World EPA Congress 2024: Implications of indication expansions on pricing and reimbursement and differences between EU4 and UK markets



Sequential launching in multiple indications is becoming increasingly common, especially in therapeutic areas such as oncology and autoimmune diseases. Determining the appropriate price for these products is complex as the product’s value tends to vary substantial between indications. Understanding the factors considered when determining value and how pricing mechanisms differ across the EU4 and UK is therefore key to successfully launching in a second indication.  


This study analyses the pricing and reimbursement considerations when launching in a second indication in the EU4 and UK.


Relevant scholarly articles, reports, and publications concerning indication expansions, pricing strategies, and reimbursement mechanisms across France, Germany, Italy, Spain, and the United Kingdom were identified and reviewed. 


Upon launching in a second indication, it is important to understand how the product’s value differs versus the first indication in which the product launched. Value comprises several factors including:

  • Added benefit: What therapeutic advantage does the drug provide over current standard of care?
  • Unmet need: Are there a lack of available treatments or do the current options fail to adequately treat the condition?
  • Population size: How many patients are likely to benefit from the new drug?
  • Competitive landscape: How many treatment options already exist for these patients?
  • Pricing dynamics: What is the net price of the product in the first indication? What is the net price of comparator products?

Across the EU4 and UK, there is variation in the pricing mechanisms applied when assessing a product in a second indication. In France, Germany, and Spain, a weighted price is applied across both indications with the population size and comparator products being key considerations in determining the value of the second indication. Meanwhile, mandatory discounts are applied in Italy proportional to the increase in population size. Unmet need, added clinical value and the quality of evidence are also considered when determining the level of discount. Finally, in the UK, a new PAS is usually agreed and applied to both indications as the product will no longer be cost-effective at the existing PAS. Differential discounting can be applied if the product meets specific criteria outlined in the NHS commercial framework and VPAG. These pricing mechanisms provide broad guidelines, but the final net price is dependent on the associated value, unmet need and target indication of the specific product.


Across the EU4 and UK, pricing mechanisms differ during indication expansions and the factors considered to determine the differential value versus the first have varying levels of influence on the discount applied. Overall, the net price of a product typically decreases when launching in a second indication as the population size and subsequent budget impact increases. Therefore, it remains important to tailor your launch strategy to each market to optimise price potential when expanding into additional indications.

Read our full research below (available 14th March).

Plus, catch up on our previous research from the last decade in pricing and market access here. For more details on the World Evidence, Pricing and Access Congress, click here.

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