CDEC will review and provide recommendations on reimbursement of drugs for rare diseases (DRDs) according to an enhanced Common Drug Review approach, as per news released today in CDR Update- Issue 103.
CADTH incorporated suggestions from stakeholder feedback (invited in October 2013) to consider two options for the review of DRDs: either establishment of a unique submission process and committee for DRDs, or integration of DRD reviews into the established CDR review process with potential modifications.
Highlights of the integrated CDR approach for review of DRDs include:
- Enhanced engagement with outside experts who can contribute to a better understanding of the disease area, current clinical practice, standard of care, potential place in therapy, and clinical criteria/conditions as a part of the recommendation process. Experts will assist CDEC but not vote on recommendations
- The same clinical evidence submission requirements and process will apply to DRDs as other products
- Pharmacoeconomic analyses expectations are consistent with the CADTH Guidelines for the Economic Evaluation of Health Technologies in Canada, with the additional expectation thatmanufacturers provide clear information about the natural history of the disease
- Submissions from individual patients and care givers representing small patient populations will be accepted
- Earlier pre-submission meetings (6-12 months in advance of CDR submission)