Drug Reimbursement: Aligned Review Process by CADTHPublished on October 14, 2020
In an effort to make Pharmaceutical Reviews program more cohesive, transparent, and responsive, on September 30, 2020, The Canadian Agency for Drugs and Technologies in Health (CADTH) has taken a significant step forward by establishing a harmonized review process for any drug product that is submitted to CADTH for assessment.
Previously CADTH had unique procedures and policies for three review pathways — the Common Drug Review, pan-Canadian Oncology Drug Review, and Interim Plasma Protein Product Review. Now there is only one procedure that incorporates the best practices from each program. As part of the stakeholder consultation initiated by CADTH in June 2020, for feedback on its proposals to align the procedure for its drug reimbursement review processes, CADTH received and considered input from 80 organizations or individuals representing funders, drug manufacturers, patient groups, clinician groups, consultants, and others.
The new aligned drug reimbursement review process will be effective for all applications targeting the April 2021 expert committee meetings. Applications received on or after the following dates will be processed under the new drug reimbursement review procedures: October 26, 2020, for non-oncology drugs and October 20, 2020, for oncology drugs.
Principles based on which the aligned process has been established:
The procedures have been established by adapting the best practices from each of the individual drug review processes, based on the following considerations:
- transparency for all stakeholders
- efficiency for CADTH and other stakeholders who participate the process
- timeliness to ensure that CADTH recommendations are available to stakeholders and decision-makers in a timely manner
- sustainability of CADTH’s drug review programs
- equity for stakeholders who participate in the drug review process.
Highlights of the new process:
- Communications: CADTH will be consolidating all communications for its drug reimbursement review processes into a single email newsletter that is issued once per week (typically on Thursday).
- Pre-submission procedures: CADTH will proceed with the proposed revisions to the advance notification and pre-submission meeting processes.
- Confidentiality guidelines: CADTH will be adopting an interim process, based on the process used for non-oncology applications, for handling confidential information. CADTH remains committed to enhancing transparency and eliminating redactions in its drug reimbursement review processes, and will continue to discuss options with industry to improve transparency over the coming months, anticipating that further changes will be enacted in the future.
- Proposed place in therapy template: CADTH will only require that the Proposed place in therapy template be completed for oncology drug submissions (as it is required in order to inform discussions regarding the need for CADTH to develop a provisional algorithm).
- Health economics: CADTH will allow sponsors to file cost-minimization analyses for select drug products.
- Draft reports: CADTH will provide the draft review reports to sponsors for review and provide commentary. In addition, the template for sponsor commentary has been revised and the identification of any errors with data transcription will no longer count towards the overall page limitations.
- Draft recommendations: CADTH will post all draft recommendations for stakeholder feedback.
- Reconsideration process: CADTH will introduce greater flexibility into the reconsideration process (i.e., requests for major or minor revisions).
- Procedural review: A new step has been included in the procedural review process to allow CADTH to propose one or more options to resolve the issue and may avoid the need to convene a panel. This change will allow CADTH and the requestor to expedite resolution and avoid potential delays.
- Canadian Agency for Drugs and Technologies in Health (Sep. 30, 2020). News: CADTH Announces Aligned Drug Reimbursement Review Process. Retrieved from https://cadth.ca/sites/default/files/cdr/process/Consultation_Drug_Reimbursement_Reviews.pdf
- Canadian Agency for Drugs and Technologies in Health (Sep. 30, 2020). CADTH Pharmaceutical Reviews Update (Issue 17). Retrieved from https://www.cadth.ca/cadth-pharmaceutical-reviews-update-issue-17
Author: Preetha Prabhu
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....