Presentation (CTI)

OBJECTIVES: There is growing awareness of the challenges faced by introducing innovative medications in women’s health in Canada. This study aimed to generate quantifiable and tangible evidence on the access to innovative women’s health products in Canada.
METHODS: A targeted literature review (TLR) was conducted to identify women’s health conditions, excluding oncology. The Food and Drug Administration (FDA) database was searched for medications approved between January 1, 2003 to December 31, 2023 for each condition identified in the TLR. Searches were conducted on Health Canada (HC) database to verify if FDA-approved medications were also approved in Canada. If a medication was approved in Canada, Canada’s Drug Agency (CDA-AMC), INESSS, pan-Canadian Pharmaceutical Alliance (pCPA) and provincial drug plans (Ontario, Alberta, British Columbia, and Quebec) were searched to determine if the medication underwent public assessment, the outcome of the assessment, the pricing negotiation, and ultimately the listing decisions. For private payer coverage, publicly available information were searched.
RESULTS: Ten women’s health conditions were identified, corresponding to 45 drugs approved by the FDA. Of these, only 24 (53%) were also approved in Canada. Although 18/24 (83%) of drugs approved by HC sought public reimbursement, only 13 have been reimbursed publicly as of July 2024. Women’s health medications in Canada take over 3 years from approval to access, compared to approximately 2 years for general new active substances. In contrast to public reimbursement, at least 21 of the 24 approved medications are covered by private insurance.
CONCLUSIONS: Given the limited approval of innovative medications in Canada and the lengthy delays in accessing those that are approved, it is crucial for Canadian stakeholders to acknowledge the importance of women's health conditions and prioritize timely access to innovative treatments for Canadian women.