NHS England » NHS Commercial Framework for New Medicines

How do I make my views known?

1. 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/nhs-commercial-framework-for-new-medicines-phase-1
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 Commercial Framework for New Medicines, 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 engagement should note that engagement responses may be published in full as part of NHS England’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 is subject to the Freedom of Information Act. While we respect the confidentiality of any information provided to us, 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 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 be used to update the framework, which will also be subject to legal review.

8. We intend to publish the thematic report and implement any required changes to the Commercial Framework for New Medicines Framework by the end of 2024.

Background

9. The NHS Commercial Framework for New Medicines (‘the framework’), first published in 2021 and then updated in 2022, sets out how NHS England and the National Institute for Health and Care Excellence (NICE) engage with pharmaceutical companies and the commercial options available for companies bringing forward new medicines.

10. As set out in paragraphs 1.7 and 1.8 of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), NHS England is committed to promoting access to new clinically and cost-effective medicines.

11. As part of section 6 of the framework (Updating the framework) and the commitments made in the VPAG, NHS England is consulting on the framework in 2 phases to ensure that it remains up to date by reflecting key policy changes and continues to allow rapid patient access to new medicines, commensurate with their value to patients and the NHS.

12. The first of these consultations (‘Phase 1’), covered by this consultation document, is consulting on:

indication-specific pricing arrangements and the circumstances in which they will be considered (section 1)
a reflection of the Competition and Markets Authority (CMA) prioritisation statement on combination therapies (section 2)
embedding the provisions and principles supporting patient access schemes into the framework (section 3)

13. The second of these consultations (‘Phase 2′) will be launched by summer 2025 to align the framework with updated regulatory and access pathways, ensuring good connectivity with value assessment and commercial processes.

Principles of the Commercial Framework for New Medicines

14. As set out in the current framework, 6 principles guide and underpin NHS England’s commercial activity for new medicines:

Principle 1: NHS England’s commercial medicines activity serves to support NICE’s technology evaluation process, rather than act as a substitute for or alternative to it.

Principle 2: NHS England and NICE will collaborate to provide a joined-up way for companies to engage with the NHS regarding technology evaluations.

Principle 3: Commercial arrangements must be as simple as possible, minimising the burden on the NHS and frontline staff.

Principle 4: Confidential complex commercial arrangements are expected to be considered only for products which represent value at or below the lower end of the standard NICE threshold or other applicable thresholds.

Principle 5: Bespoke commercial arrangements (commercial flexibilities) will be considered on a case-by-case basis.

Principle 6: Commercially sensitive information will be kept confidential at all times.

15. While these principles are not being consulted on, it is important that the consultation proposals set out in this document are considered in the context of the framework’s principles.

Section 1: Indication-specific pricing arrangements

16. Increasingly, new medicines are found to provide clinical benefits to several different groups of patients (‘indications’) and this can be observed across a number of therapeutic areas.

17. Medicines can show differing levels of clinical effectiveness across different indications and as a result, in evaluation, the cost-effective price across indications for the same medicine can vary.

18. The current framework states that NHS England will continue to adopt uniform pricing, as set out in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).

19. Principle 3 of the framework sets out the NHS’s preference for simple patient access schemes (PASs), which are confidential and provide a fixed price or percentage discount on the list price applied at source. Simple PASs require less monitoring and minimise the administrative burden on NHS organisations. As a result, both NICE’s Commercial Liaison Team (CLT) advice on, and NHS England’s approval of, simple discounts are quicker than for more complex arrangements, leading to faster patient access.

20. For medicines with multiple indications, uniform pricing can be achieved by applying a consistent simple discount across all indications to ensure cost-effectiveness for each indication. Where relevant, this may require a simple discount to be amended within an existing PAS, for example where existing indications are already being commissioned for the medicine that is being evaluated for a new indication.

