New INESSS Evaluation Fee Schedule

Author: Patrick Manfred, Vice-President, TACT Conseil, Quebec Market Access Expert

Date: June 2, 2021

A proposal to modify the current regulation framing the fees payable to the Institut national d’excellence en santé (INESSS) to complete a scientific evaluation of a drug and/or a stable blood product was published in Part 2 of the Quebec Official Gazette, on March 18, 2021. If the Quebec government does not deviate from the regulatory calendar, the new fees are anticipated come into force as early as mid-June 2021. INESSS will update its fee schedule online as soon as the amendment to the Regulation respecting the fees payable by INESSS for the evaluation of a drug and a stable blood product is adopted. All the details related to INESSS submission fees can be found at:

https://www.inesss.qc.ca/en/themes/medicaments/manufacturer-information-centre/fees.html

Please find below the newly proposed fee schedule. Note, several new categories have been introduced. In addition, certain existing categories will experience a significant increase, while others (for example biosimilars) will only see a modest increase.

FEES PAYABLE FOR THE VARIOUS SCIENTIFIC EVALUATIONS

Scientific evaluation		Fees
Evaluation object	Type
New cellular or gene therapy	First evaluation	$89,796 per indication
	Re-evaluation	$59,864 per indication
New medication with companion test or new indication of a listed medication with a companion test	First evaluation	$68,844 per indication
	Re-evaluation	$35,918 per indication
New drug or new indication for a currently listed drug or a stable blood product	First evaluation	$59,864 per indication
	Re-evaluation	$35,918 per indication
New cutting-edge therapeutic product	First evaluation	$89,796 per indication
New radiopharmaceutical	First evaluation	$89,796 per indication
	Re-evaluation	$35,918 per indication
New medical device directly linked to the administration of a drug	First evaluation	$59,874 per dossier
	Re-evaluation	$35,918 per dossier
New biosimilar	First evaluation	$8,980 per dossier
	Subsequent evaluation (new indication)	$8,980 per dossier
	Re-evaluation	$4,490 per dossier
New concentration, strength(s) or new form(s) of a currently listed drug	First evaluation	$8,980 per dossier
	Re-evaluation	$4,490 per dossier
New nutritional formula or combination of drugs already listed or a new diagnostic agent of a currently listed non-proprietary name already registered on the drug lists	First evaluation	$5,986 per dossier
	Re-evaluation file	$2,983 per dossier
New dressing	First evaluation	$11,973 per dossier
	Re-evaluation	$5,986 per dossier
Exemption from the application of the lowest price	All exemption requests	$8,980 per dossier

Reference

http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=13&file=2111A-F.PDF

Please contact Patrick Manfred for further information on this matter.

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Patrick Manfred

Passionate about government relations, Patrick has acquired extensive expertise in analyzing health sector issues and developing particularly effective strategic plans to meet client needs while considering the impact on government decision-makers. Results-oriented, he is recognized for his ability to develop innovative solutions, with a win-win approach for the partners involved.
For over 15 years, he held senior positions across Canada, in business development, public and government relations, in various innovative companies. His knowledge and know-how affect both primary and specialized care, with demonstrated skills in negotiating and establishing rapid and optimal reimbursement of drugs and services in the public and private sectors, both in Quebec and in the rest of the country. Canada.