CADTH’s Pharmaceutical Review Updates are used to communicate new CDR and pCODR drug review processes updates to the public. PDCI has outlined below the key highlights from the most recent update. For more information on this review, please consult the CADTH’s website.
There are seven important announcements from CADTH:
- CADTH CDR/pCODR will no longer review Biosimilars
- Update on Integrating Cancer Drug Implementation Advisory Committee (CDIAC) into pCODR
- Shifting CADTH/CDR Redaction Request Process to after CDEC Recommendation
- Update to the Advance Notification Process
- Update to the Clinical Review Templates
- Canadian Blood Services (CBS) Observer Status on DPAC Formulary Working Group.
- Update to Procedure and Submission Guidelines for the CADTH CDR
CADTH CDR/pCODR will not longer review Biosimilars
Effective immediately, submissions for biosimilars should be filed directly with jurisdictions and pCPA. A biosimilar that may require a CADTH review will be considered by CADTH and the drug plans on a case-by-case basis.
As of June 1, 2019, CADTH will be stopping work on any biosimilar reviews that would have been completed after June 1, 2019. All manufacturers with ongoing biosimilar reviews that will not be completed by June 1, 2019 will receive a refund for the application fee and manufacturers with pending biosimilars have been notified of these revisions.
Questions regarding eligibility of a biosimilar for a CADTH review should be sent to firstname.lastname@example.org.
pan-Canadian Oncology Drug Review (pCODR) Review Updates
Update on Proposal to Integrate Key Functions of the Cancer Drug Implementation Advisory Committee (CDIAC) into the pCODR Process
CADTH continues to assess stakeholder feedback from the 2018 Consultation and is working to target an implementation date of July 1, 2019. CADTH will issue a notice prior to implementation of any applicable changes to pCODR procedures and guidelines. The revised processes and guideline documents should be publicly available on the CADTH website on June 12, 2019.
Common Drug Review (CDR) Review Updates
CADTH Revised CDR procedure to Shift Redaction Request Process to after CDEC Recommendation
To avoid need for multiple redaction requests, manufacturers can request redactions on final CADTH review reports after the CADTH Drug Expert Committee (CDEC) Final Recommendation has been issued. This new process is effective for all submissions, resubmissions and requests for advice filed on or after May 1, 2019. Details have been incorporated into the Procedure and Submission Guidelines for the CADTH Common Drug Review.
Updated Advance Notification Process
Effective immediately, if the economic information is incomplete when initially submitting the advance notification form to CADTH, this information should be updated as soon as possible and submitted to CADTH no later than two weeks prior to filing the submission or resubmission.
Updated Clinical Review Templates
The template used for the clinical reports prepared for standard reviews now includes a stakeholder input section that will summarize information from patient groups and clinicians earlier in the clinical review report. Additionally, evidence from non-randomized studies and indirect comparisons from the appendices has been moved to the main body of the report. A sample of the new template is found here.
Canadian Blood Services (CBS) has been added as an observer to DPAC Formulary Working Group.
This will allow collaboration between CADTH, CBS and public drug plans on drug topics that are of interest to all parties.
The Procedure and Submission Guidelines for the CADTH Common Drug Review has been updated
The updates include additional clarification on confidentiality guidelines regarding:
- removal of biosimilar review process
- details regarding the additional embargo period
- new process for requesting redactions
- confidentiality guidelines for the joint CADTH-INESSS clinical panels
- how and when patient groups are re-engaged in CDR process following initial call for patient input
- additional details regarding pharmacoeconomic review process used by CADTH
Please consult the Procedure and Submission Guidelines for the CADTH Common Drug Review for details on the revisions.