Market Access: The Pricing and Reimbursement Landscape in Canada

Have you heard of the term ‘Market Access’ and wondered what it means? The first thing you need to know about market access is that it is a complex process involving multiple stakeholders and government agencies. The entire process can take years.

Definition Market access is a process that ensures all appropriate patients who would benefit, obtain and maintain access to the medication or technology, at an appropriate price.

Process The process involves: 1. Value identification, based on payer/customer insights 2. Value creation through clinical and health economics and outcomes research (HEOR) data 3. Value communication through preparation of dossiers for submission to the appropriate agencies

Pathway to Public Drug Coverage The maximum price of a drug in Canada is set by the Patented Medicine Prices Review Board (PMPRB). When determining the maximum price of a new drug, the PMPRB takes into account the price of that drug in seven other Organization for Economic Co- operation and Development (OECD) countries – France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the USA. However, the PMPRB regulatory framework is currently undergoing modernization changes and the list of comparator countries may be revised.

Just prior to expected regulatory approval by Health Canada, manufacturers (i.e. pharmaceutical companies) submit a dossier to the Canadian Agency for Drugs and Technologies in Health (CADTH). Within CADTH, the pan-Canadian Oncology Drug Review (pCODR) is responsible for assessing oncology drugs and the Common Drug Review (CDR) assess all other drugs. To obtain coverage in Quebec, manufacturers must submit a dossier to the Institut national d’excellence en santé et en services sociaux (INESSS). CADTH/INESS review the clinical and economic data for a pharmaceutical product and output recommendations on whether the product should be reimbursed in Canada.

After receiving a recommendation from CADTH/INESS, the manufacturer may enter negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) to establish a letter of intent. The pCPA is comprised of members of all provinces and territories, created to streamline the negotiation process across Canada. The manufacturer may then enter into a product listing agreement (PLA; an agreement to cover a specific drug at a specific price) with individual jurisdictions (i.e. provinces and territories).

Pathway to private drug coverage

To obtain private drug coverage, manufacturers must submit a dossier to individual private insurance companies. Some of the major insurance providers in Canada are Manulife, Sun Life and Great-West Life.

What Market Access Means for Pharmaceutical Companies & the Life Sciences Industry Simply because a drug is approved by Health Canada, does not mean it will be marketed. Manufacturers, either alone or in collaboration with consulting agencies, must navigate the complex pricing and reimbursement landscape to ensure commercial success. A delicate balance must be struck between drug prices that are affordable, yet reasonable, considering the cost of developing the drug. Ultimately commercial success provides funds for future innovation.

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