How new medicines become available on the NHS

New medicines can transform the treatment and prevention of disease, improving – and in many cases saving – lives. But no health system has unlimited resources. This creates a political and technical challenge for governments and health systems which must decide which drugs to make available and to whom.

Few areas of health policy are as contentious as decisions to fund – or not fund – new medicines. And few are as technical and complex in terms of the levers and mechanisms involved. The King’s Fund published a new explainer on Access to new medicines in the English NHS, which seeks to cut through this complexity and shed light on how decisions are made about the pricing and funding of new medicines. It also considers the tensions and trade-offs inherent in these decisions.

This work took us into the technical processes that govern access to medicines in England. Two key institutions are central to this: the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE).

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The MHRA is responsible for licensing medicines, ensuring they are safe and effective. NICE then assesses whether these medicines offer good value for money, using health technology assessments and cost-effectiveness thresholds. There are also special access arrangements for certain medicines such as those for rare diseases, as well as pathways for approval under restricted conditions or accelerated pathways.

Recent changes have aimed to improve and streamline these processes. For example, the MHRA has introduced international recognition routes to speed up approvals post-Brexit and NICE has updated its methods to better accommodate innovative treatments.

Beyond regulatory approval, there’s the matter of price. Negotiations between the NHS and pharmaceutical companies are often confidential, but they play a critical role in determining whether a medicine becomes available.

One of the key frameworks determining spending on new medicines is the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG). This agreement between the government and the pharmaceutical industry is designed to cap NHS spending on branded medicines while supporting innovation. However, the scheme is currently under intense scrutiny. Many pharmaceutical companies argue that it’s not working as intended, and discussions are ongoing about how to reform it.

Even when a medicine is approved and funded, access can still vary significantly at the local level. Our work highlights the critical role of Integrated Medicines Optimisation Committees (IMOCs) and local formularies, which decide how and when medicines can be used in local areas.

Local variation in access can lead to concerns about equity and fairness, sometimes referred to as a ‘postcode lottery’ of medicines availability. A recent example is the weight-loss drug Wegovy, which has been approved for use under certain conditions but isn’t consistently available across the country because it can only be used within specialised weight-management services which aren’t always available.

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There are various initiatives underway to address local variation in access to new medicines, including efforts to standardise formularies and improve transparency, and to support clinical leaders to champion implementation of the latest NICE guidance.

Medicines policy must always balance competing objectives, giving patients prompt access to effective treatments while ensuring that NHS spending on medicines is affordable for the taxpayer. It also seeks to incentivise the pharmaceutical sector to develop and bring new products to market, and support long-term capacity for medicines innovation and the UK’s position as a global leader in life sciences.

This balancing act looks set to become ever more challenging. New treatment possibilities – such as those based on genomics and personalised medicine – are on the horizon. At the same time, the government is focused on economic growth, with the life sciences sector playing a key role in that agenda. Meanwhile, the NHS faces significant financial pressures and wider economic constraints are tightening. In this context it is also important to consider the appropriate balance of spending on new medicines with other areas of health-related spending, and what this means for overall population health.

It's clear from our work that the process of making new medicines available on the NHS is complex, technical, and often contentious. It involves navigating a web of regulatory approvals, price negotiations, and local decision-making, all while trying to balance access, equity, innovation and affordability. At the heart of these seemingly technical processes are patients waiting for treatment, making it vital for policymakers to get these decisions right.

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You can read the full explainer here: www.kingsfund.org.uk/insight-and-analysis/long-reads/access-new-medicines-english-nhs

This project was commissioned by the Association of the British Pharmaceutical Industry (ABPI). The research, analysis and writing were conducted independently by The King’s Fund.