The implications of adalimumab’s European patent expiry

The NHS’s bid to improve patient outcomes and save money by switching costly biological drugs for cheaper biosimilars reached a major milestone in October when adalimumab – which has the highest global turnover of any medicine – came off patent in Europe.

The NHS has already achieved savings of £210 million through the use of biosimilar medicines, according to recent figures for 2018/19, and it plans to widen the market further as adalimumab, which is used for a range of conditions, is opened up to competition from cheaper rivals.

Regional Medicines Optimisation Committees (RMOCs), which were launched last year, have been playing a pivotal role in working with NHS commissioners and providers on best value biologics and helping them to prepare for adalimumab’s patent expiry.

The role of RMOCs

NHS England’s Medicines Value programme aims to help improve outcomes whilst keeping medicines affordable. A key strand of the programme involves optimising the use of medicines via the four RMOCs, which are based in London, the south, the north, and in the Midlands and east of England. They are designed to operate as a single, strategic medicines optimisation system for the whole country.

Each RMOC is chaired by the regional medical director for the respective NHS region. RMOCs bring together decision-makers and clinicians, to share best practice and understand the evidence base for medications. In line with other NHS programmes such as Getting It Right First Time (GIRFT), reducing variation, improving outcomes and value are key objectives for RMOCs.

In addition to providing advice and making practical recommendations for local decision-makers, RMOCs promote awareness and support the implementation of national policies and initiatives relating to medicines such as NHS RightCare, NHS Improvement’s Hospital Pharmacy Transformation programme and also Commissioning for Quality and Innovation (CQUIN).

RMOCs are not legislated bodies – hence they cannot force Clinical Commissioning Groups (CCGs) to take their advice and it is down to CCGs to make the final decision on drugs through Area Prescribing Committees. However, the level of seniority among RMOC members means their recommendations are likely to be taken seriously. This makes RMOCs and their work on best value biologics highly important, since they have been tasked with coordinating support for local providers and commissioners in this area.

RMOCs and best value biologics

According to the National Commissioning Framework for Biological Medicines, (including biosimilar medicines) ‘there is the potential to realise savings of at least £200-300 million per year by 2020/21 if the NHS embraces the use of best value biological medicines in a proactive, systematic, and safe way’.

This statement is backed up by Freedom of Information (FOI) requests obtained by Wilmington Healthcare which show that 20% of all the quality, innovation, productivity and prevention (QIPP) savings will be made through implementing medicines management cost improvement schemes in 2018/19.

Previously sold under the brand name Humira, adalimumab accounts for the highest hospital drug spend in the NHS and, in 2016/17, the NHS spent more than £333 million on it. Consequently, it is hugely significant to the NHS’s best value biologics agenda.

Adalimumab is mostly locally commissioned by CCGs in line with NICE technology appraisals for rheumatology, gastroenterology;,dermatology and ophthalmology, as part of the treatment programme. Though the prescribing is managed by the hospital, the cost generally comes from a CCG’s high cost drugs budget. The product is administered by subcutaneous injection, with 57,000 patients currently receiving the medication through a homecare supply route.

RMOCs have been leading regional engagement with clinicians, commissioners and providers to support the commissioning framework’s bid to get prescribers, providers and commissioners working together to develop plans for the quick and effective uptake of best value biological medicines.

Tackling variations in the uptake of biosimilars locally has been a key focus for RMOCs. For example, despite strong evidence of the cost savings that can be generated by the biosimilar, Infliximab, there has been significant and unwarranted variation in uptake between local areas and regions. For example, in January 2017, one NHS Trust in central London had an uptake of infliximab of only 25%, whilst another just 16 miles down the Thames had an uptake rate of 99%.

The best biologics agenda and pharma

In line with the Commissioning Framework for Biological Medicines, NHS England, NHS Improvement and NHS Clinical Commissioners all support the appropriate use of biosimilars. The NHS aims to get at least 90% of new patients on the best value biological medicine within three months of the launch of a biosimilar medicine, and at least 80% of existing patients within 12 months, or sooner if possible.

This policy drive has huge implications for pharma companies, which must think differently about how they market their medicines and how they interpret and measure best value. To achieve this, pharma needs to redefine its value proposition and move the focus away from direct medicines costs to demonstrating how savings can be made across the whole care pathway.

A key issue to consider in this regard is how patients receive biologic medications. For example, do they require infusion? If so, do local hospitals have sufficient infusion capacity, usually in the form of infusion chairs in a dedicated suite, or is the drug administered as a sub-cutaneous injection or ideally and potentially in the future orally. Infusion capacity varies from hospital to hospital. However, pharma companies can check the infusion capacity of individual hospitals and build this up into regional pictures, via a dedicated Wilmington Healthcare database.

As the NHS increasingly looks to move care out of hospitals and into the community, the ability to administer drugs at home is a significant advantage and an area where pharma could deliver additional value by offering a competitive homecare service. For example, Humira has previously been offered in tandem with a homecare package. However, in preparation for the Humira patent expiry, the NHS has been considering whether it would be cheaper to run its own homecare service.

Pharma must also engage with payers and other key stakeholders to help them understand how a range of biologic products could deliver value across the whole care pathway, e.g. for a population of patients with rheumatoid arthritis. To achieve this, pharma needs to consider issues such as treatment failure rates, inpatient stays,  the impact on social care and a patient’s ability to remain in employment. These factors need to be brought to the attention of RMOCs and Medicines Optimisation when considering which ‘Best Value’ biologics help the NHS as it moves to longer-term budgeting, which is likely to involve a set of longer-term service level outcomes-based targets, rather than a single, annual financial control target.

Pharma also needs to think about the NHS’s move into integrated health and social care systems, which is particularly relevant to gastroenterology and musculoskeletal (MSK) disorders. Integrated care systems are encouraging commissioners to take an increasingly holistic view of medicines and putting greater emphasis on the role of social care in managing and preventing diseases.

Data and analysis are critical for mapping out care pathways and measuring the cost of optimal care versus suboptimal care. Data that can be used includes Hospital Episodes Statistics (HES) which contains records of all patients admitted to NHS hospitals in England. This targeted and granular data can be cross-referenced from multiple health and social care sources.

It can also define and track patient cohorts, providing balanced, objective and outcomes-focused insights. However, pharma may only use this data for the planning process to demonstrate where there is benefit for patient care, if it is published under Open Government Licence (OGL).

Other useful real-world data includes diagnostic imaging data sets and prescribing data from NHS Digital, which delves down to GP surgery level. Pharma should also consult data sources such as NHS RightCare and GIRFT.

The NHS’s best value biologics agenda has been gathering pace over the past few years and the patent expiry of adalimumab is expected to significantly accelerate the uptake of biosimilars across a range of therapy areas. This, in turn, will stimulate greater competition in the marketplace and drive down drug prices.

In common with other developments, such as the move towards integrated care systems, longer-term budgeting and the focus of bodies like RMOCs on reducing unwarranted variation, the best value biologics agenda is all about getting value for money, delivering optimal care and improving patient outcomes.

To ensure that its messages resonate with the NHS, pharma must think holistically across the whole care pathway, define how its products offer best value and clearly show how that value can be measured. This involves thinking about everything from how and where a patient receives a drug to outcomes and failure rates and using this as the basis to develop clear evidence-based propositions.

Steve How, Paul Midgley and Oli Hudson are all part of Wilmington Healthcare’s Consulting Team. For information on Wilmington Healthcare, log on to