Draft Quebec regulations propose fees for INESSS submissions

Despite a decentralised healthcare system in Canada, all provinces and territories except Quebec, follow the national body CADTH. Companies seeking reimbursement in Quebec must also make an application to the Institut national d’excellence en santé et en services sociaux (INESSS).

On February 21 2018, the Gazette officielle du Québec announced that draft regulations, proposing the introduction of fees for manufacturers submitting a scientific evaluation in Quebec., which have been submitted to the government of Québec for approval.

The fees will vary according to the type of dossier submitted to INESSS for scientific evaluation, as shown below, and intend to be less than those for CADTH, except for biosimilar submissions.

CADTH
(CDR & pCODR)
INESSS
(proposed)
TOTAL
Submission for a new drug for review $72,000(single indication) $38,921 $110,921
Submission for an existing drug for the review of a new indication $72,000 $38,921 $110,921
Submission for each subsequent indication $57,600 $38,921(if submitted separately) $96,521
Submission for a biosimilar $7,000 $19,460 $26,460

For a full list of the fees payable by types of scientific evaluation, please consult page 3 of the draft in the Gazette Officielle du Québec for INESSS and Appendix 1 of the February 2018 Guidelines for Manufacturers on Application Fees for CADTH Pharmaceutical Reviews.

For more information, see Morse Consulting.

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Published 7. March 2018 in News Canada