The Institut national d’excellence en Santé et en services sociaux (INESSS) has recently updated the Guidance Document for Submitting a Request to INESSS and affiliate documents. This document consolidates updates previously communicated through manufacturer notices and replaces the 2018 version of the guidelines.
These changes are effective March 1, 2023. Manufacturers should review the guidelines in detail while preparing registration applications to be filed on or after this date and ensure to consult the INESSS website for current templates.
A summary of changes including recommendations, revisions and new information is provided below.
- Enhance collaboration for HTA submissions by submitting to CADTH and INESSS at the same time for reviews undergoing the aligned review process.
Revisions/ Additional Details:
- Updated forms (fiche) 1-13 and A-C
- Letter of authorization to share information – template update
- Formulaire description sommaire – updated sections
- Price justification – revised table
- Price confidentiality – new section
- Pharmacoeconomic study – table from previous form has been removed and manufacturers are free to present results as they wish
- Budget Impact analysis – has been updated to better align with how BIA results are presented in published Recommendations
- Electronic submission process and file naming conventions (see section 1.2)
- Indirect comparison – additional guidance provided on the required information when submitting published and unpublished indirect comparisons (see section 4.4)
- Comparators – additional information provided with regards to preferred comparators (see section 4.5)
- New form (fiche) 13 – Lowest Price Method Exemption Request
- New template – Biosimilar formulaire description sommaire
- Acceptance of real-world evidence in addition to published studies (section 4.8/Appendix V) – includes a detailed list of information required when submitting real world studies
- Pharmacoeconomic study (section 5.1) disclosure of names of Quebec / Canadian clinicians or experts who have been consulted.
Please contact Ara Salazar, Director, Market Access at email@example.com for any questions or further information.