OBJECTIVES: The GKV Financial Stabilization Act (GKV-FinStG) introduced in November 2022 imposed stricter drug pricing rules for products with the limited added benefit, i.e., minimum 10% discount vs. patented appropriate comparator therapy (ACT) when no added benefit, and no price premium vs. patented ACT when minor or non-quantifiable benefit. We reviewed G-BA decisions post-GKV-FinStG to quantify the impact on drug prices.

METHODS: We identified added benefit ratings for non-orphan products assessed post-GKV-FinStG regardless of assessment type (first, indication extension, re-assessment) and collected data at the patient subpopulation level. We then compared annual per-patient therapy costs (pharmacy sales prices deducted by mandatory manufacturer and pharmacy rebates) vs. patented ACT from G-BA decisions to quantify cost differences vs. patented ACT. We calculated average costs if multiple patented ACTs were available, excluding combination therapies (patented and generic) to avoid potential bias.

RESULTS: To date (June 15, 2023), eight assessments were eligible for our analysis with a minor added benefit for three products (three subpopulations), and no added benefit for five products (14 subpopulations). Indication extension was the most prevalent assessment type (seven products). For products with minor added benefit, cost reduction ranged from 18.9% to 23.2%. For products with no added benefit, cost differences ranged from 13.9% increase to 45.2% reduction vs. ACT.

CONCLUSIONS: Products with no/limited added benefit are generally within the price guardrails introduced by the GKV-FinStG. Cost premiums not expected by the law for products with no added benefit likely stem from indication extensions, where manufacturers achieved more favorable prices in the first assessment or due to very low target population sizes. Our study did not account for the population size, price referencing, and effects in outcome categories (mortality, morbidity, adverse events, quality of life) that may impact drug prices.