Analysis of Health Technology Assessments of Lung Cancer Therapies in Germany in the Last Decade: Is There an Association Between Added Benefit Ratings and Negotiated Reimbursement Prices?

OBJECTIVES: Reimbursement for novel therapies in Germany is determined through a two-step process: First, the Federal Joint Committee (G-BA) conducts a clinical benefit assessment. Following this assessment, reimbursement prices, effective from the seventh month onwards, are negotiated between the GKV-Spitzenverband (Association of Statutory Health Insurance Funds) and pharmaceutical companies. This study analyzes launch prices and negotiated prices for lung cancer therapies authorized in Germany between 2013 and 2023 to explore whether there is a relationship between G-BA's ratings and reimbursement prices.

METHODS: Added benefit ratings were categorized into major/considerable and minor/no added benefit. Negotiated prices were expressed as absolute prices and as relative prices in comparison to the least expensive comparator in the respective (sub-)population.

RESULTS: Data included 22 initial G-BA assessments, covering 21 active ingredients with appraisals in 46 subpopulations (15 first-line, 31 second or later lines), among them 44 in the area of non-small cell lung cancer. Average annual therapy cost at launch was €106,525 per patient (ranging from €34,403 to €228,010). After 15 months, the average cost dropped to €62,844 per patient, a 38% reduction. Additionally, three market exits were observed. In 33 assessments where an active drug comparator (beyond best-supportive care) could be determined (27 without/6 with major/considerable benefit), the absolute cost difference compared to the least expensive comparator averaged +€23,367 (ranging from -€82,526 to +€105,350), with a relative cost difference of +244% (ranging from -61% to +871%). The median cost difference was higher for therapies with positive major/considerable benefit ratings (+€32,992) compared to those without (+€12,821).

CONCLUSIONS: Therapies with higher added benefits as assessed by the G-BA tend to maintain higher reimbursement prices over time, reflecting their superior clinical value. Since November 2022, new guidelines on German reimbursement rules prevent price premiums for therapies without recognized added benefits, likely leading to an even larger price impact of G-BA ratings.