Effective November 1, 2016, the ministry is introducing the application of generic substitution to the Exceptional Access Program (EAP).

Under this new policy, if an EAP drug has an interchangeable generic product designated through the Off-Formulary Interchangeable (OFI) mechanism, the ministry will only approve the funding of the generic product. Where Ontario Drug Benefit (ODB) recipients have had a documented adverse reaction to at least two (2) generic versions, the ministry will reimburse the higher-cost brand product. Similar to products listed on the ODB Formulary, the ‘No Substitution’ policy will apply.

Starting November 1, 2016, pharmacists must dispense an OFI generic product in the pharmacy’s inventory to ODB recipients with an EAP approval from the ministry. Pharmacists will be reimbursed the cost of the generic product that is dispensed. Given that inventory selection differs from pharmacy to pharmacy, the Health Network System (HNS) will have system rules in place on November 1, 2016, to reduce the value of the ‘Amount MOHLTC Pays’ for a brand name OFI drug product to that of the highest-cost generic in the interchangeable category. The ‘Amount MOHLTC Pays’ will therefore reflect the maximum price the ministry will pay for the drug under the EAP, unless the brand version is eligible for reimbursement. The ODB electronic formulary (e-Formulary) will have enhancements in October 2016 to show the OFI list with the ‘Amount MOHLTC Pays’ to allow prescribers and dispensers to become familiar with this information in advance.

To further inform healthcare providers and patients, the ministry has included Frequently Asked Questions (FAQs) for reference purposes. The FAQs can be located here. For questions, please contact the ministry by e-mail at: PublicDrugPrgrms.moh@ontario.ca or the Ontario Drug Benefit (ODB) Help Desk at 1-800-668-6641.