Effective immediately, CADTH will be formally engaging with the pan-Canadian Pharmaceutical Alliance (pCPA) and will be including the pCPA office in the CADTH Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) processes. This will provide an opportunity for the pCPA office to receive relevant information on drugs reviewed through the CDR and pCODR processes in a timely manner, as well as support business planning.
Important Note: The pCPA office will not provide any confidential negotiation information to CADTH.
Planned Role of the pCPA Office:
- Observer and may ask clarification questions as needed during CDR and pCODR pre-submission meetings;
- Authorized recipient of drug submission or resubmission information, including confidential or non-disclosable information as well as non-redacted outputs from the CDR and pCODR processes;
- Observer during CDEC and pERC meetings;
- Observer and may provide updates or contribute to potential drug recommendation implementation issues that fit within the scope of CDR reviews, therapeutic reviews, or optimal use reviews with respect to the Drug Policy Advisory Committee Formulary Working Group (DPAC-FWG); and
- Observer and may provide updates or contribute to potential drug recommendation implementation issues that fit within the scope of pCODR reviews with respect to the pCODR Advisory Committee-Provincial Advisory Group (PAC-PAG).
Extending the Timeline for Issuing Embargoed CDEC Drug Recommendations
CADTH received feedback from two industry association groups, two drug manufacturers, and one public drug plan with regards to the recent consultation on the topic of extending the timeline for issuing embargoed CDEC (Canadian Drug Expert Committee) drug recommendations.
Effective June 2016 and going forward, the timeline for issuing the embargoed CDEC recommendation will be extended from the current 5 to 7 business days after the CDEC meeting to 8 to 10 business days after the CDEC meeting. To reflect this change, section 8.2 (b) of the Procedure for the CADTH Common Drug Review has been revised.
This change has no impact on the duration of the current 10-business day embargo period. This change also does not affect the established CDR performance target of 180 calendar days from the date of the CDR application being accepted for review to the date of issuing the embargoed CDEC recommendation.
For more information, please click on the following link.