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HTA23 Restrictions and Real-World Evidence Requirements in the Health Technology Assessment of Gene Therapy Medicinal Products in Europe, Canada, Australia, and the United States by E Hubscher; L Wiltshire; HHI Young; A Brackley; S Ko is a Economics, Econometrics and Finance article available to read on EtoBox.

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involved a change in rating were critically assessed to summarize potential reasons for the influence of stakeholder comments on the rating. Results: In total, 45 interventions were reviewed during 17 assessments published in 2020 and 2021; 8 assessments provided multiple ratings for each intervention (6/17 for different subpopulations, 8/17 for different comparators), which resulted in 68 total ratings for combinations of interventions, populations, and comparators. Although most ratings resulted in either promising but inconclusive (P/I: 19% [13/68]) or insufficient (I: 19% [13/68]), more than one-third of cases were B+ or better (B+: 24% [16/68], A: 13% [9/ 68]). Ratings or B+ or better were given to interventions that resulted in substantial improvement in a key clinical endpoint compared with the selected comparator. When only indirect efficacy evidence was available, the ratings were C+ or below. There were only five instances where evidence ratings changed between draft and final reports. Conclusions: Although a considerable portion of evidence ratings in recent ICER reports were B+ or better, stakeholder inputs rarely made differences in ratings. Future research is warrante

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Author

E Hubscher; L Wiltshire; HHI Young; A Brackley; S Ko

Publisher

Elsevier BV

Published

2022

Language

EN

Field

Economics, Econometrics and Finance (Social Sciences)