At a Glance

4years
Of non-oncology DRD review data (2022–2025)
>60
DRDs reviewed by CDA-AMC and INESSS each
>50
DRDs received recommendations from both agencies
>2/3
Received aligned evaluations from CDA-AMC and INESSS

What the data shows

Most drugs for rare diseases (DRDs) seeking public coverage in Canada are assessed by two separate health technology assessment (HTA) agencies: CDA-AMC, which informs public drug plans across most of the country, and INESSS, which advises Quebec. Because each reviews the same drug independently, manufacturers can't assume one decision predicts the other.

MORSE analysis shows that more than 2/3 of DRDs reviewed by both CDA-AMC and INESSS in the past 4 years had aligned evaluation results.

Both agencies each reviewed more than 60 DRDs over the period, and more than 50 received recommendations from both — the basis for this alignment comparison. Although CDA-AMC reported higher positive recommendation rates than INESSS, the agencies reached concordant recommendations for the majority of submissions assessed by both.

MORSE Consulting infographic titled 'In the past 4 years, more than 2/3 of DRDs reviewed by both CDA-AMC and INESSS had aligned evaluation results.' It shows three charts: the share of DRD files receiving a positive CDA-AMC recommendation each year from 2022 to 2025 (the large majority positive each year); the share receiving a positive INESSS recommendation each year (a smaller majority positive); and a doughnut chart showing that more than two-thirds of files reviewed by both agencies were aligned, with a smaller not-aligned share.
The full MORSE data view — click to open full size. Download as PDF. Feel free to share with attribution.

Why it matters

Although CDA-AMC and INESSS decisions are generally aligned, meaningful differences remain, leading to divergent outcomes for a subset of submissions. These divergences highlight the importance of understanding each agency's distinct assessment priorities and decision-making considerations.

Differences in patient populations, available therapies and relevant comparators, treatment paradigms, and how each agency weighs clinical evidence, uncertainty, economic value, and unmet need may contribute to differing DRD recommendations and reimbursement outcomes.

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Accounting for Distinct HTA Perspectives

Understanding the factors underlying divergent CDA-AMC and INESSS recommendations can help sponsors plan for both agencies from the outset. Considering the factors most likely to influence each agency’s assessment of a given DRD can strengthen evidence generation, value demonstration, and reimbursement strategies across Canada.

Methodology & sources

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How we measured it

Data accurate as of April 17, 2026. This analysis uses the methodology of MORSE's CRaFT DRD Sub-report: a DRD is defined as a non-oncology file with an indication reviewed by CDA-AMC and designated "orphan" by either the European Medicines Agency (EMA) or the United States Food and Drug Administration (FDA) per the Orphanet portal; oncology and blood products are excluded. An INESSS recommendation is considered "positive" if the therapeutic value is recognized. Aligned recommendations include files receiving positive recommendations from both CDA-AMC and INESSS, and files receiving negative recommendations from both.

Sources: CDA-AMC Reimbursement Reviews; Orphanet — Search for an orphan drug; INESSS — Drug products undergoing evaluation and evaluated; CRaFT 2026 DRD Sub-Report, MORSE Consulting, 2026; and the MORSE Consulting Data Intelligence Tool.

What's next

For a deeper dive into Canadian market access for DRDs, MORSE's CRaFT DRD Sub-Report 2026 provides detailed analyses and insights into trends, outcomes, timelines, and outliers for non-oncology DRDs in the Canadian market.

MORSE's Canadian market access data supports evidence-based insights for complex questions. If your team is facing a market access challenge, we would welcome the opportunity to connect.

Order the CRaFT DRD Sub-Report   Talk to MORSE