Skip to main content

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

dsfgh

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). 

cdfcvcd

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).

dcv

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
xcvbv

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

Med Tech-related technology assessments from NICE in February 2026

In February 2026, the National Institute for Health and Care Excellence (NICE) published three new HealthTech Guidances (HTGs) on transcatheter tricuspid valve implantation, leadless cardiac pacemakers for bradyarrhythmia, and pulmonary artery pressure technologies for remote monitoring of chronic heart failure. The National Institute for Health and Care Excellence (NICE) develops HealthTech Guidance (HTG) to evaluate HealthTech products (such as diagnostics, medical devices, and digital technologies, including artificial intelligence) and interventional procedures. The program focuses on assessing the clinical and cost-effectiveness of HealthTech products and the safety and efficacy of interventional procedures. NICE uses a lifecycle approach for HTG, reflecting the development stage of technology: Early use (innovative technologies with potential to address NHS unmet needs but insufficient evidence); Routine use (innovative technologies with sufficient evidence for widespread NHS adoption); Existing use (assess technologies in widespread use in the NHS to inform commissioning and procurement decisions). NICE generally makes four types of recommendations: “Can be used” is the most favorable recommendation, meaning routine NHS use; “Can be used during the evidence generation period” – recommendation is conditional on evidence generation; “More research is needed” – limits the use to research settings only; “Should not be used”. The exception is existing use HTG, which recommends whether any technology should be used over other similar technologies in widespread NHS use, and what to consider when choosing between them. Recommendations are not binding, although they are typically followed by providers and commissioners. In February 2026, NICE released three new HTGs: Transcatheter tricuspid valve implantation for symptomatic severe tricuspid regurgitation is recommended during the evidence generation period as an option to treat symptomatic severe tricuspid regurgitation when open surgical tricuspid valve repair or replacement is high risk, and transcatheter tricuspid valve repair is unsuitable. More research is needed on the procedure before it can be used in the NHS when open surgical tricuspid valve repair or replacement is not high risk, or transcatheter tricuspid valve repair is suitable. Leadless cardiac pacemaker implantation for bradyarrhythmias received different recommendations based on the indications: • The procedure can be used as an option for right ventricular pacing alone for bradyarrhythmia; • When transvenous pacing is unsuitable, the procedure can be used during the evidence generation period for dual-chamber pacing or right atrial pacing alone for bradyarrhythmia; • When transvenous pacing is suitable, more research is needed on the procedure for dual-chamber pacing or right atrial pacing alone for bradyarrhythmia. Routine-use HTG on pulmonary artery pressure technologies for remote monitoring of chronic heart failure made the following recommendations: • CardioMEMS HF System (by Abbott) can be used as an option for remote monitoring of New York Heart Association (NYHA) class 3 chronic heart failure in adults at risk of hospitalization who are able to use the technology (with the help of a carer if necessary) and willing to adjust medication as directed; • More research is needed (on the clinical effectiveness, the short-term impact of the technology on quality of life, and defining which groups of people the technology is most suitable for) on the Cordella Pulmonary Artery Sensor System and the Cordella Heart Failure System (by Endotronix/Edwards Lifesciences) for remote monitoring of NYHA class 3 chronic heart failure in adults before it can be funded by the NHS. See the full details here. This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.

National Cancer Plan for the Next Decade Released in England

On February 4, 2026, the Department of Health and Social Care and NHS England published the National Cancer Plan for England, setting out a decade-long, technology-enabled transformation of cancer services, with substantial commitments to diagnostics, AI, genomics, robotic surgery, digital tools, and innovation-driven care pathways. The key ambition is that, by 2035, three out of four people diagnosed with cancer will be cancer-free, or living well with cancer after five years.

Launch of the National HealthTech Access Programme in England

On February 9, 2026, the National Institute for Health and Care Excellence (NICE) announced the launch of the new National Healthtech Access Programme (NHAP). The NHAP will expand NICE’s Technology Appraisals programme to include health technologies beyond medicines (medical devices, diagnostics, and digital tools), allowing mandatory reimbursement of recommended technologies. The first two NHAP topics are capsule sponge tests for detecting oesophageal cancer and AI tools for identifying prostate and breast cancer.

Get in Touch

Contact us to discuss your needs and learn about our services