Late stage assessment (LSA) for medtech

We've developed a late-stage assessment (LSA) approach to evaluate those categories of technologies that are already in widespread use within the NHS. 

Products assessed using the LSA approach will be published as health technology evaluations (HTE).

This process allows us to assess technologies for effectiveness and value for money.

LSAs in development

Why are we doing this?

Both patients and healthcare professionals can benefit from having a range of technologies to choose from.

The Medicines and Healthcare Regulatory Agency (MHRA) has over 3 million different technologies registered for use in the UK, with around 500,000 regularly used in the NHS. 

The main challenge for the UK health and care system is choosing from such a wide range of products and innovations in a way that maximises clinical effectiveness and value for money.

The Department of Health and Social Care's (DHSC) medtech strategy (PDF) explains in detail the benefits and challenges with product choice in the NHS. The One Year On paper, also published by DHSC, shows how our LSA approach is a key part of the wider medtech strategy.

The approach is expected to be particularly important in areas where there are many technologies in the same category, with the same purposes and benefits and price variation.

It will provide guidance on value, especially where there are claims of improvements and innovation over time, to support NHS commissioners, procurement teams, patients and clinicians.

LSA and the life cycle approach

LSA forms part of our new life cycle approach in th HealthTech programme. This means we now appraise HealthTech products throughout their product life cycle:

Early value assessement (EVA)

Considers technologies which address national unmet need, rapidly assessing products early in the life cycle that need further evidence to support wider adoption.

Multi-tech guidance (MTG)

Assesses products that have not been adopted widely, but have substantial evidence to produce guidance.

LSA multi-tech guidance

For categories of products already in use within the system.

Which technologies is LSA for?

LSA topics will be selected in collaboration with DHSC. The technologies considered for LSA are expected to have:

  • high annual cost to the NHS (based on the technologies being procured at high cost, or low cost and high volume)
  • an existing procurement framework for the category in the NHS
  • price variation between technologies in the market
  • incremental innovation and performance claims that may have led to incremental price increases.

The first LSA topics selected by DHSC are:

  • transcatheter aortic valve implantation (TAVI)
  • colostomy bags
  • drug-eluting coronary stents
  • topical antimicrobial dressings
  • compression dressings
  • continence pads
  • beds
  • slide sheets.

What's different about LSA?

Most of the LSA process is familiar. It's a multi-tech approach and looks at the available evidence in a particular product category. We also gather the views of clinical experts and patients to help us assess the value of established products.

Our recommendations will support clinicians, commissioners and patients when choosing between products.

LSA outcomes

As part of the LSA process, technologies are reviewed by an independent committee. The aim is to provide a value assessment (based on evidence, clinical and patient input) to support procurement teams when their frameworks are ready for renewal.

This is in addition to supporting clinicians, commissioners and patients in their choices.

The HealthTech programme is set to provide useful and useable guidance for products wherever they are in the life cycle.

The addition of late stage assessment will help provide a clear appraisal of value for money in these established products, ensuring value for the taxpayer and helping commissioning and procurement to get best value for the NHS and patients.

This approach will also provide recommendations that we can use to assess new iterations and innovations in the future.

Mark Chapman, director of HealthTech, NICE

Contact us

If your enquiry relates to a scheduled evaluation, please email lsa@nice.org.uk.