Drugs: Licensing

(asked on 4th July 2025) - View Source

Question to the Department of Health and Social Care:

To ask His Majesty's Government, in regard to the NHS commercial framework for new medicines, published on 29 January, whether they will consult on the principle to provide additional value for medicines at or below the lower end of the standard National Institute for Health and Care Excellence cost-effectiveness threshold range in the second phase of the review of that framework.


Answered by
Baroness Merron Portrait
Baroness Merron
Parliamentary Under-Secretary (Department of Health and Social Care)
This question was answered on 12th August 2025

In January 2025, following public consultation, NHS England published an updated NHS Commercial Framework for New Medicines. This framework includes the approach for assessing the eligibility for medicines that may treat multiple indications to qualify for indication-specific pricing, and the terms for doing so. Following consultation, NHS England adopted the following criteria for the use of indication-specific pricing:

- the medicine for the indication under consideration meets an unmet clinical need;

- the company can demonstrate with a high degree of confidence that uniform pricing would reduce the total revenue for a medicine across all indications;

- sufficient data is available within existing National Health Service systems to make such arrangements operationally feasible; and

- the cost-effective price is highly differentiated for all indications under consideration.

NHS England’s approach to indication-specific pricing has supported patient access to medicines for many new indications which would otherwise have been unavailable if the only alternative was a uniform price for all indications. The National Institute for Health and Care Excellence is able to recommend the vast majority of medicines for use in the NHS, including medicines licensed for multiple indications. The latest European Federation of Pharmaceutical Industries and Association’s Patients Waiting to Access Innovative Therapies Indicator report 2024, published in May 2025, reports that the 37% of medicines licensed between 2020 and 2023 were fully available to NHS patients in England, compared with an European Union average of 29%.

As agreed under the terms of the Voluntary Scheme for Branded Medicines Pricing, Access and Growth, and subsequently set out in the NHS England consultation response, indication-specific pricing agreements will continue to be reserved for medicines that are normally expected to have value propositions at or below the lower end of the National Institute for Health and Care Excellence’s cost-effectiveness range.

The Life Sciences Sector Plan committed to faster patient access to medicines and reduced industry costs, while ensuring good value for the NHS. A new, proportionate approach to National Institute for Health and Care Excellence appraisals and indication-specific pricing will streamline access for multi-indication medicines with strong outcomes and low affordability risk. This will create a more agile, predictable commercial environment that supports investment into the United Kingdom.

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