As part of its blood system product (BSP) evaluation process, INESSS provides an opportunity to meet with manufacturers before they submit their requests.
These meetings deal with evaluation requests for new BSPs. Health Canada may already have issued a Notice of Compliance for the BSP, or the Notice may be pending.
In the interest of efficiency, only one meeting is permitted per BSP or per indication. The meeting can be requested three to 12 months before the target date for submitting the evaluation request to INESSS. In some cases, this meeting may help to accelerate accessibility of the new products. It should be noted that when a presubmission meeting occurs, a postsubmission meeting is not considered relevant unless there are exceptional circumstances involved.
Manufacturers must identify significant issues when preparing their evaluation request in order to justify a presubmission meeting.
For information purposes, these may include:
- clinical issues: uncertainties about the clinical data (non-comparative, indirect comparisons, network meta-analyses), choice of comparator, the link between the main goal and overall survival, quality of life, the product’s place in the therapeutic arsenal, indication of the reimbursement being requested;
- economic issues: choice of pharmacoeconomic analysis type and budgetary impact, uncertainty about clinical and economic input, choice of comparator, method of data extrapolation, choice of sensitivity analyses.
The specific goals of the presubmission meeting are to:
- enable INESSS to become acquainted with the broad outline of the submission, the principal data concerning the efficacity of the BSP and significant issues identified by the manufacturer;
- provide manufacturers an opportunity to discuss with INESSS the directions they wish to take when preparing their evaluation requests;
- make any clarifications regarding certain alignments for which an in-depth knowledge of the submission is not necessary. It should be understood that the elements discussed will reflect the opinions of the professional scientists at INESSS, with no commitment as to the approach that will be used when evaluating the request.
- The meeting request must be forwarded in accordance with the Presubmission Meeting Request letter template.
- This letter must be accompanied by the completed Presubmission Meeting Request form, and, to the extent possible, by all required documentation.
- The request must be emailed to: firstname.lastname@example.org.
- INESSS evaluates whether it is appropriate to proceed with the meeting and notifies the manufacturer as soon as possible. If a meeting is deemed appropriate, INESSS schedules a time.
- The manufacturer must propose an agenda, provide the names of attendees and all documents indicated on the form that have not yet been forwarded, together with any other documents that will be needed at the meeting. This information must be sent 10 business days before the agreed-upon meeting date.
- Manufacturers: up to four people, including, if applicable, an outside consultant to deal with the economic aspects of the submission.
- INESSS: professionals and scientific coordinators assigned to the submission.
Conduct of Meeting
- Summary of the BSP indication and the clinical data;
- Presentation of the manufacturer’s directions regarding clinical and economic sections;
- Presentation by the manufacturer of any significant issues it has identified, including potential sources of pharmacoeconomic uncertainty;
- Discussion period.
Four printed copies of the presentation are required at the meeting, as well as a USB key containing all documents submitted, the presentation and all supporting documentation.
Any questions about the presubmission meeting process may be emailed to: email@example.com.