How Canadian reimbursement works
Health Canada authorises a medicine, but public coverage is a separate path. Outside Quebec, the sponsor files a reimbursement review with Canada's Drug Agency (CDA-AMC), the operating name CADTH adopted on 1 May 2024. In Quebec, the Institut national d'excellence en santé et en services sociaux (INESSS) runs its own evaluation and advises the Minister of Health.[1]
CDA-AMC reviews are deliberated by expert committees: the Canadian Drug Expert Committee (CDEC) for non-oncology drugs and the pan-Canadian Oncology Drug Review Expert Committee (pERC) for cancer drugs. The committee issues a recommendation to the participating public drug plans. A positive recommendation from CDA-AMC or INESSS then opens the pan-Canadian Pharmaceutical Alliance (pCPA) process, where public drug plans negotiate collectively with the manufacturer. Each plan decides when to list the drug on its own formulary.
Separately, the Patented Medicine Prices Review Board (PMPRB) reviews the prices of patented medicines sold in Canada. It is a price review body, not an HTA agency, and its role runs alongside reimbursement rather than as a step in it.
- 50 business daysAdvance noticeRequired before a submission, under the April 2026 procedures
- ReviewCDA-AMC reimbursement reviewStandard, complex, tailored or other pathway
- RecommendationCDEC or pERCFinal recommendation targeted within 180 calendar days, for submissions from August 2026
- NegotiationpCPAAfter a positive recommendation; an agreement leads to a letter of intent
- ListingEach public drug planSets its own listing timing
In Quebec, INESSS runs its own evaluation and advises the Minister. PMPRB reviews patented medicine prices separately.
CDA-AMC review types
The CDA-AMC Procedures for Reimbursement Reviews set out several pathways, and choosing the right one shapes the whole submission.[2]
| Pathway | When it applies |
|---|---|
| Standard | Most new drug applications that do not meet tailored or complex criteria |
| Complex | Added challenges, such as the first drug in a therapeutic area or tumour-agnostic therapies |
| Tailored | Drugs with anticipated comparable efficacy and safety to existing options, and selected new combinations or formulations |
| Plasma protein products | Products meeting the Canadian Blood Services eligibility criteria, under an interim process |
| Resubmission and reassessment | New evidence after a final recommendation, or revised conditions for a reimbursed drug |
Under the procedures CDA-AMC updated in April 2026, applying to submissions from August 2026, sponsors must give 50 business days' advance notice of a submission, resubmission or reassessment, and resubmissions follow a standard 180-day or a streamlined 150-day timeline. Tailored reviews usually carry a single pricing condition: the total drug cost should not exceed that of the appropriate comparators. A time-limited recommendation is available for drugs authorised under Health Canada's Notice of Compliance with conditions, or with terms and conditions, where a confirmatory phase III trial will complete within three years, with a reassessment filed within 270 calendar days of trial completion.
Evidence and methods requirements
Economic evaluations follow the CDA-AMC Guidelines for the Economic Evaluation of Health Technologies: Canada (4th edition). The reference case is specific and assessors check it closely:[3]
- Perspective: the publicly funded health care payer.
- Discounting: costs and outcomes beyond one year discounted at 1.5% a year.
- Outcomes: the QALY, with all outcomes weighted equally regardless of who receives them.
- Comparators: current care, meaning the interventions presently used in Canada.
- Time horizon: long enough to capture all relevant differences in costs and outcomes.
- Uncertainty: expected costs and outcomes derived through probabilistic analysis, not reported as a deterministic base case with a probabilistic add-on.
The probabilistic requirement matters most when a model is adapted from elsewhere. Models built around a deterministic base case often need their structure and reporting reworked, not only their inputs. See model adaptation and health economic modelling.
