Pangaea Express: Stricter Requirements for Patient d'exception

RAMQ announced their changes to Patient d’exception bringing in stricter requirements rolled out in three phases between July 2 to December 11, 2025. Patient d’exception is a program that allows coverage by RAMQ for medicines not included in the List of Medicinesand for exceptional drugs prescribed for a therapeutic indication that does not appear on the List of Drugs. The phases for the new requirements:

1. July 2, 2025 Therapeutic Value and Payment Authorization

a. Drugs whose therapeutic value are not recognized by INESSS are excluded from the patient d’exception. (This applies to INESSS opinions of a drug after July 2, 2025)

Exceptions to this rule include:

• The request was accepted before the publication of INESSS's unfavourable opinion
• The request is for the same indication, but the person has different characteristics from those of the population studied by INESSS (additional studies must be provided to INESSS)
• The treatment was already started with an institution’s pharmacologic committee approval

b. Applications for payment authorization request must contain all required documents or the application may be refused

2. Sept 25, 2025 – Generic Drugs Reimbursed

If a generic is marketed in Canada, only this version may be reimbursed. Exceptions include shortages or allergies to the generic versions.

3. Dec 11, 2025 -120 Day Deadline

For any new indication or new drug, the manufacturer must, within 120 days of receiving Health Canada’s Notice of Compliance submit to INESSS and receive a positive admissibility decision from INESSS (all submission documents are approved).

Where the 120 day requirement does not apply:

• As soon as a manufacturer receives a positive opinion of admissibility from INESSS, the application can be evaluated by the RAMQ
• Drugs can be renewed if already authorized through exceptional patient process
• NOC issued before December 11, 2025, the application may be evaluated by the RAMQ

Patient d’exception has helped thousands of Quebec patients gain access to medicines. Data shows in 2022, over 35,000 people used this measure with close to 350,000 requests accepted over a 10-year period.1 In the past, if a manufacturer only went the private route, patient d’exception was still available for other publicly reimbursed patients. Now, the 120-day deadline means that manufacturers no longer have much choice whether to delay submission to INESSS or submit at all if they want the drug to be accessible for any patient through this program.  The degree to which these new requirements will limit the use of the exceptional patient process remains to be seen. But it is very likely there will be patients who will not have access to medicines to treat an urgent need.

1  The Exceptional Patient Measure: A Safety Valve Allowing Quebecers in Need to Access Innovative Drugs

For more information, please contact Suzanne Solman at ssolman@pangaea-consultants.com or Marla Weingarten at mweingarten@pangaea-consultants.com