Manitoba Drug Formulary Review Process
Prior to a new drug being listed on the Manitoba Drug Benefits and Interchangeability Formulary, it must first be approved by Health Canada for sale in Canada and is then subject to a standard review process through the national Common Drug Review (CDR) and the Manitoba Drug Standards and Therapeutics Committee (MDSTC).
National Common Drug Review
Manitoba participates in the national Common Drug Review (CDR). For new drugs (chemical entities) and new combination drug products, the CDR is a national process that provides participating federal, provincial and territorial drug plans with a systematic review of the best available clinical evidence, a critique of manufacturer-submitted pharmacoeconomic studies and a formulary listing recommendation made by the Canadian Expert Drug Advisory Committee (CEDAC).
- For more information about the CDR and CEDAC, visit: www.cadth.ca
Submissions for new chemical entities, new combination products and drugs with new indications should first be filed with the CDR Directorate.
- Information on the CDR requirements and procedures is posted at: www.cadth.ca.
Pan-Canadian Oncology Drug Review
Manitoba participates in the national pan-Canadian Oncology Drug Review (pCODR) process. The pCODR process is designed to bring consistency and clarity to the assessment of cancer drugs by reviewing clinical evidence, cost-effectiveness, and patient perspectives, and using this information to make recommendations to Canada's provinces and territories (except Quebec) in guiding their drug funding decisions.
- For more information about the pCODR, visit www.cadth.ca/pcodr
Pan Canadian Pharmaceutical Alliance
Brand Name drugs
Established in August 2010, the pan-Canadian Pharmaceutical Alliance (pCPA), formerly the pan-Canadian Pricing Alliance, is part of work underway by the Council of the Federation’s Health Care Innovation Working Group (HCIWG).
The pCPA conducts joint provincial/territorial negotiations for brand name drugs in Canada to achieve greater value for publicly funded drug programs and patients. All brand name drugs coming forward for funding through the national review processes Common Drug Review (CDR) or Pan-Canadian Oncology Drug Review (pCODR) are considered for negotiation through the pCPA.
Generic drugs
As part of ongoing efforts to reduce the cost of drugs, on January 18, 2013, the HCIWG announced the first step in achieving better value for generic drugs through the Value Price Initiative. This joint approach leverages combined purchasing power to obtain the lowest generic prices achieved to date in Canada, and to be consistent with the price for these drugs on the international market. Effective April 1, 2013, the first phase of work established a price point for six of the most common drugs at 18% of the equivalent brand name product.
- Fact Sheet on Pan-Canadian Pharmaceutical Initiatives
- pan-Canadian Pharmaceutical Alliance Negotiation Guidelines
Manitoba Drug Standards and Therapeutics Committee
The Manitoba Drug Standards and Therapeutics Committee is independent of government. It includes three physicians and three pharmacists. Committee members provide recommendations on drug interchangeability and on the therapeutic and economic value of drug benefits. Committee members are appointed by the Minister of Health with recommendations by the College of Physicians and Surgeons of Manitoba, Doctors Manitoba, the Manitoba Pharmaceutical Association, and the University of Manitoba.
Before a drug is considered for Pharmacare coverage, the manufacturer must send a drug submission to the Manitoba Drug Standards and Therapeutics Committee (MDSTC). This committee takes into consideration the recommendations of the CDR along with reviews of the scientific literature, comparable drug therapies, anticipated drug costs, and therapeutic benefits before making a recommendation regarding benefit listing.
Product Listing Agreement
For all drugs under consideration for listing on the Manitoba Formulary the manufacturer must sign a utilization management agreement (Product Listing Agreement (PLA)). The PLA provides a statement of the benefit of the product as compared to currently listed products, as well as cost impact projections, assurances of appropriate promotion and provision for health outcomes research.
Based on the MDSTC’s recommendations, Manitoba Health's review and the signing of a PLA, the Minister of Health through signing the Specified Drug Regulation and the Manitoba Drug Benefits and Interchangeability Formulary gives the final approval for benefits under the Pharmacare drug benefit program.
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