Pangaea Express - OPDP Enforcing Generic Substitution for EAP products

October 20, 2016

By Marla Weingarten

Effective November 1, 2016, the ministry is enforcing generic substitution to the Exceptional Access Program (EAP). ”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.”

EAP Approvals

Currently, EAP approvals for drugs that are not listed on the ODB Formulary do not require generic substitution as is required for drugs that are listed on the ODB formulary. Ontario is the only province in Canada that has not yet moved to a generic substitution requirement for drugs that require special authorization. Starting November 1, 2016, pharmacists must dispense an OFI generic product and will be reimbursed the cost of that generic product. “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.” This “Amount MOHLTC Pays” will be the maximum price the ministry will pay for a drug under EAP. For the ODB to reimburse the brand name, the Health Canada Side Effect Reporting Form must be completed by the prescriber and forwarded to the pharmacist with the required, “No substitution” written on the script.

Not a surprise considering Ontario was the last hold-out but this will certainly limit physician and patient choice for EAP medications.

For more details, click here or contact Marla Weingarten, Consultant, The Pangaea group