21. NHS England will continue to prefer simple discounts and uniform pricing for all medicines, including multi-indication products. However, NHS England recognises that the approach in the current framework may create challenges in certain circumstances for companies bringing forward multi-indication medicines.

22. As an exception to uniform pricing, indication-specific pricing allows for the price of a medicine to reflect the differences in clinical and cost-effectiveness across indications. In the absence of indication-specific pricing, companies may choose not to bring forward indications that have lower levels of effectiveness as to do so would have pricing implications for existing indications. Indication-specific pricing may therefore result in increased access to new indications for a given medicine.

23. As indication-specific pricing is a type of commercial access arrangement (CAA), arrangements will be considered in line with Principle 5 of the framework, which states that bespoke commercial arrangements (commercial flexibilities) will only be considered on a case-by-case basis.

24. To give companies clarity on the potential commercial options available to them, NHS England proposes that indication-specific pricing arrangements will only be considered when each of the following criteria are met:

1. the indication meets an unmet clinical need
2. the company can demonstrate with a high degree of confidence that uniform pricing would reduce the total revenue for a medicine across all indications
3. sufficient data is available within existing NHS systems to make such arrangements operationally feasible
4. the cost-effective price is highly differentiated for all indications under consideration

25. While indication-specific pricing arrangements could increase patient access to medicines in certain circumstances, it will inevitably lead to higher prices for multi-indication products than under a uniform price. Indication-specific pricing arrangements are an example of price discrimination, whereby different prices are paid for the same medicine, leading to increased company revenues and increased costs to NHS England.

26. High quality, complete data is needed to monitor how many patients are treated across each of the different indications for a given medicine. NHS England’s prior approval system data (currently Blueteq) provides data on patients starting treatment by indication and is required for transacting indication-specific pricing arrangements. This data is not currently available for integrated care board (ICB) or primary care commissioned medicines. NHS England is unable to consider indication-specific pricing arrangements for multi-indication medicines where prior approval system data (or equivalent) is not currently available.

27. Where prior approval system data is available, the data required for a CAA may not be complete, creating financial risk to NHS England when considering indication-specific pricing arrangements.

28. As a result of the additional costs associated with indication-specific pricing arrangements relative to uniform pricing and the risk of data incompleteness, indication-specific pricing arrangements for medicines meeting the criteria outlined above will be considered in line with Principle 4 of the framework. This principle states that confidential complex commercial arrangements are expected to be considered only for products that represent value at or below the lower end of the standard NICE threshold, or other applicable thresholds.

29. NHS England and NICE understand the need to, where possible, engage early with companies on any issues related to non-uniform pricing and the feasibility on indication-specific pricing arrangements. Companies are encouraged to engage with NHS England as early as possible to enable NHS England to provide a steer on potential flexibility to mitigate any delay later in the evaluation process.

30. Where an indication-specific arrangement is agreed for a technology, the indication-specific price under this arrangement will then be the price used in any subsequent evaluations that include the technology in that indication.

Section 2: Combination therapy pricing

31. Combination therapies combine 2 or more component medicines into a single treatment. Using drugs in combination, rather than as monotherapies, has the potential to provide additional clinical benefits for patients. A number of combination therapies are currently available to patients in the NHS across different therapy areas.

32. Combination therapies tend to comprise the following components:

a ‘backbone’ medicine (or medicines) that is already available to patients in the NHS as a monotherapy
an ‘add-on’ medicine (or medicines); this may also be available as a monotherapy

33. The individual components that make up a combination therapy can be provided by the same or different pharmaceutical companies.

34. The current framework identifies combination therapies as an area where bespoke commercial solutions may be required.

35. During NICE’s evaluation process, challenges may arise for combination therapies where the backbone medicine has been priced close to the cost-effectiveness threshold when approved as a monotherapy. It can then be difficult to meet cost-effectiveness thresholds when the cost of the add-on medicine is considered, unless the price of the backbone therapy is reduced.

36. Where the components of the combination therapy are provided by different companies, a pricing discussion between the companies would be required, potentially creating competition law concerns.

