Call for Feedback Deadline: 5:00 pm EST on November 9, 2015 via e-mail to: firstname.lastname@example.org
CADTH is inviting stakeholder comments on the proposed revisions to both the CADTH Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) procedures on:
Please access the consultation details by clicking on the links above.
Background and Context
CADTH is building on past experiences, learnings, and successes of CDR and pCODR to create more transparent and predictable processes for all stakeholders. As part of the work to align pCODR and CDR, and to build on best practices of both review processes, CADTH is proposing the following changes:
1. Mandatory advance notification period of 180 calendar days
CADTH is proposing to establish a mandatory advance notification period of 180 calendar days for all pending submissions and resubmissions to CDR and pCODR. As part of this initiative, the submitter/manufacturer would also be required to provide a follow-up confirmation of the anticipated filing date one month before that date, at which time there would be public notification to allow patient groups time to prepare their input in the process.
The key objective of having advance notification is to help CADTH improve forecasting of the quantity and type of CDR and pCODR applications to be filed. This, in turn, will help with better resource planning, including clinical expert recruitment, and budgeting for both programs.
2. Disclosure of the submitted price
Over the years, CADTH has encountered a variety of issues concerning different interpretations by pharmaceutical manufacturers when the “submitted price” for a drug is filed as a confidential price for review through CDR or pCODR. These situations have led to confusion between individual manufacturers and CADTH jurisdictional customers.
In view of this, CADTH is proposing that a submitter/manufacturer be required to agree to the disclosure of the submitted price (i.e., the submitted price will no longer be considered confidential). This revision would enhance transparency for both the CDR and pCODR processes.
How to Submit Your Feedback
- To provide feedback, you must identify yourself — feedback provided by individuals who do not identify themselves and the organization they represent will not be considered.
- Only one response per organization will be considered. If more than one response is received, only the first response received will be considered.
- Feedback must be provided in 11-point font using this template and saved in one of the following formats:
- Microsoft Word document (.doc or .docx)
- Unlocked PDF document that permits copying and pasting of text.
- Feedback should be presented clearly and succinctly.
If you have any questions about the feedback process, please email us at email@example.com. We thank you in advance for your interest.