Last Updated : January 9, 2020
CADTH has undertaken an internal review of our processes for drugs and devices, and established a revised process for the review of cell and gene therapies that leverages the strengths of both programs. This new process will offer stakeholders the benefits of firm performance targets and well-established processes for conducting reviews and issuing recommendations for drug products, with the additional ethical and implementation considerations that are an important strength of CADTH’s medical devices processes. The following document provides a brief overview of the new process:
CADTH has updated the Fee Schedules for CADTH Pharmaceutical Reviews to accommodate the following changes:
CADTH will be implementing revisions to the economic category 1 requirements for all standard review submissions filed on or after March 2, 2020. These revisions will include the following:
CADTH is providing advance notification of these pending revisions to allow time for sponsors to plan accordingly. Any sponsors with questions regarding these requirements should contact CADTH (firstname.lastname@example.org) with the complete details of their questions.
In August 2019, CADTH consulted on a proposal to revise the category 1 requirements for our single drug review processes. Effective for all submissions filed on or after March 2, 2020, CADTH’s single drug review processes will include the following additional category 1 requirements:
CADTH also consulted on the inclusion of a systematic literature review as a category 1 requirement for all submissions and resubmissions that are filed for review through the standard review processes. CADTH is continuing to develop the guidance documentation for that proposed revision to the process and anticipants announcing further details in the months to follow.
To increase transparency and promote alignment across our drug review processes, CADTH will no longer redact any conflict of interest information from patient group input or registered clinician input submissions that are filed for drugs being reviewed through CADTH’s pan-Canadian Oncology Drug Review (pCODR) process. This change will be effective for all calls for patient input and registered clinical input issued on or after January 2, 2020.
CADTH is pleased to announce the formation of the Pharmaceutical Advisory Committee, a new advisory body that will provide strategic advice to CADTH on drug-related issues and topics. This committee has been formed through the merger the Drug Policy Advisory Committee and the pCODR Advisory Committee. Consolidation of these committees will offer efficiency for both CADTH and the participating jurisdictions. CADTH wishes to thank all jurisdictional representatives who served on the previous advisory committees for their contributions.
CADTH has found that sponsors are routinely requesting the redaction of information that has already been disclosed in documents posted by other health technology assessment agencies and/or regulatory authorities. Specifically, CADTH has noted that sponsors are frequently overlooking the following sources of information when requesting the redaction of information from CADTH reports:
Requesting redaction of information that has been publicly disclosed results in an inefficient use of resources for both CADTH and the sponsor.
CADTH is aligning the terminology in the single drug review processes as follows:
These revisions are effective immediately and will be reflected on the CADTH website and in the procedural documentation for the single drug review processes.
The annual CADTH Medical Device and Drug Portfolio Information Sessions were held on November 25, 2019. The event provided attendees with information about priority initiatives and process changes from CADTH’s medical device and drug portfolios. If you are interested in more information, the slides are available here and the presentations are available on CADTH’s YouTube page.