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…
A Comparison of Proposed INESSS and Current CADTH Evaluation Fees On February 21, 2018, the Quebec government released draft regulations (Gazette Officielle du Québec) that outline fees payable to Institut national d'excellence en santé et en services sociaux (INESSS) for the scientific evaluation of a drug or stable blood product. The fees are expected to vary based on the type of dossier submitted for scientific review with INESSS determining…
Quebec Panel On Tuesday, June 13, 2017, the Canadian Association for Healthcare Reimbursement (CAHR) held the Market Access 201 conference in Toronto. The theme for this conference was Parallel or Intersecting Paths, the Future of Public and Private Reimbursement in Canada which consisted of five fascinating panels focusing on key topics of interest to the Canadian pharmaceutical stakeholders. Over the coming weeks, MORSE will be releasing summaries for each…
INESSS Introduces New Pre-NOC and Biosimilar Guidance 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. Pre-NOC Review Unlike the CADTH pre-NOC guidelines…