How do I make my views known?
- This public consultation is open for 8 weeks, from 31 July 2024 until midnight on 25 September 2024. You can respond by:
- completing the online consultation at www.engage.england.nhs.uk/consultation/budget-impact-test-threshold
- downloading and printing a copy of this consultation response form, and sending your completed form to Medicines Access Policy Team, NHS England, Wellington House, 133-135 Waterloo Road, London, SE1 8UG
2. Alternatively, you can ask us to post you a copy of the consultation response form. Please contact: england.commercialmedicines@nhs.net
3. We would like to hear from anyone with an interest in the subject of the consultation. We are committed to involving patients and potential future patients in the development of the Budget Impact Test (BIT) threshold, and we are particularly keen to hear from as many patients, carers and patient representatives as possible to inform these proposals.
4. Anyone responding to this consultation should note that responses may be published in full as part of NHS England and NICE’s commitment to openness and transparency. If you wish to refer to confidential information in your response, please provide it in a separate document, clearly marking each page ‘confidential’.
5. NHS England and the National Institute for Health and Care Excellence (NICE) are subject to the Freedom of Information Act. While both organisations respect the confidentiality of any information provided to them, you should be aware that we may be obliged to release even confidential information under that Act. Please do not include sensitive personal data in your response.
Consultation questions
6. The consultation questions are included in Annex A. We look forward to receiving your responses.
Post-consultation
7. Following this consultation, NHS England and NICE will consider all relevant feedback. We anticipate a large number of responses and because of this, we expect to publish feedback on the NHS England website in the form of a thematic report summarising all the material issues raised. The feedback will inform any update to the BIT threshold.
8. We intend to publish the thematic report and implement any required changes to the BIT threshold by the end of 2024.
About this consultation
9. 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.
10. NICE and NHS England have joint responsibility for the 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 of the threshold potentially being exceeded.
As such, this is a joint consultation between the 2 organisations.
Background
11. Introduced in March 2017 following public consultation, the BIT applies during NICE’s technology evaluation process.
12. Its purpose is to manage the affordable introduction of higher cost technologies to the NHS. While a new technology can be assessed as cost-effective, it can also have a high budget impact when the medicine costs at scale and any associated costs are considered, for example service/infrastructure requirements.
13. The BIT compares the ‘world with’ the positive recommendation to the ‘world without’ the technology, identifying technologies expected to create affordability challenges. More detail on the methods used to assess budget impact can be found in the NICE RIA team’s Assessing resource impact process manual.
14. The BIT threshold is exceeded if the budget impact is expected to be greater than £20 million in any of the first 3 years of a technology’s use in the NHS. For multiple technology appraisals (MTA), the BIT threshold is exceeded if the evaluated technologies’ joint budget impact exceeds the threshold.
15. If the threshold is breached, NHS England can engage in commercial discussions with the company producing the technology under consideration, with the intention of managing the affordability challenge associated with the implementation of the technology, as set out in NHS England’s Commercial Framework for New Medicines. The Commercial Framework for New Medicines is also being consulted on, with more details available at: www.engage.england.nhs.uk/consultation/nhs-commercial-framework-for-new-medicines-phase-1
16. Where a commercial discussion does not result in mitigation of the affordability challenge, NHS England can then request a variation to the funding requirement from NICE to extend the statutory implementation period for the technology. In considering the request, NICE will consider any relevant aspects of the commercial discussion.
17. Budget impact, and the application of the BIT, do not influence NICE’s consideration of the clinical and cost-effectiveness of a technology.
Proposals for consultation
18. The 2024 Voluntary Scheme on Branded Medicines Pricing, Access and Growth (VPAG) made a commitment to consult on raising the BIT threshold from £20 million to £40 million:
19. “NHS England and NICE commit to reviewing the Budget Impact Test (BIT) threshold, and to launching a consultation on increasing the threshold to £40 million, within the first six months of the 2024 Voluntary Scheme coming into effect. Following the consultation, any subsequent change to the threshold would take effect after the consultation and remain in effect until the expiry of the 2024 Voluntary Scheme.” (paragraph 3.36, page 27)
20. This consultation is seeking views on the proposal to increase the BIT threshold from £20 million to £40 million.
21. Increasing the BIT threshold to £40 million will ensure the BIT continues to target those technologies presenting the greatest budget impacts for the NHS, while ensuring that the threshold is only exceeded in a minority of evaluations, in line with the intention of the original BIT policy.
22. Following the consultation, any change to the BIT threshold would apply to technologies that have not reached final draft guidance in the NICE evaluation process at the point of implementation.
23. Technologies that have already reached final draft guidance at the point of implementation of any change to the BIT threshold will be treated under the existing policy (£20 million threshold and no change to the expected commercial mitigations).
24. This consultation is not considering any other aspects of the BIT’s associated methodology and processes.
Annex A: Consultation questions
Q1: To what extent do you agree or disagree that the BIT threshold should be increased from its current level of £20 million?
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
- Don’t know/NA
Please provide any further comments here:
Q2: To what extent do you agree or disagree that, as set out in the VPAG agreement, the BIT threshold should be increased to £40 million?
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
- Don’t know/NA
Please provide any further comments here:
Publication reference: PRN01397_ii