. The collection, use and disclosure of personal information on the HNS are governed by section 13 of the ODBA and the Personal Health Information Protection Act, 2004. 2. Drug Utilization Review (DUR) The HNS assists pharmacists in providing quality health care through a drug utilization review (DUR) mechanism. The DUR program, part of the HNS, provides an analysis of both previous prescription information/claims data and current prescription data to identify potential problems. Its primary function is to enhance the current principles of good pharmacy practice with additional information sources. The HNS's prospective DUR currently monitors for: • Potential drug interactions • Potential double doctoring • Duplicate prescriptions • Potential multiple pharmacy use • Refil too soon/too late Retrospective claims analysis wil also provide insights into drug trends and issues. It can help identify patterns that could form the basis for further study and the development of strategies leading to more rational drug use. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.8 3. Drug Cost The drug cost in the Formulary is the Drug Benefit Price (DBP) as defined in the Ontario Drug Benefit Act (ODBA) and the DIDFA. The DBP for a drug in a particular dosage form and strength reflects the amount, calculated per gram, mil ilitre, tablet, capsule or other appropriate unit, for which a listed drug product in that dosage form and strength wil be reimbursed by the ministry. Some drug products are listed in package ("Pk") sizes (i.e., pressurized inhalers). For these products, the DBP is for the package size listed. For ointments, creams, powders and liquids the DBP is usually per gram or per mil ilitre. For tablets, capsules and suppositories, other than those designated "Pk," the DBP is per unit dosage form. Claims must be submitted in alignment with the product listing in the Formulary. Products that are benefits are reimbursed under the ODB program at the listed DBP (or if interchangeable products are listed, at the lowest DBP for an interchangeable category) plus a mark-up plus the lesser of a pharmacy's posted usual and customary fee or the ODB dispensing fee, minus the applicable co-payment amount for every ODB prescription fil ed. 4. Cost Sharing People whose prescription drugs or additional benefits are paid for by the ODB program are required to contribute a co-payment amount for each prescription. There are two categories of co-payments: 1) ODB recipients pay up to $2 toward the dispensing fee for each prescription if they are one of the following: • A senior single person with an annual net income of less than $16,018 • A senior couple with a combined annual net income of less than $24,175 • Receiving benefits under the Ontario Works Act, 1997 or the Ontario Disability Support Program Act, 1997 • Receiving professional services under the Home Care Program • A resident of a long-term care home under the Long-Term Care Homes Act, 2007, or Homes for Special Care Act, R.S.O. 1990 • Eligible for benefits under the Tril ium Drug Program and their deductible for the quarter has been paid 2) Single seniors with annual net income greater than or equal to $16,018 or a senior couple with a combined annual income greater than or equal to $24,175 each pay their first $100 (i.e., deductible) in prescription costs each year. After that, each senior may pay up to $6.11 (i.e., co-payment) toward the ODB dispensing fee on each prescription for an eligible benefit. The ODB deductible for newly eligible seniors in the higher co-payment category is prorated based on the number of months they are eligible for ODB in their first year of eligibility. The ODB program begins August 1 of each year. The HNS wil automatically Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.9 track and notify pharmacists of an individual's deductible based on the month when they become eligible in their first year of ODB coverage. Only allowable drug expenses wil count towards the $100 deductible, namely, prescriptions for drug products in Part III-A of the Formulary/CDI on the e-Formulary, prescriptions for nutrition products and diabetic testing agents approved as benefits under the ODB program, extemporaneous products that are designated pharmaceutical products under the ODBA, and products that are approved under the EAP. The ODB deductible and co-payment are tracked through the HNS according to the ODB benefit year. The ODB benefit year begins August 1 and ends on July 31 of the subsequent 5. Drug Quantity For most ODB-eligible recipients the maximum quantity that may be charged under the ODB program must not exceed that required for a 100-day course of treatment. The quantity dispensed is subject to the rules set out in the ODBA, and the DIDFA as well as to the details of the prescription as directed by the prescriber. For recipients who are eligible for benefits under the Ontario Works program, the maximum quantity of medication claimed under the ODB program must not exceed that required for a 35-day course of treatment; and in the case of medications to which the Trial Prescription Program applies, the maximum quantity for which the EO is required to pay is a quantity sufficient for 30 days. Additional quantity restrictions are also enforced by the HNS for some Tril ium recipients receiving prescriptions in the third and fourth quarter of the benefit year. Please refer to Part VII for additional drug quantity restrictions related to the Tril ium Drug Program. The HNS provides pharmacists with a "refil too soon" warning for claims where additional supplies are submitted more than ten days prior to the end of a previous supply. Pharmacists should use their professional judgment in consultation with the prescriber and patient when dispensing the second prescription. The ministry recognizes that there are circumstances in which recipients have a valid and appropriate reason for obtaining an early refil of a medication (e.g., dose change). In these cases, the reason for the early refil must be documented. The ministry wil monitor claims to ensure that pharmacies comply with the HNS warnings and recoveries of payments wil be made where claims are submitted inappropriately. Effective March 1, 1999, ODB recipients traveling outside the province for between 100 and 200 days, may obtain an early refil (up to a 100-day supply) of medication before leaving the province. In order to obtain an early refil for a vacation supply, ODB recipients must provide the pharmacist with a letter, or a copy of their travel insurance, confirming that they are leaving the province for between 100 and 200 days. The letter or copy of travel insurance must be maintained and be readily retrievable by the pharmacist for a period of 24 months, for audit purposes. It is recommended that these documents be maintained in a separate file, instead of attaching to the prescription hardcopy. Pharmacists must have the letter or copy of their travel insurance confirming travel outside of Ontario before submitting claims for a vacation supply and overriding
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.10 any rejections generated by the HNS (use intervention code "MV" to override the "duplicate claim" rejection if two claims for 100-day supply of medication are submitted for the recipient on the same day). Please refer to Part VII for Tril ium vacation supply 6. Payment of Dispensing Fees under the Ontario Drug Benefit (ODB) Program Conditions on Payment of Dispensing Fees In order to receive payment of a dispensing fee under the ODB program, the dispenser must supply at one time the lesser of:
1. The maximum quantity of the listed drug product that the dispenser is authorized to supply at one time; or 2. The maximum quantity permitted under section 18 of O. Reg. 201/96. The amount referred to above (in either item 1 or 2) is the "Maximum Quantity." In most cases, the Maximum Quantity is a 35-day supply for Ontario Works recipients, a 30-day supply for the Trial Prescription Program, or a 100-day supply. The dispenser is permitted to dispense a quantity that is not the Maximum Quantity only if one of the following conditions applies: The ODB recipient is a resident of a long-term care home The ODB recipient is a resident of any other residential facility funded by the Government of Ontario that is designated by the Executive Officer (e.g., Home for Special Care) and published on the ministry website at: The listed drug product is a product or belongs to a class of drug product that is specified by the Executive Officer and published on the ministry website at: dispenser has determined that the quantity supplied should be less than the Maximum Quantity because, in the dispenser's professional opinion, • The safety of the ODB recipient is a concern, or Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.11 • There is a risk of abuse or diversion if the drug product is supplied to the ODB recipient.** The dispenser has determined that the quantity supplied should be less than the Maximum Quantity because, In the dispenser's professional opinion, the ODB recipient is incapable of managing his or her medication as a result of physical, cognitive or sensory impairment; and The ODB recipient or the person presenting the prescription agrees that the quantity supplied should be less than the Maximum *Note: In the case of Exceptions 1 to 3, ODB recipients who are deemed to require more frequent dispensing should be assessed regularly to verify an ongoing need for more frequent dispensing. **Note: In the case of Exception 3, the dispenser must perform all of the following: The dispenser must make a written record of the reasons for his or her opinion; The dispenser must notify the prescriber in writing about the assessment and retain a copy of the notification; and Upon request, the dispenser must provide the ministry with copies of the written record and the written notification to the prescriber. ***Note: In the case of Exception 4, the dispenser must perform of al the following: The dispenser must make a written record of the reasons for his or her opinion; The dispenser must notify the prescriber in writing about the assessment and retain a copy of the notification; The dispenser shall obtain in writing the agreement of the ODB recipient or the person presenting the prescription; Upon request, the dispenser must provide the ministry with copies of the written record, agreement and notification to the prescriber; and Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.12 The exception is only valid for a period of 365 days. A dispenser's assessment that a patient requires more frequent dispensing because of a physical, cognitive or sensory impairment must be re-assessed annually. Records of this annual assessment must be maintained as part of the ODB recipient's permanent pharmacy health record. Al claims are subject to recovery if found to be ineligible for reimbursement under the Two Fees / Calendar Month In most cases, the Executive Officer wil only pay a dispenser a maximum of two (2) dispensing fees per calendar month for the supply of a listed drug product, even if the prescription directs more frequent dispensing. This rule is subject to the rule respecting Chronic-Use Medications (see section below). The two-dispensing-fees-per-month rule does not apply if: The ODB recipient is a resident of a long-term care home The ODB recipient is a resident of any other residential facility funded by the Government of Ontario that is designated by the Executive Officer and published on the ministry website at: The listed drug product is supplied in the Maximum Quantity (see definition in previous section "Conditions on Payment of Dispensing Fees") and is a product or belongs to a class of drug product that is specified by the Executive Officer and published on the ministry website at: The listed drug product is a product or belongs to a class of drug product that is specified by the Executive Officer and published on the ministry website at: dispenser has supplied the drug in a quantity that is less than the Maximum Quantity because, in the dispenser's professional opinion, The safety of the ODB recipient is a concern, or Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.13 There is a risk of abuse or diversion if the drug product is supplied to the Note: Where the dispenser has supplied less than the Maximum Quantity for safety/abuse/diversion reasons, the dispenser must make a written record of the reasons for his or her opinion, notify the prescriber in writing about the assessment, and retain copies of the written record and prescriber notification. Al claims are subject to recovery if found to be ineligible for reimbursement under the ODB program. Dispensing Fees for Chronic-Use Medications Effective October 1, 2015 changes were made to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act to establish a limit on the number of dispensing fees
that can be bil ed to the Executive Officer for certain chronic-use medications.
Dispensers are entitled to receive a maximum of five (5) dispensing fees per 365-day period, commencing on the day the first claim for an identified chronic-use medication is submitted to the ministry on or after October 1, 2015. Dispensers are encouraged to provide most ODB recipients with a 100 days' supply of most chronic-use medications to ensure that they receive a dispensing fee for each dispensing event. The chronic-use medications subject to this new rule are listed on the ministry website: This limit on the number of dispensing fees for chronic-use medications does not apply in the circumstances listed below. In these circumstances, the general rule of a maximum of two-dispensing-fees-per-month applies, unless the dispensing event is also exempt from that rule (see section above). ODB recipients who receive drug benefits under the Ontario Works Program. ODB recipients who are residents of long-term care homes ODB recipients who are residents of any other residential facility funded by the Government of Ontario that is designated by the Executive Officer (e.g., Home for Special Care) and published on the ministry website The listed drug product dispensed is an extemporaneous preparation. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.14 ODB recipients who are on a complex medication regime where patient safety is at risk and who require more frequent dispensing of the listed drug product to assist with the proper administration of the medication regime.** ODB recipients who require more frequent dispensing due to an established physical, cognitive or sensory impairment.** ODB recipients who are deemed to require more frequent dispensing must be assessed regularly to verify an ongoing need for more frequent dispensing. **Note: In the case of Exceptions 5 and 6, the dispenser must perform all of the • The dispenser must make a written record of the reasons for his or her • The dispenser must notify the prescriber in writing about the assessment and retain a copy of the notification; • The dispenser shall obtain in writing the agreement of the ODB recipient or the person presenting the prescription; • Upon request, the dispenser must provide the ministry with copies of the written record, agreement and notification to the prescriber; and • Exceptions 5 and 6 are only valid for a period of 365 days. A dispenser's assessment that a patient requires more frequent dispensing because of a physical, cognitive or sensory impairment or because the patient is on a complex medication regime, must be re-assessed annually. Records of this annual assessment must be maintained as part of the ODB recipient's permanent pharmacy health record. Al claims are subject to recovery if found to be ineligible for reimbursement under the Note: Any reference in this section to the term "written", "in writing" or "written record" includes electronic records and electronic copies of written records. 7. Cost-to-Operator Claims Effective March 1, 2007, in accordance with clause 14(3)(b) of O. Reg 201/96 made under the ODBA, the al owable use of the ‘MI' (Cost-to-Operator or ‘CTO') intervention code is restricted to cases where a pharmacy is unable to acquire the lowest DBP product in an interchangeable category and must dispense the original product or a higher-priced interchangeable drug product. Supporting documentation (manufacturer's or wholesaler's invoice), which clearly indicates that the generic product had been ordered and was unavailable during the appropriate time period, must be retained on file for 24 months for post-payment verification. Overpayments due to inappropriate Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.15 submission of MI intervention codes are subject to recovery through post-payment 8. Medical y Necessary "No Substitution" Claims The ministry wil provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances — where a patient has experienced a significant adverse reaction with two lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada adverse drug reaction form for each lower-cost interchangeable drug product trialed (Canada Vigilance Adverse Reaction Reporting Form); and • Write "No Substitution" or "No Sub" on a written prescription or indicate "No Substitution" to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient's record for future use and reference. When the pharmacist receives a prescription with the written notation "No Substitution," reimbursement wil be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada adverse drug reaction form for each of the lower-cost interchangeable drug product trialed. This form must be completely fil ed out noting the details of the adverse reaction and signed by the Upon receipt, the pharmacist must:
• Clearly note on the adverse drug reaction form - "ODB NO SUBSTITUTION";
• Fax or mail the completed and signed form to Health Canada's Canada Vigilance • Retain his or her copy of the completed and signed adverse drug reaction form. The adverse drug reaction form wil not have to be renewed. However, in accordance with sections 19 and 29 of O. Reg. 201/96 made under the ODBA, the dispensary must retain a copy of the prescription and the required Health Canada adverse drug reaction form (completed and signed by the prescriber). The prescriber must write "No Substitution" or "No Sub" on renewal or subsequent new written prescriptions, and indicate "No Substitution" on subsequent new oral prescriptions. The dispenser wil be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed, signed adverse reaction form is not available at the pharmacy during an audit, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category wil be recovered. The pharmacist must mail or fax the completed form to: Canada Vigilance Program, Marketed Health Products Directorate, Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.16 Postal Locator 0701E, Ottawa, Ontario K1A 0K9 Fax: 1-866-678-6789 Please refer to Health Canada's Canada Vigilance Program website to obtain a copy of the adverse drug reaction (Canada Vigilance Drug Reaction Reporting) form at For additional information on the Canada Vigilance Program, please call 1-866-234- 2345 or visit: An ODB recipient with a valid "no substitution" prescription that was fil ed prior to October 1, 2015 wil be permitted to renew and refil their brand therapy as directed, as long as the appropriate documentation remains on file. 9. Limited Use Products Designating Listed Drugs as LU Benefits Drug products reimbursed under the ODB program are evaluated and recommended for listing by the ministry's expert drug advisory committee, the CED. LU drugs are those drugs recommended by the CED as having value in specific circumstances, but are not appropriate for general listing in the Formulary/CDI. LU drugs may: • Have the potential for widespread use outside the indications for which benefit and cost-effectiveness have been demonstrated • Be clinically useful, but are associated with predictable severe adverse effects and a less toxic alternative is available as a general benefit • Be very costly and a lower-cost alternative is available as a general benefit As a result, the CED may recommend that a drug product be reimbursed only when specific clinical criteria/conditions have been met. The CED and the ministry wil continue to review existing LU products to determine if there are opportunities to transition a given product to a general benefit listing. LU Reimbursement Process Patients may take the LU prescription to the pharmacy, or prescribers may fax it directly to the pharmacy. The Reason for Use (RFU) code, may be communicated in writing, electronically or verbally. The authorization periods for an LU prescription are noted with the drug listing in the Formulary and are based on the initial date that the first LU prescription is dispensed. See Part XII for more detailed information about the LU claims process, including instructions for prescribers and pharmacists related to LU prescriptions. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.17 In instances where an ODB-eligible patient does not meet the listed LU criteria, physicians may make a written request for special consideration for coverage under the ODB program's EAP (see Part VIII of the Formulary/CDI for further details). ODB Audit of LU Claims The Inspection Unit of Ontario Public Drug Programs routinely conducts on-site audits of all pharmacies for post-payment verification of claims reimbursed under the ODB program. In addition, the ministry may request copies of LU prescriptions from pharmacies by mail for purposes of carrying out office audits relating to ODB claims for LU products. The ministry wil recover monies paid for LU product claims if one of the following applies: • The LU (RFU) code indicated on the prescription does not meet the listed LU clinical criteria • The LU (RFU) code is not provided with the prescription • The prescription is incomplete (e.g., the date, drug, patient name or the correct CPSO number or college registration number is missing or the prescriber has not signed the prescription) • The LU authorization period is expired • A prescription with valid LU documentation was not obtained/retained in the pharmacy for 24 months Pharmacists are reminded that copies of prescriptions with LU documentation must be retained by the pharmacy for 24 months as required by section 29 of O. Reg. 201/96 made under the ODBA. 10. Extemporaneous Preparations An extemporaneous preparation is defined in section 1(1) of O.Reg 201/96 made under the ODBA as a "drug or combination of drugs prepared or compounded in a pharmacy according to a prescription." Section 17 of the ODBA gives the EO of Ontario Public Drug Programs ("the Executive Officer") the authority to: • Determine the conditions which must be met before an extemporaneous preparation is designated as a designated pharmaceutical product ("DPP") and therefore deemed eligible for reimbursement under the ODB program; and • Determine the drug benefit price of a DPP including a formula by which the drug benefit price may be calculated. Effective October 1, 2006, an extemporaneous preparation that is not equivalent to a manufactured drug product wil be deemed by the EO to be a DPP and therefore eligible for reimbursement under the ODB program, if: a) The preparation is for internal consumption and contains a solid oral dosage form of a listed drug product and no other active substance; Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.18 b) The preparation is for injection and is prepared by or under the direct supervision of a pharmacist (i.e., a person holding a certificate of registration from the OCP in accordance with the Pharmacy Act, 1991 and the Regulated Health Professions Act, 1991) (see restrictions below); c) The preparation is for dermatological use and contains a listed drug product used for dermatological purposes and no other active substances other than one or more of the following: camphor, compound benzoin tincture, hydrocortisone powder, liquor carbonis detergens, menthol, salicylic acid, sulfur or tar distil ate; d) The preparation is for a topical nitrogen mustard preparation; e) The preparation is for a topical preparation consisting of liquor carbonis detergens, salicylic acid, sulfur or tar distil ate, but no other active substances, compounded in petrolatum jelly or lanolin; f) The preparation is for an ophthalmic solution containing amikacin, cefazolin or g) The preparation is for an ophthalmic solution containing gentamicin or tobramycin in a concentration greater than three mil igrams per mil ilitre. Restrictions Regarding Extemporaneous Injectables 1) Compounded injectable products which contain one or more of the drug products noted below are not eligible for reimbursement as DPPs under the ODB program unless approved by the EO under the EAP: Alprostadil, amphotericin B lipid complex, ancestim, azithromycin, baclofen, calcitriol, cefotaxime, cephalothin, clodronate, daclizumab, danaparoid, darbepoietin, deferoxamine, desmopressin, dolasetron, epoetin alfa, epoprostenol, estradiol dienanthate/estradiol benzoate/testosterone enanthate benzilic acid hydrazine, etanercept, filgrastim, fludarabine, fondaparinux, glatiramer acetate, hepatitis A vaccine, hepatitis B vaccine, infliximab, interferon alfa-2b/ribavirin, interferon beta-1a, interferon beta-1b, iron dextran, iron sucrose, ketorolac, levofloxacin, mycophenolate mofetil, nandrolone decanoate, pamidronate disodium, peginterferon alfa 2-b, somatrem, somatropin, sumatriptan, verteporfin, zoledronic acid. 2) Any injectable drug product which received a Notice of Compliance from Health Canada on or after September 4, 2003 is ineligible for reimbursement as a DPP under the ODB program unless approved by the EO under the EAP. 3) Any injectable drug product that is listed in Part III-A of the Formulary as an LU benefit is ineligible for reimbursement as a DPP under the ODB program unless the patient meets the clinical criteria outlined. Claims for these products in respect of patients who do not meet the defined LU criteria may be considered by the EO for reimbursement under the EAP. Please refer to Section 6.1 of the Ontario Drug Programs Reference Manual for requirements regarding claims for extemporaneous preparations. Pharmacists are Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.19 reminded that claims reimbursed under the ODBA are subject to post-payment The web posting is considered the authoritative source of information on the extemporaneous preparations policy. Please refer to the ministry's web posting for details on extemporaneous preparations that are eligible for reimbursement under the In the event that there are any discrepancies or inconsistencies between the foregoing list and the list posted on the ministry's website, the website wil be considered authoritative. Questions can be directed to the ministry's ODB Help Desk. 11. Professional Pharmacy Services The Ontario government on the advice from the Ontario Pharmacy Council has launched a number of professional pharmacy services. Please refer to the ministry's website for information on the following professional pharmacy services at: • MedsCheck program • MedsCheck at Home • MedsCheck for Ontarians living with Diabetes • MedsCheck for Long-Term Home Residents • Pharmaceutical Opinion program • Pharmacy Smoking Cessation program D. Information and Assistance
1. Personal Health Information Protection Act, 2004 and Freedom of
Information and Protection of Privacy Act The information on ODB claims, including those on paper and electronic media, is collected for purposes related to the administration of the ODBA. It is collected under the authority of subsection 13(1) of the ODBA and clause 36(1)(h) of the Personal Health Information Protection Act, 2004. For further information please contact: Drug Program Services Ontario Public Drug Programs Hepburn Block, 9th Floor 80 Grosvenor Street, Queen's Park Toronto ON M7A 1R3 Tel.: 416-212-4724 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.20 Fax: 416-325-6647 2. Inquiries and Assistance The following information is provided to assist prescribers, pharmacists and manufacturers in obtaining details on the Ontario Drug Benefit program, claims submission and payments. Payments
Program Payments Financial Management Branch Kingston, ON K7L 5J3
Manual Claims Submissions
Ministry of Health and Long-Term Care Claims Services Branch ODB Paper Claims Processing P.O. Box 2300, Stn ‘A', LCD1 Hamilton, ON L8N 4A2 For new ODB program registrations and registry inquiries, please contact: Ministry of Health and Long-Term Care Claims Services Branch Provider Registry Kingston, ON K7L 5K1 NOTE: Dispensary operators are requested to notify the Provider Registry three weeks
in advance of a change in status for openings, closures or transfers of ownership. Inquiries and correspondence on this publication should be directed to: Drug Program Services Ontario Public Drug Programs Hepburn Block, 9th Floor 80 Grosvenor Street, Queen's Park Toronto ON M7A 1R3 Tel.: 416-212-4724 Fax: 416-325-6647 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I.21 Preamble
Ontario Drug Benefit Formulary
The percentage of the Drug Benefit Price (the "mark-up") that is prescribed for the purpose of paragraph 3 of subsection 6(1) of the Ontario Drug Benefit Act is: 8 percent when the total drug cost is less than $1,000.00; 6 percent when the total drug cost is greater than or equal to $1,000.00. Total drug cost equals the Drug Benefit Price of the drug product supplied multiplied by the total quantity of the drug product supplied. Formulary Listings
Part III-A
Benefits List
The list of benefits may be accessed through the electronic ODB Formulary (e- Formulary) on the ministry's website at Part III-B
Off-Formulary Interchangeable Drugs
Part III-B: Off-Formulary Interchangeability
Off-Formulary Interchangeability (OFI) is the application of interchangeable
designations to drug products where the original products are not listed as ODB benefits in the Formulary/CDI. OFI became effective April 1, 2007 when changes to Regulation 935 under the DIDFA came into force. Listed off-formulary interchangeable drug products are reviewed by the CED or by the ministry, and upon approval of the Executive Officer, are determined to be interchangeable with the brand non-benefit 04:00 ANTIHISTAMINICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.1 08:00 ANTI-INFECTIVE AGENTS 08:12:04 ANTIBIOTICS ANTIFUNGALS GENERIC NAME STRENGTH DOSAGE
BRAND NAME
TERBINAFINE HCL
Auro-Terbinafine Jamp-Terbinafine Novo-Terbinafine 08:12:12 ANTIBIOTICS ERYTHROMYCINS GENERIC NAME STRENGTH DOSAGE
BRAND NAME
AZITHROMYCIN 600mg
PMS-Azithromycin Apo-Clarithromycin Mylan-Clarithromycin PMS-Clarithromycin Ran-Clarithromycin Ratio-Clarithromycin Sandoz Clarithromycin 02266547 SDZ Teva-Clarithromycin Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.2 08:12:16 ANTIBIOTICS PENICILLINS GENERIC NAME STRENGTH DOSAGE
BRAND NAME
AMOXICILLIN
Novamoxin Chewable 02036347 NOP Novamoxin Chewable 02036355 NOP 2g & 250mg INJ PD- TAZOBACTAM
Tazobactam for Injection Tazobactam for Injection 3g & 375mg INJ PD- Tazobactam for Injection Tazobactam for Injection Tazobactam for Injection Piperacil in/Tazobactam 4g & 500mg INJ PD- Piperacil in/Tazobactam Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.3 08:12:24 ANTIBIOTICS TETRACYCLINES GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
DOXYCYCLINE
MINOCYCLINE HCL
Mylan-Minocycline Novo-Minocycline Ratio-Minocycline Sandoz Minocycline 02237313 SDZ Mylan-Minocycline Novo-Minocycline Ratio-Minocycline Sandoz Minocycline 02237314 SDZ TIGECYCLINE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.4 08:12:28 ANTIBIOTICS OTHER ANTIBIOTICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CEFAZOLIN
Cefazolin for Injection 02297205 ORC Cefazolin for Injection 02108127 NOP Cefazolin for Injection 02297213 ORC Cefazolin for Injection 02108135 NOP CEFOXITIN
Cefoxitin for Injection Cefoxitin for Injection Cefoxitin for Injection Cefoxitin for Injection CEFTRIAXONE
INJ PD-1 Rocephin DISODIUM
Ceftriaxone Sodium for Injection USP Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.5 08:18:00 ANTIVIRALS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ACYCLOVIR
ADEFOVIR
DIPIVOXIL

