Carol Baldwin, Local Journalism Initiative Reporter, Wakaw Recorder
In Canada, 1 in 12 people live with a rare disease and for most, the cost of treatment is unaffordable. The Governments of Canada and the province of Saskatchewan signed the bilateral National Strategy for Drugs for Rare Disease (DRD) agreement on Friday, January 10. The federal and provincial Ministers of Health met at the Jim Pattison Children’s Hospital to sign the agreement, which provides $40 million in federal funding for drugs for three rare diseases.
Federal Health Minister Mark Holland says it is hard enough to finally receive a diagnosis of a rare disease and navigate the healthcare system without having to worry about paying for the medications. He believes this agreement will help and adds that Saskatchewan is not the only province on board, “This is our fourth agreement. We’ve signed agreements with B.C., Newfoundland and Labrador, and Alberta.”
The first drugs to be funded through the National Strategy for Drugs for Rare Diseases are:
-Poteligeo, an intravenous chemotherapy drug, for the treatment of mycosis fungoides or Sézary syndrome; public drug coverage will be in the order of $35,000 for the first treatment, and $17,000 for subsequent treatment cycles and it is estimated about six people in Saskatchewan will be diagnosed this year;
-Oxlumo is used to treat hyperoxaluria type 1, a condition that leads to crystals forming in the body. These crystals can cause permanent damage to tissues, specifically the kidneys, leading to loss of function. Oxlumo may help to prevent the formation of crystals. Treatment costs can be as high as $1.7 million for the first treatment as adults, and over $500K as children. Adult patients face costs of over $1 million every year after, and up to $400K for children.
-Epkinly for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of blood cancer which causes tumours in the lymph nodes or other organs including the spleen, liver or bone marrow. It is estimated that 42 people will be diagnosed with this disease each year, and public drug coverage for the first 28-day treatment cycle for each patient will be $14,000, with subsequent cycles varying in cost. Epkinly is the first drug to receive a time-limited reimbursement recommendation from Canada’s Drug Agency (CDA-AMC), which is a recommendation to publicly fund a drug for a certain period of time on the condition that the manufacturer will conduct ongoing clinical studies that address uncertainty in the evidence. Additionally, it is the first drug to go through the pan-Canadian Pharmaceutical Alliance (pCPA) Temporary Access Process, a new negotiation pathway developed by the pCPA to establish temporary access to drugs that have received a time-limited reimbursement recommendation from CDA-AMC.
Saskatchewan’s Health Minister Jeremy Cockrill says the province already covers the cost of these drugs, but the funding will help sustain Saskatchewan’s publicly funded drug plan. “What this agreement today does it [sic] helps us to ensure that we’re expanding coverage and looking at adding more drugs down the road to address other rare diseases that affect children and patients of all ages.”
On March 22, 2023, the government of Canada announced up to $1.5 billion over the next 3 years in support of the first-ever National Strategy for Drugs for Rare Diseases. This funding will help increase the access to and affordability of effective drugs for rare diseases (DRD) while contributing to the improvement of the health of patients across Canada. As part of this overall investment, up to $1.4 billion was made available to provinces and territories through bilateral agreements.
In the lead-up to this bilateral agreement, the provinces and territories, except Quebec, worked together to develop a small common list of new drugs to be listed and cost-shared across the country and initiated discussions on a collaborative approach to improve screening and diagnostics for rare diseases. The common list of new drugs was developed with provinces and territories to ensure that the National Strategy delivers the most possible benefits to all patients with rare diseases. Recognizing the unique challenges associated with decision-making about drugs for rare diseases, the common list is designed to further the development, collection, evaluation and use of real-world data and evidence in decision-making about the listing and reimbursement of rare disease drugs within Canada’s existing pharmaceutical management system.
The three-year bilateral agreements are part of the strategy’s initial phase, which aims to build, test, and learn in collaboration with governments and health system partners. Insights gained from these initial agreements with provinces and territories, as well as from Strategy-funded projects by pan-Canadian partners, will inform recommendations for the design of future phases of the Strategy.
By signing these bilateral agreements, provinces and territories, including Saskatchewan, are committing to collaborate with the Government of Canada and other participating provinces and territories. Together, they will design and implement evidence-collection projects that complement ongoing initiatives by Canada’s Drug Agency (CDA-AMC) and the Canadian Institute of Health Information. These efforts will improve the collection and utilization of real-world data and evidence for decision-making regarding new drugs for rare diseases.
The names of other drugs on the common list will be published online under Health Canada on a drug-by-drug basis following the conclusion of the pCPA price negotiations for each drug. (https://www.canada.ca/en/health-canada/corporate/transparency/health-agreements/shared-health-priorities/drugs-for-rare-diseases-bilateral-agreements/common-list-drugs.html) A full copy of the agreement can be found at https://www.canada.ca/en/health-canada/corporate/transparency/health-agreements/shared-health-priorities/drugs-for-rare-diseases-bilateral-agreements/saskatchewan.html#a5
