Analysis of the new NHS White Paper – Part 2

MAP Insights: The NHS Commercial Framework and the options it provides

The NHS Commercial Framework for New Medicines has now been published in alignment with the 2019 voluntary scheme for branded medicines pricing and access (VPAS).

It aims to facilitate timelier and more streamlined discussions about value, affordability and transactability, and to drive earlier and more purposeful engagement between the NHS, industry and the National Institute for Health and Care Excellence (NICE). It is hoped that the new framework will support patient access to proven, affordable and transformative medicines. The Commercial Framework has been designed to ensure that all companies understand the full range of commercial options available to them.

The commercial options that are available under the Framework fall into four broad categories, each of which is outlined below.

Patient access schemes (PAS) (simple and complex)

Companies should always include a PAS (if they are going to include one as part of their health technology assessment strategy) in their initial submission to NICE. A simple PAS provides a fixed price or percentage discount on the list price that is applied at source and applies consistently across all indications for a given technology. Where the technology being appraised for a particular indication is already routinely commissioned for a different indication, a simple PAS discount may increase the discount within an existing PAS. A simple PAS involves a more rapid review than a complex PAS and is the preferred option for the NHS. A strong rationale is required to justify the use of a complex PAS.

Commercial access agreements (CAA)

CAAs are confidential and are available at the discretion of NHS England (NHSE) where the company wants to propose an enhanced value offer for medicines or where there are unusual or unique circumstances where launching a product is considered particularly challenging or commercially unviable. Examples of CAAs include budget caps, price/volume agreements, cost-sharing agreements and outcome-based agreements.

Managed access agreements (MAA) 

For products with clinical and/or financial uncertainty, NICE can recommend that the NHS and the company explore an MAA. MAAs consist of two key components: a data collection agreement to mitigate clinical uncertainty and either a commercial access agreement (CAA) or a PAS. They provide time-limited (e.g. 4–5 years) interim funding subject to collection of additional data with a committed future date for reappraisal, which may result in routine commissioning. MAAs require the company to agree to offer the treatment at a cost-effective price for the duration of the MAA. It is important to note that MAAs have exit clauses in place, including the obligation to maintain funding and existing patient access should any reassessment result in a negative decision.

Budget impact schemes 

Budget impact schemes are an alternative where the potential net budget impact is expected to exceed £20 million per year in any of the first three years of a technology’s use in the NHS. The NHS will engage in commercial discussions with the relevant companies as an alternative to requesting a variation to the statutory funding requirement. The aim of these discussions is to mitigate the affordability challenge of immediately funding the technology for other NHS services. If an agreement between the NHS and the company is not reached, the NHS may request a variation to the statutory funding requirement.

The framework also provides further clarity on the difference between a managed access agreement (MAA) and a commercial access agreement (CAA).

  •  MAAs consist of two key components – a data collection agreement to mitigate clinical uncertainty and either a CAA or a simple PAS.

  •  CAAs are a commercial financial arrangement to enhance the value proposition for a medicine. They are agreed directly through engagement with NHSE and NHS Improvement and can be in addition to a simple PAS discount. Therefore, a CAA can either be part of a MAA or a standalone commercial financial arrangement.

The revised NHS Commercial Framework is likely to have a clarifying effect on market access for companies seeking to enter the UK market. Rare diseases may particularly benefit from creative commercial access arrangements, given the difficulties in generating evidence through traditional trial programmes. It will be important for companies to continue to engage with NHSE, NHS Improvement and NICE at an early stage. This engagement will ensure that drug development programmes provide the relevant levels of evidence for both regulatory and reimbursement purposes and will confirm that market access proposals are pragmatic and can be implemented within the confines of NHS practice.

MAP will continue to monitor key policy developments and publish articles that are relevant to all stages of the market access journey and processes.

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