CADTH Pharmaceutical Reviews Update — Issue 11

Canada's Drug Agency Program Updates

1. Canada's Drug Agency Drug Portfolio Information Session

This annual session is an opportunity for all interested stakeholders to get the latest information about priority initiatives and process changes from the Canada's Drug Agency pharmaceutical reviews portfolio. Updates on other relevant Canada's Drug Agency initiatives will also be provided. The session also includes an open forum, where attendees can direct questions to Canada's Drug Agency President and CEO Dr. Brian O’Rourke, and other senior staff at Canada's Drug Agency.

Event Date: Monday, November 25, 2019
Time: 1:30 p.m. to 4:00 p.m. EST
Location: Vantage Venues, Garden Hall, 16th Floor, 150 King Street West, Toronto, Ontario

The session will be presented in English and can be attended in person or via live broadcast. There is no charge to attend, but advance registration is required. Registration closes on Tuesday, November 19, 2019.

Full details and the registration link are available on the Canada's Drug Agency website.

Questions may be sent by email to [email protected].

2. Interim Plasma Protein Product Review Process

Canada's Drug Agency and Canadian Blood Services (CBS) are pleased to announce the establishment of a new interim process for the review of plasma protein products. The interim process builds upon the strengths of both agencies to provide stakeholders with an objective, transparent, evidence-informed review process for plasma protein products. The interim process will be in place while provincial and territorial governments (except Québec) complete a review of PPPs and drug formulary processes in collaboration with CBS, Canada's Drug Agency, as well as other key stakeholders.

The objectives of the interim process for the review of plasma protein products are as follows:

• promote efficiency within Canadian health technology assessment processes by seeking alignment of procedures, guidelines, and timelines
• facilitate greater transparency, collaboration, and information-sharing between Canada's Drug Agency, CBS, and stakeholders.

Canada's Drug Agency and CBS have prepared a process in brief document that provides an overview of the new interim process.

3. Expanding the Therapeutic Review Process to Oncology Products

The CADTH Therapeutic Review Framework and Process has been updated to include oncology products. A therapeutic review is an evidence-based review of publicly available sources regarding a therapeutic category of drugs or a class of drugs in order to support drug reimbursement decisions and drug policy decisions, and to encourage the optimization of drug therapy. Canada's Drug Agency Therapeutic Reviews may be useful in any scenario where there is uncertainty regarding the comparative clinical effectiveness and cost-effectiveness of drugs in a particular therapeutic category or drug class. These changes have been incorporated into the pan-Canadian Oncology Drug Review (pCODR) Procedures and effective immediately.

4. Expanding the Canada's Drug Agency Tailored Review Process

To make the application and review process more efficient in specific cases, Canada's Drug Agency offers opportunities for tailored reviews for selected new combination products and subsequent entry non-biologic complex drugs. Going forward, Canada's Drug Agency is expanding the tailored review process to include selected additional drug products, such as new formulations of existing drugs that are eligible for review by Canada's Drug Agency (e.g., those with a new route of administration).

The decision to conduct a tailored review will be made by Canada's Drug Agency on a case-by-case basis after reviewing the applicable considerations form filed by the sponsors. Sponsors planning to file a submission for a new combination product or a new formulation of an existing drug are required to complete and submit a tailored review application form to Canada's Drug Agency ([email protected]) before filing the submission. Canada's Drug Agency will review the provided information and, with input from the drug plans, determine if the drug should undergo a tailored or standard review. Canada's Drug Agency has also updated the tailored review submission template to simplify the document and improve the instructions for sponsors.

5. Revised Processes for Checkpoint Meetings

Effective immediately, all checkpoint meetings for drugs being reviewed through the Canada's Drug Agency pCODR process will be held via teleconference. Canada's Drug Agency will no longer be offering in-person checkpoint meetings. All sponsors with scheduled checkpoint meetings will be contacted by Canada's Drug Agency to make alternative arrangements. These changes have been incorporated into the pCODR Procedures.

6. Revised Process for Cell and Gene Therapies

Canada's Drug Agency has undertaken an internal review and established a novel process for the review of cell and gene therapies. This new process will offer stakeholders the benefits of firm performance targets and well-established methods for conducting reviews and issuing recommendations for drug products, with the additional ethical and implementation considerations that are an important strength of the Canada's Drug Agency medical devices programs. Complete details of the new process for the submission and review of cell and gene therapies will be announced in the near future.

7. Alignment of Canada's Drug Agency Drug Review Processes

Canada's Drug Agency has been undertaking work to improve and align the procedures for our single drug review processes and the announcement of a new consolidated review process is forthcoming. Highlights of this announcement will include:

• a new consolidated procedural document that will replace the multiple individual documents currently used for the single drug review and therapeutic review processes
• complete details regarding the integration of the new interim plasma protein product review process and a process for the review of cell and gene therapies
• new aligned submission requirements and review processes.

8. Consultations on the Canada's Drug Agency Pharmaceutical Review Programs

Stakeholder feedback on the Canada's Drug Agency drug program consultations closed on September 27, 2019. Canada's Drug Agency received a total of 28 responses from pharmaceutical companies, government agencies, industry associations and consortia, and consulting firms. Canada's Drug Agency is currently reviewing this feedback and will communicate a summary and next steps at a later date.

9. Archiving of Drug Program Updates

Canada's Drug Agency launched the Pharmaceutical Reviews Update in August 2018 to consolidate the communications for its drug review processes. As part of these changes, Canada's Drug Agency will be removing all 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 Canada's Drug Agency website. Canada's Drug Agency will continue to routinely remove outdated Web postings and notify stakeholders that the documents have been added to the archive file.