e-2868 (Health)

The Government of Canada recognizes the importance of patients having access to drugs that may help treat their serious or life-threatening conditions, and is committed to supporting Canadians’ access to safe and effective health products.

In Canada, the management of pharmaceuticals is a shared responsibility among the federal, provincial and territorial governments. The federal government is responsible for assessing the safety, efficacy and quality of drugs before authorizing them for sale in Canada. The provincial and territorial governments are responsible for the delivery of health care for their residents, including determining which drugs are reimbursed and under what conditions for their eligible populations.

On December 16, 2020, Health Canada approved Zolgensma for sale in Canada. Once approval has been issued, provincial and territorial drugs plans then decide if the drug will be eligible for public reimbursement. To help inform this decision, public drug plans use the recommendations and advice of the Canadian Agency for Drugs and Technologies in Health’s (CADTH) Common Drug Review and, in Quebec, the Institut national d’excellence en santé et en services sociaux (INESSS). Health Canada, along with CADTH and INESSS, have introduced an option for sponsors to seek aligned reviews for submissions. This aligned review process reduces time lags between the market authorization of a drug and the Health Technology Assessments (HTAs) performed by CADTH and INESSS which support its listing on a public plan. Through this process Zolgensma qualified for an earlier HTA review by CADTH and INESSS, up to 180 days before Health Canada made its regulatory decision about the drug’s market authorization.

CADTH is still in the process of evaluating the HTA submission; whereas, INESSS has completed its review and has recommended that Zolgensma be reimbursed with conditions. For more information on the reviews and their outcomes, Canadians may visit the following links:

     CADTH: https://cadth.ca/onasemnogene-abeparvovec  

     INESSS: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Janvier_2021/Zolgensma_2020_12.pdf

Even if a drug is not listed on their formulary, individual provincial and territorial drug plans may review certain claims for reimbursement on a case-by-case basis and inquiries may be made specifically to the respective province or territory.

We know that for many Canadians who require high-cost prescription drugs to treat rare diseases, the cost of these necessary medications can be astronomically high. That is why Budget 2019 proposed to invest up to $1 billion over two years, starting in 2022-23, with up to $500 million per year ongoing to help Canadians with rare diseases access the effective drugs they need. As reaffirmed in the 2020 Speech from the Throne and Fall Economic Statement, this includes working with willing provinces, territories and stakeholders to establish a national strategy for high-cost drugs for rare diseases.

To support the development of a national strategy for high-cost drugs for rare diseases, engagement efforts are underway with the provinces and territories, patients along with other key stakeholders, and the public. The government has released a discussion paper and welcomes input from Canadians through public town halls and/or responses to an online questionnaire. All Canadians are invited to share their ideas before the engagement closes on March 26, 2021.

The engagement webpage can be accessed here: https://www.canada.ca/en/health-canada/programs/consultation-national-strategy-high-cost-drugs-rare-diseases-online-engagement.html.

The Government of Canada will continue working with provinces, territories and other partners to lower the costs of medications and improve access.