Summary

Biological medicines, including biosimilar medicines, play an important role in healthcare, opening up many possibilities for the treatment of disease and illness. 8 of the top 10 medicines prescribed in our hospitals by spend are biological medicines, and they are used to treat a range of conditions from cancer through to chronic inflammatory conditions such as rheumatoid arthritis and inflammatory bowel disease. 

With some widely used biological medicines due to lose patent protection between now and 2028, we have a substantial opportunity for early and widespread adoption of better value versions, and estimate that this could free up to £1 billion in savings to reinvest in patient care.

This is because biosimilars – highly similar to the original biological medicines already approved in the UK (known as ‘reference products’) in terms of structure, biological activity, safety and immunogenicity profile – are typically offered to the NHS at a price lower than that of the original.

Biosimilars are manufactured after the reference product patent expires, and so the manufacturer does not need to cover the high clinical development costs associated with creating the original molecule. Once licensed by the Medicines and Healthcare products Regulatory Agency (MHRA), biosimilars are interchangeable with their reference products and with other biosimilars of the same reference product when approved.

The NHS has made considerable progress in embedding best value biological medicines use into routine clinical practice – for example, for adalimumab – but there remains considerable variation in uptake and more to do collectively if the NHS is to fully capitalise on the opportunities as better value products become available.

This commissioning framework for best value biological medicines sets out NHS England’s ambitions to establish a best value first approach, by accelerating and widening the adoption of best value biological medicines across the NHS. The revised framework builds on previous work to support integrated care boards (ICBs) and providers to act promptly to secure savings opportunities as more competitive biosimilars enter the market, and emphasises the importance of taking a collaborative approach from the outset.

Introduction

In an environment where demand for high-cost disease modifying medicines is increasing, early adoption and widespread use of best value biological medicines, including biosimilar medicines, will free up resources so that many more patients benefit from reinvestment in services and improved access to new and innovative therapies.

The benefits of their widespread adoption go beyond the direct financial savings for the NHS. Driving down prices may mean lower treatment thresholds are affordable and more people can be offered a biological medicine earlier in the treatment of their condition, helping avoid future costs associated with deterioration in health.

In 2017 we set an objective that at least 90% of new patients will be prescribed the best value biological medicine within 3 months of launch and at least 80% of existing patients within 12 months, or sooner if possible. Since then, the NHS has successfully generated efficiencies from the loss of exclusivity of several high spend biological medicines and uptake of best value products, such as for rituximab, trastuzumab and adalimumab. In the last 3 years the NHS has made £1.2 billion total cost savings from switches, £400 million of which has been from adalimumab switches alone. 

In addition, the MHRA has now updated guidance on the licensing of biosimilar products for interchangeability: “Once authorised, a biosimilar product is considered to be interchangeable with their reference product, which means a prescriber can choose the biosimilar over the reference product (or vice versa) and expect to achieve the same therapeutic effect. A biosimilar product is also considered to be interchangeable with another biosimilar to the same reference product”. The guidance further explains that “as a result of interchangeability, switching patients from one product to another (reference product or biosimilar) has become an acceptable clinical practice”.

Given the success achieved to date and regulatory changes – which provide clinicians and patients with increased confidence in the safety of these products – we believe the NHS can further accelerate its uptake of best value biological medicines as this market matures and more patents expire. Therefore, NHS England has set new ambitions:

• 100% of new patients requiring biological medicines will be initiated on the best value biological, where clinically appropriate, within 3 months following its launch
• at least 80% of existing patients will be on the best value biological medicine within 10 months of its launch

Note: Treatment decisions should always be based on the clinical judgement for individual patients, but if more than one medicine is suitable treatment, the best value biological medicine, including biosimilars, should be chosen.

National prioritisation of biological medicines

NHS England’s horizon scanning data identifies that the NHS spends approximately £1.4 billion on biological medicines that are due come off patent between now and 2028. This presents an opportunity to secure up to £1 billion in potential savings through the timely uptake of best value biological medicines once they are launched. 

NHS England has prioritised switching for 5 biological medicines, based on volume of patients across primary and secondary care, value (size of efficiencies opportunity available), the opportunity for patient optimisation in the pathway, as well as the potential complexity of a switch. 

 Table 1: Nationally prioritised biological medicines

Working with systems, NHS England will develop a national programme of work for each of these nationally prioritised best value biological medicines. The intention of these programmes is to embed the best value first approach into commissioning and clinical practice through switching as early as appropriate and to reduce variation at a local level through national oversight.

This will include consideration of existing national guidance and other biological medicines in the same treatment pathway that are available now or may be in the near future, so that patients are not repeatedly switched to different products; as well as review of different approaches to take within the treatment pathway.

Working closely with stakeholders, NHS England will start developing co-created implementation plans 12–18 months in advance of the better value products for these medicines coming to market, to support the system and prepare for their entry into the NHS.

Based on horizon scanning intelligence closer to patent expiry, the list of prioritised medicines may be updated.

Supporting the system

The 2025/26 priorities and operational planning guidance highlights the need for patients to be prescribed the best value biological medicine where a biosimilar is available.

NHS England is clear that the NHS must collaborate if it is to be proactive in supporting the uptake of best value biological medicines. This joined-up approach will need to be co-ordinated, whether by ICBs or NHS England Specialised Commissioning and supported by the regional and national NHS England teams.

