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