ENTECAVIR
Sandoz Famciclovir Sandoz Famciclovir LAMIVUDINE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.6 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Apo-Lamivudine HBV Apo-Valacyclovir Mylan-Valacyclovir Novo-Valacyclovir PMS-Valacyclovir ZIDOVUDINE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.7 08:20:00 PLASMODICIDES (ANTIMALARIALS) GENERIC NAME
STRENGTH DOSAGE FORM BRAND
ATOVAQUONE & 250mg &
PROGUANIL HCL 100mg
Mylan-Atovaquone 02402165 MYL MEFLOQUINE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.8 08:40:00 MISCELLANEOUS ANTI-INFECTIVES GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CEFEPIME
Cefepime for Injection 02319020 APX Cefepime for Injection 02319039 APX Apo-Levofloxacin Novo-Levofloxacin PMS-Levofloxacin Sandoz Levofloxacin LINEZOLID
Linezolid Injection 10:00 ANTI-NEOPLASTIC AGENTS GENERIC NAME
STRENGTH DOSAGE FORM BRAND
ERLOTINIB
Teva-Erlotinib 02377691 TEV Teva-Erlotinib 02377705 TEV Teva- Erlotinib 02377713 TEV Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.9 12:00 AUTONOMIC AGENTS 12:04:00 PARASYMPATHOMIMETIC (CHOLINERGIC) AGENTS GENERIC NAME STRENGTH DOSAGE FORM
BRAND NAME
DONEPEZIL HCL 5mg
DISINTEGRATING TAB Co Donepezil ODT 02397617 COB 3.6176 Sandoz Donepezil ODT DISINTEGRATING TAB Co Donepezil ODT 02397625 COB 3.6176 Sandoz Donepezil ODT PILOCARPINE
Salagen Tablets 02216345 PFI Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.10 12:08:00 PARASYMPATHOLYTIC (CHOLINERGIC BLOCKING) AGENTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
GLYCOPYRROLATE 0.2mg/mL
02043610 WYA N/A VIAL PK (PRESERVATIVE 02382857 OMG 7.9500 SCOPOLAMINE
INJ SOL-1ML Scopolamine Hydrobromide Inj. 02242810 OMG 4.5000 Hydrobromide Inj. INJ SOL-1ML Scopolamine Hydrobromide Inj. 02242811 OMG 5.0000 Hydrobromide Inj. TRIMEBUTINE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.11 12:20:00 SKELETAL MUSCLE RELAXANTS GENERIC NAME STRENGTH DOSAGE
BRAND NAME
BACLOFEN
Lioresal Intrathecal Lioresal Intrathecal Lioresal Intrathecal TIZANIDINE HCL 4mg
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.12 20:00 BLOOD FORMATION AND COAGULATION 20:12:00 COAGULANTS AND ANTI-COAGULANTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
100ML VIAL Integrilin Eptifibatide Injection 02405083 TEV Eptifibatide Injection 02367858 TEV FONDAPARINUX 7.5mg/0.6ml 0.6ML INJ SOL-
PREF SYR (PRESERVATIVE Sodium Injection WARFARIN
20:12:16 COAGULANTS AND ANTI-COAGULANTS HEMOSTATICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
TRANEXAMIC
Gd-Tranexamic Acid Tranexamic Acid Tablets 02401231 STE Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.13 24:00 CARDIOVASCULAR DRUGS 24:04:00 CARDIAC DRUGS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
SOTALOL HCL
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.14 24:06:00 ANTILIPEMIC DRUGS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
FENOFIBRATE
Novo-Fenofibrate Novo-Fenofibrate-S Sandoz Fenofibrate S 02288044 SDZ GEMFIBROZIL
Novo-Gemfibrozil Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.15 24:08:00 HYPOTENSIVE DRUGS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CLONIDINE HCL
VERAPAMIL HCL
Mylan-Verapamil SR LISINOPRIL &
Novo-Lisinopril/HCTZ Sandoz Lisinopril RAMIPRIL
ENALAPRIL MALEATE &
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.16 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
VALSARTAN
Sandoz Valsartan Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.17 24:12:00 VASODILATING DRUGS GENERIC NAME
STRENGTH DOSAGE FORM BRAND NAME DIN/PIN
BETAHISTINE
02240601 SPH N/A DIHYDROCHLORIDE

Auro-Betahistine 02449145 AUR 0.2070 Novo-Betahistine 02280183 NOP 0.2070 02243878 SPH N/A Auro-Betahistine 02449153 AUR 0.3557 Co Betahistine 02374757 COB 0.3557 Novo-Betahistine 02280191 NOP 0.3557 PMS-Betahistine 02330210 PMS 0.3557 02247998 SPH N/A Auro-Betahistine 02449161 AUR 0.4983 Co Betahistine 02374765 COB 0.4983 Novo-Betahistine 02280205 NOP 0.4983 PMS-Betahistine 02330237 PMS 0.4983 BOSENTAN
MONOHYDRATE

02386194 COB 32.0893 02383497 MYL 32.0893 PMS-Bosentan 02383012 PMS 32.0893 Teva-Bosentan 02398400 TEV 02386208 COB 32.0893 02383500 MYL 32.0893 PMS-Bosentan 02383020 PMS 32.0893 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.18 GENERIC NAME
STRENGTH DOSAGE FORM BRAND NAME DIN/PIN
Teva-Bosentan 02398419 TEV 32.0893 00067385 BOE N/A 00067393 BOE N/A 00895660 BOE N/A MONONITRATE

