October 14, 2016
Effective October 1st, 2016 amendments to Ontario Regulation 201/96 under the Ontario Drug Benefit Act and Regulation 935 under the Drug Interchangeability and Dispensing Fee Act (DIDFA) will come into effect. In June 2016, the government outlined a proposal to amend the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act as part of the Ministry of Health and Long Term Care’s “Patient’s First: Action Plan for Health Care”. These amendments, which allow the Ontario Public Drug Program to increase patient access to drugs and streamline the generic drug listing process, were vetted through a consultation process and have now been approved by the Ontario Government.
The amendments will:
1. Enable more appropriate access to certain drugs through Formulary listing, which are now only available under the Exceptional Access Program The proposed amendments would authorize the Executive Officer (EO) of Ontario Public Drug Programs to list a drug on the Formulary without a full submission from a manufacturer if the EO had sufficient evidence that the product was therapeutically effective and had a low risk of inappropriate utilization if funded outside the EAP.
2. Allow for new strengths of a generic product that do not have a comparable reference product to be considered for listing based on evidence other than product-specific clinical studies The amendments to Regulation 935 made under the DIDFA would allow the ministry to accept HC's Declaration of Equivalence (DOE)* and allow more generic drugs to be eligible for the faster, streamlined review process (approx. 2 months before listing). DOE: When Health Canada reviews generic drugs and finds them to be equivalent (i.e. as safe and effective) to the brand product, it issues a DOE.
3. Allow for the remaining generic products with a Declaration of Equivalence designation from Health Canada to be reviewed under the faster, streamlined drug submission process. To be considered for listing under ODB, generic products had to show that they were equivalent to their brand reference product in the same strength that is already considered to be clinically effective. In some cases, generic manufacturers could not provide this information because there was no brand product of equal strength available on the market. The proposed amendments would allow the ministry to accept other information to show that these “generic line extensions” are clinically effective (e.g. bioequivalence data and formulation proportionality data).
Regarding the Exceptional Access Program, how many drugs only available on this list that will move to the formulary is anyone’s guess.
For more information, please contact Marla Weingarten, Consultant, The Pangaea Group