Implications of Indication Expansions on Pricing and Reimbursement and How This Differs Between EU4 and UK Markets

OBJECTIVES: 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.

• 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.

CONCLUSIONS: 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.