CADTH’s Pharmaceutical Reviews 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 website.
This CADTH update primarily focuses on the integration of new CADTH review processes that help align with Canadian health technology assessment (HTA) bodies. Even though there are no anticipated dates for the release of the official procedural documents, the implementation of review processes may have an impact on manufacturer submissions in the near future. Below you will find the three CADTH review process updates:
1. CADTH and Canadian Blood Services (CBS) New Interim Review Process for Plasma Protein Products
The new interim review process eligibility criteria are that the product:
- Is a biological drug manufactured from human plasma or a biological drug whose active ingredient(s) are functional equivalents of the foregoing, used in the practice of Transfusion Medicine, and
- Is not carried in the health system already.
- The product meets the eligibility requirements for consideration as a new category on the CBS formulary, or
- Whether the product would be reviewed by CBS as a new brand within an already approved category on the CBS formulary.
Manufacturers making drug product submission will have to complete the eligibility request form and submit to email@example.com. For more information on review process and procedures, please consult the CADTH and Canadian Blood Services Interim Plasma Protein Product Review Process.
2. CADTH Revised Process for Cell and Gene Therapies
CADTH will provide complete details for submission and review process of cell and gene therapies in the near future. The new process will offer stakeholders performance targets, methods for conducting reviews, and drug product recommendations with ethical and implementation considerations of CADTH’s medical devices program.
3. Alignment of CADTH Single Drug Review Processes
CADTH’s new consolidated review process will align procedures for single drug review processes. The new consolidated review process will include:
- New consolidated procedural document that will replace multiple individual documents currently in use.
- Details regarding the new interim plasma protein product review process and process for cell and gene therapies review.
- New aligned submission requirements and review processes.
Other Key CADTH Review Updates Include:
- CADTH Drug Portfolio Information Session
- The annual session is an opportunity for all stakeholders to obtain the latest information on initiatives and process changes from CADTH’s pharmaceutical reviews portfolio.
- The event was held on Monday, November 25th, 2019 from 1:30-4pm EST. Please refer to the CADTH website for more information.
- Expanding Therapeutic Review Process to include Oncology Products
- The CADTH Therapeutic Review Framework and Process has been updated to include oncology products. Changes have been incorporated into the pan-Canadian Oncology Drug Review (pCODR) Procedures and are effective immediately.
- Expanding CADTH’s Tailored Review Process
- CADTH has expanded the tailored review process to include selected additional drug products, such as new formulation of existing drugs that are eligible for CADTH review.
- Decision to conduct a tailored review process is on a case-by-case basis and manufacturers are required to submit a tailored review application form to firstname.lastname@example.org.
- Revised Process for Checkpoint Meetings
- Effective immediately, all checkpoint meetings for drugs being reviewed through the pCODR process will be held via teleconference.
- CADTH Consultations Update
- Consultations closed on September 27, 2019 and CADTH is currently reviewing feedback and will communicate a summary at a later date.
- Archiving Drug Program Updates
- CADTH will be removing previous postings for CDR Updates, pCODR Updates, Therapeutic Review Updates, Updates for Patient Groups, as well as older consultation documents. These documents will be consolidated into a single archive document available on the CADTH website.