MORSE Consulting’s Lana Duan gave a virtual presentation at the recent CDA-AMC symposium 2026 on Subsequent Submissions in Canadian Market Access, focusing on trends, timelines, and outcomes at CDA-AMC, pCPA, and jurisdictional listing.

As drug development increasingly targets diverse populations and evolving treatment paradigms, understanding market access for therapies with expanding clinical criteria and/or new indications is critical. We speculated that prior positive HTA reviews do not guarantee success for subsequent submissions for the same drug, as robust clinical evidence is the key determinant for HTA success; on the other hand, existing pCPA LOIs and prior listings can accelerate access for subsequent submissions for the same product, likely by reducing negotiation complexity and minimizing implementation challenges.

We looked at non-oncology drugs with final CDA-AMC recommendations between 2015-2025, excluding non-sponsored and request for advice reviews, and categorized files by whether the drug had a prior review completed in the timeframe and classified by reason for subsequent review (criteria change, resubmission, or new indication). Two reviewers then sub-categorised criteria change submissions by expansion type, including age group or subtype.

We found that among 23 criteria-change submissions, nearly half involved age expansion, mostly from older to younger populations. Prior CDA AMC reviews did not ensure success for subsequent submission, but new indication submissions showed higher success rate, and both criteria change and new indication submissions showed faster downstream timelines at pCPA and jurisdictional listing. Existing negotiations, agreements, and system familiarity likely improve efficiency in pCPA negotiations and provincial implementation.

Access the virtual presentation at CDA-AMC’ symposium attendee hub until end of July 2026: Visit Attendee Hub (Sponsors and e-presentations -> Abstract presentations)”