The Advanced Therapy Medicinal Products (ATMP) Programme is part of the Highly Specialised Services portfolio. The programme commissions and prepares the NHS for new, complex products such as chimeric antigen receptor (CAR)-T cell therapy. These products require a greater level of commissioning support, and also require a national approach due to the nature of the products.

ATMPs are medicinal products that are either:

• a gene therapy – a technique that uses a gene to treat, prevent or cure a disease or medical disorder
• a somatic cell therapy – a technique that transfers the genetic material into cells not involved in reproduction so that they treat the individual but are not passed on to future generations
• a tissue engineered product – a medicine containing engineered cells or tissues, which is intended to regenerate, repair or replace human tissue.

The programme complements and supports the six National Programmes of Care, the Innovative Medicine Fund and the Cancer Drugs Fund. It provides leadership and oversight of the commissioning of new, highly complex products that achieve, or have the potential to achieve, demonstrable improvements in the quality, equity, value and outcomes for patients.

The activity of the programme prepares the NHS in England to implement the health technology evaluation recommendations made by the National Institute for Health and Care Excellence (NICE). In addition, NHS England undertakes horizon scanning and early engagement activities with companies and clinicians to understand the potential implications of selective highly complex products that may become available to the NHS.

The activities of the programme are focused on new ATMP treatments or indications that require:

• a new product recommendation by NICE
• complex service preparedness
• a new service to be established in the NHS
• a significant reconfiguration to any existing service
• development of a new care pathway in an existing service.

The programme can also support new treatments which are not ATMPs where the above factors are relevant: this includes point-of-care manufactured treatments.

There are no specific clinical reference groups for the programme as it spans many clinical areas. Where clinical input is needed, it will be gathered from existing clinical reference groups in the National Programmes of Care.

The ATMP programme team is a ‘multidisciplinary’ team, which has expertise in multiple areas such as commissioning, finance, pharmacy and project management. The programme team engages with relevant health organisations such as NICE and the Medicines Healthcare and products Regulatory Agency as well as NHS England national and regional teams, providers (for example, hospitals) and local commissioners.

Service specifications

Service specifications are important in clearly defining the national standards of care expected from organisations funded by NHS England to provide specialised care. Specifically, service specifications describe core and developmental service standards. Core standards are those that all funded providers should be able to demonstrate. Developmental standards are those that may require further changes in practice over time to provide excellence in the field. The specifications are developed by specialised clinicians, commissioners, expert patients and public health representatives.

Service specifications for ATMPs can be found on the relevant Programme of care webpages.

The National Advanced Therapy Medicinal Products Programme team

• National Senior Programme of Care Manager: Ben Doak
• National Programme of Care Manager: Kiran Moyo
• Senior Finance Manager: Michelle Thayre
• Pharmacy Lead: Sarah McAleer
• Project Manager: Andy Foster

Please send enquiries to england.innovativetreatments@nhs.net.