The framework was first published in 2021, following consultation, given a commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access. We believe that it is essential that the framework has the stability of a long-term strategy but remains up-to-date to reflect key developments that impact on its implementation.

A consultation (‘Phase 1’) on the framework was conducted in 2024, to be more explicit about enhanced commercial flexibilities and when they can be offered, with a further consultation (‘Phase 2’) due by summer 2025.

Whilst the focus of the framework is on new medicines, we will continue to consider the case for developing a related framework for best value biologics (biosimilars) and generic medicines.

Further guidance on biosimilars is available in the commissioning framework for biological medicines.

NHS England and NICE have established processes for providing advice to companies across the product lifecycle.

NICE provides early engagement opportunities for companies through NICE Advice. These fee-based services sit outside NICE’s formal guidance-producing processes and operate on a not-for-profit basis and in accordance with government requirements for managing public money.

NHS England offers free commercial surgeries to discuss a variety of commercial issues companies may face. Commercial surgeries bring together the relevant expertise and skill mix from both NHS England and NICE to discuss issues. For commercial surgeries to be as useful as possible, NHS England asks companies to complete the required template and give 4 weeks’ notice of when they are requesting a surgery.

Companies and patient groups can also engage with NHS England, from a commissioning perspective, on clinical matters through clinical stakeholder surgeries. These surgeries are a method for companies and patient groups to gain in-depth understanding of particular therapeutic areas from key opinion leaders and NHS system stakeholders, and where a new treatment might sit in existing care pathways.

The framework enables closer alignment of these existing approaches, providing clarity on these opportunities, their timing and the nature of the advice available.

NHS England provides a single point of contact for all commercial queries but also a triage function to enable faster and more consistent engagement between the NHS and companies.

Once a query has been submitted, we will acknowledge the receipt of the query, triage it internally and then send the company a rapid response either giving advice, signposting to advice, or organising a meeting.

Previous versions of the framework set out that NHS England does not operate blended pricing or pricing by indication. However, we recognised that approach may create challenges in certain circumstances for companies bringing forward multi-indication medicines.

We will now consider indication-specific pricing mechanisms, and the framework provides clarity the circumstances when such arrangements will be considered.

Realising the full potential health benefits from combination drug therapies can be challenging, given the need for commercial confidentiality and the requirement to maintain competition.

The Competition and Markets Authority (CMA), as the sole competent authority for the UK, has published a prioritisation statement on combination therapies following engagement with NHS England, NICE and the Association of the British Pharmaceutical Industry (ABPI).

NHS England and NICE support the CMA’s statement and will engage with companies in accordance with the negotiation framework to enable patient access to health improving combination therapies on the basis of this statement. NHS England will also consider requests for data to support company-to-company arrangements for combination therapies, as set out in section 5 of the framework.

Data on the number of active simple patient access schemes, complex patient access schemes, commercial access arrangements, and managed access arrangements by technology evaluation is published by NICE’s Commercial Liaison Team.