AUTHORS: Manahill Baig, Gillian Nicol, Rahul Vadehra, Paul Craddy
OBJECTIVES
Sequential launching in multiple indications is increasingly common, particularly in oncology and autoimmune diseases. Determining the appropriate price for multi-indication products is complex due to substantial value variation between indications. Understanding the factors influencing value and the differing pricing mechanisms across the EU4 and UK is crucial for successful secondary indication launches.
INTRODUCTION
This study examines pricing and reimbursement considerations for launching in a second indication in the EU4 and UK.
METHODS
A review of scholarly articles, reports, and publications on indication expansions, pricing strategies, and reimbursement mechanisms across France, Germany, Italy, Spain, and the United Kingdom was conducted.
RESULTS
When launching in a second indication, it is important to understand the product’s value compared to its first indication. Key value factors include:
- Added benefit: Therapeutic advantage over the current standard of care.
- Unmet need: Availability and adequacy of existing treatments.
- Population size: Number of patients likely to benefit.
- Competitive landscape: Existing treatment options.
- Pricing dynamics: Net price of the product in the first indication and comparator products.
Across the EU4 and UK, pricing mechanisms vary for second indications:
- France, Germany, Spain: A weighted price considering population size and comparator products.
- Italy: Mandatory discounts proportional to population size increase, considering unmet need, added clinical value, and evidence quality.
- UK: A new PAS applied to both indications, with potential differential discounting based on NHS commercial framework and VPAG criteria.
- These mechanisms provide broad guidelines, but the final net price depends on value, unmet need, and target indication.
CONCLUSION
Pricing mechanisms differ across the EU4 and UK for indication expansions. Factors determining differential value influence the discount applied, typically decreasing the net price due to increased population size and budget impact. Tailoring launch strategies to each market is essential to optimise price potential in additional indications.
Read our full research below (available post-conference).
Plus, read our other research abstracts for ISPOR Europe 2024 here.