NHS England will:

• support systems with prioritisation of best value biological medicines opportunities through the regional procurement pharmacy specialists (RPPSs) and regional specialised commissioning pharmacists
• continue to work with partners, including patient groups, industry and professional groups, to support a best value first approach
• share in advance with systems the national programme of work that we will put in place for the prioritised best value biological medicines. We will do this work in collaboration with ICBs and with a focus on developing ‘do once’ tools and support nationally to ensure consistency in approach
• implement national frameworks through the Medicines Procurement and Supply Chain (MPSC) team to drive value for best value biological medicines. Any provider or organisation that treats NHS patients and purchases products at MPSC pricing must be registered as a purchasing point with NHS England and agree to the key conditions of access (see Annex and the MPSC webpage for further details)
• publish any national tools and support on the NHS England website or FutureNHS alongside any procurement frameworks, or share these via the RPPS teams
• develop a national reference pricing approach as a financial enabler for prioritised best value biological medicines

How the range of measures described in the framework are used to support biosimilar entry will depend on factors specific to individual pathways.

Implementation through NHS commissioning and contracting systems

Collaborative working across the system – commissioners, providers and their clinical teams – is essential for the quick and consistent realisation of the potential savings and any other benefits from a switch to a best value biological medicine.

The 4 key stages to consider when commissioning best value biological medicines are:

• assessment of the opportunity – positive service impact within current treatment pathways, savings opportunities and the availability of products at least 12 months in advance, once information is received from regional procurement colleagues
• engagement/implementation plan – identifying key stakeholders (clinical, pharmacy, homecare teams, procurement and finance) and development of an implementation plan
• resource enablement – considering the resources needed to support rapid uptake
• evaluation and monitoring – monitoring uptake through prescribing data

In addition, it is important to consider clinical decision-making and shared decision-making with the patient. Research shows that for patients, the most frequently cited enabler of uptake is positive framing of a biosimilar, while for healthcare professionals it is the cost benefit (see Barriers and enablers affecting the uptake of biosimilar medicines viewed through the lens of actor network theory: A systematic review).

Examples of approaches taken will be shared on FutureNHS. If you would like to share a successful approach, please do contact NHS England’s Medicines Value and Access team england.medicines@nhs.net.

Resource enablement

NHS England supports appropriate resourcing arrangements to enable effective adoption at pace. The speed of adoption will depend on the complexity of the switch, but adoption will become easier as the practice of best value prescribing is embedded, and over time we would expect incentives to cease.

Implementation of any switching to a best value biological medicine relies on the efforts of provider staff. However, current funding flows mean that without agreed financial arrangements all savings will accrue to the commissioner (either ICB or NHS England Specialised Commissioning).

No party should be financially worse off because of a switch. Enacting any agreement between commissioners and providers should align with the direction set out in the Revenue finance and contracting guidance for 2025/26. 

When deciding if a financial incentive is required, commissioners and providers should consider whether:

• for the chosen approach the extra savings from providing this justify the additional work and cost to the NHS
• an incentive already exists in the system such that providers may accrue savings if they make switches, for example the high-cost medicine is in a block contract

Incentives should not be put in place for switches that are simple to make and do not need any extra resources. Financial incentives should only be agreed when they support switching at pace.

Commissioners and providers should discuss with their RPPS the price being paid for best value biological medicines and they can then look to MPSC frameworks for better value opportunities (see Annex).

Once the implementation plan has been agreed, the ICB and provider can express this in their local NHS Standard Contract by describing the overall approach, any approved financial incentive and any data or reports required to monitor uptake (see the NHS Standard Contract webpage).

Development of national reference prices for prioritised best value biological medicines

NHS England will develop national reference prices for the 5 nationally prioritised biological medicines listed in Table 1, drawing on what we have learnt from the adalimumab switching programme that has saved an estimated £400 million over 3 years. This will ensure a consistent approach across ICBs and NHS England Specialised Commissioning.

Providers will receive a nationally set payment for all patients treated with the biological reference product or biosimilar, which will include costs for the delivery of additional clinical capacity required to facilitate a switch. This will ensure a margin is available for continued prescribing of a reference product where appropriate, but also create a financial incentive to switch patients, as any reduction in expenditure from switches can be reinvested in local services and any margin can be appropriately shared between the ICB and provider.

Establishing national reference prices will appropriately incentivise the prescribing of best value biological medicines, while also providing transparency in pricing to reward those manufacturers that price most competitively. A reference price will only be developed for 1–2 years, with the intention of removing the medicine from the high-cost drugs list when this period expires.

Annex: Role of tendering for medicines in the NHS

The Medicines Procurement and Supply Chain (MPSC) contracts for biological medicines on behalf of the NHS in England. National frameworks are implemented across the 7 regions, which complies with all current policy, legislation and guidance.

Biological medicines, including biosimilars, are prescribed by brand and allocated individual national product codes that include the brand name. They are included in the new to market tenders that are the most appropriate for their chemical structure and/or therapeutic indications.

MPSC determines the exact timing of new biosimilar inclusion in the contracting process from horizon scanning, market intelligence, clinical need or criticality, and the system’s ability to onboard the biosimilar at the most appropriate point in the contract cycle for the 7 regions.

The aim of this national tendering programme is to leverage the NHS’s purchasing power in both the short and long term and to use the emerging market to the best advantage of the NHS, while maintaining a competitive and sustainable market.

Publication reference: PRN01716