Hanover

With all eyes on set piece General Election announcements, the draft NHS Commercial Framework for Medicines has been published, making good on a commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). Many in industry were hopeful it would provide detail on how and when commercial flexibilities could be unlocked to secure medicine reimbursement. The framework does indeed set out where and when NHS England will apply additional commercial flexibility, but makes clear that a simple Patient Access Scheme (straight discount) will remain the preferred option.

The draft provides additional clarity on the types of complex schemes that NHS England is prepared to consider:

  • Cap on total budget
  • Price/volume agreement
  • Cost-sharing
  • Starting/stopping criteria
  • Outcomes-based agreement

However, they stress that any case-by-case deals should not be seen as precedents to agreeing similar deals, with simple Patient Access Schemes (PAS) to remain the preferred option.

The draft provides little detail on what circumstances would warrant such flexibility, which is likely intentional.

By keeping things top line NHS England retains the ability to explore “bespoke commercial solutions” as appropriate; a point reinforced with the framework termed a “living document” that will be “updated over time”, allowing NHS England to flex with needs and requirements of the system.

Interestingly, the draft framework appears to leave the door open for deals on multi-indication medicines (following commitments to explore the mechanism in the previous PPRS), where launching a new indication would be commercially unviable and a discount would adversely affect company revenue.

NHS England’s willingness to explore flexible solutions is nothing new – in 2016 a letter from NHS England Chief Executive Simon Stevens launching the Accelerated Access Review remarked “where it makes sense, we’ll increasingly be open to agreeing innovative win/win product-specific reimbursement models”.

While the Framework is less than prescriptive on the process for unlocking complex commercial deals, it is clear in its desire to reduce delays to patient access post-marketing authorisation. This could signal the commercial incentive is towards speed of access rather than price – securing NICE approval by ensuring a new medicine falls within the ICER threshold, and thus avoiding protracted negotiations with NHS England.  Speed of access could also help companies’ bottom line due to the 36-month exemption commitment made in VPAS.

With the consultation exercise looking to solidify the commercial options available to companies, it is important that industry take this opportunity to highlight the importance of a flexible approach to medicines pricing for emerging innovations,  reiterating that innovative medicines traditionally do not sit at, or below, the lower end of the standard NICE threshold.