Systematic literature review and indirect treatment comparison to expand a treatment population

Our client needed to demonstrate equivalence of outcomes associated with their treatment versus a comparator reimbursed in a wider patient population to support a NICE fast-track appraisal. The required analysis needed to be robust, transparent, and compliant with NICE guidelines to support a cost-minimisation argument and to help achieve reimbursement in a wider patient population.

We worked with our client to develop a systematic literature review capable of identifying all available evidence describing the efficacy and safety of their product and the relevant comparator that complied with NICE guidelines. Following the completion of the review, Initiate conducted a comprehensive feasibility assessment of the identified studies to assess the appropriateness of their inclusion in an indirect treatment comparison and pre-specify the most appropriate methods for the analysis.

We then completed the indirect comparison using NICE compliant methods specified in the feasibility assessment and documented the methods and findings in a comprehensive analysis technical report ready for inclusion in a NICE submission.

The indirect treatment comparison successfully supported a conclusion of equivalent patient outcomes between the two products and was a fundamental part of our client’s NICE submission, which was successful in having the product reimbursed in a wider patient population.