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
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 348 projects in England

News and insights

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.

New procedure and diagnostic codes added to the private reimbursement schedule in England

In April 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 195 and 091 with changes to be implemented no later than June 12, 2024. Ninety new procedure codes and five new diagnostic codes were implemented in ENT, gastrointestinal, in-vitro diagnostics, nephrology and urology, neurology and neurosurgery, pulmonary and airways, orthopedics, robotic surgery, men's health, and general surgery fields.

2024/25 Prescribed Specialised Services Operational Tool released in England

On April 3, 2024, NHS England published the 2024/25 Prescribed Specialised Services (PSS) Operational Tool. This Tool is used as a mechanism to identify whether healthcare activity belongs to specialized services using so-called identification rules. Forty-three new service lines were introduced in multiple areas, and eight service lines were amended.

Get in touch

Contact us to discuss your needs and learn about our services