Consultations on Enhanced and Aligned Review Processes and Program Updates.
CADTH released its Pharmaceutical Reviews Update — Issue 16 on June 25, 2020. It includes two consultations with respect to enhanced and aligned review processes, in addition to program update announcements. Highlights of the consultations and program updates are described below.
|Consultations – Feedback due to CADTH by August 10, 2020|
|Consultation on Alignment of Drug Reimbursement Review Procedures||This consultation invites stakeholder feedback on a revised procedure that CADTH is proposing for all its drug reimbursement review processes (i.e., pCODR, CDR, and PPP). CADTH’s objective is to align their procedures, submission requirements, and internal processes.
The consultation includes a list of information sources that CADTH would not consider confidential, and that would be subject to disclosure if included in CADTH reports and recommendations; highlights of the list include:
CADTH notes that some types of submitted information may be deemed by CADTH to be confidential, including, market research data, implementation plans for how the product could be provided in the health care system, and confidential business information. Sponsors must clearly identify it as such in their submission and provide a rationale for its redaction.
Proposal to accept cost minimization analyses for drugs meeting all of the following:
Proposal to enhance and align stakeholder input via:
Proposal to establish three categories of reconsideration requests:
Major and minor revision requests would be accepted from sponsors and drug plans only; editorial requests would be accepted by the former in addition to patient and clinician groups providing input to the review.
Remaining differences between oncology and non-oncology drug reviews
Despite the proposed changes to align drug reimbursement review procedures, CADTH notes that the following application types would remain for oncology drugs only:
The full consultation document may be found here.
|Consultation on the Health Canada, CADTH, and INESSS Aligned Review Process||Proposal to:
Full details may be found here.
|Other CADTH Program Updates|
|Process for Drugs with Expanded Health Systems Implications||CADTH announced revisions to the CADTH Optimal Use process to accommodate reviews for products that are not particularly suited to the drug reimbursement review process; e.g., cell and gene therapies that pose significant implementation challenges.
Details provided here.
|Changes to the Provisional Algorithm Process for Oncology Drugs||Changes to this process include:
Details regarding the provisional algorithm process may be found here.
|Clarification of Economic Requirements||Minor changes were made the to the economic requirements related to:
|Revised Fee Schedule||The fee schedule has been revised to include a:
The revised fee schedule may be found here.
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