MINISTRY OF HEALTH Exceptional Access Program Reimbursement Criteria for Frequently Requested Drugs June 22, 2021 1 Disclaimer The information in this document is updated on a regular basis. Although we strive to ensure that all information is accurate at the time of posting, please be aware that some items may be subject to change from time-to-time. The following list of drugs and indications that will be considered for funding under the Exceptional Access Program is not exhaustive. Physicians may wish to contact the EAP directly by phone at 416-327-8109 or 1-866-811-9893 or by email at [email protected] to see if a specific drug product and or indication not listed below may be considered for EAP funding. The information provided in this document and website is intended for information purposes only and does not provide any medical diagnosis, symptom assessment, health counselling or medical opinion for individual users. This information also does not constitute medical advice for physicians or patients. For more detailed information on prescription drugs, please consult a qualified healthcare professional. 2 Reimbursement Criteria for Frequently Requested Drugs and Indications For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved 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 specified) • funding for a renewal beyond the previously approved initial period, unless otherwise specified. Note that the terms “fund”, “funded”, or “funding” within this document are interpreted and applied by the Ministry in accordance with the clinical evidence used to establish the reimbursement criteria. The Ministry does not distinguish between the source of the drug funding (e.g. public or private payer[s]) in administering the EAP reimbursement criteria. Consider the following: The “non-funding” of specific combination treatments as identified by the criteria will not be reimbursed regardless of the funding source(s) of either therapy. The funding criteria are established based on the reviewed clinical evidence through the submission process and are not to be misconstrued with the source(s) of funding. Example 1: If drug A has approved reimbursement criteria and drug B has approved reimbursement criteria but the combination therapy of drug A plus drug B has not been reviewed through the established process and/or has no reimbursement criteria, the EAP will not fund either drug individually or as combination therapy if the intended use is for combination therapy, regardless of the actual source of funding of either drug A or drug B. Example 2: If drug A has approved reimbursement criteria and drug B does not have approved reimbursement criteria, and drug A used in combination with drug B does not have approved reimbursement criteria, funding for drug A will not be provided if the intent is to use drug A as combination with drug B, regardless of the source of funding for drug B. The duration of funding of a regimen identified in the criteria is in accordance with the duration of therapy supported by the clinical evidence and is not related to or dependent on source(s) of funding. Example 1: If the approved reimbursement criteria states that “The Ministry will fund drug C for a period of 3 years” and drug C was already used by the patient for 2 years funded by another payer (e.g. private payer, manufacturer, out-of-pocket), the Ministry will only be obliged to fund drug C for the remaining one year if the request meets the approved EAP reimbursement criteria. Such a limitation in the duration of funding is aligned with the clinical evidence provided to the Ministry at the time of the review. 3 For a limited number of requests where expert opinion is required, the requests are reviewed by an external reviewer who is a medical expert in the field. Where available, a link has been provided to the information page containing details of the Committee to Evaluate Drugs (CED) review and subsequent the Executive Officer’s funding decision for the particular drug and indication. Information on whether the drug and indication can be considered through the Telephone Request Service (TRS) is also included. EAP requests may be submitted for numerous other drugs not listed below, or for drugs listed below but for different indications. However, EAP funding will only be considered for drugs and indications that have been reviewed by the CED and approved for funding by the Executive Officer. For more information, please refer to the main EAP webpage. Some of the drugs considered through EAP are also listed on the ODB Formulary for a different indication as Limited Use (LU) benefit. You can check whether the drug is listed by searching the e-Formulary. For details on how the EAP reimbursement criteria are developed, please refer to the main EAP webpage. To assist physicians applying for exceptional access, the ministry has developed a standard form. Use of form is not mandatory but does facilitate provision of all relevant information. Where applicable, please ensure that all relevant clinical information is provided demonstrating that the patient meets the reimbursement criteria. Note: The dosage form and strength of the product that has been approved for reimbursement consideration are those that have been approved by the Committee to Evaluate Drugs (CED). In most cases, these are the dosage forms and strengths submitted to the CED by the manufacturer for consideration, however, it may not be inclusive of all dosage forms and strengths available through the manufacturer. 4 Biosimilar Policy and the Reimbursement of Biologic Originators through The Exceptional Access Program Reimbursement for Remicade®, Enbrel®, Humira®, Rituxan®, and Copaxone® (not a biologic but a complex molecule included under this policy) through the Ontario Drug Benefit (ODB) program is provided only for eligible ODB recipients who are treatment experienced on a case-by-case basis. All patients must meet specified initiation criteria and renewal criteria associated with the treatment depending on the duration of use of the biologic by the patient. This requirement must be met irrespective of whether the drug was originally funded through a private health insurance plan, a clinical trial, compassionately by another payer, accessed in another country or jurisdiction, or paid for out-of-pocket and it is intended to optimize consistency and equity of funding for Ontarians in accordance with the evidence-review processes. Patients who are treatment naïve to the biologic are funded for the biosimilar version for its Health Canada approved indications. The biosimilar version of these drugs can be accessed as a limited use benefit upon meeting specified criteria for their Health Canada approved indications. If a request does not meet the LU criteria on the ODB formulary, case-by-case consideration may be provided through the EAP. Patients must be provided with a new prescription and meet the Limited Use Criteria or Exceptional Access Program criteria to be publicly reimbursed for either the biologic originator or its biosimilar versions. The biosimilar version is generally available for all its Health Canada approved indications on the ODB formulary as a limited use benefit. Additionally, requests for a biologic for indications where Health Canada has not granted notice of compliance for the biologic originator or the biosimilar versions, if approved for funding through a case-by-case process, will be granted access to the biologic originator and the biosimilar versions. Please visit the Ministry website to view the more detailed information pertaining to each biologic originator/biosimilar announcement in the Executive Officer Communication Notices. Frequently Asked Questions pertaining to each biologic/drug at the time of implementation are also found on the Ministry website. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx You can find the limited use criteria associated with funded biosimilars on the e-formulary or the latest version of the Ontario Drug Benefit Formulary. The searchable electronic formulary is available at the following URL on the Drugs and Devices Division’s website: https://www.formulary.health.gov.on.ca/formulary/ 5 Table of Contents ANEMIA .......................................................................................................................... 13 Darbepoetin ................................................................................................................ 13 Epoetin Alpha .............................................................................................................. 15 Iron dextran complex ................................................................................................... 18 Iron sucrose ................................................................................................................ 18 Iron isomaltoside ......................................................................................................... 18 Lenalidomide ..............................................................................................................