37. In addition, the company providing the backbone medicine may have no incentive to reduce its price if doing so would have implications for the pricing of the backbone medicine in other indications.

38. As a result, NHS England and NICE committed to supporting the Association of the British Pharmaceutical Industry’s (ABPI) efforts to develop solutions to enable company-to-company engagement in line with competition law, and to result in increased patient access to health-improving combination therapies.

39. The ABPI has since developed a negotiation framework that is intended to support companies to reach commercial agreements for combination therapies in a way that minimises the potential for competition law concerns to arise. Under this negotiation framework, companies supplying component medicines for a combination therapy would agree a ‘contribution payment’, paid from the supplier of the backbone medicine to the supplier of the add-on medicine. The ‘contribution payment’ would compensate the supplier of the add-on medicines for supplying its component at a price level required to achieve cost-effectiveness for the combination therapy.

40. Since the framework update in 2022, the CMA, as the sole competent authority for the UK, published a prioritisation statement on combination therapies following engagement with NHS England, NICE and the ABPI.

41. The CMA’s statement on combination therapies sets out that “the CMA will not prioritise the investigation of commercial negotiations and any subsequent agreements that are carried out according to the negotiation framework, where particular market features are present and provided certain conditions are met.”

42. The market features and conditions referenced are stated in paragraphs 2.7, 2.9 and 5.2 of the CMA’s statement.

43. This statement overcomes a key challenge in bringing forward new combination therapies where the components are provided by different companies. As a result, companies can follow the negotiation framework set out in the CMA’s statement to engage with other companies to develop commercial approaches, including the sharing of data, to bring forward combination therapies, while minimising the risk of raising competition law concerns.

44. NHS England and NICE are supportive of the CMA’s statement and will engage with companies following the negotiation framework to enable patient access to health improving combination therapies.

45. Companies are encouraged to seek to reach a commercial agreement using data sources already available to them. Where this is not possible, NHS England will consider requests for data from companies that are already engaged in the NICE evaluation process for their combination therapy.

46. On company request, NHS England will provide companies supplying components of a given combination therapy with data from the NHS England prior approval system (currently Blueteq) on the number of new approvals, but no more frequently than on a quarterly basis. NHS England does not have access to this data for ICB or primary care commissioned drugs and indications.

47. Access to the Systemic Anti-Cancer Therapy (SACT) dataset may be requested via the Data Access Request Service for a fee. This allows companies to request record-level data for specific drug administrations from SACT data.

48. To maintain patient confidentiality, any data values under 10 patients will be supressed from these data sources.

49. Data on a medicine provided by another company that is not party to the combination therapy agreement and data from commercially sensitive datasets, such as the Minimum dataset or Pharmex data, will not be provided as per Principle 6 of the framework.

50. Companies can also access Secondary Care Medicines Data at a product level nationally, as the finalised data is published by the NHS Business Services Authority on an annual basis.

51. Requests for data where required for commercial agreements for combination therapies should be directed to the Medicines Value and Access triage function at NHS England (commercialmedicines@nhs.net).

Section 3: Embedding patient access scheme provisions and principles

52. PASs are the starting point or default option for all companies to consider when developing their value proposition for evaluation by NICE. Unless a medicine is to be considered at list price by NICE, companies should always include a PAS in their initial evidence submission to NICE.

53. The guidance on PASs in the current framework covers the distinction between simple and complex PASs, and NHS England and NICE’s roles and responsibilities with respect to PASs. Further guidance on the timing, transparency, and monitoring and review of PASs is provided in paragraphs 5.25 to 5.56 of the 2014 Pharmaceutical Price Regulation Scheme (PPRS).

54. Proposals from companies for PASs, first submitted to NHS England and then referred to NICE’s CLT, are considered against a set of principles included in the 2014 PPRS. These principles set out the roles and responsibilities related to PASs, ensure the costs, administration and operational requirements of proposed PASs are considered, and ensure their feasibility for implementation in the NHS. The PAS principles can be found in Appendix 1.