02301288 PMS 0.4950 TRANSDERMAL Nitro-Dur 01911910 MEK N/A 02407442 MYL 0.4463 TRANSDERMAL Nitro-Dur 02011271 MEK N/A 02407477 MYL 0.8743 TADALAFIL
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.19 28:00 CENTRAL NERVOUS SYSTEM DRUGS 28:08:04 ANALGESICS NONSTEROIDAL ANTI-INFLAMMATORY AGENTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
DICLOFENAC
POTASSIUM

Apo-Diclo Rapide PMS-Diclofenac K Sandoz Diclofenac Teva-Diclofenac-K DICLOFENAC
TOP SOL Pennsaid ETODOLAC
KETOROLAC
TROMETHAMINE

NABUMETONE
Mylan-Nabumetone Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.20 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
NAPROXEN
ENT TAB Naprosyn E Teva-Naproxen EC ENT TAB Naprosyn E Mylan-Naproxen EC Teva-Naproxen EC ENT TAB Naprosyn E Mylan-Naproxen EC Teva-Naproxen EC NAPROXEN
OXAPROZIN
28:08:08 ANALGESICS OPIATE AGONISTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ACETYLSALICYLIC ACID
00226327 NOV N/A & BUTALBITAL &
CAFFEINE
00608238 RPH 1.3863 ACETYLSALICYLIC ACID
00176192 NOV N/A & BUTALBITAL &
CAFFEINE & CODEINE
PHOSPHATE
Ratio-Tecnal C1/4 00608203 RPH 1.4865 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.21 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
00176206 NOV N/A Ratio-Tecnal C1/2 00608181 RPH 1.8203 FENTANYL
02280345 JNO N/A TRANSDERMAL
Co Fentanyl Matrix Patch 02386844 COB 3.1980 Mylan-Fentanyl Matrix 02396696 MYL 3.1980 PMS-Fentanyl MTX 02341379 PMS 3.1980 Ran-Fentanyl Matrix 02330105 RAN 3.1980 02311925 TEV 3.1980 Sandoz Fentanyl Patch 02327112 SDZ 3.1980 OXYCODONE HCL 5mg
02231934 PFP N/A 02319977 PMS 0.1776 00789739 SDZ 0.1776 02240131 PFP N/A 02319985 PMS 0.2760 00443948 SDZ 0.2760 02240132 PFP N/A 02319993 PMS 0.4358 02262983 SDZ 0.4358 TRAMADOL HCL
02426153 APX 0.6386 Taro-Tramadol ER 02450429 TAR 1.0374 Taro-Tramadol ER 02450437 TAR 1.8915 Taro-Tramadol ER 02450445 TAR 2.7485 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.22 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
TRAMADOL HCL
ACETAMINOPHEN

Apo-Tramadol/Acet 02336790 APX 0.6264 02439050 AUR 0.6264 Tramadol/Acetaminophen Co Tramadol/Acet 02383209 COB 0.6264 Jamp-Acet-Tramadol Mar-Tramadol/Acet 02388324 MAR 0.6264 Mint-Tramadol/Acet Mylan-Tramadol/Acet 02425599 MYL 0.6264 PMS-Tramadol-Acet 02401657 PMS 0.6264 Ran-Tramadol/Acet 02388197 RAN 0.6264 02347180 TEV 0.6264 02388294 ODN 0.6264 28:10:00 OPIATE ANTAGONISTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
NALTREXONE HCL
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.23 28:12:00 ANTICONVULSANTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
GABAPENTIN
Gabapentin Tablets USP Gabapentin Tablets USP Jamp-Gabapentin Tablets Mylan-Gabapentin Ratio-Gabapentin Gabapentin Tablets USP Gabapentin Tablets USP Mylan-Gabapentin Ratio-Gabapentin Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.24 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
OXCARBAZEPINE 150mg
Apo-Oxcarbazepine Jamp-Oxcarbazepine Apo-Oxcarbazepine Jamp-Oxcarbazepine Apo-Oxcarbazepine Jamp-Oxcarbazepine Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.25 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
PREGABALIN
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.26 28:16:04 PSYCHOTHERAPEUTIC AGENTS ANTIDEPRESSANTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
FLUOXETINE HCL 10mg
Fluoxetine Capsules BP Mylan-Fluoxetine Ratio-Fluoxetine Sandoz Fluoxetine PAROXETINE HCL 10mg
Mylan-Paroxetine Ratio-Paroxetine Sandoz Paroxetine Tablets 02431777 SDZ Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.27 28:16:08 PSYCHOTHERAPEUTIC AGENTS TRANQUILIZERS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ALPRAZOLAM
Mylan-Alprazolam Mylan-Alprazolam CLOZAPINE
OLANZAPINE
Jamp Olanzapine FC Apo-Olanzapine ODT Co Olanzapine ODT Jamp-Olanzapine ODT Mar-Olanzapine ODT Mint-Olanzapine ODT Mylan-Olanzapine ODT 02382733 MYL Novo-Olanzapine OD PMS-Olanzapine ODT Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.28 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Ran-Olanzapine ODT Sandoz Olanzapine QUETIAPINE
Quetiapine Tablets 28:16:12 PSYCHOTHERAPEUTIC AGENTS OTHER PSYCHOTROPICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CARBONATE

TRYPTOPHAN
Ratio-Tryptophan Ratio-Tryptophan Ratio-Tryptophan Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.29 28:20:00 C.N.S. STIMULANTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
METHYLPHENIDATE 20mg
MODAFINIL
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.30 28:24:00 SEDATIVES AND HYPNOTICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
LORAZEPAM
BUSPIRONE
HYDROCHLORIDE

MIDAZOLAM HCL
ZOLPIDEM
TARTRATE

Apo-Zolpidem ODT Apo-Zolpidem ODT ZOPICLONE
Jamp-Zopiclone Tablets 02406969 JPC Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.31 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Sandoz Zopiclone Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.32 28:92:00 MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ALMOTRIPTAN
Mylan-Almotriptan Mylan-Almotriptan Sandoz Almotriptan 02405334 SDZ Teva-Almotriptan ATOMOXETINE HCL
Novo-Atomoxetine Mylan-Atomoxetine 02378930 MYL Novo-Atomoxetine Mylan-Atomoxetine 02378949 MYL Novo-Atomoxetine Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.33 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Mylan-Atomoxetine 02378957 MYL Novo-Atomoxetine Mylan-Atomoxetine 02378965 MYL Novo-Atomoxetine Mylan-Atomoxetine 02378973 MYL Teva-Atomoxetine Mylan-Atomoxetine 02378981 MYL Teva-Atomoxetine ELETRIPTAN
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.34 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Apo-Frovatriptan Teva-Frovatriptan MEMANTINE HCL
Sandoz Memantine 02344807 SDZ Sandoz Memantine 02375532 SDZ NARATRIPTAN
HYDROCHLORIDE

Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.35 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Novo-Naratriptan Novo-Naratriptan Sandoz Naratriptan 02322323 SDZ PRAMIPEXOLE
MONOHYDRATE
Mylan-Pramipexole 02376369 MYL Teva-Pramipexole RIZATRIPTAN
Apo-Rizatriptan RPD Co Rizatriptan ODT Mint-Rizatriptan ODT Mylan-Rizatriptan ODT Nat-Rizatriptan ODT PMS-Rizatriptan RDT Sandoz Rizatriptan ODT 02351870 SDZ Teva-Rizatriptan ODT 02396661 TEV Jamp-Rizatriptan Jamp-Rizatriptan IR Apo-Rizatriptan RPD Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.36 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Co Rizatriptan ODT 02374749 COB Mint-Rizatriptan ODT 02439581 MIN Mylan-Rizatriptan ODT Nat-Rizatriptan ODT PMS-Rizatriptan RDT 02393379 PMS Sandoz Rizatriptan ODT 02351889 SDZ Teva-Rizatriptan ODT 02396688 TEV Van-Rizatriptan ODT Jamp-Rizatriptan Jamp-Rizatriptan IR SUMATRIPTAN SUCCINATE 25mg
Mylan-Sumatriptan 02268906 MYL Novo-Sumatriptan DF 02286815 NOP Mylan-Sumatriptan 02268914 MYL Ratio-Sumatriptan Sandoz Sumatriptan Novo-Sumatriptan DF 02286823 NOP Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.37 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Mylan-Sumatriptan 02268922 MYL Ratio-Sumatriptan Sandoz Sumatriptan Novo-Sumatriptan DF 02286831 NOP Taro-Sumatriptan Apo-Zolmitriptan Jamp-Zolmitriptan Mint-Zolmitriptan Mar-Zolmitriptan Mylan-Zolmitriptan Nat-Zolmitriptan PMS-Zolmitriptan Sandoz Zolmitriptan Teva-Zolmitriptan Apo-Zolmitriptan Rapid Jamp-Zolmitriptan ODT Mint-Zolmitriptan ODT Mylan-Zolmitriptan ODT PMS-Zolmitriptan ODT Sandoz Zolmitriptan ODT Septa-Zolmitriptan-ODT Teva-Zolmitriptan OD Van-Zolmitriptan ODT Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.38 40:00 ELECTROLYTIC, CALORIC AND WATER BALANCE 40:28:00 DIURETICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
HYDROCHLOROTHIAZIDE 12.5mg
02274086 PMS N/A Hydrochlorothiazide 02327856 APX 0.0322 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.39 52:00 EYE, EAR, NOSE AND THROAT PREPARATIONS 52:04:04 ANTI-INFECTIVES ANTIBIOTICS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
OPH SOL-3ML PK Vigamox Act Moxifloxacin 02404656 ACV Apo-Moxifloxacin 02406373 APX PMS-Moxifloxacin 02432218 PMS 52:04:12 ANTI-INFECTIVES OTHER ANTI-INFECTIVES GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CIPROFLOXACIN 0.3%
Sandoz Ciprofloxacin Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.40 52:08:00 ANTI-INFLAMMATORY AGENTS GENERIC NAME
STRENGTH
BRAND NAME
FLUTICASONE
02213672 GSK N/A PROPIONATE
Apo-Fluticasone 02294745 APX 02296071 RPH 21.9700 MOMETASONE
02238465 MEK N/A TRIAMCINOLONE 55mcg/Metered NAS SP-120
ACETONIDE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.41 52:36:00 OTHER EYE, EAR, NOSE AND THROAT AGENTS GENERIC NAME
STRENGTH
BRAND NAME
IPRATROPIUM
KETOTIFEN
OPH SOL- Zaditor Ophthalmic Solution OLOPATADINE
OPH SOL- Patanol Mint-Olopatadine Sandoz Olopatadine 02358913 SDZ OPH SOL- Pataday Sandoz Olopatadine 02420171 SDZ Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.42 56:00 GASTROINTESTINAL DRUGS 56:22:00 ANTIEMETICS AND ANTINAUSEANTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
NABILONE
ONDANSETRON
HCL DIHYDRATE

Ondansetron Injection 02265524 NOP Ondansetron Injection 09857323 NOP Ondansetron Injection 02265532 NOP Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.43 56:40:00 MISCELLANEOUS G.I. DRUGS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ESOMEPRAZOLE 20mg
Act Esomeprazole Apo-Esomeprazole Mylan-Esomeprazole Ran-Esomeprazole Act Esomeprazole Apo-Esomeprazole DR TAB 02339102 APX Mylan-Esomeprazole DR PMS-Esomeprazole DR Ran-Esomeprazole DR TAB 02423987 RAN OMEPRAZOLE
Mylan-Omeprazole DR CAP 09857350 MYL Teva-Omeprazole DR 02295407 TEV Mylan-Omeprazole Sandoz Omeprazole PANTOPRAZOLE 20mg
ENT TAB Pantoloc Apo-Pantoprazole Jamp-Pantoprazole Mar-Pantoprazole Novo-Pantoprazole PMS-Pantoprazole Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.44 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Ran-Pantoprazole Sandoz Pantoprazole 02301075 SDZ Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.45 68:00 HORMONES AND SUBSTITUTES 68:16:00 ESTROGENS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ESTRADIOL
68:20:02 ANTI-DIABETIC AGENTS ORAL ANTI-DIABETIC AGENTS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
GLIMEPIRIDE
Novo-Glimepiride Ratio-Glimepiride Sandoz Glimepiride Novo-Glimepiride Ratio-Glimepiride Sandoz Glimepiride Novo-Glimepiride Ratio-Glimepiride Sandoz Glimepiride Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.46 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
METFORMIN HCL
Apo-Metformin ER Sandoz Metformin FC 02246821 SDZ Accel Pioglitazone Apo-Pioglitazone Auro-Pioglitazone Jamp-Pioglitazone Mint-Pioglitazone Mylan-Pioglitazone Novo-Pioglitazone Hydrochloride Tablet PMS-Pioglitazone Ran-Pioglitazone Sandoz Pioglitazone Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.47 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Van-Pioglitazone Accel Pioglitazone Apo-Pioglitazone Auro-Pioglitazone Jamp-Pioglitazone Mint-Pioglitazone Mylan-Pioglitazone Novo-Pioglitazone Hydrochloride Tablet PMS-Pioglitazone Ran-Pioglitazone Sandoz Pioglitazone Van-Pioglitazone Accel Pioglitazone Apo-Pioglitazone Auro-Pioglitazone Jamp-Pioglitazone Mint-Pioglitazone Mylan-Pioglitazone Novo-Pioglitazone Hydrochloride Tablet PMS-Pioglitazone Ran-Pioglitazone Sandoz Pioglitazone Van-Pioglitazone REPAGLINIDE
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.48 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Auro-Repaglinide Sandoz Repaglinide Auro-Repaglinide Sandoz Repaglinide Auro-Repaglinide Sandoz Repaglinide RASAGILINE
MESYLATE

68:32:00 PROGESTOGENS AND ORAL CONTRACEPTIVES GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CYPROTERONE
ACETATE & ETHINYL
ESTRADIOL
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.49 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Novo-Cyproterone/ Ethinyl Estradiol Ran-Cyproterone/ Ethinyl Estradiol PROGESTERONE 100mg
Teva-Progesterone 84:00 SKIN AND MUCOUS MEMBRANE PREPARATIONS 84:36:00 MISCELLANEOUS SKIN AND MUCOUS MEMBRANE PREPARATIONS GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
IMIQUIMOD
88:00 VITAMINS 88:16:00 VITAMIN D GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
CALCITRIOL
Calcitriol Injection Calcitriol Injection Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.50 92:00 UNCLASSIFIED THERAPEUTIC AGENTS
GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
ALENDRONATE
Alendronate Sodium 02381478 ACH Teva-Alendronate CABERGOLINE
CINACALCET
Mylan-Cinacalcet CLOPIDOGREL
BISULFATE

