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Market access for medical technologies in England

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in England

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Key topics

There are three key themes describing market access for medical technologies in England:

  • Reimbursement: payment mechanism via HRG system, add-on reimbursement via High Cost Device List
  • Funding: approval by the national (NHS England) or regional (Integrated Care Boards) payers
  • Health technology assessment: obtaining recommendations from the National Institute for Health and Care Excellence (NICE)

England has a number of innovative payment schemes for medical technologies (including Med Tech Funding Mandate). 

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Reimbursement

The payment mechanisms for hospital, day case, and ambulatory specialist care are defined in the NHS Payment Scheme, which is approved by NHS England for two years (the financial year starts in April).

The key payment mechanism (“aligned payment and incentive scheme”) includes fixed (global budget) and variable (activity/quality-based) components. The global budget (fixed component) is the key budget allocation mechanism for non-elective (urgent) healthcare services. The fixed budget is based on historical budgets provided and the agreed volume of activity (HRG can serve as a reference). 

The role of the HRG system is limited to all elective (non-urgent) procedures. HRGs are determined by a combination of a procedure (OPCS; released every three years) and diagnosis (ICD-10) codes. 

Add-on reimbursement via High Cost Device List exists for certain medical devices, procedures, and a number of in-vitro diagnostic tests (mostly molecular oncology).

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Funding

It is essential for the industry to determine the responsible commissioner, as it impacts the market access pathway and its complexity in England. Most innovative, complex procedures will fall under the category of specialized services and require approval by NHS England. 

Local commissioners typically maintain lists of not routinely commissioned or restricted services.
 

Health technology assessment

Health technology assessment by NICE is very influential. NICE has several programs focused on medical devices. The most important programs are listed below. 

Interventional Procedures Program

  • The Interventional Procedures Program is developed for most of the novel interventional/invasive procedures entering the English market
  • The program focuses solely on clinical evidence
  • Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit"
  • Recommendations are not binding, although they are followed by providers and commissioners (especially by local commissioners)

Diagnostic Assessment Program

  • A complex assessment program for diagnostic tests and technologies. The program focuses on both clinical and cost-effectiveness
  • Recommendations are not binding, but they can be a substantial asset when promoting technology in England

Medical Technologies Evaluation Program

  • The program focuses on the identification and assessment of cost-saving technologies
  • It considers clinical effectiveness and cost analysis
  • Evidence requirements are lower compared to other programs at NICE
  • Recommendations are not binding, but they can be a substantial asset when promoting technology in England
     

Early Value Assessment Program

  • The pilot program focuses on rapid assessment of digital technologies
  • The focus is on technologies that address national unmet needs
  • Evidence requirements are lower compared to other programs at NICE
  • Recommendations are not binding

Late Stage Assessment Program

  • The program assesses technologies in widespread use in the NHS
  • The goal is to assess if the value added by incremental innovation justifies the price variation and informs commissioning and procurement decisions
  • Recommendations are not binding
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Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. Most IVD tests are funded using a global budget principle as part of the funding of the labs. 

Some expensive tests are subject to payment via the High Cost Device List. 

Genomic tests are regulated via the National Genomic Test Directory. 

MTRC has experience with more than 381 projects in England

News and insights

Seven innovations were awarded in the NHS Cancer Programme Innovation Open Call 3 in England

On July 9, 2025, the NHS Cancer Programme granted £14.4 million to seven projects through the third Innovation Open Call. The projects aimed to fast-track the implementation of proven, late-stage innovations for the early detection and diagnosis of cancer.

NICE implemented a new HealthTech program in England

On July 14, 2025, NICE published a HealthTech program manual. A new program will combine the former Medical Technologies Evaluation and Diagnostic Assessment programs and the Interventional Procedures program. The HealthTech program will produce two types of guidance: HealthTech guidance for devices, diagnostics, and digital products, and Interventional Procedures guidance. A life-cycle approach will be utilized for assessment and recommendations: early use, routine use, and existing use (late stage assessment).

10 Year Health Plan for England released

On July 3, 2025, the UK Government published the 10 Year Health Plan for England as part of its mission to build a health service fit for the future. It sets out how the government will reinvent the NHS through three radical shifts - hospital to community, analogue to digital, and sickness to prevention. This transition will be supported by a new NHS operating model, improved transparency of care quality, a redesigned workforce model, innovation to power transformation, and a new financial foundation. Five transformative technologies will drive reform: data, AI, genomics, wearables, and robotics. Other MedTech-related initiatives include expanding NICE's technology appraisals to devices, diagnostics, and digital products and implementing the 'Innovator passport'.

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