Recent Landscape of Drug Re-Assessments by G-BA – What Is the Impact of New Evidence on the Benefit Assessment Outcome?

OBJECTIVES: German Federal Joint Committee (G-BA) regularly conducts re-assessments of drugs following the decision expiry. We examined recent G-BA re-assessments to identify key drivers of the benefit re-assessment outcome, focusing on new evidence submitted by manufacturers.

METHODS: We compared drug re-assessment decisions with the first assessments from 2022 onwards (to June 2023) in terms of added benefit rating and data package submitted and analyzed key drivers of re-assessment outcomes.

RESULTS: G-BA re-assessed 16 products, mostly in the oncology area (11/16 products); seven products received orphan drug designation. Added benefit rating did not change after re-assessments of nine products; increased for four products, and decreased for another one. In another assessment, G-BA increased the benefit rating for one out of four subpopulation. For products with favorable re-assessment outcomes, two products increased the benefit rating from ‘no’ and ‘non-quantifiable’ to ‘considerable’ and ‘major’ added benefit, respectively (olaparib in ovarian carcinoma, and cerliponase alfa in neuronal ceroid lipofuscinosis). For these products, longer-term randomized controlled trial (RCT) data (more recent data cut-offs), additional RCT, a meta-analysis of RCT, single-arm registries, and natural history studies were used as part of the new data package. The overall use of real-world evidence (RWE) in re-assessments was scarce (3 products) but appeared to contribute to benefit re-assessment outcome for one product (cerliponase alfa). G-BA also acknowledged indirect treatment comparison of single-arm and natural history studies given the pediatric and rare indication (cerliponase alfa). Favorable mortality, morbidity, safety, and quality of life outcomes based on the new evidence also contributed to the increased benefit rating.

CONCLUSIONS: Clinical data is still the mainstay of G-BA’s re-assessment but, although demonstrated by limited cases, RWE can also contribute to benefit outcome re-assessment. Manufacturers could leverage RWE to increase the likelihood of a higher added benefit rating in the re-assessments of their products.