If requested from public drug programs, drugs will be eligible when at least 1 of the following circumstances apply: • clinical data are available for the indication of interest, to permit CADTH and the expert committees to evaluate the effectiveness of the drug • approval for use of the drug for the indication of interest has been issued by other regulatory authorities (e.g., US FDA or the Europe. [...] The protocol specifies the following aspects of the review: • the populations, intervention, comparators, outcomes, and study designs that will be used to conduct a systematic literature review • any supplemental information that will be included in the review to provide additional context (e.g., description, evidence of validity, and clinical importance of the outcome measures) • any relevant evi. [...] Commentary in the clinical report regarding the potential place in therapy of the drug under review is provided by 1 or more clinical experts with expertise in the diagnosis and management of the condition for which the drug is indicated. [...] To accommodate the absence of an industry sponsor: • DIN holders will not have the opportunity to review and comment on the draft CADTH clinical review report before the expert review committee. [...] In the absence of a sponsor, DIN holders will not have the opportunity to review and comment on the draft CADTH economic report before the expert review committee.
Authors
- Pages
- 8
- Published in
- Canada
