Introduction

As part of Section 6 of the framework (updating the framework) and the commitments made in the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), NHS England committed to consulting on the framework in 2 phases to ensure that it reflects key policy changes and continues to allow rapid patient access to new medicines, commensurate with their value to patients and the NHS.

Phase 1 of the consultation was limited in its nature and scope – around making the framework more explicit about existing enhanced commercial flexibilities and when they can be offered. Phase 2 (to be launched by end-June 2026) will concern updates to ensure the framework’s continued alignment with updated regulatory and access pathways, ensuring good connectivity with value assessment and commercial processes.

Consultation phase 1 was launched on 31 July 2024 for 8 weeks, closing on 25 September 2024. It consulted on:

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

Engagement events were also held with key stakeholder groups during the consultation period.

We received 62 responses to the consultation from a range of stakeholders in the following proportions:

• 52% pharmaceutical industry
• 18% patient, carer, patient group or not for profit organisation
• 15% industry trade body or group
• 10% other
• 6% NHS organisation

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 the framework 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.

Response to the 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?

Of 62 responses:

• strongly agree – 2 (3%)
• agree – 7 (11%)
• neither agree nor disagree – 6 (10%)
• disagree – 12 (19%)
• strongly disagree – 40 (56%)
• don’t know – 0 (0%)

Key themes

• A theme was that the proposed criteria for indication-specific pricing are restrictive and medicines should not have to meet every stated criteria.
• However, some respondents felt that having explicit criteria is an improvement over the previous position as it will lead to more transparency and fairness across companies, and helps inform company decision making.
• Some respondents suggested that the pipeline of new medicines, for which an increasing number are expected to have multiple indications, highlights the importance of explicit guidance on indication-specific pricing.
• The unmet need criterion, if defined in a narrow sense, may limit patient and clinician choice and therefore may impact on company launch decisions.
• Some respondents recognised the challenges around data availability, but suggested NHS England should be more pragmatic on the data requirements to prevent inequities in access. Suggestions included the use of alternative datasets or transacting indication-specific pricing without the need for data collection on the number of patients treated by indication.

Q2: To what extent do you agree or disagree that the criteria provide clarity on the circumstances in which NHS England will consider indication-specific pricing arrangements?

Of 62 responses:

• strongly agree – 0 (0%)
• agree – 15 (24%)
• neither agree nor disagree – 7 (11%)
• disagree – 9 (15%)
• strongly disagree – 30 (48%)
• don’t know – 1 (2%)

Key themes

• While some respondents felt that the proposed criteria add some clarity with respect to the previous framework, they also considered the individual criteria lack specificity and suggested that further explanatory guidance should be provided to aid understanding.
• The unmet need criterion should clarify whether medicines that are not the first to market will still be able to meet an unmet need.
• On the revenue loss criterion, respondents requested further information on the components of revenue to be considered and whether the revenue projection can include potential future indications.
• Some respondents suggested that the criteria need to maintain a balance between providing additional guidance and allowing the flexibility of case-by-case decision-making. Within this, respondents recognised the practical challenges in setting fixed parameters for each criteria.
• The text relating to the use of indication-specific prices in subsequent evaluations could be interpreted in different ways and requires clarification.
• Respondents requested further clarity on the engagement routes and timing of when discussions relating to indication-specific pricing can occur in the overarching evaluation process.
• Clarity was also requested relating to the application of the indication-specific criteria, and commercial access arrangements more generally, through the development and publication of metrics.

Feedback outside the scope of this consultation

• Some responses to the proposals on indication-specific pricing suggested that NHS England should take a more permissive approach, allowing for more indication-specific pricing arrangements to be agreed.
• The principles of the framework and how they can impact on company launch decisions, and therefore patient access, were raised as issues. Specifically, principle 4 and the requirement for value propositions to be at or below the lower end of the standard NICE cost-effectiveness threshold were raised, given the existence of other cost control mechanisms and the inconsistent magnitude of impact its application has on medicines.
• Respondents raised the broader value and access policy within the UK and the impact this has on the competitiveness of the UK’s life sciences sector and company investment decisions.

Section 2: Combination therapy pricing

Q3: To what extent do you agree or disagree that NHS England should support the CMA’s position statement to enable company-to-company engagement over combination therapies?

