The Institut national d’excellence en santé et en services sociaux (INESSS) released its new submission guidelines on June 2nd, 2017. The guidelines, which are now effective, include revised and new Form applications and letter templates for drug submissions.
The two major highlights relate to pre-NOC review and the introduction of new guidelines for biosimilar submissions.
Unlike the CADTH pre-NOC guidelines where all drugs are eligible when Health Canada is highly likely to issue an NOC or NOC/c for the indications to be reviewed by CDR within 90 calendar days, INESSS has introduced three conditions that need to be met for eligibility for the pre-NOC review process.
- The medication treats a serious health condition
- The available data indicates that the medication significantly improves the patient’s health versus the currently listed treatment options on either the Régime général d’assurance medicaments (RGAM) Formulary or the Drug Formulary for Institutions
- The NOC is expected within 180 days for cancer drugs and within 90 days for any other drugs
Submission Guidelines for Biosimilars
Up until June 2nd, a biosimilar manufacturer was expected to file a New Drug application and form (and any additional information that was requested on an as needed basis by the INESSS reviewers). With the new guidelines, manufacturers must now file a customized form for biosimilars, form 5, which provides requirements such as:
- comparative characterisation data between biosimilar and reference product
- comparative clinical data and
- justification for data extrapolation