INESSS has announced the implementation of a waiting list for requests for scientific evaluation received by INESSS as of November 16, 2020. PDCI has outlined below the key highlights from the most recent newsletter.
The Institut national d’excellence en santé et en services sociaux (INESSS) has reported a significant increase in requests for scientific evaluation from manufacturers. The current available resources do not allow them to meet the current demand within the time limits previously committed to. Therefore, INESSS announced via the INESSS Express newsletter, dated November 30, 2020, the establishment of a waitlist for the scientific evaluations of drugs, stable blood products and technologies.
Terms of the Waitlist
- Manufacturers may continue to submit their requests for evaluation at any time.
- The review of admissibility will be made as soon as possible, on a first come, first served basis.
- If there is a waiting list, INESSS is committing to advising manufacturers of the admissibility decision within 15 working days of receipt of the request filing.
Note: this situation applies to requests for evaluations received by INESSS as of November 16, 2020.
- INESSS will communicate the admissibility decision to the manufacturers in a letter sent by email. The manufacturer may be informed that their file is:
- Not admissible, or
- Admissible and put on the waiting list, or
- Admissible and the assessment is initiated.
Requesting Waitlist Prioritization
A manufacturer can request that their file be prioritized in the waitlist when completing the mandatory advance notification form. This request is subject to INESSS’ decision. If the criteria are met, the applications will be evaluated on a first come, first served basis, before other pending evaluations that are not prioritized.
Criterion for Waitlist Prioritization
- The drug is aimed at treating a serious health problem;
- The available data suggest that the drug significantly improves the health state of patients compared to the current treatment options listed in the Liste des Medicaments or the Liste des medicaments – Establishments
- Potential to generate savings in the health and social services system.
For more information, please consult the
INESSS Express newsletter dated November 30, 2020.
Please contact Ara Salazar, Director of Market Access, to learn more about how these changes may affect your upcoming submissions.