OBJECTIVES: Multi-indication therapies commonly experience list price decreases following indication expansion, due to the budget impact associated with the newly targeted patient population and country-specific pricing policies. This research examines multi-indication pricing dynamics in average list price markets (Germany and France). The aim is to understand differences in multi-indication pricing and reimbursement (P&R) and identify cases where a new indication delivered added clinical value outweighing the increased budget impact.

METHODS: European Commission (EC) authorized therapies between 2012-2022 were screened for products with ≥ 3 indications. For these products, list prices in Germany and France were collected from Navlin to examine pricing dynamics. For products with a ≥ 20% price increase, P&R data was extracted from the Gemeinsamer Bundesausschuss (G-BA) and Haute Autorité de Santé (HAS) to identify price increase drivers.

RESULTS: Of 87 authorized multi-indication therapies, 40 had ≥ 3 indications. Whilst 29 products experienced price decreases or price maintenance, 10 products in Germany and 1 in France experienced at least one price increase. Average annual fluctuation levels ranged from -4% to 0% in France and -11% to +2% in Germany. Three products had price increases ≥ 20% in Germany (dapagliflozin, dapagliflozin and metformin, ruxolitinib), compared to 1 in France (human normal immunoglobulin). G-BA evaluation analysis demonstrated that price increases in Germany were linked to re-assessments based on additional data submission, following a change of comparator therapy or indication expansion with a higher benefit rating than the initial indication. Reasons for the price increase in France could not be identified from publicly available data.

CONCLUSIONS: In Germany, a higher benefit rating of a new indication can occasionally lead to price increases. These increases seem mainly driven by re-assessment based on new data. This suggests that the German system allows more flexibility in applying value-based pricing for multi-indication products compared to France.