Of 62 responses:

• strongly agree – 28 (45%)
• agree – 16 (26%)
• neither agree nor disagree – 6 (10%)
• disagree – 1 (2%)
• strongly disagree – 1 (2%)
• don’t know – 10 (16%)

Key themes

• Responses reiterated the importance of finding a solution to the commercial barriers faced by combination products and were predominantly positive about NHS England’s intention to support the CMA position statement.
• Respondents highlighted how the importance of enabling access to future treatment for several therapy areas will only continue to grow.
• Some felt combination products using the CMA framework should have automatic eligibility for indication-specific pricing given the terms set out in the CMA position statement.
• Respondents highlighted the need for early engagement and clarity on existing engagement routes for companies engaging with the CMA framework.
• There was also appetite for implementation metrics to monitor use and effectiveness of the CMA framework in increasing approvals for combination products.

Q4: To what extent do you agree or disagree with the proposed approach for data sharing, where necessary, to facilitate company-to-company commercial agreements for combination therapies?

Of 62 responses:

• strongly agree – 5 (8%)
• agree – 38 (61%)
• neither agree nor disagree – 7 (11%)
• disagree – 3 (5%)
• strongly disagree – 0 (0%)
• don’t know – 9 (15%)

Key themes

• Support for the proposed data sharing approach was comprehensive and responses emphasised how reliant the successful implementation of the CMA framework will be on data from NHS England.
• However, concerns were raised regarding data quality and respondents requested that additional datasets be used, without compromising confidentiality, to facilitate commercial arrangements.
• In the context of increased delegation, respondents reflected the need to future proof the system’s data infrastructure to facilitate such commercial flexibilities for ICB and primary care commissioned medicines.
• Further clarity was requested on the Data Access Request Service, in particular the fee structure, criteria for data provision and timelines for data access to assist company planning.

Q5: To what extent do you agree or disagree that there are circumstances where the CMA’s position statement would not support commercial arrangements for combination products?

Of 62 responses:

• strongly agree – 22 (35%)
• agree – 15 (24%)
• neither agree nor disagree – 11 (18%)
• disagree – 1 (2%)
• strongly disagree – 1 (2%)
• don’t know – 12 (19%)

Key themes

• Despite widespread support for NHS England’s intention to support the CMA position statement, which may unblock some commercial barriers, concerns were raised regarding remaining barriers.
• Respondents felt that the commercial framework would not provide a solution in scenarios where the business case for the backbone company is not sufficiently strong, for example where the backbone product is close to reaching loss of exclusivity or the combination product would not be cost-effective at zero price.

Feedback outside the scope of this consultation

• Respondents requested greater clarity in the framework regarding:
  • the operationalisation of such commercial arrangements
  • exit criteria for such commercial arrangements, such as in the event of loss of exclusivity for a component medicine, and the processes that will follow

Section 3: Embedding patient access scheme provisions and principles

Q6: To what extent do you agree or disagree with the proposal to embed the PAS provisions and principles from the 2014 Pharmaceutical Price Regulation Scheme (PPRS) in the framework?

Of 62 responses:

• strongly agree – 12 (19%)
• agree – 32 (52%)
• neither agree nor disagree – 6 (10%)
• disagree – 2 (3%)
• strongly disagree – 0 (0%)
• don’t know – 10 (16%)

Key themes

• The proposal to transfer the PAS guidance and principles from 2014 PPRS into the new commercial framework was supported.
• There were some requests for clearer definitions of simple and complex PAS, and examples of the types of arrangement that could be agreed under each, to support broader understanding and subsequent implementation.
• There was also a request to reconcile the content regarding private patients in the planning guidance on NHS England Medicines Procurement and Supply Chain frameworks with the NICE Patient Access Scheme Liaison Unit forms.

There was appetite for NHS England to increase transparency regarding how decisions relating to patient access schemes are made and the associated timings.

Feedback outside the scope of this consultation

• Respondents reiterated the importance of enabling PAS delivery in primary care in the next consultation, especially in the context of increased delegation.
• Some respondents felt there is opportunity to update the PAS principles based on the years of experience since the principles were first launched in 2014.
• More generally, some respondents highlighted how the perceived multiplicity of price control mechanisms in the UK is creating an unfavourable market for new launches.

Publication reference: PRN01610ii