As previously indicated in our July 2025 bulletin, the Régie de l’assurance maladie du Québec (“RAMQ”) has been implementing significant reforms to the Exceptional Patient Measure (in French, la mesure du patient d’exception, “PE Measure”). The latest RAMQ notice has now confirmed that the last stage of these changes will come into effect on December 11, 2025.
Key Requirement Now Enforceable
For patients to access any new drug or indication through the PE Measure, the manufacturer must:
- Submit an application to Institut national d'excellence en santé et services sociaux (INESSS) for listing within 120 days of receiving Health Canada’s Notice of Compliance (“NOC”), and
- Obtain a positive admissibility decision from INESSS, which follows the manufacturer’s two-month advance notice, and confirms that the contents of the application, namely, the results of clinical and pharmacoeconomic studies, are sufficient for INESSS’ evaluation.
If these conditions are not met within the 120-day period, requests for coverage under the PE Measure for that indication will be refused.
Exceptions
The 120-day rule does not apply if:
- The NOC was issued before December 11, 2025.
- INESSS has published a notice to the Minister regarding the indication in question.
- Reimbursement for the drug has already been authorized under the exceptional patient provision.
- The patient began taking the drug covered by private insurance while it was eligible.
Implications
Manufacturers must ensure timely submissions to INESSS to maintain eligibility but even so, patients may lose access to important medications.
