On July 23, 2024, the Governments of Canada and British Columbia (BC) announced the execution of a National Strategy for Drugs for Rare Diseases (DRD) Agreement. This is the first DRD agreement reached since the federal government announced its rare disease strategy in early 2023.
Background
As we reported, in March 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase access to, and the affordability of, new and emerging drugs for rare diseases, and to support enhanced access to existing drugs, screening, and early diagnosis. Up to $1.4 billion of the investment is to be allotted to the provinces and territories through bilateral agreements.
Common List
The federal government engaged with provinces and territories to develop a small common list of drugs to be funded and cost-shared nationwide. 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 in Canada.
New drugs for addition to the common list will be published online by Health Canada, on a drug by drug basis, after the pan-Canadian Pharmaceutical Alliance (pCPA) concludes its price negotiation process. The identity of any drug for addition to the common list will not be disclosed prior to the conclusion of a Letter of Intention by the pCPA. P/T who choose to sign bilateral agreements may then elect to make the drugs on the common list available to their residents.
At present, there are only 2 drugs publicly announced on the common list:
- Poteligeo (for the treatment of mycosis fungoides or Sézary syndrome – the most common forms of a rare type of blood cancer); and
- Oxlumo (for the treatment of primary hyperoxaluria type 1 – a rare condition which leads to crystals forming in the body).
BC elected to make both drugs available to its residents.
British Columbia DRD Agreement
According to the Government of Canada’s announcement, through the DRD Agreement, the federal government agreed to provide $194 million over three years (beginning in 2024-2025) to improve access to drugs for rare diseases, early diagnosis, and screening, beginning with funding to support BC in providing access to the common list’s two drugs.
Eligible expenditures by BC which the federal government has agreed to contribute to under the DRD Agreement include:
- operating costs such as salaries and benefits, training and professional development, travel and accommodation, materials and supplies, and equipment;
- costs related to changes to public drug plans (e.g., adding new drugs to the formulary);
- costs associated with improving and broadening rare disease treatments and services;
- information technology and related investments, including enhancement of data collection, analysis, and sharing capacity; and
- activities associated with evaluation and reporting obligations.
BC must submit annual financial statements to the federal government tracking use of the funding and any carryover or overpayment. BC must also submit an annual report on the outcomes and results achieved used the funding. Those results will be made publicly available on the Government of BC’s website.
BC has also committed to work with Canada, and with other provinces and territories who may sign bilateral agreements, on developing and implementing a plan for improving screening and diagnostics for rare diseases. The planning work will take place over the first two years of the agreement period, with investments to begin no later than the third year.