INESSS is mandated to evaluate drug listing requests and then make recommendations to the Minister of Health and Social Services as part of the updating of the List of Medications (the formulary for the basic drug insurance plan) and the List of Medications – Institutions.
Approach to Evaluating Drugs for Listing Purposes
INESSS carries out its drug evaluation mandate on the basis of the four aspects provided in Section 7 of its Constituent Act:
In exercising the functions described in Paragraph 8 of Section 5, the Institute must first assess the therapeutic value of a medication. If this is not established to its satisfaction, INESSS sends a notice to that effect to the Minister.
If the Institute considers that the therapeutic value of a medication has been established, it sends its recommendation to the Minister after assessing:
- the reasonableness of the price charged;
- the cost-effectiveness ratio of the medication;
- the impact that entering the medication on the list will have on the health of the general public and on the other components of the health and social services system;
- the advisability of entering the medication on the list, given the purpose of the basic prescription drug insurance plan.
These four evaluation aspects are also used by INESSS in exercising the functions described in Paragraph 9 of Article 5.
The evaluation of drugs for listing purposes was updated in July 2018 following recent developments in the area of drug evaluation and new, innovative therapies.
This document explains the drug evaluation approach used at INESSS. It includes a description of the basic principles that apply to all products for listing purposes.
Process of Evaluating Drugs for Listing Purposes
The drug evaluation process includes a number of steps and is spread over a period that can vary from 90 to 180 days, depending on the type of request. INESSS’s commitments to evaluating medications are stated in its Declaration of Services to Citizens.
- A manufacturer planning to forward an evaluation request for a new drug, a previously listed drug, a biosimilar drug or a product analog to a complex non-biologic medication must advise INESSS at least two months in advance, using the advance notice form. This period allows INESSS to plan its evaluation work and to start the consultation process with citizens, patients, caregivers, health professionals, associations and groups by posting the drug on its work plan. The consultation period begins four weeks before the manufacturer’s target date for submitting its evaluation request and lasts for a total of seven weeks.
- The drug manufacturer submits a Registration Application to INESSS. This request includes in particular the clinical and pharmacoeconomic study results. INESSS draws on the information provided by the manufacturer and also uses any studies or additional information it considers relevant.
- If the request submitted is admissible, INESSS changes the evaluation status on its work plan for medications already posted and adds the admissible requests for which no advance notice is required. This plan is published on the Institute’s website in the Drug Products Undergoing Evaluation and Evaluated section in the Continuous Evaluation table; it is updated weekly.
- All of the scientific evidence is analyzed by professionals in the Direction du médicament [drug branch] and members of the Comité scientifique permanent de l’évaluation des médicaments aux fins d’inscription (CSEMI) [standing scientific committee on entry on the list of medications]. Outside experts are usually called on to collaborate, particularly when new drugs are being evaluated. Voting committee members deliberate over the evaluation aspects set out in the Act respecting the Institut national d’excellence en santé et en services sociaux.
- The CSEMI or the Direction de l’évaluation des médicaments et des technologies à des fins de remboursement forwards its report to INESSS’s Board of Directors, which then ratifies the recommendations for medications that have received a Notice of Compliance from Health Canada for the indication under study.
- The Minister of Health and Social Services is responsible for deciding whether or not to make a listing available in Québec and uses INESSS’s recommendation to update the lists of medications at the appropriate time.
- INESSS issues the Notices to the Minister containing its post-evaluation recommendations for specific drugs and the reasons therefor. These Notices to the Minister are available on INESSS’s website after a 30-day moratorium. At the time they are made public, the List of Medications (the formulary for the basic drug insurance plan) and the List of Medications - Institutions are published in electronic format by the Régie de l’assurance maladie du Québec.
- The Minister’s decisions are published on INESSS’s website in the Drug Products Undergoing Evaluation and Evaluated section, in the Evaluated Drug Products table.