Taking a proportionate approach to technology appraisals

In 2022 we developed a new proportionate approach to our technology appraisals.

We applied light-touch, faster evaluations to simpler low-risk decisions.

This allowed us to produce rapid guidance for these topics. It also makes sure we continue to have enough time for complex areas that need tailored support.

Phase 1 of the proportionate approach

In 2022, we introduced the first phase of a new proportionate approach to technology appraisals.

We simplified, removed, or reconfigured parts of the appraisals process. This means we applied light-touch, faster approaches to simpler, low-risk decisions allowing us to produce rapid guidance for some topics.

We’ve recommended 6 treatments in the first phase of this project, benefitting around 175,000 patients.

This process helped speed up our technology appraisals process by up to 20 weeks (45%) and increased our capacity for guidance on more complex treatments.

Treatments recommended through the proportionate approach pilots

Bimekizumab for treating axial spondyloarthritis - 12 weeks faster, eligible patient population of around 3,800 people in England.
Mirikizumab for treating moderately to severely active ulcerative colitis – eligible patient population of over 23,000 people.
Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction – eligible patient population 150,000.
Tofacitinib for treating ankylosing spondylitis (TA920) – eligible patient population of just over 25,000 people.
Macular oedema (diabetic, chronic, phakic eyes, treated) - fluocinolone acetonide intravitreal implant (TA953) - eligible patient population of around 2,400 people.

Bimekizumab for treating active psoriatic arthritis – 12 weeks faster than standard processes.
Somatagron for treating growth disturbance – 7 weeks faster than standard processes.
Nintedanib for treating idiopathic pulmonary fibrosis - 8 weeks faster than standard processes.
Vutrisiran for treating amyloidosis - 20 weeks faster than standard processes.
Eptinezumab for treating migraine - 8 weeks faster than standard processes.
Nivolumab for resectable non -small-cell lung cancer - 9 weeks faster than standard processes.

How we developed the proportionate approach to technology appraisals

We carried out a series of pilots that involved new ways of working. These were developed using test-and-learn principles, exploring multiple ideas and developing them through direct experience in real technology appraisals.

We engaged with our stakeholders and industry partners throughout, to ensure we incorporated their real-time input and feedback into the project.

In July 2023, we consulted on these approaches as part of the first modular update to our health technology evaluation manual. The proportionate approaches were then incorporated into the manual as part of standard process and methods in October 2023.

Phase 2 of the proportionate approach

In phase 2, we developed the following ways of working:

Pathways approach to technology appraisals

We successfully completed a pilot of a pathways approach in renal cell carcinoma. Cabozantinib with nivolumab for untreated advanced renal cell carcinoma (TA964) was published in April 2024 using a pathways approach. Read the report for the renal cell carcinoma pathway. A model is available on GitHub.

A final report on the pilots using a pathways approach will be released later in 2024/25.

Following feedback on the pathway approach we have realigned our work on to prioritise our current strategic ambitions.

As a result, we will no longer focus on pathways models we've built, owned and maintained. Instead, we are exploring how we can make better use of reference models, that can be used within the current STA framework.

High value steps

This approach looked at identifying the most important parts of the appraisals process to allow us to consider ways of getting to these stages sooner, while maintaining the rigour and robustness of our appraisals processes.

We will use the findings from this approach to improvements to our processes in 2024/25.

The high value steps approach also involved workstreams on ‘new ways of working’:

Committee meeting management

Analysis and improvements to the managing of committee time and discussions, to ensure appropriate consideration for each topic discussion.

Changes made have led to greater consistency and time management across committee meetings.

Process improvements

Work on internal processes, which to improve the efficiency of our appraisal project teams.

Proportionate reviews

Exploring the use of proportionate processes for topic reviews, including biosimilars and generics.

Development of this work continues into the 2024/25 business year.

Products with many indications

Some treatments are being licensed for many indications, such as immuno-oncology treatments.

We explored alternative methods and processes for evaluating treatments that we have looked at many times before, and for which more indications are expected. This involved exploring a potential non-standard incremental cost-effectiveness ratio (ICER) value signal for products that have multiple indications.

Following consultation with numerous stakeholders, we found that none of the approaches explored could provide an output that sufficiently meets our current objective. We found that none provide an ICER-based signal through an approach that increases speed of access and reduces the resource required for the evaluation.

This workstream has been closed. We will reconsider the decision when ongoing academic work suggests alternative approaches that may warrant further consideration. Or we will look again when solutions are in place that allow exploration of past appraisals in more depth but with less resource requirements. We will also explore a solution as part of other work supporting wider NICE objectives.

Rapid Entry to Managed Access

NICE and NHS England agreed to draft principles for rapid entry to managed access (REMA) at the end of 2023.

We then developed an options appraisal on methodology to implement REMA according to the draft principles. However, it was recognised that REMA has many co-dependencies and could not be developed in isolation.

As a result, we have paused development on REMA while we review the impact of the International Recognition Procedure for new medicines, and the forthcoming NHS England consultation on the commercial framework, on its Technology Appraisals process.

Find out more

For more information on these approaches, please email: nice@nice.org.uk.