Quebec, INESSS and the PMPRB
INESSS assesses therapeutic value first. Where that is demonstrated, it considers the fairness of the price, the relationship between cost and effectiveness, the consequences for population health and the wider health and social services system, and whether listing fits the purpose of the general drug insurance plan. Its deliberative committee for reimbursement and access reports to the Board, and the Minister decides on listing. INESSS has its own submission guide, so a CDA-AMC dossier needs adaptation rather than a straight copy.
The PMPRB's new Guidelines came into effect on 1 January 2026. The Initial Review compares the Canadian list price with the highest international price among the schedule countries, and medicines above that threshold go to an In-Depth Review. Pharmacoeconomic value is not a factor in these Guidelines, so cost-effectiveness arguments belong in the HTA and pCPA work rather than the PMPRB filing.[4]
Global evidence and the EU JCA
Canada sits outside Regulation (EU) 2021/2282, so joint clinical assessment does not apply. In practice, though, many Canadian submissions are prepared alongside European ones. For new oncology medicines and ATMPs assessed under the JCA since 12 January 2025, the systematic reviews and indirect comparisons built for the EU dossier can often support the clinical section of a CDA-AMC submission, provided the comparators reflect Canadian current care. Planning the systematic literature review and indirect treatment comparisons with both uses in mind avoids duplicated work.
What we deliver
- Pathway assessment and eligibility inquiry support for CDA-AMC reviews
- Cost-utility models built or adapted to the Canadian reference case, with probabilistic analysis as the base
- Budget impact analyses for public drug plans
- Canadian costing and comparator selection reflecting current care
- Clinical evidence sections, systematic reviews and indirect treatment comparisons
- Adaptation of CDA-AMC dossiers for INESSS submissions
- Responses to reviewer questions and comments on draft recommendations
- Price threshold analysis to support pCPA discussions and resubmissions
What assessors look for
CDA-AMC reviewers critically appraise the sponsor's model and can reanalyse it under alternative assumptions. The issues that tend to drive a reanalysis are familiar:
- Comparators that do not reflect Canadian practice, or that omit a relevant option.
- Survival extrapolations that are not justified against external data or clinical opinion.
- Utility values or treatment durations that favour the new drug without clear support.
- Indirect comparisons with unaddressed heterogeneity between trials.
- A model that cannot easily be run probabilistically, or whose settings are hard to change.
A transparent, flexible model makes the reviewer's reanalysis closer to your own, and the price discussion that follows starts from common ground.
Why Evidaxia
We have worked on CDA-AMC projects and build cost-effectiveness and budget impact models for HTA bodies in Excel/VBA and Python. Our founder is a former NICE HTA Technical Lead and Analyst, so we build models expecting them to be reanalysed. See also UK HTA submissions.
References
- Institut national d'excellence en santé et en services sociaux (INESSS). Evaluation approach and process for medicines [Internet]. Quebec: Institut national d'excellence en santé et en services sociaux (INESSS); [date unknown] [cited 2026 Oct]. Available from: https://www.inesss.qc.ca/thematiques/medicaments/approche-modalites-et-processus-devaluation.html
- Canada's Drug Agency (CDA-AMC). Procedures for reimbursement reviews [Internet]. Ottawa: Canada's Drug Agency (CDA-AMC); [date unknown] [cited 2026 Oct]. Available from: https://www.cda-amc.ca/sites/default/files/Drug_Review_Process/Drug_Reimbursement_Review_Procedures.pdf
- Canada's Drug Agency (CDA-AMC). Guidelines for the economic evaluation of health technologies, 4th edition [Internet]. Ottawa: Canada's Drug Agency (CDA-AMC); [date unknown] [cited 2026 Oct]. Available from: https://www.cda-amc.ca/guidelines-economic-evaluation-health-technologies-canada-4th-edition
- Patented Medicine Prices Review Board (PMPRB). Guidelines [Internet]. Ottawa: Patented Medicine Prices Review Board (PMPRB); [date unknown] [cited 2026 Oct]. Available from: https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/guidelines.html
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.