OBJECTIVES : Multi-indication drugs pose a particular dilemma since they often provide different levels of clinical benefit across indications or patient sub-populations. The objective of the study was to evaluate how payers manage pricing of drugs for multiple indications across US and EU3.

METHODS : In-depth-interviews with 10 US payer (5 Pharmacy Directors and 5 Medical Directors) and HTA advisors (n=2 each) across Germany, France and UK were conducted in September- October 2018. A synthesis of insights generated from the literature and interviews was performed.

RESULTS : In the US, payers consider pipeline indications in formulary management discussion for the potential increase in patient population and resulting budget impact. Payers prefer to be more restrictive in management at the time of launch of first indication if there are many pipeline indications for the product. Indication-based pricing still faces logistic hurdles to implement. In Germany, a mixed pricing model is followed. An indication-specific price (ISP) is negotiated for every new indication/subpopulation of a product. A mixed price valid for all approved indications is calculated from the ISPs weighted by the volume per indication as stated in the G-BA resolution. In France, ASMR ratings are given separately for each indication and an average volume weighted price is negotiated. Medicinal products with high ASMRs (ASMR I-III) are guaranteed price for a duration of five years following the date of official marketing. The duration of the price guarantee can be extended by 1 year for products which have obtained an ASMR I-III for an extension of indication. The challenges of implementing ISP limits the use of this technique in UK. In summary, ISP is applied indirectly in Germany and France through weighted prices based on HTA outcomes and population.

CONCLUSIONS : Direct indication-specific pricing can be difficult to implement, as it requires robust data systems and infrastructure for successful execution.