Updates to the NHS Commercial Framework must deliver more flexibility to support timely access to medicines

NHS England (NHSE) has published an update to the commercial framework for new medicines. In this article, Victoria Jordan, ABPI’s Director of Value and Access Policy, reflects on what has been achieved and what must be prioritised as phase two of the consultation approaches.

A key commitment in the 2024 Voluntary Scheme for Pricing, Access, and Growth (VPAG) is to improve patient outcomes by supporting access to cost-effective medicines. Part of this will be achieved by evolving commercial arrangements - enhancing commercial flexibilities – and consulting on a new commercial framework.

The first update to the framework has been helpful, with some important clarifications, but its scope was limited. A more ambitious approach for the next consultation phase -expected in summer 2025 - is critical to building on the progress that has been made.

Recap on the consultations

NHSE published two consultations in July 2024: one on the commercial framework for new medicines and another on the budget impact test threshold.

The ABPI previously outlined the importance of these consultations and the outcomes it hoped they would achieve. On 29 January 2025, NHSE published updates to the framework, incorporating policy changes from both consultations.

What’s new in the updated framework?

While NHSE has made several changes, they remain within a limited scope. Some of the ABPI’s major concerns remain unaddressed, but the framework now provides greater clarity, helping companies understand when NHSE may grant commercial flexibility and how to engage effectively.

Key changes include:

Indication-specific pricing

For the first time, indication-specific pricing has a dedicated section in the framework, established as an “alternative to uniform pricing.” This is increasingly needed to support patient access to medicines treating multiple diseases, including combination therapies, cell and gene therapies, and rare disease and cancer treatments.

The criteria for securing indication-specific pricing are clearer. However, the combined effect of the four criteria alongside the requirement to provide additional value beyond being at or below the lower end of NICE’s cost-effectiveness threshold remain significant barriers. Many medicines requiring commercial flexibility may struggle to meet these conditions, limiting patient access.

Engagement with NICE and NHSE

NHSE has provided more guidance on how and when companies should engage regarding commercial flexibility. Early engagement should support more productive discussions and give companies time to act on NHSE’s advice before NICE evaluation.

However, the framework does not commit to providing companies with a formal indication or agreement in principle that commercial flexibility may be granted, something that could make the NICE evaluation process more efficient and improve the timeliness of guidance.

Combination therapies

The Competition and Markets Authority (CMA) combination therapies prioritisation statement outlines a framework for companies to collaborate on commercial agreements that enable cost-effective pricing in certain circumstances.

To use this framework, companies need access to NHS data on patient treatment numbers and treatment duration. NHSE’s commitment to supporting data sharing is crucial in enabling companies to work together on pricing agreements for combination therapies.

The ABPI will continue to monitor concerns regarding data access timelines and costs and will work with NHSE to address implementation challenges.

Budget impact test threshold

The framework confirms an increase in the budget impact test threshold, which triggers commercial discussions to address affordability concerns. The threshold has doubled from £20 million to £40 million in any of the first three years of a medicine’s use.

This is a positive change that will help speed up NICE guidance delivery and reduce NHSE’s administrative burden.

Implementation will be vital

The framework clarifies NHSE’s approach to commercial flexibilities, supports earlier engagement with companies, and improves access to NHS data for combination therapies in line with the CMA framework.

Successful implementation must now demonstrate the framework is supporting access to new medicines and indications, including through granting commercial flexibilities, when these are required.

Clear metrics should be developed, agreed upon, and reported regularly to ensure the framework is applied consistently. Expanding on the NICE reporting spreadsheet linked in the commercial framework would be a good next step.

Looking ahead to the next phase of consultation

A second consultation on the commercial framework is expected in June 2025. This is an opportunity to consider what further updates are needed to support the introduction of innovative medicines in England.

To strengthen the framework, NHSE should:

• Define commercial flexibility options for locally commissioned medicines, including primary care Patient Access Schemes.
• Enable ‘in principle’ commercial agreements to improve NICE evaluation efficiencies.
• Clarify NHSE’s role in supporting system preparedness for faster, equitable adoption of new medicines.
• Gather early feedback on the updated framework’s implementation to inform adjustments, particularly around indication-specific pricing and data access.
• Establish clear metrics for NHSE and industry to assess where the framework is effective and where improvements are needed.
• Align policy with current practice, ensuring the Patient Access Scheme aligns with NICE’s manual.

The biggest concern: The “at or below” principle

The industry’s top concern for the next consultation is Principle 4 of the commercial framework, which creates a restrictive barrier for medicines seeking commercial flexibility.

To access commercial flexibility, companies must price medicines below the cost-effective value determined by NICE, specifically at the lower end of the cost-effectiveness threshold - often referred to as the “at or below” principle.

This principle is highly problematic as it imposes an additional barrier that many medicines requiring commercial flexibility cannot overcome, ultimately limiting patient access.

The principle detaches price from the value proposition established by NICE, conflicts with evolving NICE methods, and penalises medicines offering additional benefits. It also conflicts with the government’s ambitions for the life sciences sector, which is identified as one of its eight priority growth sectors for the upcoming industrial strategy.

The ABPI believes that the “at or below” principle must be included for meaningful consideration in the scope of the second consultation. Addressing this issue will be essential to ensuring that the commercial framework delivers its intended benefits.