Teva-Clopidogrel FINASTERIDE
Auro-Finasteride Mylan-Finasteride Sandoz Finasteride MONTELUKAST
GRAN PK Singulair Sandoz Montelukast 02358611 SDZ Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.51 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Auro-Montelukast Mint-Montelukast Mylan-Montelukast Sandoz Montelukast 02330393 SDZ Teva-Montelukast Auro-Montelukast Jamp-Montelukast Mint-Montelukast Montelukast Sodium 02379236 ACH Mylan-Montelukast PMS-Montelukast FC 02373947 PMS Sandoz Montelukast 02328593 SDZ Teva-Montelukast PAMIDRONATE
DISODIUM
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.52 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
RILUZOLE
SILDENAFIL
Apo-Sildenafil R PMS-Sildenafil R Ratio-Sildenafil R Sandoz Sildenafil Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.53 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Sandoz Sildenafil Sandoz Sildenafil TETRABENAZINE 25mg
Apo-Tetrabenazine PMS-Tetrabenazine Tetrabenazine Tablets ZOLEDRONIC ACID
Zometa Concentrate 02248296 NOV PMS-Zoledronic Acid Taro-Zoledronic Acid Zoledronic Acid-Z Zoledronic Acid for Injection Zoledronic Acid for Injection Zoledronic Acid for Injection Concentrate Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.54 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Zoledronic Acid for Injection Concentrate Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 I I-B.55 Consolidated Alphabetical
Index of Drug Products
Listed in Part III-B
Part IV: Consolidated
Alphabetical Index of Drug
Products Listed in Part III-
PRODUCT NAME
STRENGTH
DOSAGE FORM
ACCEL PIOGLITAZONE ACCEL PIOGLITAZONE ACCEL PIOGLITAZONE ACETYLSALICYLIC ACID &
BUTALBITAL & CAFFEINE
ACETYLSALICYLIC ACID &
BUTALBITAL & CAFFEINE &
CODEINE PHOSPHATE
ACT ESOMEPRAZOLE
ACT ESOMEPRAZOLE ACT MOXIFLOXACIN (PRESERVATIVE-FREE) ACT OLOPATADINE 0.2% ACYCLOVIR
ADEFOVIR DIPIVOXIL
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.1 PRODUCT NAME
STRENGTH
DOSAGE FORM
ALENDRONATE
ALENDRONATE SODIUM ALMOTRIPTAN
ALPRAZOLAM
AMOXICILLIN
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.2 PRODUCT NAME
STRENGTH
DOSAGE FORM
APO-CLARITHROMYCIN APO-DICLO RAPIDE APO-DIPYRIDAMOLE APO-DIPYRIDAMOLE APO-DIPYRIDAMOLE Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.3 PRODUCT NAME
STRENGTH
DOSAGE FORM
APO-ESOMEPRAZOLE APO-ESOMEPRAZOLE APO-FROVATRIPTAN APO-LAMIVUDINE HBV APO-LEVOFLOXACIN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.4 PRODUCT NAME
STRENGTH
DOSAGE FORM
APO-METFORMIN ER APO-METHYLPHENIDATE APO-MOXIFLOXACIN (Preservative-Free) APO-OLANZAPINE ODT Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.5 PRODUCT NAME
STRENGTH
DOSAGE FORM
APO-OXCARBAZEPINE APO-OXCARBAZEPINE APO-OXCARBAZEPINE APO-PANTOPRAZOLE APO-PIOGLITAZONE APO-PIOGLITAZONE APO-PIOGLITAZONE APO-RIZATRIPTAN RPD DISINTEGRATING 02393492 APO-RIZATRIPTAN RPD DISINTEGRATING 02393484 APO-SILDENAFIL R Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.6 PRODUCT NAME
STRENGTH
DOSAGE FORM
APO-TADALAFIL PAH APO-TETRABENAZINE APO-TRAMADOL/ACET NAS SP-120 DOSE PK APO-TRIAMCINOLONE AQ 55MCG/METERED DOSE APO-VALACYCLOVIR APO-ZOLMITRIPTAN APO-ZOLMITRIPTAN RAPID APO-ZOLPIDEM ODT APO-ZOLPIDEM ODT Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.7 PRODUCT NAME
STRENGTH
DOSAGE FORM
DISINTEGRATING 02269457 DISINTEGRATING 02269465 TAB INJ SOL-PREF (PRESERVATIVE 02258056 ATOMOXETINE HCL
ATOVAQUONE & PROGUANIL
AURO-BETAHISTINE AURO-BETAHISTINE AURO-BETAHISTINE AURO-FINASTERIDE AURO-MONTELUKAST AURO-MONTELUKAST AURO-PIOGLITAZONE AURO-PIOGLITAZONE AURO-PIOGLITAZONE Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.8 PRODUCT NAME
STRENGTH
DOSAGE FORM
AURO-REPAGLINIDE AURO-REPAGLINIDE AURO-REPAGLINIDE AURO-TERBINAFINE BACLOFEN
BETAHISTINE
BOSENTAN MONOHYDRATE
BUSPIRONE
BUSPIRONE HYDROCHLORIDE
CABERGOLINE
CALCITRIOL
INJ SOL AMP-1ML PK INJ SOL AMP-1ML PK CALCITRIOL INJECTION USP INJ SOL AMP-1ML PK Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.9 PRODUCT NAME
STRENGTH
DOSAGE FORM
CALCITRIOL INJECTION USP INJ SOL AMP-1ML PK CEFAZOLIN FOR INJECTION CEFAZOLIN FOR INJECTION CEFAZOLIN FOR INJECTION CEFAZOLIN FOR INJECTION CEFAZOLIN SODIUM
CEFEPIME
CEFEPIME FOR INJECTION CEFEPIME FOR INJECTION CEFOXITIN FOR INJECTION CEFOXITIN FOR INJECTION CEFOXITIN FOR INJECTION CEFOXITIN FOR INJECTION CEFOXITIN SODIUM
CEFTRIAXONE DISODIUM
CEFTRIAXONE FOR INJECTION INJ PD-1 VIAL PK 02292904 CEFTRIAXONE SODIUM FOR INJ PD-1 VIAL PK 02325632 CETIRIZINE HYDROCHLORIDE
CINACALCET
CLONIDINE HCL
CLOPIDOGREL BISULFATE
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.10 PRODUCT NAME
STRENGTH
DOSAGE FORM
CLOZAPINE
CO FENTANYL MATRIX PATCH 12MCG/HR CO OLANZAPINE ODT CO OLOPATADINE 0.1% Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.11 PRODUCT NAME
STRENGTH
DOSAGE FORM
CO RIZATRIPTAN ODT DISINTEGRATING 02374749 CO RIZATRIPTAN ODT DISINTEGRATING 02374730 CO TRAMADOL/ACET CYPROTERONE ACETATE &
ETHINYL ESTRADIOL
DEFEROXAMINE MESYLATE
DICLOFENAC POTASSIUM
DICLOFENAC SODIUM
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.12 PRODUCT NAME
STRENGTH
DOSAGE FORM
DONEPEZIL HCL
DOXYCYCLINE HYCLATE
ELETRIPTAN
ENALAPRIL MALEATE &
ENTECAVIR
EPTIFIBATIDE INJECTION EPTIFIBATIDE INJECTION ESTRADIOL
ETODOLAC
EXTRA STRENGTH ALLERGY FENOFIBRATE
FENTANYL TRANSDERMAL
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.13 PRODUCT NAME
STRENGTH
DOSAGE FORM
FINASTERIDE
FLUOXETINE HCL
FLUOXETINE CAPSULES BP FLUTICASONE PROPIONATE
FONDAPARINUX SODIUM
FONDAPARINUX SODIUM (PRESERVATIVE 02406896 GABAPENTIN
GABAPENTIN TABLETS USP GABAPENTIN TABLETS USP GABAPENTIN TABLETS USP GABAPENTIN TABLETS USP Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.14 PRODUCT NAME
STRENGTH
DOSAGE FORM
GD-TRANEXAMIC ACID GEMFIBROZIL
GLIMEPIRIDE
GLYCOPYRROLATE INJECTION 0.2MG/ML INJ SOL-2ML VIAL IMIQUIMOD
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.15 PRODUCT NAME
STRENGTH
DOSAGE FORM
IPRATROPIUM BROMIDE
JAMP-ACET-TRAMADOL JAMP-GABAPENTIN TABLETS JAMP-GABAPENTIN TABLETS JAMP-MONTELUKAST JAMP OLANZAPINE FC JAMP-OLANZAPINE ODT JAMP-OXCARBAZEPINE JAMP-OXCARBAZEPINE JAMP-OXCARBAZEPINE JAMP-PANTOPRAZOLE JAMP-PIOGLITAZONE JAMP-PIOGLITAZONE JAMP-PIOGLITAZONE JAMP-RIZATRIPTAN JAMP-RIZATRIPTAN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.16 PRODUCT NAME
STRENGTH
DOSAGE FORM
JAMP-RIZATRIPTAN IR JAMP-RIZATRIPTAN IR JAMP-TERBINAFINE JAMP-ZOLMITRIPTAN JAMP-ZOLMITRIPTAN ODT DISINTEGRATING 02428237 JAMP-ZOPICLONE TABLETS JAMP-ZOPICLONE TABLETS KETOROLAC TROMETHAMINE
KETOTIFEN
KETOTIFEN OPHTHALMIC LAMIVUDINE
LINEZOLID
LINEZOLID INJECTION LIORESAL INTRATHECAL INJ SOL-1ML PK (PRESERVATIVE- LIORESAL INTRATHECAL INJ SOL-20ML PK (PRESERVATIVE- LIORESAL INTRATHECAL INJ SOL-5ML PK (PRESERVATIVE- Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.17 PRODUCT NAME
STRENGTH
DOSAGE FORM
LITHIUM CARBONATE
LISINOPRIL &
LORATADINE
MAR-OLANZAPINE ODT RAPID DISSOLVE TAB MAR-PANTOPRAZOLE MAR-TRAMADOL/ACET MAR-ZOLMITRIPTAN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.18 PRODUCT NAME
STRENGTH
DOSAGE FORM
DISINTEGRATING 02240519 DISINTEGRATING TAB MEFLOQUINE HCL
MEMANTINE HCL
METFORMIN HCL
METHYLPHENIDATE HCL
MIDAZOLAM HCL
MIDAZOLAM INJECTION INJ SOL-2ML VIAL MINOCYCLINE HCL
MINT-MONTELUKAST MINT-MONTELUKAST Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.19 PRODUCT NAME
STRENGTH
DOSAGE FORM
MINT-OLANZAPINE ODT RAPID DISSOLVE TAB MINT-OLOPATADINE OPH SOL-5ML PK 02422727 MINT-PIOGLITAZONE MINT-PIOGLITAZONE MINT-PIOGLITAZONE MINT-RIZATRIPTAN ODT ORALLY DISINTEGRATING TAB MINT-RIZATRIPTAN ODT ORALLY DISINTEGRATING TAB MINT-TRAMADOL/ACET MINT-ZOLMITRIPTAN MINT-ZOLMITRIPTAN ODT ORALLY DISINTEGRATING TAB MODAFINIL
MONTELUKAST SODIUM
MONTELUKAST SODIUM MOXIFLOXACIN HCL
MYLAN-ALMOTRIPTAN MYLAN-ALMOTRIPTAN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.20 PRODUCT NAME
STRENGTH
DOSAGE FORM
MYLAN-ALPRAZOLAM MYLAN-ALPRAZOLAM MYLAN-ATOMOXETINE MYLAN-ATOMOXETINE MYLAN-ATOMOXETINE MYLAN-ATOMOXETINE MYLAN-ATOMOXETINE MYLAN-ATOMOXETINE ATOVAQUONE/PROGUANIL MYLAN-CINACALCET MYLAN-CLARITHROMYCIN MYLAN-ESOMEPRAZOLE MYLAN-ESOMEPRAZOLE MYLAN-FENTANYL MATRIX MYLAN-FINASTERIDE HG MYLAN-FLUOXETINE MYLAN-GABAPENTIN MYLAN-GABAPENTIN MYLAN-MINOCYCLINE MYLAN-MINOCYCLINE MYLAN-MONTELUKAST MYLAN-MONTELUKAST MYLAN-NABUMETONE MYLAN-NAPROXEN EC Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.21 PRODUCT NAME
STRENGTH
DOSAGE FORM
MYLAN-NAPROXEN EC MYLAN-NITRO PATCH MYLAN-NITRO PATCH MYLAN-OLANZAPINE ODT MYLAN-OMEPRAZOLE MYLAN-OMEPRAZOLE DR CAP 10MG MYLAN-PAROXETINE MYLAN-PIOGLITAZONE MYLAN-PIOGLITAZONE MYLAN-PIOGLITAZONE MYLAN-PRAMIPEXOLE MYLAN-RIZATRIPTAN ODT DISINTEGRATING 02379201 MYLAN-RIZATRIPTAN ODT DISINTEGRATING 02379198 MYLAN-SUMATRIPTAN MYLAN-SUMATRIPTAN MYLAN-SUMATRIPTAN MYLAN-TRAMADOL/ACET MYLAN-VALACYCLOVIR MYLAN-VERAPAMIL SR MYLAN-ZOLMITRIPTAN MYLAN-ZOLMITRIPTAN ODT DISINTEGRATING 02387158 Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.22 PRODUCT NAME
STRENGTH
DOSAGE FORM
NABILONE
NABUMETONE
NALTREXONE HCL
NAPROXEN
NAPROXEN SODIUM
NARATRIPTAN
NAS SP-120 DOSE PK 55MCG/METERED DOSE NAT-RIZATRIPTAN ODT DISINTEGRATING 02436604 NAT-RIZATRIPTAN ODT DISINTEGRATING 02436612 NAT-ZOLMITRIPTAN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.23 PRODUCT NAME
STRENGTH
DOSAGE FORM
NOVAMOXIN CHEWABLE NOVAMOXIN CHEWABLE NOVO-ATOMOXETINE NOVO-ATOMOXETINE NOVO-ATOMOXETINE NOVO-ATOMOXETINE NOVO-ATOMOXETINE NOVO-BETAHISTINE NOVO-BETAHISTINE NOVO-BETAHISTINE CYPROTERONE/ETHINYL ESTRADIOL NOVO-DOXYLIN TABLETS NOVO-ENALAPRIL/HCTZ NOVO-ENALAPRIL/HCTZ NOVO-FENOFIBRATE NOVO-FENOFIBRATE-S NOVO-GEMFIBROZIL NOVO-GLIMEPIRIDE NOVO-GLIMEPIRIDE NOVO-GLIMEPIRIDE NOVO-LEVOFLOXACIN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.24 PRODUCT NAME
STRENGTH
DOSAGE FORM
NOVO-LISINOPRIL/HCTZ (TYPE NOVO-MINOCYCLINE NOVO-MINOCYCLINE NOVO-NARATRIPTAN NOVO-NARATRIPTAN NOVO-OLANZAPINE OD NOVO-PANTOPRAZOLE NOVO-PIOGLITAZONE NOVO-PIOGLITAZONE NOVO-PIOGLITAZONE NOVO-SUMATRIPTAN DF NOVO-SUMATRIPTAN DF NOVO-SUMATRIPTAN DF NOVO-TERBINAFINE NOVO-VALACYCLOVIR OLANZAPINE
OLOPATADINE HCL
OMEPRAZOLE
ONDANSETRON HCL
DIHYDRATE
ONDANSETRON INJECTION ONDANSETRON INJECTION INJ SOL-2ML VIAL Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.25 PRODUCT NAME
STRENGTH
DOSAGE FORM
ONDANSETRON INJECTION INJ SOL-4ML VIAL OXAPROZIN
OXYCODONE HCL
PAMIDRONATE DISODIUM
PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM PANTOPRAZOLE SODIUM
PAROXETINE HCL
PILOCARPINE HCL
PILOCARINE HYDROCHLORIDE PIOGLITAZONE HCL
HYDROCHLORIDE TABLETS Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.26 PRODUCT NAME
STRENGTH
DOSAGE FORM
HYDROCHLORIDE TABLETS HYDROCHLORIDE TABLETS PIPERACILLIN SODIUM &
TAZOBACTAM SODIUM
PIPERACILLIN & TAZOBACTAM PIPERACILLIN & TAZOBACTAM PIPERACILLIN & TAZOBACTAM PIPERACILLIN & TAZOBACTAM PIPERACILLIN AND TAZOBACTAM FOR INJECTION 3G & 375MG PIPERACILLIN/TAZOBACTAM PIPERACILLIN AND TAZOBACTAM FOR INJECTION PIPERACILLIN/TAZOBACTAM PMS-AZITHROMYCIN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.27 PRODUCT NAME
STRENGTH
DOSAGE FORM
PMS-CLARITHROMYCIN PMS-DICLOFENAC K PMS-ESOMEPRAZOLE DR PMS-FENTANYL MTX PMS-HYDROCHLOROTHIAZIDE 12.5MG PMS-LEVOFLOXACIN PMS-METHYLPHENIDATE PMS-MONTELUKAST FC PMS-MOXIFLOXACIN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.28 PRODUCT NAME
STRENGTH
DOSAGE FORM
PMS-OLANZAPINE ODT PMS-PANTOPRAZOLE PMS-PIOGLITAZONE PMS-PIOGLITAZONE PMS-PIOGLITAZONE PMS-RIZATRIPTAN RDT DISINTEGRATING 02393379 PMS-RIZATRIPTAN RDT DISINTEGRATING 02393360 PMS-SILDENAFIL R Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.29 PRODUCT NAME
STRENGTH
DOSAGE FORM
PMS-TETRABENAZINE PMS-TRAMADOL-ACET PMS-VALACYCLOVIR PMS-ZOLEDRONIC ACID (PRESERVATIVE- 02403056 PMS-ZOLMITRIPTAN PMS-ZOLMITRIPTAN ODT DISINTEGRATING 02324768 PRAMIPEXOLE
MONOHYDRATE
PREGABALIN
QUETIAPINE
QUETIAPINE TABLETS RAMIPRIL
RAN-CLARITHROMYCIN RAN-CYPROTERONE/ ETHINYL 2MG & 0.035MG Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.30 PRODUCT NAME
STRENGTH
DOSAGE FORM
RAN-ESOMEPRAZOLE RAN-ESOMEPRAZOLE RAN-FENTANYL MATRIX RAN-OLANZAPINE ODT RAPID DISSOLVE TAB 02414120 RAN-PANTOPRAZOLE RAN-PIOGLITAZONE RAN-PIOGLITAZONE RAN-PIOGLITAZONE RAN-TRAMADOL/ACET RASAGILINE MESYLATE
RATIO-CLARITHROMYCIN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.31 PRODUCT NAME
STRENGTH
DOSAGE FORM
RATIO-FLUOXETINE RATIO-FLUTICASONE RATIO-GABAPENTIN RATIO-GABAPENTIN RATIO-GLIMEPIRIDE RATIO-GLIMEPIRIDE RATIO-GLIMEPIRIDE RATIO-MINOCYCLINE RATIO-MINOCYCLINE RATIO-PAROXETINE RATIO-SILDENAFIL R RATIO-SUMATRIPTAN RATIO-SUMATRIPTAN RATIO-TECNAL C1/2 RATIO-TECNAL C1/4 RATIO-TRYPTOPHAN RATIO-TRYPTOPHAN RATIO-TRYPTOPHAN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.32 PRODUCT NAME
STRENGTH
DOSAGE FORM
REPAGLINIDE
RILUZOLE
RIZATRIPTAN
INJ PD-1 VIAL PK 00851957 SANDOZ ALMOTRIPTAN SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ CIPROFLOXACIN SANDOZ CLARITHROMYCIN Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.33 PRODUCT NAME
STRENGTH
DOSAGE FORM
SANDOZ DICLOFENAC RAPIDE 50MG SANDOZ DONEPEZIL ODT DISINTEGRATING 02367688 SANDOZ DONEPEZIL ODT DISINTEGRATING 02367696 SANDOZ FAMCICLOVIR SANDOZ FAMCICLOVIR SANDOZ FENOFIBRATE S SANDOZ FENTANYL PATCH SANDOZ FINASTERIDE A SANDOZ FLUOXETINE SANDOZ GLIMEPIRIDE SANDOZ GLIMEPIRIDE SANDOZ GLIMEPIRIDE SANDOZ LEVOFLOXACIN SANDOZ LISINOPRIL HCT SANDOZ MEMANTINE SANDOZ MEMANTINE FCT SANDOZ METFORMIN FC SANDOZ MINOCYCLINE SANDOZ MINOCYCLINE SANDOZ MONTELUKAST SANDOZ MONTELUKAST SANDOZ MONTELUKAST SANDOZ MOXIFLOXACIN (PRESERVATIVE-FREE) SANDOZ NARATRIPTAN SANDOZ OLANZAPINE ODT SANDOZ OLOPATADINE Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.34 PRODUCT NAME
STRENGTH
DOSAGE FORM
SANDOZ OLOPATADINE 0.2% SANDOZ OMEPRAZOLE SANDOZ PANTOPRAZOLE SANDOZ PAROXETINE SANDOZ PIOGLITAZONE SANDOZ PIOGLITAZONE SANDOZ PIOGLITAZONE SANDOZ PRAMIPEXOLE SANDOZ REPAGLINIDE SANDOZ REPAGLINIDE SANDOZ REPAGLINIDE SANDOZ RIZATRIPTAN ODT DISINTEGRATING 02351889 SANDOZ RIZATRIPTAN ODT DISINTEGRATING 02351870 SANDOZ SILDENAFIL SANDOZ SILDENAFIL SANDOZ SILDENAFIL SANDOZ SUMATRIPTAN SANDOZ SUMATRIPTAN SANDOZ VALSARTAN SANDOZ ZOLMITRIPTAN SANDOZ ZOLMITRIPTAN ODT DISINTEGRATING 02362996 SANDOZ ZOPICLONE SCOPOLAMINE
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.35 PRODUCT NAME
STRENGTH
DOSAGE FORM
HYDROBROMIDE INJECTION HYDROBROMIDE INJECTION HYDROBROMIDE INJECTION HYDROBROMIDE INJECTION SEPTA-ZOLMITRIPTAN-ODT DISINTEGRATING 02428474 SILDENAFIL
SOTALOL HCL
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.36 PRODUCT NAME
STRENGTH
DOSAGE FORM
DISINTEGRATING 02391678 DISINTEGRATING 02370433 SUMATRIPTAN SUCCINATE
TADALAFIL
TARO-SUMATRIPTAN TARO-TRAMADOL ER TARO-TRAMADOL ER TARO-TRAMADOL ER TARO-ZOLEDRONIC ACID (PRESERVATIVE-FREE)
TAZOCIN
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.37 PRODUCT NAME
STRENGTH
DOSAGE FORM
TETRABENAZINE TABLETS TERBINAFINE HCL
TEVA-ALENDRONATE TEVA-ALMOTRIPTAN TEVA-CLARITHROMYCIN TEVA-CLOPIDOGREL TEVA-DICLOFENAC-K TEVA-FROVATRIPTAN TEVA-LISINOPRIL/HCTZ (TYPE Z) TEVA-MONTELUKAST TEVA-MONTELUKAST Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.38 PRODUCT NAME
STRENGTH
DOSAGE FORM
TEVA-NAPROXEN EC TEVA-NAPROXEN EC TEVA-NAPROXEN EC TEVA-PRAMIPEXOLE TEVA-PROGESTERONE TEVA-RIZATRIPTAN ODT TEVA-RIZATRIPTAN ODT TRAMADOL/ACETAMINOPHEN TEVA-ZOLMITRIPTAN TEVA-ZOLMITRIPTAN OD ORALLY DISINTEGRATING VAN-ZOLMITRIPTAN ODT ORALLY DISINTEGRATING TIGECYCLINE
PD INJ-5ML VIAL PK (PRESERVATIVE-FREE) TIZANIDINE HCL
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.39 PRODUCT NAME
STRENGTH
DOSAGE FORM
TRAMADOL HCL
TRAMADOL HCL &
TRANEXAMIC ACID
TRANEXAMIC ACID TABLETS TRIAMCINOLONE ACETONIDE
TRIMEBUTINE MALEATE
TRYPTOPHAN
PD INJ-5ML VIAL PK (PRESERVATIVE-FREE) VALSARTAN
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.40 PRODUCT NAME
STRENGTH
DOSAGE FORM
VAN-PIOGLITAZONE VAN-PIOGLITAZONE VAN-PIOGLITAZONE VAN-RIZATRIPTAN ODT Orally Disintegrating VERAPAMIL HCL
INJ SOL-2ML VIAL (PRESERVATIVE-FREE) VPI-BACLOFEN INTRATHECAL INJ SOL-1ML PK (NO VPI-BACLOFEN INTRATHECAL INJ SOL-20ML PK (NO VPI-BACLOFEN INTRATHECAL INJ SOL-5ML PK (NO WARFARIN
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.41 PRODUCT NAME
STRENGTH
DOSAGE FORM
ZIDOVUDINE
INJ SOL-2ML VIAL INJ SOL-4ML VIAL ZOLEDRONIC ACID
ZOLEDRONIC ACID-Z (PRESERVATIVE- 02401606 FREE) INJ SOL-5ML PK ZOLEDRONIC ACID FOR (PRESERVATIVE- 02421550 FREE) INJ SOL-5ML PK ZOLEDRONIC ACID FOR (PRESERVATIVE- 02407639 FREE) INJ SOL-5ML PK ZOLEDRONIC ACID FOR INJECTION CONCENTRATE (PRESERVATIVE- 02422425 FREE) INJ SOL-5ML PK ZOLEDRONIC ACID FOR INJECTION CONCENTRATE (PRESERVATIVE- 02413701 ZOMETA CONCENTRATE (PRESERVATIVE- 02248296 DISINTEGRATING 02243045 ZOPICLONE
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.42 PRODUCT NAME
STRENGTH
DOSAGE FORM
Ontario Drug Benefit Formulary/CDI Edition 42 Effective August 30, 2016 IV.43 Index of Pharmacologic-
Part V: Index of
Therapeutic Classification
CLASSIFICATION NAME
04:00

