Stage 1 · Regulatory
Health Canada
Asks: is it safe? Does it work? Is it made to a good standard?
Health Canada's Health Products and Food Branch reviews the scientific evidence from preclinical and clinical trials, and how the drug is manufactured, packaged and labelled, to determine its safety, efficacy and quality. The sponsor files a New Drug Submission (NDS), or a Supplement to an NDS (SNDS) for a new indication of an approved drug.
NOCNotice of Compliance — the drug is approved for sale in Canada for the indication.
NOC/cApproval with conditions — approved on promising evidence, with confirmatory studies required.
NONNotice of Non-compliance — not approved until deficiencies are addressed.
Approval is a licence to sell, not a promise that anyone will pay. In Canada the two are separate decisions, made by different bodies, on different evidence.
Where MORSE helpsPlanning the reimbursement evidence package alongside the regulatory one, so reimbursement may proceed as soon as the NOC lands.
Services →HTA: CDA-AMC and INESSS
Asks: how does this compare with what we already have — and is it worth the price?
Once a drug is approved (and increasingly, in parallel with approval), it goes to a health technology assessment body. HTA looks at the clinical evidence against existing treatment options, the cost-effectiveness of the drug at its proposed price, its budget impact, and patient and clinician input, and then recommends to public drug plans whether they should reimburse it and on what conditions.
Canada has two: CDA-AMC for all provinces and territories except Québec, and INESSS for Québec. Their processes are similar, but their conclusions may align or differ. They run separately, and a sponsor files to both.
CDA-AMC (Canada's Drug Agency)
Formerly CADTH, renamed in 2024. Its expert committees — CDEC for non-cancer drugs and pERC for cancer drugs — use a deliberative framework to consider clinical value, unmet clinical need, economic considerations, health-system impact and, since the 2025 process enhancements, social and ethical considerations. They then issue a recommendation to which negotiating conditions may be attached.
Reimburse
Reimburse with conditionsThe most common outcome; conditions often include a price reduction.
Do not reimburse
INESSS (Québec)
INESSS conducts a two-step evaluation of new medicines. First, it assesses the drug's therapeutic value, including its clinical benefits and place in therapy. If therapeutic value is recognized, INESSS evaluates reimbursement value, considering price, cost-effectiveness, budget impact and the medicine's contribution to the needs of Québec's population. INESSS provides recommendations to Québec's Minister of Health regarding inclusion on the provincial drug formulary.
Register
Register with conditionsMay include registration as an exception drug.
Refusal to register
Where MORSE helpsHTA strategy and submission support, and the data behind it — MORSE tracks every CDA-AMC and INESSS decision and how they align.
Insights: HTA alignment →pCPA (pan-Canadian Pharmaceutical Alliance)
Asks: what confidential price and terms can participating public plans agree upon?
Rather than each public plan negotiating separately, participating federal, provincial and territorial plans negotiate together through the pCPA. Using the HTA recommendation as its starting point, the pCPA negotiates confidential prices and coverage terms with the manufacturer. A successful negotiation ends in a Letter of Intent, which each plan then turns into its own product listing agreement. Expedited pathways include the early negotiation process (ENP) for select oncology drugs and the pCPA Temporary Access Process (pTAP) for promising drugs with conditional approval.
Concluded with an LOIAgreement in principle on net price and reimbursement terms and conditions.
Concluded without agreementNo joint agreement was reached.
Negotiation not pursuedThe pCPA did not open a negotiation.
Where MORSE helpsNegotiation strategy and net-price forecasting, grounded in what comparable drugs actually achieved and how long it took.
CRaFT report →Public payers
Asks: can we afford it, and for which patients?
Each province and territory, and federal programs such as the Non-Insured Health Benefits program, runs its own drug plan with its own formulary. After the pCPA Letter of Intent is executed, each plan decides whether to list the drug, under what clinical criteria and reimbursement mechanism, and when. Listing is not automatic or simultaneous across drug plans: the same drug can be available in one province months before another.
Full benefitCovered for eligible plan members without special approval.
Special authority / exceptional accessCovered when specific criteria are met, usually on request from the prescriber.
Not listed/reimbursed
Where MORSE helpsProvincial listing forecasts and launch sequencing, drawn from MORSE's public payer dataset.
Reports →Private payers
Asks: will we cover it for our plan members, and how?
Most working Canadians and their families get drug coverage through an employer-sponsored plan run by a private insurer. Private plans make their own decisions, generally soon after Health Canada approval and usually without waiting for HTA or the pCPA, so private payer coverage can provide an earlier route to patients. Insurers increasingly manage high-cost drugs with prior authorization, managed formularies and their own negotiated agreements. Public and private benefits may also be coordinated, which raises the question of which plan pays first.
Where MORSE helpsPrivate payer strategy and evidence — see MORSE's Insights on drugs for rare diseases in private plans.
Insights: private payers →PMPRB (Patented Medicine Prices Review Board)
Asks: is the list price excessive compared with other countries?
The PMPRB is a federal body that runs alongside the reimbursement path. From first sale, it monitors the list price of every patented medicine. Under the Guidelines in force since January 2026, prices are screened against the highest price in a basket of eleven comparator countries (the PMPRB11) and against inflation; a price above those thresholds triggers an in-depth review. The PMPRB regulates the ceiling on the list price, not the confidential net price negotiated with payers.
Where MORSE helpsPricing strategy that works within the PMPRB ceiling and the payer negotiation at the same time.
Services →Patients
Asks: can I get it, and who pays?
Public and private coverage follow different routes and may sometimes be coordinated, but both lead to the same patient-level questions: does my plan cover this treatment, do I meet its criteria, and what portion might I need to pay myself? The gap between "approved in Canada" and "accessible to me" is where most of the confusion — and most of the work of market access — lives.
Where MORSE helpsClosing that gap: MORSE works with manufacturers to bring evidence, price and timing together so that a good drug becomes a covered one.
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