Deciding which medicines are used in the NHS

Between 2019 and 2022, 93 new medicines were approved for use in the NHS in England and Wales, and 90 were approved for use in Scotland (see data tables; sheet 11).

In July 2025, the government published its 10 Year Health Plan for England and a Life Sciences Sector Plan. Both documents set out commitments to speed up approval processes for new medicines. The sector plan sets a target for the UK to be “one of the top three fastest places in Europe for patient access to medicines and MedTech” by 2030.

Who approves new medicines in the UK? Medicines and Healthcare products Regulatory Agency

All new medicines in the UK go through two separate approval processes before they can be made available to patients. First, the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), must license the medicine for use. A medicines license, known as a marketing authorisation, allows a medicine to be sold and supplied throughout the UK.

National Institute for Health and Care Excellence

Before a medicine can be used in NHS services, it must go through a second evaluation and approval process, known as a health technology assessment. The National Institute for Health and Care Excellence (NICE) assesses new medicines and makes recommendations about how and when they should be used in the NHS in England.

NICE recommendations also apply and in Wales and are usually endorsed by the Department of Health in Northern Ireland following a local review.

Scottish Medicines Consortium

In Scotland, the Scottish Medicines Consortium (SMC) conducts its own assessment of new medicines being considered for use in the NHS.

How are new medicines assessed?

The MHRA, NICE and SMC all consider evidence provided by pharmaceutical companies about a new medicine before it is approved for use. The MHRA will license a new medicine for sale and supply in the UK when it considers that the benefits of a medicine outweigh its risks.

NICE and the SMC consider whether a new medicine provides greater benefits (or fewer side effects) than existing treatments, and whether it will be cost-effective and provide value for money for the NHS.

If a new medicine is more effective and cheaper than existing NHS treatments, it will be recommended for use in the NHS. If it is more effective, but also more expensive, NICE and the SMC will consider how much the additional health benefits of using the new medicine will cost.

In the UK, new medicines have typically been recommended for use in the NHS if they will provide an extra year of life in good health, or an equivalent health benefit, for around £20,000 to £30,000. In some cases, NICE and the SMC can recommend more expensive treatments for NHS use, such as medicine used to treat severe health conditions or rare diseases.

From April 2026, NICE will increase the cost level at which it will deem a medicine to be cost-effective. It will recommend that the NHS provides medicines that provide an extra year of good health for between £25,000 to £35,000. This change is part of the UK-US pharmaceuticals trade deal announced on 1 December 2025. In addition, the government announced that NICE will review the method used to measure health-related quality of life, which could lead to more medicines being considered cost-effective.

On 9 December 2025, the government launched a consultation on proposals to allow the Secretary of State to set the cost-effectiveness threshold used by NICE. The consultation is open until 13 January 2026.

How well do medicines approval and evaluation processes work?

According to NICE, 84% of its technology appraisals result in a positive recommendation for a new medicine. NICE’s latest annual report shows that it increased the average speed of publishing its recommendations by 26% in 2024/25, compared with the previous financial year.

European data shows that, as of January 2025, England was ranked sixth for patient access to EU or UK licensed medicines. In this analysis, 65% of medicines licensed between 2020 and 2023 were recommended for use in England. This rate is lower than the rate in Germany, Italy, Austria, Switzerland and Spain, but it is above the EU average rate of 46%. Scotland is also above the EU average rate for patient access to new medicines, ranked 12th, with 57% of new medicines recommended.

The UK Government publishes another measure, called the uptake ratio, which compares the actual use of new medicines in the UK with 15 comparator countries. The most recently available data for this measure shows that after one year, the uptake of medicines recommended by NICE between 2018 and 2022 was about half that of the average uptake in the comparator countries.

In practice, the actual use of new medicines varies across and within the UK. NICE and the SMC do not always make the same recommendation about whether a medicine should be used in the NHS. Even when new medicines are recommended, there is variation in how quickly they are adopted in different parts of the UK.

Increasing patient access to new medicines

The government’s 10 Year Health Plan for England and Life Sciences Sector Plan include commitments to speed up approval processes for new medicines and reduce variation in uptake across the UK. These include plans to allow pharmaceutical companies to register early for parallel MHRA and NICE decisions about new medicines and the introduction of a single national formulary, replacing local lists of medicines with a national list of medicines available to use in the NHS.

The 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG) is an agreement between the Department of Health and Social Care and the pharmaceutical industry. The VPAG includes commitments and funding to support and improve medicines approval processes in the UK, including:

• setting out an aim for NICE to evaluate all new medicines within three months of them receiving a marketing authorisation from the MHRA
• developing and testing new approaches to health technology assessment via the NICE Health Technology Assessment Innovation Laboratory (HTA Lab)
• implementing NICE recommendations in the NHS in England
• tracking and publishing regular updates on the uptake of new medicines in the NHS.

Further reading

Commons Library, How are medicines prices set in the UK?, July 2025

Parliamentary Office of Science and Technology, Treating rare diseases: the challenge of orphan drugs, July 2025

The King’s Fund, Access to new medicines in the English NHS