55. Voluntary schemes that have followed the 2014 PPRS and the framework itself have referred to the PAS guidance and principles in the 2014 PPRS.

56. As part of Phase 1 of the consultation on the framework, NHS England intends to embed the relevant PAS guidance and principles in the framework, to ensure companies submitting PASs have the complete information in the framework.

57. In doing so, the emphasis of the PAS guidance, principles, and the related roles and responsibilities of NHS England, NICE and companies are intended to stay unchanged. The PAS guidance and principles themselves are therefore not subject to consultation.

58. When embedding the PAS guidance and principles in the framework, consideration will be given to align this with the existing guidance and principles of the framework itself. The framework’s principles are set out earlier in this document (see section ‘Principles of the Commercial Framework for New Medicines’).

59. Given the framework was first published after the PAS principles were introduced in the 2014 PPRS, some PAS principles are already broadly reflected within the principles of the framework. For example, PAS principles 1 and 2 closely align with framework principles 1 and 2. As such, the updated framework would not explicitly reference PAS principles 1 and 2.

60. Where PAS guidance and principles from the 2014 PPRS are not fully reflected in the current framework, the relevant text from the 2014 PPRS will be incorporated in the technical guidance related to PASs in section 5 of the framework (Commercial options).

61. It is important that PASs are sustainable and deliver the benefits expected of them. The NICE CLT actively review all operational PASs currently used within the NHS, with each scheme reviewed about every 12 months. NICE CLT will contact companies as their PAS reviews are scheduled for each drug.

Appendix 1 – PAS principles

PAS principle 1: Arrangements must respect the role of NICE in providing the NHS with an independent assessment and evaluation of the evidence on an intervention.

PAS principle 2: PAS proposals are to be discussed first and agreed in principle by NHS England and the company. NICE’s principal role is to assess the impact of such proposals on cost-effectiveness taking into account the details of the proposed PAS.

PAS principle 3: The full costs to the NHS of any such arrangements should be included in the costs considered by the Appraisal Committee.

PAS principle 4: PAS should be clinically robust, clinically plausible, appropriate and monitorable (e.g. if it is a responder scheme, there must be a relatively straightforward way to measure a patient’s clinical response).

PAS principle 5: Any PAS should be operationally manageable for the NHS without unduly complex monitoring, disproportionate additional costs and bureaucracy. Any burden for the NHS should be proportionate to the benefits of the PAS for the NHS and patients. Clarity is also required on the exact duration of any agreement and the circumstances in which it might be terminated.

PAS principle 6: It is important that the cumulative administrative burden of PAS remains manageable for all parties involved in their operation, including frontline NHS staff. It is reasonable for NHS England to take this issue into account when considering the viability of individual PAS proposals. Priority is likely to be given to PAS proposals that deliver the greatest benefits to patients, for example in enabling the NHS to address a previously unmet need.

PAS principle 7: PAS should be consistent with existing financial flows in the NHS and with commissioning arrangements (e.g. payers must be able to calculate the effective price for their patient population, so the costs and savings accrue to those services making commissioning and treatment decisions).

PAS principle 8: The NHS in England and Wales must be consulted on PAS proposals, in particular where these involve additional data collection beyond that associated with the conventional purchase of medicines – for example, in relation to patient numbers, or the monitoring and recording of a patient’s condition over and above that for the normal management of a patient. The Patient Access Scheme Liaison Unit (PASLU) at NICE will advise NHS England on the feasibility of Patient Access Scheme proposals, and the PASLU process includes arrangements for consultation with the NHS.

Annex A – Consultation questions

Section 1: Indication-specific pricing arrangements

Q1: To what extent do you agree or disagree with the criteria proposed for the circumstances when NHS England will consider indication-specific pricing arrangements?

Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
Don’t know/NA