In August 2017, CADTH launched an open consultation to gather feedback on proposed changes to the following aspects of our drug review programs:
- the process for reviewing biosimilars through the CADTH Common Drug Review (CDR) and the CADTH pan-Canadian Oncology Drug Review (pCODR)
- the resubmission eligibility criteria used by the CDR and pCODR programs
- the checkpoint timeline for the pCODR program.
Today we are pleased to announce the operational changes that have been made to enhance the drug review programs. These changes reflect our careful consideration of all feedback that was provided, as well as input from the participating jurisdictions. Below are key highlights, but for a complete description of the changes we encourage all stakeholders to review our updated procedural documents:
- CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars
- CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars
1. Revisions to CADTH’s Biosimilar Review Process
Based on the feedback that we received and given our experience reviewing biosimilars, CADTH is revising our process to reduce duplication of work, optimize resources, and facilitate decision-making for biosimilars for all participating jurisdictions. CADTH believes that a streamlined approach for biosimilar reviews will support improved access for patients.
- Shorter timeline
- Fewer submission requirements
- Abbreviated biosimilar summary dossier template.
Effective February 13, 2018, the streamlined process will apply to all new biosimilar submissions filed with CADTH. For more information, please see our “Frequently Asked Questions.”
For more details about the requirements that are needed for making a biosimilar submission, please see the CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (non-cancer indications) and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars (for cancer indications).
2. Revisions to Resubmission Criteria for pCODR Process
In November 2017, CADTH implemented the proposed revision to the resubmission eligibility criteria for the CDR process, whereby a new randomized controlled trial may no longer be required for a resubmission based on improved efficacy. (See CDR Updated – Issue 130) for details.)
CADTH is now expanding this application to the pCODR program, as part of our efforts to create a more transparent and predictable drug review process for all stakeholders. Similar to the CDR program, before initiating a resubmission, a submitter will be required to file a completed pCODR Resubmission Eligibility Form and provide copies of one or more new studies that would address the specific issues identified in a pERC recommendation. A resubmission will be assessed to determine if the information provided by the submitter meets the definition of new information and that the information addresses the specific issues identified in a pERC recommendation. This assessment will be conducted by a three- to five-person pERC panel who will review the type of new information being submitted and conclude if it will be eligible for a resubmission. The panel will include the pERC Chair and/or Vice- Chair.
3. Other Administrative Changes
To enhance the pCODR process, the following administrative changes have been applied:
- Checkpoint response timelines: To allow the pCODR review team sufficient time to review the responses, CADTH is requesting that a submitter provide responses to the clarifying questions and any applicable requests for additional information at least one (1) business day in advance of a scheduled checkpoint meeting. A submitter will still have 10 business days to prepare responses to the clarifying questions and the request for additional information to the pCODR program.
- Updated pCODR templates: CADTH has made administrative changes to the templates identified below for the pCODR program to provide additional clarity and guidance to all stakeholders. We kindly ask that all stakeholders use these updated templates for new submissions to pCODR.
- pCODR Pre-submission Information Form – Submission & Resubmission
- Patient Input Template for CADTH CDR and pCODR Programs
- Biosimilars Patient Input Template for CADTH CDR and pCODR Programs
- pCODR Registered Clinician Input on a Drug Review
- Biosimilars Clinician Input Template for CADTH pCODR Program
- Biosimilars Provincial Advisory Group Input Template for CADTH pCODR Program
- pCODR Resubmission Eligibility Form
- Stakeholder Feedback on a pCODR Expert Review Committee Initial Recommendation.
4. New Fee Guidance for Applications to CADTH’s Pharmaceutical Review Programs
CADTH has implemented a new fee structure that applies to both the Common Drug Review and pan-Canadian Oncology Drug Review programs. The new CADTH Guidelines on Application Fees for Pharmaceutical Reviews replace the separate application fee guidelines which previously existed for each program.
Other important highlights include:
- The new, reduced fee for the new biosimilar review process
- An annual fee adjustment based on fluctuations in the Consumer Price Index
If you have questions about the information in this update, please contact us at email@example.com.