Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry
The NHS has already achieved savings of £210m through the use of biosimilar medicines, according to recent figures for 2018/19, and it plans to widen the market further now that Adalimumab has been opened up to competition from cheaper rivals in Europe.
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 the patent expiry of Adalimumab, which has the highest global turnover of any medicine,
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 £200-300m per year by 2020/21 if the NHS embraces the use of best value biological medicines in a proactive, systematic and safe way’.
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 £333m on it. Consequently, it is hugely significant to the NHS’s best value biologics agenda.
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.
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 percent of new patients on the best value biological medicine within three months of the launch of a biosimilar medicine, and at least 80 percent 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?
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.
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.
Data and analysis are critical for mapping out care pathways and measuring the cost of optimal care versus sub-optimal 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 focussed 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 datasets 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.
Conclusion
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.