During the course of its evaluation process for the registration of drug products, INESSS offers the opportunity of a presubmission appointment with the drug manufacturers.
The evaluation requests for a new drug or a new indication for a drug already registered are targeted. The drug may have received a Notice of Compliance from Health Canada or its Notice of Compliance may be pending. More specifically, this corresponds to requests submitted to INESSS in accordance with checklist 1 or 2.
For cost-effective reasons, only one appointment is allowed per drug and per indication. The appointment may be sought 3 to 12 months prior to the target date for the submission of the evaluation request to INESSS. In certain cases, the appointment can allow the reduction of delays for the benefit of new drugs becoming accessible. Note that, when a presubmission meeting has taken place, a post-submission appointment is not deemed relevant, except in extraordinary circumstances.
Significant issues must be identified by the manufacturer when putting together the evaluation request to justify a presubmission appointment.
For example, it can relate to:
- clinical issues: uncertainties on clinical data (non-comparative, indirect comparison, network metanalysis), the choice of comparator, the connection between primary objective and overall survival, quality of life, the drug’s position in the therapeutic armamentarium, indication of the requested reimbursement;
- economic issues: the choice of the type of pharmacoeconomic analysis and budgetary impact, uncertainty on clinical and economic inputs, the choice of comparator, the method of extrapolation of the data, the choice of sensitivity analyzes.
Specific objectives of the presubmission appointment are:
- to allow INESSS to take note of the outline of the request file, primary data concerning the therapeutic value of the drug and the significant issues identified by the manufacturer;
- to give the manufacturer the opportunity to discuss with INESSS the direction it wishes to take in the putting together of its evaluation request;
- to allow to ascertain, where necessary, certain alignments which do not require specific knowledge of the file. It should be noted that the items under discussion will reflect INESSS scientific professionals’ opinion, without any commitment on the avenues that will be followed during the evaluation of the request.
Terms and conditions
- The request for appointment must be forwarded according to the template letter Demande de rencontre présoumission.
- This letter must be accompanied by the completed form Demande de rencontre présoumission : Nouveau médicament ou nouvelle indication d’un médicament and, when possible, by all the required documents.
- The request must be sent by email to the following address: email@example.com.
- INESSS evaluates the possibility of proceeding with this appointment, and thus informs the manufacturer without undue delay. In that case, it schedules the appointment meeting. The invitation for the meeting is sent by INESSS
- The manufacturer must provide a proposed agenda, the name of the people who will be present, all documents listed in the form that haven’t already been transmitted as well as all additional documents necessary to the meeting. This information must be sent 10 business days before the date of the meeting.
- For the manufacturer, a maximum of four people including, if applicable, an external consultant for economic aspects.
- For INESSS, up to four representatives, including professionals and scientific coordinators.
Conduct of the virtual meeting
- Summary of indication of the drug and clinical data;
- Presentation of the manufacturer’s direction concerning the clinical and economic aspects;
- Presentation by the manufacturer of significant issues it identified, including what could be a source of pharmacoeconomic uncertainty;
- Discussion period.
During the meeting, an electronic copy of the documents presented must have been received at least 24 hours before the meeting.
Duration of meeting
45 minutes maximum, including the exchange period.
For any questions regarding the process of the presubmission appointment, you may contactthe Direction de l’évaluation des médicaments et des technologies à des fins de remboursement by email firstname.lastname@example.org