INESSS has published its updated fee schedule for its scientific evaluation of drugs, stable blood products and technologies in the February 18, 2023 Gazette du Québec. Fees for all submission types have increased 6.44% as of January 1, 2023, bringing fees to:
- $63,791 for a new drug, new indication or new stable blood product submission;
- $95,579 for evaluation of a new cell or gene therapy or new breakthrough therapeutic product;
- $9,558 for evaluation of a biosimilar or a new concentration, strength or form of a listed medicine.
For the full Fee Schedule, please see the Gazette du Québec publication.
CADTH plans to publish and consult stakeholders on its proposal for issuing time-limited reimbursement recommendations contingent on evidence generation and formal reassessment. The consultation is scheduled to be open March 16 to April 13, 2023. More information to follow.
CADTH has made administrative and format updates to processes and requirements. Below PDCI has summarized the updates and provided implications for manufacturers. For full details please see Issue 34 of CADTH’s Pharmaceutical Reviews Update.
- New SharePoint Application Process: CADTH is replacing its submission portal, Collaborative Workspaces, with a new Microsoft SharePoint site. Effective February 16, 2023, all new applications must be filed using the SharePoint site. In March 2023, CADTH will contact manufacturers to transition active files to the new system on a rolling basis. More details on requesting access to the secure SharePoint site, log in processes (including Multi-factor Authentication) and file upload instructions can be found in the CADTH Update.
- New Application Requirement: Effective for applications filed on or after April 3, 2023, CADTH will require a RIS file with all references used in the pharmacoeconomic evaluation technical report and budget impact analysis technical report.
- Ethics Review Revised Process and Template: For efficiency, when multiple products with a similar mechanism of action and with indications in the same or a similar therapeutic area are evaluated, CADTH will use a summary report to identify relevant ethical considerations as opposed to conducting a new review for each application. A sample ethics review template is available here from the CADTH website.
- Biosimilar Eligibility Clarification: CADTH has updated its Procedures to clarify that biosimilars are typically not reviewed through CADTH’s reimbursement review process, except in exceptional circumstances where a biosimilar meets other eligibility criteria. Sponsors with questions about biosimilar eligibility should submit an eligibility request form.
For more details on the above updates, please see CADTH’s Pharmaceutical Reviews Update — Issue 34.
Please contact Ara Salazar, Director, Market Access at firstname.lastname@example.org for any questions or further information.