By Khola Khan, Chief Pharmaceutical Officer's Clinical Fellow, NHS Improvement

Advances in translational medicine and a growing demand for treating chronic conditions has led to increased NHS use of biological medicines. Figures from secondary care trusts show that in the financial year 2017/18, the total spend on rheumatology medicines was 6.1% (£0.44 billion) of the total NHS provider organisation spend on medicines; of which 80% (£0.35 billion) was on biological medicines.

The increased use of best value biological medicines will save the NHS money, which could then be made available to fund other services and medicines for NHS patients.  

This article provides an overview of biosimilar medicines and their impact on the past, present and the future, as the biological medicine on which we spend most in the NHS – adalimumab - comes off patent this month, October 2018, with other biosimilar options likely to be available to NHS trusts from 1 December 2018.

If patients receiving adalimumab for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis (JIA) are treated with the best value biological product, significant NHS resources will be released which can be reinvested in patient care.

The story so far…

Somatotropins, the first biosimilar medicines, received their marketing authorisation from the European Commission in 2006.  Now there are many biosimilars available from more than a dozen originator products, and the number is rising every year.

The use of best value biological medicines offers the longer term potential for increased patient access to important medicines and, by creating competition, reduced costs. Competition also provides an incentive for originator companies to develop new biological medicines.

Switching patients to biosimilar infliximab, etanercept and rituximab saved the NHS £210 million in 2017/18. Adalimumab is used across a range of specialties, including rheumatology, gastroenterology, dermatology and ophthalmology and consequently is the medicine on which the NHS spends the most - over £400 million - annually. It will come off patent on 16 October 2018.

Opportunities missed and delivered?

There is growing practical NHS experience that demonstrates the safety and clinical effectiveness of biosimilar medicines and the savings generated from their introduction in clinical practice. This has included structured switch programmes, weight-based dose tapering, and the use of research to identify other cost savings through clinical pathways, allowing savings to be reinvested in improvements to patient care.

However, despite this success, there is evidence of significant and unwarranted variation in the use and uptake of best value biological medicines. The Commissioning Framework for Biological Medicines, published by NHS England in September 2017, said 90% of new patients should be started on the best value biological within three months of a biosimilar launch when they become eligible for biologic therapy. Also, it is expected that at least 80% of existing patients should be switched to the best value biologic within 12 months.

Although every biosimilar product poses different challenges there has been a significant amount of learning from the transitions to biosimilar infliximab, etanercept and rituximab (see figure 1), and excellent supporting work such as that by the Cancer Vanguard. It is noted that the adalimumab transition will be very similar to that for etanercept due to patient care being predominantly delivered via homecare.

Next steps and the launch of biosimilar adalimumab

The originator adalimumab product Humira® is coming off patent in October 2018, with adalimumab biosimilar product contracts expected to be in place for NHS patients by December.

The vast majority of adalimumab use is locally commissioned by clinical commissioning groups (CCGs) in line with NICE technology appraisals. A small proportion (approximately 6%) is commissioned by NHS England’s Specialised Services for uveitis.

The product is administered by subcutaneous injection, with around 46,000 patients in England currently receiving the medicine through a homecare supply route.

NHS England has established a national biosimilar medicines programme board which includes NHS commissioners, clinicians, patient groups, industry, NICE and MHRA. This board provides strategic oversight and direction to inform and support national delivery of biosimilar medicines.

A working group has also been created and works primarily to provide national oversight of the implementation of best value adalimumab, to co-ordinate action, to identify any potential issues, and to provide support and engage with patient groups to help with implementation.

All resources can be found on the Specialist Pharmacy Service (SPS) website. The NHS England Commercial Medicines Unit (CMU) is scheduling the procurement process for adalimumab and best value adalimumab products are scheduled to be available in the NHS from 1 December 2018.

Current indications are that there will be five products available in the UK at this time (the originator and four biosimilars):

  • Amgevita® (Amgen)

  • Hulio® (Mylan/Fujifilm Kyowa Kirin)

  • Humira® (AbbVie)

  • Hyrimoz® (Sandoz)

  • Imraldi® (Samsung Biogen)

Further detail is being compiled regarding these and future biosimilar products, and this will be circulated to the NHS in due course. The adalimumab working group has followed the principles set out in the commissioning framework and the work programme is being structured according to the framework below:

  • Assessment of the opportunity

  • Engagement

  • Implementation

  • Monitoring and data collection

All the specialities using adalimumab have experience of implementing previous biosimilars with varying degrees of uptake, therefore work is being undertaken to ensure that lessons can be learned to enable more efficient implementation of best value adalimumab.

Citrate-free formulations

Feedback from patient groups and some clinicians has indicated that access to citrate free products may be required to avoid potential discomfort in injection, particularly in paediatrics. This has been considered in the creation of the tender and is addressed in the commissioning intentions document recently released by NHS England.

British Society for Rheumatology Biologics Register

A small study (De Cock et al, 2018) from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis shows that currently patients switched from biologics back to the originator is minimal, with inefficacy being the main reason for switching back to the originator.

What can BSR rheumatologists do?

NHS rheumatologists have an opportunity to save tens of millions of pounds by rapidly adopting the best value adalimumab product. This will require excellent communication between patients, clinicians, administration teams and primary care.

Key suggested actions are:

  • Inform your patients now that it’s happening

  • Start having conversations with them to reassure

  • Check that progress is underway for homecare of new products

  • Check relevant ‘gain share’ agreements are in place

  • Encourage registration of switchers with BSRBR

  • Encourage participation in post marketing surveillance

A national template patient letter, template patient newsletter article and frequently-asked-questions are available to all via the SPS website. 

This will soon be followed by a briefing for specialist nurses. For further information please refer to the Regional Medicines Optimisation Committees pages on the SPS website.