Introduction

NICE and NHS England work together to enable access to new drugs and medical technologies. [Technology is a term used to define medicines, products and treatments, as per the NICE health technology evaluations manual.] NICE and NHS England have joint responsibility for the Budget Impact Test (BIT) threshold. NICE, through the Resource Impact Assessment (RIA) team, is responsible for independently assessing budget impact and identifying where the threshold is likely to be exceeded, while NHS England is responsible for commercial discussions following identification that the threshold has potentially been exceeded.

As part of commitments made in the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), NHS England committed to consulting on raising the BIT threshold from £20 million to £40 million:

The BIT threshold consultation launched on 31 July 2024 for an 8 weeks, closing on 25 September 2024 (concurrently with consultation on updates to the NHS Commercial Framework). NHS England received 45 responses from a range of stakeholders in the following proportions:

• 53% pharmaceutical industry
• 16% NHS organisation
• 13% industry trade body or group
• 11% patient, carer, patient group or not for profit organisation
• 7% other

The thematic analysis below considers the themes respondents raised (both frequently and less frequently) that were directly relevant to each consultation question. We also set out how we have updated our proposals to reflect this feedback.

We also summarise the feedback we received that is not directly relevant to the consultation questions. Where we received feedback outside the scope of the consultation proposals, we have noted this and will continue to engage with stakeholders through existing engagement routes.

Responses to the consultation questions

Q1: To what extent do you agree or disagree that the Budget Impact Test threshold should be increased from its current level of £20 million?

Of 45 responses:

• strongly agree – 15 (33%)
• agree – 21 (47%)
• neither agree nor disagree – 6 (13%)
• disagree – 0 (0%)
• strongly disagree – 3 (7%)
• don’t know – 0 (0%)

Key themes

• There was a generally positive response to the proposal to increase the BIT threshold, with 36 of 45 (80%) stakeholders responding either ‘strongly agree’ or ‘agree’.
• Stakeholders support an increase in the BIT threshold to ensure that BIT targets the medicines that present the greatest affordability challenge for the NHS and minimises the administrative impacts on NHS England.
• The main issue for respondents who responded negatively to the proposal was the inflationary impact an increased BIT threshold would have on medicine spend within the NHS.

Q2: To what extent do you agree or disagree that, as set out in the VPAG agreement, the Budget Impact Test threshold should be increased to £40 million?

Of 45 responses:

• strongly agree – 12 (27%)
• agree – 20 (44%)
• neither agree nor disagree – 7 (16%)
• disagree – 0 (0%)
• strongly disagree – 6 (13%)
• don’t know or N/A – 0 (0%)

Key themes

• There was a generally positive response to the proposal to increase the BIT threshold to £40 million, as set out in the VPAG agreement, with 32 of 45 (71%) stakeholders responding either ‘strongly agree’ or ‘agree’.
• Some respondents suggested that the BIT threshold should be increased above the proposed level of £40 million.
• However, other respondents suggested that the proposed increase to £40 million goes too far and would represent an above inflation increase relative to when the BIT was first introduced in 2017.
• Some respondents noted that raising the BIT threshold would be inflationary for NHS medicines spend, and some gave this as a reason for disagreeing with the proposal.
• There was a request within responses for any change to the BIT threshold to apply to any medicine that is already engaged in the NICE evaluation process, rather than only tor those that have not yet reached the point of final draft guidance.

Feedback outside the scope of this consultation

• Respondents requested a more comprehensive policy review of the BIT methods and processes, including requests for increased clarity and guidance on existing process.
• Procedural and methodological changes were also proposed, such as the exclusion of medicines exiting managed access from BIT assessments and improvements in engagement with companies.
• Respondents suggested that the BIT threshold level should be subject to a rolling review.
• Respondents questioned whether the BIT was still required given advances in horizon scanning capabilities since the introduction of the BIT.
• Respondents noted that the BIT adds complexity to the broader commercial environment, which reduces the attractiveness of England as a launch market for new medicines.

Publication reference: PRN01610iii