On October 1, 2016, amendments to regulations made under the
Ontario Drug Benefit Act ("ODBA") and the
Drug Interchangeability and Dispensing Fee Act
("DIDFA") came into force that aim to increase
access to existing unlisted drug products and also accelerate the
introduction of bioequivalent products into the market by way of a
faster review process and less stringent requirements for generic
line extension products.
To provide guidance to manufacturers seeking to navigate the drug
submission process after this date, the Ontario Public Drug
Programs published an addendum to the Ontario Guidelines for Drug
Submission and Evaluation on October 6, 2016, which can be found here.
Increased access to unlisted, non-formulary drugs
Section 12 of Ontario Regulation 201/96 made under the ODBA
("ODBA Regulation") was amended to authorize the
executive officer to transition unlisted, non-formulary drugs
available through Ontario's Exceptional Access Program to the
Ontario Drug Benefit Formulary without a full submission by the
drug manufacturer, as previously required by the ODBA
Regulation.1
If the executive officer is satisfied that the drug is clinically
effective and has a low risk for inappropriate utilization, then
the executive officer may transfer the drug from the Exceptional
Access Program to the Ontario Drug Benefit Formulary. The goals of
the amendment to the ODBA Regulation are to increase access to
drugs that are known to be both safe and effective, increase
availability to drugs that require urgent access, and increase
availability of drugs that may be less costly than newer listed
alternatives.
Faster review for all bioequivalent generic drugs
Amendments to Ontario Regulation 935 made under the
DIDFA ("DIDFA Regulation") are aimed at
permitting an accelerated review process for all generic products
that have been issued a Declaration of Equivalence from Health
Canada.2
Previously, there were two review processes (streamlined and
non-streamlined) for listing generic products that had received a
Declaration of Equivalence from Health Canada. Approximately 95% of
products could be reviewed under the streamlined review process and
be listed on the formulary in approximately two months.
These products primarily consisted of certain aqueous solutions,
solid oral dosage forms for systemic effect, dermatological
products that contain one or more glucocorticoids as the only
active ingredient(s), and drug products with a transdermal route of
administration for systemic effect. However, the remaining 5% of
products were subject to a non-streamlined review process, which
took approximately four months before listing and required review
by the ministry's expert advisory committee, the Committee to
Evaluate Drugs.
Increased/alternative access to interchangeability
Additionally, the amendments to the DIDFA Regulation will permit
a manufacturer of certain drug products to provide in
vitro studies to satisfy the executive officer that the drug
is interchangeable with a product listed on the
formulary.3 This provision of the DIDFA Regulation will
apply to drug products that have a non-systemic effect where Health
Canada has not issued a Declaration of Equivalence, and where blood
concentrations of the product cannot be measured and clinical
studies with a pharmacodynamic endpoint are inappropriate or
difficult to conduct.
New types of evidence permissible to allow for generic line extension products
In addition, the amendments to the DIDFA Regulation will allow
"generic line extension products" (i.e. new strengths for
existing drugs) to be considered for listing where no comparable
reference product exists in the same strength.4
Prior to the amendments, a generic manufacturer seeking listing on
the formulary was required to show bioequivalence to the brand
reference product in the same strength already considered to be
clinically effective. The amendments now relieve generic
manufacturers of this requirement by permitting the executive
officer to accept alternative forms of evidence to establish that
the generic line extension product is clinically effective, such as
bioequivalence data and formulation proportionality data.
Links:
The Consolidated OBDA Regulation
The Consolidated DIDFA Regulation
Addendum 1 to the Ontario Guidelines for Drug
Submission and Evaluation
Communication from the Executive Officer dated
September 26, 2016
Footnotes
1 O. Reg 201/96 at ss. 12(2.1).
2 O. Reg 935 at ss. 6(3.1). Subsections 6(5.1), 6(6), 6(7), 6(7.1)
and 6(7.2) are revoked.
3 O. Reg 935 at s. 6(6).
4 O. Reg 935 at s. 6(7).
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