ANTI-INFECTIVE AGENTS
Other Antibiotics Antitubercular Agents Plasmodicides (Antimalarials) Urinary Anti-Infectives Miscellaneous Anti-Infectives ANTINEOPLASTIC AGENTS
AUTONOMIC AGENTS
Parasympathomimetic (Cholinergic) Agents Parasympatholytic (Cholinergic Blocking) Agents Sympathomimetic (Adrenergic) Agents Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 V.1 CLASSIFICATION NAME
12:16
Sympatholytic (Adrenergic Blocking) Agents Skeletal Muscle Relaxants BLOOD FORMATION AND COAGULATION
Antianemia Drugs Coagulants and Anti-Coagulants Hematopoietic Agents Hemorrheologic Agents CARDIOVASCULAR DRUGS
Antilipemic Drugs Hypotensive Drugs (For Diuretics See 40:28) Vasodilating Drugs CENTRAL NERVOUS SYSTEM DRUGS
Nonsteroidal Anti-Inflammatory Agents Opiate Partial Agonists Miscellaneous Analgesics and Antipyretics Opiate Antagonists Psychotherapeutic Agents Other Psychotropics C.N.S. Stimulants Sedatives and Hypnotics Miscellaneous Central Nervous System Drugs Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 V.2 CLASSIFICATION NAME
36:00

DIAGNOSTIC AGENTS
Adrenal Insufficiency ELECTROLYTIC, CALORIC AND WATER BALANCE
Replacement Agents Potassium-Removing Resins Uricosuric Drugs COUGH PREPARATIONS
EYE, EAR, NOSE AND THROAT PREPARATIONS
Other Anti-Infectives Anti-Inflammatory Agents Local Anesthetics Vasoconstrictors Other Eye, Ear, Nose and Throat Agents GASTROINTESTINAL DRUGS
Antacids and Adsorbents Antidiarrhea Agents Antiemetics and Antinauseants Miscellaneous G.I. Drugs GOLD COMPOUNDS
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 V.3 CLASSIFICATION NAME
64:00

HEAVY METAL ANTAGONISTS
HORMONES AND SUBSTITUTES
Anti-Diabetic Agents Oral Anti-Diabetic Agents Insulins (Rapid Acting) Insulins (Intermediate Acting) Insulins (Long Acting) Insulins (Pre-Mixed) Parathyroid Agents Pituitary Agents Progestogens and Oral Contraceptives SKIN AND MUCOUS MEMBRANE PREPARATIONS
Other Anti-Infectives Anti-Inflammatory Keratolytic Agents Miscellaneous Skin and Mucous Membrane Agents VITAMINS
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 V.4 CLASSIFICATION NAME
88:12
UNCLASSIFIED THERAPEUTIC AGENTS
Nutrition Products Diabetic Testing Agents Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 V.5 Facilitated Access Drug
Part VI-A
Facilitated Access to
HIV/AIDS Drug Products
Part VI-A: Facilitated
Access to HIV/AIDS Drug
Products
The following list of drug products prescribed to ODB-eligible persons with HIV/AIDS are reimbursed through the Facilitated Access process under the EAP. Under this mechanism, approved physicians are exempt from the usual paperwork associated with the provision of these products (i.e., exempt from obtaining special approval under the EAP), provided that the physician's College of Physicians and Surgeons of Ontario (CPSO) registration number also appears on the prescription for purposes of Eligibility Criteria
For the treatment of HIV/AIDS. Note: The prescriber must be approved for the Facilitated Access mechanism. Reimbursement for other indications may be considered through the EAP. Physician List
Pharmacies have been provided with a list of physicians approved to participate in the Facilitated Access mechanism (Physician List). Any changes to this list are communicated to pharmacies via the ONE-mail system. The ministry is responsible for determining physician eligibility to participate based on one of the following criteria: • Infectious disease specialist (as per CPSO's website) • Affiliation with an HIV centre/clinic • Prior EAP approval on file for any HIV drug Facilitated Access (FA) Drugs which are also Listed as LU
Benefits
Patient meets LU criteria: For Facilitated Access (FA) drugs which are listed as LU
benefits in Part III-A of the Formulary/CDI AND prescribed for an indication listed under the LU criteria, an LU prescription must be completed for reimbursement. More details Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-A.1 about the LU reimbursement process are available in Part I - Section C.9 and Part XII of the Formulary/CDI. Patient does not meet LU criteria: For FA drugs which are listed as LU benefits AND
prescribed for indications that do not meet the LU criteria, the claim can be processed through the FA mechanism if FA reimbursement criteria are met (see eligibility criteria above). Reimbursement for other indications may be considered through the EAP. Please note that the interchangeability of different brands of drugs available through this mechanism has not been evaluated by the ministry, unless they are designated as interchangeable in Part III-A or Part III-B of the Formulary/CDI. Where interchangeability has not been designated, it is necessary for the prescriber to specify the generic drug name, or the particular brand on the prescription, in order for the drug product(s) to be reimbursed by the ministry under this mechanism. Should a difficulty be encountered by pharmacies attempting to submit claims for these medications, the ODB Help Desk can be contacted. PHARMACISTS ARE REMINDED THAT THE PHYSICIAN LIST IS STRICTLY
CONFIDENTIAL AND SHOULD NOT BE SHARED WITH NON-PHARMACY STAFF.
THE MINISTRY EXPECTS PHARMACISTS TO TAKE RESPONSIBILITY FOR
ENSURING THIS INFORMATION IS TREATED ACCORDINGLY.
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-A.2 Facilitated Access
HIV/AIDS DRUGS
GENERIC NAME

