What more needs to be done?

The release of the CMA statement has supported companies engaging with each other but may not be able to provide a complete solution, especially when the backbone therapy (the existing medicine that the new one is added to) is nearing the end of its patent. There is no single solution that will resolve all these challenges – stakeholders will need to continue working together to make progress.

 

1.    HTA decision-making frameworks

In England,⁷ NICE determines whether a combination therapy is cost-effective using the same methods and decision-making framework as it does for individual medicines. Challenges relating to how value is recognised and how NICE’s committees make decisions with uncertain evidence bases tend to be exacerbated in combination therapy appraisals.

The company that manufactures the new component is usually responsible for submitting an evidence package to NICE for the combination therapy and must price their component on top of the (often confidential) price of other component(s).

This methodology has fundamental challenges, some of which are technically complex. A key challenge is that by extending patients’ lives when they are treated with a combination therapy, the patient receives treatments for longer and the costs to the NHS increase. These extra costs can be enough for the therapy not to be judged cost-effective – in some cases even when the new component is priced at £0.

 

2.    Indication-specific pricing

Medicine components of combination therapies are often already approved, or in the pipeline, to treat other diseases (indications). Indication-specific pricing, charging a different price for the same medicine depending on which condition it is used to treat, is needed to recognise the value of different uses of the medicine to support patient access to combination therapies.

The NHS England Commercial Framework for New Medicines was updated in 2025, ³ and, for the first time, included a dedicated section for indication-specific pricing, established as an "alternative to uniform pricing." The criteria for securing indication-specific pricing are now 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 remains a significant barrier. Many medicines requiring commercial flexibility, including combination therapies, will struggle to meet these conditions, limiting patient access.

 

3.    Further guidance and flexibility on commercial agreements

Based on a survey of ABPI members, further guidance would be helpful to complement the CMA statement, so companies can reach commercial agreements for combination therapies not otherwise able to be recommended by NICE.

The price of combination therapy components will likely change, for example because patents expire and cheaper versions of the medicine (generics and biosimilars) become available. It would be helpful to confirm in the Commercial Framework that the price of another component can go up to compensate for this (while the total price of the combination remains cost-effective). A rapid review or pragmatic approach to updating the commercial agreement(s) would support a more holistic solution that builds on the framework set out in the CMA statement.

 

Summary

The release of the CMA statement was a step in the right direction in aiming for greater patient access to ground-breaking combination therapies, however substantial challenges still remain in bringing these therapies to patients in the UK.

There is not one single solution that will further support access to combination therapies. Stakeholders must work together to make progress across three key policy priorities (HTA decision-making frameworks, indication-specific pricing, further guidance and flexibility on commercial agreements) if patients are to benefit from these clinically important therapies now and in the future.