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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


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). 



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).



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

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 348 projects in England

News and insights

The 2024 annual call for changes in the national screening programs is now open in the UK

On July 1, 2024, the annual call for proposals to the UK National Screening Committee (UK NSC) was launched. During the call, stakeholders can propose potential new screening topics or modifications of existing screening programs. The deadline for applications is September 30, 2024.

Med Tech-related health technology assessments from NIHR in June 2024

In June 2024, the National Institute for Health and Care Research (NIHR) in England released three MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned management for non-acute anterior cruciate ligament injury, laparoscopic cholecystectomy, and antenatal/newborn screening programs. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

Med Tech-related technology assessments and clinical guidelines from NICE in April 2024

In April 2024, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedures Guidance (lymphovenous anastomosis during axillary or inguinal node dissection, epidermal radiotherapy using rhenium-188 paste), two new Medical Technologies Guidance (Kurin Lock for blood culture collection and GaitSmart rehabilitation exercise program), and one new Health Technology Evaluation using early value assessment approach (digital technologies to deliver pulmonary rehabilitation programs for adults with COPD). Furthermore, two clinical guidelines were updated.

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