STRENGTH DOSAGE
BRAND NAME
PMS-Azithromycin Novo-Doxylin Tablets Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-A.3 GENERIC NAME
STRENGTH
BRAND NAME
Note: Recommended for the treatment of oral/esophageal candidiasis in patients who have failed to respond with nystatin or imidazoles and when oral tablets of fluconazole cannot be tolerated. Mylan-Fluconazole Novo-Fluconazole Mylan-Fluconazole Novo-Fluconazole Note: Recommended for the treatment of oral/esophageal candidiasis unresponsive to less expensive alternatives. 10mg/ml Note: Only those products on the current list of approved NPs for patients who satisfy the functional impairment criteria. Note: Recommended for the treatment of cryptosporidium. Therapy should be discontinued if no benefits are observed after a three week trial. 250mg Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-A.4 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Micro-K Extencaps Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-A.5 Part VI-B
Facilitated Access to
Palliative Care Drug
Products
Part VI-B: Facilitated
Access to Pal iative Care
Drug Products
The following list of drug products used to treat ODB-eligible patients undergoing palliative (end-of-life) care are reimbursed through the Facilitated Access (FA) mechanism under the EAP. Under this mechanism, a select group of participating physicians are exempt from the usual paperwork associated with the provision of these products (i.e., exempt from obtaining approval under EAP on a case-by-case basis). Eligibility Criteria
Palliative Care (PC) medication claims reimbursed under the ODB program must be prescribed in accordance with the following patient eligibility criteria: "This patient has a terminal il ness and has chosen outpatient palliative treatment. Life expectancy is less than six months and the medications are being requested for symptom control for a maximum period of six months." To facilitate the reimbursement process at the pharmacy, the prescriber is asked to indicate either, "Palliative" or "P.C.F.A.", on the prescription to signify that the patient meets the above-noted eligibility criteria. The physician's CPSO registration number must be included on the prescription for purposes of verification. Physician List
Pharmacies have been provided with a list of physicians approved to participate in the Facilitated Access mechanism. Any changes to this list are communicated to pharmacies via their ONE-mail system. The OMA is responsible for determining physician eligibility to participate based on the following criteria: • Physicians who do more than 20 palliative care consults in a year • Physicians who do more than 50 palliative care visits in a year • Physicians who have been identified as a provider of palliative care by a regional director for CCO • Physicians who have been identified as a provider of palliative care by the executive of the section of palliative medicine at the OMA Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-B.1 • Physicians who have been identified as a provider of palliative care by an End of Life Network or Community Care Access Centre • Physicians who are members of a Palliative Alternate Funding Plan (AFP) • Physicians who work in collaboration with a Palliative Care Physician Physicians wishing to obtain further information can contact the Ontario Medical Association at (416) 599-2580 ext. 3265, or 1-800-268-7215 ext. 3265, or by e-mail at EAP Requests
This mechanism facilitates reimbursement for FA drugs for palliative care patients for an initial six-month course of therapy only. EAP requests are required for coverage of FA drugs beyond the initial six-month period, coverage of FA drugs prescribed for use in other clinical settings, and for coverage of drugs not listed in Part III-A or Part VI-B of the Formulary/CDI. Physicians are encouraged to submit renewal requests at least 4 to 6 weeks prior to the expiration date. Please note that the interchangeability of different brands of drugs available through this mechanism has not been evaluated by the ministry, unless they are designated as interchangeable in Part III-A, or Part III-B of the Formulary/CDI. Where interchangeability has not been designated, the prescription must specify the generic drug name or the particular brand name in order for it to be reimbursed by the ministry under the FA mechanism. Pharmacies should note that adjudication for these medications via the HNS wil be allowed with the proviso that the PIN specifically assigned to each drug product is used for bil ing. Attempts to adjudicate these medications with the DIN may result in rejection of the claim. Should a difficulty be encountered by pharmacies attempting to adjudicate claims for these medications, the ODB Help Desk should be contacted. PHARMACISTS ARE REMINDED THAT THE PHYSICIAN LIST IS STRICTLY
CONFIDENTIAL AND SHOULD NOT BE SHARED WITH NON-PHARMACY STAFF.
THE MINISTRY EXPECTS PHARMACISTS TO TAKE RESPONSIBILITY FOR
ENSURING THIS INFORMATION IS TREATED ACCORDINGLY.
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-B.2 Facilitated Access
Palliative Care Drugs
GENERIC NAME

STRENGTH DOSAGE
BRAND NAME
Sandoz Dimenhydrinate Sandoz Furosemide GLYCOPYRROLATE 0.2mg/ml Glycopyrrolate Injection GLYCOPYRRONIUM 0.2mg/ml Sandoz Glycopyrrolate Sandoz Lorazepam METOCLOPRAMIDE 10mg/2ml Sandoz Metoclopramide HCL MIDAZOLAM HCL Sandoz Midazolam Midazolam Injection SDZ 09857479 SDZ (Preservative-Free) Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-B.3 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
INJ SOL-10ML Pamidronate Disodium INJ SOL-10ML Pamidronate Disodium INJ SOL-10ML Pamidronate Disodium Sandoz Phenytoin Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-B.4 GENERIC NAME
STRENGTH DOSAGE
BRAND NAME
Hydrobromide Injection Hydrobromide Injection Hydrobromide Injection Hydrobromide Injection Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI-B.5 Trillium Drug Program
Part VII: Trillium Drug
The Tril ium Drug Program (TDP) was established on April 1, 1995, to help people who have high drug costs in relation to their incomes. This is an annual provincial government program. Each year starting August 1, drug costs must be paid up to the deductible level before eligibility for coverage begins. The TDP deductible is based on income and family size. The TDP runs from August 1 of one year to July 31 of the following year. The annual deductible is paid in four installments over the Tril ium benefit year. For example, a family with an annual deductible of $500, wil pay $125 for prescriptions purchased at the start of each quarter on August 1, November 1, February 1, and May 1. After the deductible is paid in each quarter, the family wil receive benefits for that quarter and may be asked to pay up to $2 per prescription for an eligible drug product. Any unpaid deductible in a quarter wil be added to the next quarter's deductible. By regulation costs covered by other entities (i.e., private insurers and employers, are not counted towards the TDP deductible). TDP deductibles must be paid by the household's out-of-pocket New applicants to Tril ium can choose the date within the program year on which they wish to be enrolled. The deductible is prorated based on the number of days left in the program year. The prorated deductible applies only for the first year of enrollment into People may qualify for the TDP if they: • Have a valid Ontario Health Card; and • Are not currently eligible to receive drug benefits under the ODB program; and • Do not have prescription drug costs fully covered by a private insurance plan; • Are paying a large part of their income for prescription drugs. The following are considered to be allowable prescription drug expenses that can be counted toward the Tril ium deductible: • Products listed as ODB benefits • Products on the Facilitated Access list in Part VI of the Formulary/CDI • Any drug product which has been approved by the EO on an individual basis, under section 16 of the ODBA or in accordance with the regulations under the ODBA [O.Reg. 201/96 sec. 3(4) iv, 3(5)] Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI .1 • Products on the Nutrition Products list and Diabetic Testing Agents list in Part IX of the Formulary/CDI • Extemporaneous products designated as pharmaceutical products under the regulations made under the ODBA • Products listed in Schedule 2 to O. Reg. 201/96 (insulin, adrenocorticotrophic hormones, nitrate vasodilators) For Trillium-eligible recipients, the ministry wil pay for the lesser of a 100 days' supply or a quantity sufficient to extend up to 30 days after the end of the Tril ium eligibility period (e.g., in July, a quantity sufficient to last until August 30 wil be covered). In addition, to ensure proper application of the Tril ium program for households that have not met their annual deductibles as of the third quarter, the days' supply for claims submitted during this period cannot exceed more than 30 days beyond the end of the third quarter (i.e., beyond May 30th of each benefit year). The HNS automatically calculates the days' supply in these circumstances and wil not reimburse any exceeded During the first and second quarters of the Tril ium benefit year (August 1 - January 31 of the following calendar year), a vacation supply claim of up to 100 days may be allowed (in addition to the regular 100 maximum days' supply) for Tril ium recipients travelling outside the province for between 101 and 200 days, before they leave In order to obtain a refil for a vacation supply of up to 100 days of ODB medication, provided that the prescription allows for the additional supply, recipients must provide the pharmacist with documentation confirming that they are leaving the province for more than 100 days including either: • A letter signed and dated by the recipient indicating travel dates • A copy of the recipient's travel documentation (e.g., travel insurance) Vacation supply claims must not be submitted through the HNS for Tril ium recipients during the third and fourth quarters of the Tril ium benefit year (February 1- July 31). Tril ium recipients must pay for their vacation supply for the third and fourth quarters of the benefit year. Pharmacists should advise Tril ium recipients that the ministry wil not reimburse vacation supplies paid for out-of-pocket during the third and fourth quarters of the benefit year except in rare circumstances. Each program year, Tril ium recipients enrolled in the previous program year wil automatically be renewed unless one of the fol owing conditions applies: • Household members have declined to give consent for the ministry to access household income information directly from Canada Revenue Agency (CRA), or consent is missing • Any household member is turning 16 years of age prior to August 1 • The household has not utilized the TDP for the previous two benefit years • Al members of the household are over 65 years of age Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI .2 A confirmation letter is mailed to households starting June of each year confirming TDP details for the program year. It is required that households inform the program of any changes or incorrect information. Tril ium applications can be obtained through the TDP at 1-800-575-5386, from local pharmacies, or can be downloaded from the ministry's website at: Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI .3 Part VIII
Exceptional Access
Program (EAP)
Part VII : Exceptional
Access Program (EAP)
The Exceptional Access Program (EAP) facilitates patient access to drugs not funded in the ODB Formulary where no listed alternative is available. In order to receive coverage through the EAP, the patient must be eligible to receive benefits under the ODB The EO, on behalf of the ministry, considers requests for coverage of drug products that are not listed in the ODB Formulary/CDI. Funding decisions for drug products considered by the EAP are based on recommendations and guidelines from the ministry's expert advisory committee, the CED and approved by the EO. Also, the program is supported by an extensive roster of expert medical advisers who may be involved in criteria development and/or the review of individual requests for the coverage of drug products. Al EAP requests wil be considered according to the policies described below to ensure a fair and consistent review of each request. Modernization initiatives to facilitate the EAP process are ongoing. Funding Decision
Typically the CED recommends consideration through the EAP for drug products where strong clinical evidence is not available to support efficacy and/or cost-effectiveness, when compared to other drugs already funded through the ODB program. EAP requests are only considered for a drug or indication(s) which has been approved for funding by the EO. For manufacturer-initiated reviews, each complete submission undergoes a rigorous review by the CED. The CED makes recommendations to the EO as to whether a drug product should be listed as a formulary benefit and/or designated as an interchangeable drug product (for generic drugs). The CED also makes recommendations as to whether or not drug products should be available through the EAP, and may develop clinical criteria. Please note, the EAP does not consider funding for non-drug products, which include diabetic test strips, medical or assistive devices, natural health products, or nutrition products. Please refer to Part IX of the ODB Formulary/CDI for nutrition products and diabetic test strips that are covered under the ODB program. The EO may also request that the CED perform a review and provide a recommendation for a drug or indication in the absence of a manufacturer submission for the purposes of consideration under EAP. Normally, this occurs for indications which have not been approved by Health Canada (i.e., off-label indications). For Health Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI I.1 Canada approved indications, the onus is on the manufacturer to submit information to the Ontario Public Drug Programs to request a product review. Following the CED's review, the EO makes the final decision regarding the reimbursement of the product. EAP Criteria
For a drug to be considered for funding, the EAP reimbursement criteria must always be met prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. This includes: • Funding for continued treatment that was previously supplied through a clinical trial, or paid for by other means (such as a third party payer) Note: First time applications for the funding of ongoing treatments must meet both initial and renewal criteria for the drug being requested (unless otherwise • Funding for a renewal beyond the previously approved initial period, unless otherwise specified Selected drug-specific criteria used in the consideration of EAP requests are available on the ministry's website, in order to improve transparency and assist physicians in making EAP drug requests. EAP Application Process
To apply through the EAP, the patient's physician must submit a request documenting complete and relevant medical information to the ministry, providing the clinical rationale for requesting the unlisted drug and reasons why covered benefits are not suitable. Al requests are reviewed according to the guidelines and criteria recommended by the CED and approved by the EO. This review includes a thorough assessment of the patient's specific case and clinical circumstances, as provided by the physician, as well as the scientific evidence available. If EAP approval is granted, the coverage period begins as of the effective date and extends only to the specified date. To assist physicians applying for exceptional access, please refer to the Request for an Unlisted Drug Product – Exceptional Access Program (EAP) Form on the ministry's website at:Additionally, the criteria for the funding of frequently requested drugs considered through the EAP are posted on the ministry's website at: Physicians are encouraged to utilize this resource to ensure that they provide the adequate clinical information necessary for the EAP to assess the requested drug(s). Only physicians practicing in Ontario may request coverage for an EAP drug. Requests should be sent to the attention of: Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI I.2 Exceptional Access Program (EAP) Unit Exceptional Access Program Branch 3rd Floor, 5700 Yonge Street Toronto ON M2M 4K5 Fax: (416) 327-7526 Toll free fax: 1-866-811-9908 (Faxed requests are preferred – DO NOT mail in a previously faxed request) Questions from physicians related to a specific request should be directed to the EAP unit by calling the general branch telephone number: 416-327-8109 or toll-free at 1-866- 811-9893. Pharmacists with questions regarding the status of an individual's coverage for a specific drug should call the ODB Help Desk. To minimize delays, please ensure that your request is written legibly. Each request should include a concise clinical description and therapeutic plan which must include, but is not limited to, the following: • Physician's name, CPSO number, street address, fax number, telephone number, physician's signature (mandatory) • Patient's name, date of birth, health card number (HCN) / ODB eligibility number • Trade or generic name, strength and dosage form of the requested drug product • Specific diagnosis for which the drug is requested or reason for use • If the patient has been taking the product, provide duration of therapy and objective evidence of its efficacy • Details of both drug and non-drug alternatives that have been tried to treat the condition including dosages (for drugs), length of therapy and response to • Where alternatives are not appropriate, outline the reasons • Concomitant drug therapy to treat other conditions, and relevant details of these co-morbid conditions • Other relevant information (e.g., culture and sensitivity reports, serum drug levels, laboratory results, bone mineral density reports, consultation reports) Extension of Coverage for EAP Drugs
If it is anticipated that a patient wil continue to require the product beyond the approval period, the physician is required to request an extension of coverage. It is recommended that the request for continued reimbursement and all supporting documentation (including details of current dose and clinical status) be submitted to the ministry at least four to six weeks prior to the expiration of the current approval. It should be noted that coverage wil not be continued automatically between expiration and re-issuance of approval. Physicians are encouraged to review the EAP criteria for renewal consideration of individual drugs to ensure that sufficient and appropriate information is provided to facilitate a timely response. The request should include a Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI I.3 summary of the patient's progress on the drug product, any changes in drug therapy, the rationale for the continued need for the product and a list of all concomitant drug Please refer to the EAP Reimbursement Criteria for further information at: EAP - Telephone Request Service
The Telephone Request Service (TRS) offers physicians another way to submit EAP
requests for a group of selected drugs. In most cases, these requests wil be assessed in real-time. Physicians or their delegates may call the TRS to submit their requests and obtain a faster funding decision for selected drugs and indications. Please visit the ministry's website for the evaluation questionnaires and reimbursement criteria at: Physicians and their delegates are encouraged to review the TRS Reimbursement Criteria before calling to ensure that the drug they are requesting is one that can be considered through this service and additional y, to ensure that they provide the necessary information for EAP staff to make a funding decision during the call. Requests for drug products or indications not currently available through TRS will be asked to be submitted via fax. Physicians and their delegates may call 1-866-811-9893 or 416-327-8109 and select the TRS option. The hours of operation of EAP's TRS are from 8:30 AM to 5:00 PM Monday to Friday. Service is not available on weekends, provincial statutory holidays, and Remembrance Day. Please refer to the ministry's web posting for additional information at: Compassionate Review Policy
Where there are rare clinical circumstances in immediately life-, limb-, or organ- threatening conditions, the EO considers requests for drugs or indications in the absence of a final funding decision. Requests must meet the criteria for the Compassionate Review Policy. Note: For cancer drugs, Cancer Care Ontario (CCO) administers the Case-by-Case Review Program (CBCRP) on behalf of the MOHLTC. The new CBCRP extends and adapts the Compassionate Review Policy to therapies that wil be administered in cancer centres and hospitals. The CBCRP considers funding requests for cancer drugs (both oral therapies and injectable drugs) for cancer patients who have a rare clinical circumstance that is immediately life threatening (i.e., death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI I.4 funded treatment. For further information on CBCRP including eligibility criteria and how to apply, please visit the CCO website at: While CCO administers the CBCRP, the EO of Ontario Public Drug Programs makes all final funding decisions. Funding for Drugs being used in Clinical Trials
This section is intended to clarify the circumstances in which EAP funding wil be considered for drugs being used within the context of a clinical trial. Generally, the ODB program does not fund drugs being studied under a clinical trial. These costs should be funded by the trial organizer and accounted for within the study budget. Supportive therapies may be considered for funding under all of the following circumstances: • Funding wil only be considered for ODB-eligible recipients (must be ODB eligible at the time of enrollment in the trial) • Funding wil only be considered for products currently funded by the ODB program according to their approved criteria • EAP request should indicate that the requested product is being used as supportive therapy as part of a clinical trial Manufacturer-sponsored trials wil be excluded, and it is expected that manufacturers wil provide funding for study treatments as part of the trial budget. For trials that are not manufacturer sponsored, investigators are asked to provide prior notification to the ministry of impending requests for funding of supportive therapies for a clinical trial. Requestors should indicate trial details, funding details, patient numbers, and timelines for their request prior to submitting the first request to EAP. Inquiries regarding the EAP should be directed to: Phone: 416-327-8109 or 1-866-811-9893 Fax: 416-327-7526 or 1-866-811-9908 Exceptional Access Program 3rd Floor, 5700 Yonge St. North York, ON M2M 4K5 The decision on reimbursement of individual requests wil be communicated by letter to the requesting physician. If coverage is approved, the physician may provide a copy of the ministry's response letter to the patient to take to their pharmacy. It should be noted that while pharmacies are not required to keep a copy of the response letter on file, retaining a copy of the letter may facilitate the pharmacy's awareness of covered products and may also assist in the monitoring of the approval duration of the request to avoid a gap in treatment should ongoing coverage be required. (Note: The ministry is aware of its obligations under the Personal Health Information Protection Act, 2004 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI I.5 (PHIPA) to ensure the confidentiality of all personal patient information which it holds on file as provided by requesting physicians. Physicians are requested to ensure continuation of this vigilance as it relates to patient privacy issues, particularly when transmitting EAP approval information to other parties.) The HNS adjudicates EAP claims online. Coverage begins on the specified coverage date and is valid until the expiration date noted on the authorization letter. For drugs approved under the EAP, the ministry wil reimburse pharmacists an amount equal to the Drug Benefit Price as outlined in the Formulary/CDI or listed on the ministry's website, plus a mark-up, and the lesser of a pharmacy's posted usual and customary fee or the ODB dispensing fee, minus the applicable co-payment amount. For products not outlined in the Formulary/CDI, the ministry wil pay dispensers the acquisition cost plus a mark-up and the lesser of a pharmacy's posted usual and customary fee or the ODB dispensing fee minus the applicable co-payment amount. The EO may enter into agreements with manufacturers to establish DBPs for products reimbursed under the EAP. In such cases, drug products reimbursed under the EAP wil be adjudicated at the established DBP. Please refer to the ministry's website for further information at: Products are approved for reimbursement under the EAP for a specific timeframe (i.e., days, weeks, one or more years), depending on the drug product and medical condition Retroactive reimbursement of approved requests may be considered by the EO on a case-by-case basis. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 VI I.6 Additional Benefits:
Nutrition
Products/ Diabetic Testing
Part IX: Additional
Benefits: Nutrition
Products/ Diabetic Testing
Agents
Nutrition Products

