Are BSC and Patient-Individual Therapy as Appropriate Comparators Detrimental for AMNOG Benefit Assessment and Price Rebates in Germany?

OBJECTIVES: The choice of an appropriate comparator (ACT) is made by the Federal Joint Committee (G-BA) according to specific criteria. Although mostly concrete comparators are assigned, adequate therapeutic options might be lacking for certain subpopulations or therapy lines. Consequently, the G-BA might choose patient individual therapy or best-supportive-care (BSC) as ACT. The assignment of an inconcrete ACT is both challenging to meet but also underlining a high unmet therapeutical need. This study aimed to assess the consequences of inconcrete ACTs on the granted added medical benefit and price rebates in the field of oncology.

METHODS: A database containing all AMNOG assessments was screened for the years 2011 until February 2023. Data of oncology assessments with ‘patient individual’ or ‘BSC’ were extracted for all assessed subgroups. Information about therapy line, patient population and comparator were categorized, and added medical benefit and pricing rebates were analyzed.

RESULTS: Within 540 assessed subgroups in the field of oncology, 66 (12%) were assigned inconcrete comparators of which 33% were granted an added medical benefit. In contrast, assessments with concrete ACT achieved an added medical benefit in 49% of cases. The majority of inconcrete ACT was BSC (n=51), of which 12% were attributed a considerable, 18% a minor, 8% a non-quantifiable and 63% no added medical benefit. If the ACT was met correctly, an added medical benefit was granted in 88% of cases. Average price rebates after negotiations were higher for inconcrete vs. concrete ACT (25% vs. 18%) with the highest difference for assessments with no added medical benefit (36% vs. 21%). The assessed subpopulations were mostly indicated for first- and second-line therapy.

CONCLUSIONS: Inconcrete ACT are a challenge in the AMNOG benefit assessment but, if the evidence is accepted by the G-BA, they might positively influence the added benefit and pricing debates.