UK VPAG - 2024 Voluntary Scheme Published in Full
The Department of Health and Social Care (DHSC) has now published the full text of the long-awaited 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). This highly anticipated document follows the summary of the heads of agreement published on 20 November 2023 which outlined the new VPAG scheme set for implementation from 1 January 2024.
The full 2024 VPAG publication details the complete terms of the agreement negotiated by the DHSC, NHS England and the ABPI. Notably, suppliers of branded medicines to the NHS have been given some additional breathing space to decide whether to opt into the 2024 VPAG scheme; the deadline for submitting the relevant forms to the DHSC has been extended from 31 December 2023 to 15 January 2024. Manufacturers who apply up until this deadline will be official scheme members from 1 January 2024, otherwise they will be subject to the Statutory Scheme.
The full publication provides manufacturers with more clarity and guidance on the key changes to the scheme’s workings, which are broadly consistent with the announcement back in November as highlighted in Decisive Consulting’s coverage (https://www.linkedin.com/pulse/navigating-evolving-uk-life-sciences-landscape-oalve). These include the decision for the first time to separate affordability mechanisms for ‘newer’ and ‘older medicines, increasing the cap on the NHS’s allowed branded medicines spend, and improved exemption terms for small-and-medium sized companies.
The new voluntary scheme presents an opportunity to enhance the commercial flexibilities offered by the NHS and NICE. To this end there will be two consultations on updates to the NHS Commercial Framework for New Medicines:
The first consultation (to be launched within 6 months of the VPAG scheme) aims to make explicit where non-uniform pricing mechanisms (also known as ‘indication-specific) could be applied;
The second consultation (to be launched within 18 months) aims to align the commercial flexibilities offered with updated access and regulatory pathways.
VPAG also highlights the NHS and NICE’s commitment to consult on the possibility of raising the Budget Impact Test (BIT) Threshold from £20m to £40m in the first 6 months of VPAG, as well as exploring two outcomes-based pilot initiatives for Advanced Therapy Medicinal Products (ATMPs). The full publication provides more details on the commitments to improving the access and uptake environment for clinical and cost-effective medicines.
The full document also provides clearer details on the joint government-industry ‘Investment Programme’ that aims to raise £400m from scheme members. The programme focuses on three UK-wide initiatives with indicative funding allocations, namely: Clinical trials (~75% of programme funding), Manufacturing (~20%, and Innovative HTA Approaches (~5%).
Proposals for the new Statutory Scheme will be consulted upon in early 2024 as to ensure greater alignment with the VPAG scheme. Notably, the consultation will include proposals to align to the VPAG’s ‘older’ medicine affordability mechanisms as to maintain “broad commercial equivalence” across the two schemes.
Are you considering a product launch in the UK? Are you questioning how the VPAG or Statutory Scheme or may impact your existing portfolio? Were you concerned the VPAG or Statutory Scheme may deter potential UK launches? Get in touch with Decisive Consulting Ltd to explore how we can help navigate your journey through Market Access.
Get in touch with Decisive Consulting Ltd to explore how we can help navigate your journey through Market Access.
Written by Craig Smith
Decisive Dialogue 15th December 2023
Bibliography
Department of Health and Social Care (2023). “2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth”. Available at: https://assets.publishing.service.gov.uk/media/657b2977095987001295e139/2024-voluntary-scheme-for-branded-medicines-pricing-access-and-growth.pdf [Accessed 15.12.23]