Nutrition Products (NPs) are listed substances reimbursed as additional benefits for ODB-eligible persons in defined circumstances. Enteral nutrition products are eligible for coverage under the ODB program only when prescribed by a physician as the patient's sole source of nutrition. Patients tolerating some solid foods and requiring only supplementation in addition to food are not eligible Eligibility Criteria: Enteral nutrition products wil be reimbursed for ODB-eligible persons when prescribed as the patient's sole source of nutrition and when one of the following criteria is met: • Oropharyngeal or gastrointestinal disorders resulting in esophageal dysfunction or dysphagia (e.g., head and neck surgery, neuromuscular disorder, or cerebral vascular disease where dysphagia prevents eating) • Maldigestion or malabsorption disorder and/or significant gut failure where food is not tolerated; (e.g., pancreatic insufficiency, biliary obstruction, short bowel • For patients requiring the use of a chemically defined diet as a primary treatment of a disease where the therapeutic benefit has been demonstrated (i.e., Crohn's Each claim for reimbursement must be supported by a valid and fully completed Nutrition Product form. Nutrition Product forms are valid for one year following the date completed. Physicians can order Nutrition Product forms by calling 1-888-310-9008, or print the Nutrition Product form from the ministry's website at: Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.1 Pharmacists are required to retain a copy of the Nutrition Product form on file for 24 months after which any NP claim is submitted to the HNS. For example, an NP claim submitted for ODB reimbursement with a date of service on December 31, 2010, must be substantiated with a valid and completed Nutrition Product form signed and dated by the prescribing physician (from January 1, 2010 to December 31, 2010) and retained on file until December 31, 2012. Exclusion Criteria: An NP wil not be reimbursed under the ODB program if it is intended for one of the • Prescribed weight loss in the treatment of obesity • Food allergies • Body building • Voluntary meal replacement • Nutritional supplement • Used as a replacement for breast feeding for infants with normal gastrointestinal absorptive function After conducting a patient assessment, the prescriber or dietician may select any Nutrition Product from the approved list; however, only the prescriber can complete the Nutrition Product form. Depending on which NP is prescribed, the ODB-eligible person may have to pay the pharmacy the difference between the cost the ministry wil reimburse the pharmacy and the current listed price for that NP. In many cases, the maximum paid by the ministry covers the entire cost (see attached Maximum Al owable Reimbursement Schedule for the list and price of the approved NPs under the ODB Reimbursement of NPs is not considered through the EAP. Maximum Al owable Reimbursement Mechanism and Pricing Schedule — Nutrition Products Administration A valid prescription from a prescriber is required for pharmacists to dispense approved NPs under the ODB program to eligible recipients. Pharmacists and prescribers are reminded that the nutritional requirements for persons residing in long-term care homes and Homes for Special Care are met by the facility responsible for the care of these Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.2 patients. Claims for NPs for these residents are not reimbursed under the ODB Claims Pharmacists should note the maximum amount the ministry wil reimburse pharmacies for each approved NP. Cost-to-operator claims wil not be accepted. NP claims are not eligible for a mark-up. Reimbursement Process The maximum allowable reimbursement process provides ODB-eligible recipients with coverage for the cost of NPs in a given category, up to a maximum price established for that category, minus the co-payment. The ministry wil reimburse pharmacies the amount identified in the column Amount MOHLTC Pays plus the lesser of the posted
usual and customary fee or the ODB dispensing fee, minus the co-payment portion. No amount more than that shown in the column Amount Patient Pays plus the co-
payment portion can be charged to recipients. The following maximum allowable reimbursement schedule lists those NPs that are approved for coverage and identifies a maximum price (per 1000kcal) for specific categories. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.3 Maximum Allowable
Reimbursement Schedule
for Nutrition Products
A.1 COMPLETE POLYMERIC – LACTOSE FREE MAXIMUM = 5.04
STRENGTH,
BRAND NAME DOSAGE
PIN/NPN MFR
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
Renal Nutren 1.5 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.4 A.2 COMPLETE POLYMERIC – FIBRE CONTAINING
MAXIMUM = 7.68
STRENGTH,
BRAND NAME FORM,
PIN/NPN MFR
($) PER MOHLTC PATIENT
1000K PKG
Modified Compleat LIQ-1000ML PK 09854231 NON Modified Ensure with Cal IsoSource HN with Fibre Jevity 1 Cal Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.5 A.3 COMPLETE POLYMERIC – HIGH NITROGEN MAXIMUM = 5.11
STRENGTH,
BRAND NAME DOSAGE FORM, PIN/NPN MFR PER
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
09854266 NES 4.99 Cal IsoSource HN 97984663 NES 4.03 IsoSource VHN LIQ-250ML PK 09853553 NES 8.51 09854452 ABB 5.04 Osmolite 1 CAL LIQ-235ML PK 97973165 ABB 5.07 09857095 ABB 5.04 09854169 ABB 5.11 B. INCOMPLETE POLYMERIC
MAXIMUM = 8.50
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
09853154 NES 8.61 C.1 MODULAR – PROTEIN
MAXIMUM = 15.90
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
09854193 IMM 49.50 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.6 C.3 MODULAR - FAT
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
D. CHEMICALLY DEFINED FORMULA
MAXIMUM = 35.26
STRENGTH,
AMT ($) AMT ($)
BRAND NAME DOSAGE FORM, PIN/NPN MFR PER
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
97984779 NES 28.46 09853090 NES 27.36 09857126 NES 27.36 09857101 NES 28.46 09857102 NES 28.46 09854390 ROS 8.83 09854391 ROS 8.83 09854401 MJN 10.40 97982750 NES 13.90 09853618 NES 23.44 97982830 NES 23.70 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.7 E.1 PEDIATRIC FORMULA, COMPLETE POLYMERIC – LACTOSE FREE
MAXIMUM = 10.51
STRENGTH,
BRAND NAME DOSAGE FORM, PIN/NPN MFR PER
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
09854215 NES 6.59 97984370 ABB 10.51 E.2 PEDIATRIC FORMULA, COMPLETE POLYMERIC – FIBRE CONTAINING
MAXIMUM = 10.51
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
09857173 NES 10.37 09854223 NES 6.59 09857419 ROS 7.77 Pediasure With 1KCAL/ML LIQ- 09854371 ROS 10.51 09857142 NON 6.55 F. PEDIATRIC FORMULA, INCOMPLETE POLYMERIC
MAXIMUM = 20.16
STRENGTH,
AMT ($) AMT ($)
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLT
PACKAGE SIZE
1000K PKG
C PAYS PAYS
97973084 ABB 20.16 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.8 G.1 PEDIATRIC FORMULA, CHEMICALLY DEFINED – OLIGOMERIC (SEMI-
ELEMENTAL) MAXIMUM=13.13
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
LIQ-4x237 ML PK 97984558 ABB 9.55 09857345 MJN 8.78 09857523 ABB 11.35 G.2 PEDIATRIC FORMULA, CHEMICALLY DEFINED – MONOMERIC (ELEMENTAL)
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
09857336 NUT 30.05 Flavoured) E028 Splash 09857335 NUT 30.05 Flavoured) Neocate Junior 09854207 NUT 35.15 09857433 NUT 28.24 09857369 MJN 22.90 09853308 NES 35.15 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.9 H. PEDIATRIC FORMULA, OTHERS
MAXIMUM = N/A
STRENGTH,
BRAND NAME DOSAGE FORM, PIN
($) PER MOHLTC PATIENT
PACKAGE SIZE
1000K PKG
09857172 MJS 8.51 09854398 NUT 13.89 09857497 NUT 16.16 09857388 NUT 16.16 09857393 NES 14.50 09853588 NES 28.46 09857124 ABB 8.02 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-A.10 Diabetic Testing Agents
Blood Glucose Test Strips (BGTSs) are listed substances that are covered as additional benefits for ODB-eligible persons in defined circumstances. Effective August 1, 2013, the EO introduced changes to the reimbursement of BGTSs for eligible ODB program recipients. For more information, please visit the ministry's website on diabetes test strips at: General Rules and Maximums
The HNS wil track and determine appropriate levels of reimbursement of BGTSs based on the current diabetes therapy used by eligible ODB recipients. When a claim is submitted for BGTS for eligible ODB recipients, the HNS will automatically review the anti-diabetes medications claims in the previous six months, to identify claims for insulin products and other anti-diabetes medications. The HNS will then apply a maximum number of self-monitoring BGTSs that may be reimbursed for the recipient in the following 365 days as follows: Diabetes Treatment History
Number of BGTS Allowed
within a 365-day Period
Patients managing diabetes with insulin Patients managing diabetes with anti-diabetes medication with high risk of causing hypoglycemia1 Patients managing diabetes using anti-diabetes medication with low risk of causing hypoglycemia2 Patients managing diabetes through diet/lifestyle therapy only (no insulin or anti-diabetes medications) 1Including but not limited to glyburide, gliclazide, chlorpropamide, tolbutamide, repaglinide, nateglinide, or glimepiride 2Including but not limited to metformin, sitagliptin phosphate monohydrate, saxagliptin, acarbose, rosiglitazone, pioglitazone, linagliptin, liraglutide or empagliflozin Recipients wil be allotted the indicated number of test strips for use over the course of a 365-day period. The test strip allotment wil apply to both online and paper claims. When submitting a claim for insulin or anti-diabetes medication along with a claim for BGTS, pharmacists should submit all anti-diabetes medications prior to entering
the BGTS claim. This ensures that the most current drug profile is included in the
historical treatment review, and patients are al ocated the proper number of test strips. Similarly, all related paper claims should be submitted for processing as soon as Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-B.1 Pricing Schedule — Diabetic Testing Agents
Administration
A valid prescription from a physician is required for pharmacists to dispense approved
Blood Glucose Test Strips (BGTS) under the ODB program to eligible recipients. harmacists should note the maximum amount the ministry wil reimburse pharmacies for each approved test strip. Cost-to-operator claims wil not be accepted. Test strips claims are not eligible for a mark-up. Please note: Only one PIN for each brand of test strips can be used for bil ing. Package size should not be used since reimbursement is based on the number of unit strips of each product dispensed. Reimbursement for Blood Glucose Test Strips
The ministry wil reimburse pharmacies the amount identified in the column Amount
MOHLTC Pays plus the lesser of the posted usual and customary fee or the ODB
dispensing fee, minus the co-payment portion. The pharmacy cannot charge eligible recipients any amount other than the co-payment for supplying BGTS under the ODB Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-B.2 The following pricing schedule lists those BGTS approved for coverage and the maximum price, up to which they wil be reimbursed. Pricing Schedule for
Diabetic Testing Agents
BLOOD GLUCOSE TEST STRIPS
PRODUCT NAME
AMOUNT ($) MOHLTC
PAYS PER UNIT
Accu-Chek Advantage Accu-Chek Compact Accu-Chek Inform II Test Strips Accu-Chek Mobile Advantage Comfort BGStar Blood Glucose Strips 2.7IU CareSens N Blood Glucose Test Strip 09857526 EZ Health Oracle FreeStyle Precision Test Strips GE200 Blood Glucose Test Strips Ideal Life Glucose Test Strip MediSure Blood Glucose Strip Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-B.3 PRODUCT NAME
AMOUNT ($) MOHLTC
PAYS PER UNIT
Prestige Smart System Spirit Blood Glucose Test Strip Suretest Blood Glucose Test Strips TrueTrack Smart System Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 IX-B.4 Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 X.1 A. List of Manufacturers
ABBREVIATION MANUFACTURER
AAP

Abbott Laboratories Limited Abbott Diabetes Care Ltd. AbbVie Corporation Accel Pharma Inc. Accord Healthcare Inc. Acon Laboratories Incorporated Actelion Pharmaceutiques Canada Inc. Actavis Pharma Company Agila Specialties Pvt Ltd. Actavis Group PTC ehf Agila-Jamp Canada Inc. Alcon Canada Inc. Alveda Pharmaceuticals Inc. Amgen Canada Inc. Acerus Pharmaceuticals Corporation Atnahs Pharma UK Limited ARA Pharmaceuticals Inc. ABBREVIATION MANUFACTURER
ASC

Actavis Specialty Pharmaceuticals Co. Astellas Pharma Canada Inc. Aspen Pharma Trading Limited Astra Pharma Inc. Aton Pharma Inc. Auro Pharma Inc. Auto Control Medical Ayerst Laboratories, Division of Ayerst, McKenna & Harrison Bayer Inc., Health Care Division Barr Laboratories Inc. Baxter Corporation Bayer Inc., Consumer Care Division BD Consumer Healthcare Axcan Pharma Inc. Bionime Corporation Biovail Pharmaceuticals Canada Draxis Health Inc. Boehringer-Ingelheim (Canada) Ltd./Ltee Bristol Myers Squibb Canada Inc. Bausch & Lomb Canada Inc. Burroughs Wel come Inc. Ciba Pharmaceuticals, Division of Ciba-Geigy Canada Ltd. ABBREVIATION MANUFACTURER
CIP

