CADTH will screen the information provided by the sponsor to determine if: • the information provided by the sponsor represents new information • the (one or more) new studies provided by the sponsor address specific issues identified by the expert committee in the final recommendation document or support the sponsor’s request for revised reimbursement criteria. [...] The sponsor will be apprised of any revisions to the anticipated timeline for the review, deferral by the expert committee, or the subsequent recommendation not reflecting the most currently available product monograph information relating to the drug under review. [...] The inclusion of evidence from section 5 in the CADTH clinical report will be determined solely by CADTH based on the following factors: • the additional information may address an important gap in the pivotal and RCT evidence • the sponsor has provided the additional information in a format that allows CADTH to complete a detailed review and appraisal of the data (e.g., in accordance with the CON. [...] For reassessments: • The base-case analysis must reflect the scope of the reassessment: ▪ If the reassessment is focussed on proposed revisions to the existing reimbursement criteria for the drug under review (e.g., a proactive reassessment initiated by the sponsor), the base-case analysis must reflect the target population that would be covered under the revised reimbursement criteria that have b. [...] In this situation, CADTH will notify the sponsor regarding the deficiency and the timelines of the review may be affected (i.e., may result in the application being reviewed at a later meeting of the expert review committee).
Authors
- Pages
- 159
- Published in
- Canada
