On February 28, 2019, Health Canada and CADTH, with INESSS participating as an observer, announced a new joint Early Parallel Scientific Advice collaboration. The initiative seeks to provide more timely access to medicines for Canadians. Through this initiative, drug sponsors will obtain advice in parallel from Health Canada and CADTH to ensure drug sponsors seek to obtain the type of evidence needed for market authorization and reimbursement in Canada.
Drug sponsors will submit briefing materials to all three organizations. Health Canada, CADTH and, as observer, INESSS will participate in a face-to-face preparatory meeting to discuss draft scientific advice with the drug sponsor. At the conclusion of the process, Health Canada and CADTH will provide a written record of scientific advice. The Early Parallel Scientific Advice will be non-binding and confidential, following the same general process, fees and timelines as CADTH’s Scientific Advice Program.
The following drug products are eligible for Early Parallel Scientific Advice:
- New drug products
- Existing drug products with new indications
- Drugs for rare diseases
- Oncology products.
Health Canada highlights Early Parallel Scientific Advice will be most beneficial for drugs for rare diseases, conditions with challenging clinical populations; new therapeutic areas; complex or adaptive trial designs; or development plans that may include real-world evidence. This new initiative may expedite future Canadian reimbursement timelines particularly for new therapies where the above situations apply by incorporating HTA input into Phase III trial design. If you wish to participate in the Early Parallel Scientific Advice please contact CADTH at firstname.lastname@example.org.
To discuss the advantages of seeking Early Parallel Scientific Advice for an upcoming drug product, please contact John-Paul Dowson at email@example.com
pCODR Initiates Consultation on Integrating Key Functions of the CDIAC into the pCODR Process
Also on February 28, 2019, CADTH announced a consultation on integrating Key Functions of the Cancer Drug Implementation Advisory Committee (CDIAC) into the pCODR Process.
CADTH is proposing a number of changes to the existing pCODR process, including operational changes to:
- pCODR pre-submission requirements
- pCODR submission requirements
- pERC initial and final recommendation
- Terms of reference for PAG, CGP, and pERC mandate and membership.
The full proposal is here: CADTH’s Proposal to Integrate Key Functions of CDIAC into the pCODR Process. Organization feedback must be received by CADTH by 5:00 p.m. EDT on March 28, 2019. Only one response per organization will be considered.