Cipher Pharmaceuticals Inc. Cobalt Pharmaceuticals Company Clay-Park Labs Inc. Cytex Pharmaceutical Co. Desbergers Limited Dioptic Laboratories, Division of Akorn Pharmaceuticals Canada Dominion Pharmacal Dr. Reddy's Laboratories Canada Inc. ECL Pharma Group Ltd. Endo Pharmaceuticals Inc. Entra Health Systems Elan Pharmaceuticals Inc. Erfa Canada Inc. Euro-Pharm International Canada Fournier Pharma Inc. Merck Frosst Canada & Cie, Merck Frosst Canada & Co. Frank W. Horner Inc. Galderma Canada Inc GlaxoSmithKline Consumer Healthcare Inc. Geigy Pharmaceuticals, Division of Ciba-Geigy Canada Ltd. Genmed, A Division of Pfizer Canada Inc. ABBREVIATION MANUFACTURER
GIL

Gilead Sciences Canada, Inc. Glaxo Canada Inc. Glaxo Wel come Inc. Glenmark Pharmaceuticals Canada Inc. Generic Medical Partners G Pohl Boskamp GMBH & Co KG Graceway Pharmaceuticals GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care Genzyme Canada Inc. Healthpoint Canada HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG Hoffmann-La Roche Limited Hoechst Marion Roussel Canada Inc. Home Diagnostics Inc Hospira Healthcare Corporation Hoechst-Roussel Canada Inc. Immunex Corporation Immunotech Research Ltd. InterMune Canada Inc. Iolab Canada Inc. Ivax Laboratories Incorporated Jacobus Pharmaceutical Company Inc. Johnson & Johnson Inc. ABBREVIATION MANUFACTURER
JAN

JHP Pharmaceuticals LLC Janssen-Ortho Inc. Jamp Pharma Corporation Laboratoires Fournier S.A. Laboratoires Thea Lederle – Division of Cyanamid Canada Inc. Lifescan Canada Ltd. Eli Lil y Canada Inc. Lupin Pharma Canada Limited Mallinckrodt Canada ULC Paul Maney Labs, Division of Canapharm Ind. Inc. Marcan Pharmaceuticals Inc. Mayne Pharma (Canada) Inc. McNeil Consumer Products Co. Medisense Canada Inc. Medical Futures Inc. MediHub International Inc. Merck Canada Inc. Melia Pharm Inc. MedTec Products Inc. ABBREVIATION MANUFACTURER
MEZ

Merz Pharmaceutical Gmbh Merck Frosst Canada Ltd. Merck Frosst/Schering Pharma GP Mint Pharmaceuticals Inc. Mead Johnson Nutritionals Mead Johnson Canada 3M Pharmaceuticals, Division 3M Canada Inc. MM Therapeutics Inc. Marion Merrell Dow Canada Merck Sharp & Dohme Canada, Division of Merck Frosst Canada Mylan Pharmaceuticals ULC Natco Pharma (Canada) Inc. Nadeau Laboratory Ltd. Nestle Clinical Nutrition Next Generation Pharma Inc. Nova Biomedical Corporation Novartis Nutrition Corporation Novo Nordisk Canada Inc. Novartis Pharma Canada Inc. Nutricia North America Nycomed Canada Inc. Odan Laboratories Ltd. Omega Laboratories Ltd. Orchid Healthcare ABBREVIATION MANUFACTURER
ORG

Organon Canada Ltd./Ltee Oryx Pharmaceuticals Inc. Otsuka Pharmaceutical Co. Ltd. Ovation Pharmaceuticals Inc. Paladin Labs Inc. Patriot, A Division of Janssen Inc. Parke-Davis, Division Warner-Lambert Canada Inc. Pediapharm Licensing Inc. Pendopharm Inc., Division of Pharmascience Inc. Pfizer Canada Inc. Proctor & Gamble Inc. Proctor & Gamble Pharmaceuticals Canada, Inc. Pharmacia & Upjohn Pharmascience Inc. Pharmaceutical Partners of Canada Questcor Operations Ltd. Ranbaxy Pharmaceuticals Canada Inc. RB Pharmaceuticals Ltd. Roberts Pharmaceutical of Canada Inc. Roche Diabetes Care GmbH Laboratoire Riva Inc. Rivex Pharma Inc. Roche Diagnostics, A Division of Hoffmann-La Roche Limited ABBREVIATION MANUFACTURER
ROG

Rougier Pharma, Division of Ratiopharm Inc. Ross Laboratories – Abott (Nutritional Products) Rhone-Poulenc Rorer – Ethical Division Rhone-Poulenc Rorer Consumer Inc. Schering-Plough Canada Inc. Sanis Health Inc. Salix Pharmaceuticals Inc. Schering Canada Inc. Sanofi Aventis Canada Inc. Searle Canada Inc. Schering-Plough Canada Inc. Sandoz Canada Inc. Searle Canada Inc. Sepracor Pharmaceuticals Inc. Septa Pharmaceuticals Inc. Servier Canada Inc. Shire Pharma Canada ULC SHS International Ltd. SHS North America Sigma-Tau Pharmaceutical Inc. Skymed Corporation Smith & Nephew Inc. Smith Kline Beecham Pharma Inc. Shire Orphan Therapies Inc. Solvay Pharma Inc. ABBREVIATION MANUFACTURER
STA

Stason Pharmaceuticals Inc. Stiefel Canada Inc. Stallergenes Canada Inc. Sunovion Pharmaceuticals Canada Inc. Takeda Canada Inc. Taro Pharmaceuticals Inc. Therasense Canada Inc. Teva Canada Limited Theramed Corporation TaroPharma, a Division of Taro Pharmaceuticals Inc. Tremblay Harrison Inc. Triton Pharma Inc. The Upjohn Company of Canada Valeo Pharma Inc. Valeant Canada Ltd. Vanc Pharmaceuticals Inc. Vi V Healthcare ULC Lundbeck Canada Inc. VPI Pharmaceuticals Inc. Waymar Pharmaceuticals Inc. Warner Chilcott Canada Co. Watson Laboratories Inc. ABBREVIATION MANUFACTURER
WAY

Wyeth Pharmaceuticals Wel Spring Pharmaceutical Canada Corp. Whitehal -Robins Inc. Westwood Squibb Pharmaceuticals Wyeth-Ayerst Canada Inc. Xediton Pharmaceuticals Inc. Zymcan Pharmaceuticals Inc. B. List of Dosage Form
DOSAGE FORM
Cleansing Lotion Combination Pack Controlled Release Ent Microsph Cap Enteric Coated Microspheres in Capsules Extended Release DOSAGE FORM
Multiple Dose Vial Orally Disintegrating Tablet Ophthalmic Solution DOSAGE FORM
Paste or Pastille Therapeutic System Patch Powder for Inhalation Powdered Extract Prefil ed Autoinjector Prefilled Syringe Prolonged-Release Rectal Aerosol Foam Single Dose Vial Soft Gelatin Cap Sprinkle Capsule Square Centimetre Sustained Release DOSAGE FORM
Topical Solution Section Currently Not in
Limited Use Drug Products
Part XII: Limited Use Drug
Products
Introduction

Please refer to the e-Formulary to access up-to-date information on Limited Use (LU) product listings and their clinical criteria. For information about the designation of LU benefits, see Part I of the Formulary/CDI. Finding an LU Drug Product and its Designated Clinical
Criteria
LU drug products are listed in the Formulary/CDI with specific clinical criteria/conditions for use. These LU criteria identify the clinical conditions for which these drugs wil be reimbursed by the ODB program. Each LU criterion has a corresponding RFU code. LU drugs are eligible for coverage only in situations where the clinical criteria have been met. Any other indication may be considered through the EAP described in Part VIII of the Formulary/CDI. LU Reimbursement Process
Completing an LU Prescription
Claims for LU drugs wil be reimbursed under the ODB program only when prescribed
for an ODB-eligible recipient in accordance with the criteria outlined for each product and accompanied by a valid, fully completed prescription with the appropriate LU documentation (RFU code). The pharmacist should review the prescription and process the claim only if all the required information is provided. The LU authorization is valid for the duration indicated by the listed LU criteria. As of September 27, 2005, some LU drugs used in chronic conditions have been granted extended authorization periods beyond one year. For drugs with an "indefinite" authorization period, it is only necessary for the prescriber to confirm that the patient meets the LU clinical criteria by completing an LU prescription once. For other drugs with a defined LU authorization period, a new LU prescription must be completed according to the authorization period provided in the LU criteria (usually on an annual basis). An exception to this policy may occur in situations where LU criteria Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 XI .1 have changed. In situations where LU criteria have changed, prescribers must consider whether recipients meet the new criteria. If so, a new LU prescription must be completed within three months of the change in LU criteria. Documentation that the patient meets the LU criteria may be provided on a regular prescription form according to the following instructions. Failure to have the RFU code appropriately documented on the prescription may result in: • Prescription not being fil ed by the pharmacist • Recoveries of monies paid to pharmacies by the ministry • Patient being required to pay for the LU drug prescription Al LU prescriptions require an RFU code to be completed by the prescriber. The RFU code verifies that the patient meets the LU criteria. Effective May 16, 2008, the RFU code can be communicated by one of the following methods: • Writing on an LU prescription • Electronically on an electronically-generated LU prescription • Verbally during a verbal order of an LU prescription by a prescriber* • Verbally during an LU prescription transfer between pharmacies* *Verbal communications of RFU codes must be documented by the receiving pharmacy in writing LU prescriptions preprinted by manufacturers or generated by a dispensary's computer software, are neither valid nor acceptable by the ministry. Faxed copies of LU prescriptions are acceptable (pharmacies should copy thermal paper faxes onto regular paper for record-keeping purposes). Pursuant to subsection 29(1) of O. Reg. 201/96 made under the ODBA, a valid LU prescription with RFU code must be kept on file for 24 months to support the LU claim. Monitoring and Accountability Framework Reimbursement for LU claims is made under the authority of section 23 of the ODBA and can only be made if the LU clinical criteria set out in the Formulary/CDI have been met. By writing the RFU code on a prescription for the LU drug product, the authorized prescriber affirms that the patient meets the clinical criteria. For the purposes of claims review under the ODBA, it may be necessary on occasion for prescribers to provide supporting documents on request. Pursuant to section 46(1) of the Personal Health Information Protection Act, 2004, a health information custodian may be required to disclose personal health information about an individual to the ministry for the purpose of monitoring or verifying claims for payment for health care funded wholly or in part by the ministry. LU prescriptions may therefore be monitored by the ministry to ensure that the RFU code indicated is in accordance with the LU criteria listed in the Formulary/CDI. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 XI .2 A Guide to Completing LU Prescriptions for Prescribers
In order to ensure the LU prescription is fully completed, fil in the prescription form as you normally would. In addition it is necessary to: • Provide the appropriate RFU code (e.g., RFU# 123); and • Sign and date the prescription; and • Fil in your CPSO number (for prescribers other than physicians, fil in your college registration number and indicate the professional college to which you The initial LU prescription with the RFU code must be fully complete before patients take the prescription to the pharmacy, or prescribers fax it directly to the pharmacy. Al LU prescriptions require an RFU code to be completed by the prescriber. The RFU code verifies that the patient meets the LU criteria. Effective May 16, 2008, the RFU code may be communicated by one of the following methods: • Writing on an LU prescription • Electronically on an electronically-generated LU prescription • Verbally during a verbal order of an LU prescription by a prescriber The LU authorization wil be valid for the duration indicated by the listed LU criteria. During this period, any repeat prescription may be given verbally to a pharmacist. For drugs with extended or indefinite authorization periods, a new prescription may be required after a certain period of time to allow the drug to be dispensed in accordance with the regulations of the OCP. If a patient has met the LU criteria before being eligible for ODB coverage, and supporting documentation is available (e.g., the diagnostic test was done prior to the person turning 65), that information can stil be used to verify the LU claim. For instance, a patient who had step-up therapy in the past wil not have to have step-up therapy again to prove eligibility to receive an LU drug as long as supporting documentation is Reimbursement for LU claims is made under the authority of section 23 of the ODBA and can only be made if the authorized LU criteria have been met. Prescribers should not complete an LU prescription if the patient's clinical condition does not meet one of the listed LU criteria. A written request for special consideration for coverage can be made under the ODB program's EAP (see Part VIII). The pharmacist must have a fully completed prescription with the appropriate RFU code before submitting an ODB claim. Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 XI .3 A Guide to LU Prescriptions for Pharmacists
All drug products, including LU drugs, are to be dispensed in accordance with the regulations of the OCP. Pharmacists must ensure that all of the following information has been provided by the • The appropriate RFU code • The date and prescriber's signature • The physician's CPSO number (for prescribers other than physicians, the prescriber's college registration number is required) Only the prescriber may fil in this information. If the CPSO or college registration number is missing, pharmacists may enter it only if they are certain it is the correct number. Claims for LU products must contain a valid CPSO or college registration number (i.e., 99999 is not acceptable). Please note: • Payments made in respect of LU claims with incomplete documentation (i.e., prescriptions that do not include the appropriate RFU code, date, prescriber's signature, CPSO number or college registration number) wil be subject to recovery by the ministry • Pharmacists should ensure the LU criteria have been applied appropriately • Where a pharmacist has concerns about whether the clinical criteria have been met, the pharmacist should discuss it with the prescriber and record the outcome of the discussion on the prescription according to standard pharmacy practice • The initial LU prescription with the RFU code must be fully complete before Al LU prescriptions require an RFU code to be completed by the prescriber. The RFU code verifies that the patient meets the LU criteria. The RFU code may be communicated by one of the following methods: • Writing on an LU prescription • Electronically on an electronically-generated LU prescription • Verbally during a verbal order of an LU prescription by a prescriber Pharmacists may also communicate the RFU code verbally during an LU prescription transfer between pharmacies. Verbal communications of RFU codes must be documented by the receiving pharmacy in writing. The LU authorization must be documented and wil be valid for the duration indicated by the listed LU criteria. During this period any repeat prescription may be given verbally by a prescriber to a pharmacist. For drugs with extended or indefinite authorization periods, a new prescription may be required after a certain period of time to allow the drug to be dispensed in accordance with the regulations of the OCP. If a patient has met the LU criteria before being eligible for ODB, and supporting documentation is available (e.g., the diagnostic test was done prior to the person turning 65), that information can stil be used to verify the LU claim. For instance, a patient who Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 XI .4 had step-up therapy in the past wil not have to have step-up therapy again to prove eligibility to receive an LU drug as long as supporting documentation is available. Reimbursement for LU claims is made under the authority of the ODBA and can only be made if the authorized LU criteria have been met. Pursuant to subsection 29(1) of O. Reg. 201/96 made under the ODBA, a valid LU prescription with RFU code must be kept on file for 24 months to support the LU claim. Note: if the pharmacist is prescribing the drug therapy according to his/her scope of practice, the pharmacist can complete the LU documentation to confirm that the patient meets the LU criteria. As the prescriber of the medication, documentation of the assessment must be recorded appropriately before the claim is submitted. Documentation may be requested for post-payment verification. The pharmacist must have a fully completed prescription with the appropriate
RFU code before submitting an ODB claim.
Ontario Drug Benefit Formulary/CDI Edition 42 Ef ective August 30, 2016 XI .5

Source: http://www.health.gov.on.ca/en/pro/programs/drugs/formulary42/edition_42.pdf

Hiv/aids in the context of other global challenges

An executive summary for tackling global challenges HIV/AIDS in the Context of Other Global Challenges Special Report for the UN High-Level Meeting on AIDS, 8-10 June 2011 HIV/AIDS in the Context of Other Global Challenges Special Report for the UN High-Level Meeting on AIDS Global2015 e. V. is an independent, non-profit and non-partisan association, registered under German law.Its mission is to provide a comprehensive analysis and survey of the most urgent global challenges for human needs and life, and to encourage further action in tackling challenges such as world nutri-tion, climate change, and epidemics.