Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment the Government has made of the merits of innovative funding arrangements for new products with a high upfront one-off costs for example gene therapy and car-T therapies.

NHS England is engaging with a number of manufacturers of cell and gene therapies to explore alternative funding models. These discussions are taking place within the scope of NHS England’s remit to consider commercial propositions:

- where the net budget impact is forecast to exceed £20 million in any of the first three years of routine commissioning once the company has established a cost effective price with the National Institute for Health and Care Excellence (NICE);

- for drugs entering the cancer drugs fund; and

- for highly specialised technologies.

Commercial propositions are developed on a case by case basis respecting longstanding industry agreements with the National Health Service on commercial confidentiality to ensure they offer the best outcomes for patients and taxpayers compared to alternatives. NHS England’s approach takes into account available evidence on outcomes from treatments, the nature of the market place, international approaches to pricing, NICE recommendations and rules for reimbursement in England, and the data and administrative burden for the NHS in ensuring such arrangements can be effectively transacted.

This approach has also been informed by the findings of work led by NICE on exploring the assessment and appraisal of regenerative medicines and cell therapy products and the subsequent observations about implications for commercial arrangements.

NHS England is working in close collaboration with clinical stakeholders, service providers, NICE and drug manufacturers to ensure patients can benefit from these innovative technologies in a safe, cost-effective and affordable manner. These new treatments pose complex new challenges in terms of new service delivery and funding models and require an approach which recognises the potential but uncertainty surrounding the clinical evidence due to the novelty of these treatments and how the associated risks can be shared between both parties.