How Will the New VPAG Rebate Regulations Affect Launch Strategy in the UK?

Author(s)

Robert A1, Lysakova-Ivanova M2
1Avalere Health, Manchester, LAN, UK, 2Avalere Health, London, England, UK

Presentation Documents

OBJECTIVES: Manufacturers and suppliers of branded medicines to the NHS are legally obligated to participate in one of two drug price control schemes: the ‘Statutory Scheme’ or the ‘Voluntary Scheme’. In November 2023, the UK Government announced a new 5-year voluntary scheme for branded medicines pricing, access, and growth (VPAG).

METHODS: A targeted literature search of relevant gray literature published between June and December 2023 was conducted to understand and characterize the differences between the old Voluntary Scheme and VPAG, the potential impact of VPAG on the revision of the Statutory Scheme in 2024, and the impact this may have on UK pricing and launch strategy.

RESULTS: Under VPAG, companies will pay differential rebates, depending on their product mix, namely whether a product is a ‘newer’ or older medicine; a similar adjustment has been announced for the Statutory Scheme but the details of this aren’t due to be announced until later in 2024. The aggregate rebate that one manufacturer pays under this scheme will thus differ from another, which is a marked change from the previous Voluntary Scheme. Additionally, sales will be permitted to increase by up to 4% per year by 2027, which is double the rate allowed under the older scheme.

CONCLUSIONS: Companies will need to evaluate their portfolios to understand what aggregated rebate rate their unique product mix will result in. Generative AI platforms could be a robust tool for analyzing this data in the context of the wider UK market. For companies with complex portfolios (e.g., a mix of advanced therapy medicinal products (ATMPs) and generics), it is advisable to seek early dialog with NHS England through the newly established single contact pathway to optimize UK pricing strategies under the new rebate measures.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)

Code

HPR68

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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