Lilly Canada’s Omvoh® medication took another step towards becoming available to people in Canada with moderate or severe ulcerative colitis, namely the successful conclusion of pan-Canadian Pharmaceutical Alliance (pCPA) negotiations on September 3, 2024 (see step 3 in the backgrounder that follows).
This is welcome news since the possibility of running out of treatment options is a concern of those in the Crohn’s and colitis community. More approved drug treatment options are always welcome.
Despite completing the first three approval steps in the drug approval process, this is not a guarantee that Omvoh® will be available in all provinces. Despite all provinces participating and following a shared approach on the pCPA, individual provinces may choose not to cover a drug under their provincial drug programs. In provinces such as British Columbia and Quebec, if a drug is not included in the provincial drug plan, private insurance providers will also not include it.
Crohn’s and Colitis Canada calls on all provinces to reimburse all drugs recommended by pCPA in the same way. Equal access to approved medications – regardless of where someone lives in Canada – is essential to achieve our promise to cure Crohn’s and colitis and improve the quality of life of everyone affected by these diseases.
Backgrounder - Canada’s drug approval process explained
Step 1 – Health Canada Approval
Approval of new medications by Health Canada is the first step in making new drugs available to people in Canada. Health Canada reviews new drugs for safety, efficacy and quality in accordance with Canada’s Food and Drug regulations. Upon successful review, a Notice of Compliance (NOC) is issued.
Step 2 – Health Technology Assessment
Following Health Canada approval, health technology assessments are undertaken by Canada’s Drug Agency (CDA-AMC) as well as Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS). These agencies consider available evidence regarding clinical effectiveness, safety and cost-effectiveness of the drug under review. Following consultation with expert(s) and review of submissions from the public (patients and patient organizations), recommendations are published outlining whether the drug should be reimbursed and under what conditions.
Step 3 – pan-Canadian Pharmaceutical Alliance (pCPA) Negotiations
Following a positive recommendation from CDA-AMC and/or INESSS, the pCPA may enter negotiations with the manufacturer on behalf of federal, provincial and territorial governments on the price of the drug. Successful negotiations conclude with a letter of intent (LOI) setting out the agreed price and other terms.
Step 4 – Approval by Drug Plan Managers
Each province or territory then enters final negotiations with the manufacturer. Failed negotiations at this final stage lead to discrepancies between provinces and territories on the list of drugs they cover.
Impact of Canada’s approval process
A recent analysis by Innovative Medicines Canada reveals that Canadian patients typically have a two-year wait between new drug approval by Health Canada and inclusion in public drug plans. As a result, patients in the United Kingdom, Australia, and many European Union countries gain access to approved medicines a year or more sooner than Canadians.