Pfizer commissioned this article written by Dr James Galloway (JG). No honorarium was paid to JG but Pfizer funded the article’s publication and has final editorial control.
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In November 2018, the patent on the blockbuster drug adalimumab, a biologic therapy licensed for rheumatoid arthritis (RA), expired. Several media headlines highlighted the implication of this in terms of benefit to the NHS, with estimates of over £150 million in savings with the latest price changes1, given it’s the single medicine on which hospitals spend the most. Biologics were first licensed for RA almost 20 years ago, with a price of around £10,000 per patient per year; the off-patent replacements are being launched at less than half the original prices. Yet, at present, the changes in price do not appear to be translating into wider access to the medication for patients.
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Rheumatoid arthritis (RA) is an expensive disease, costly in human and financial terms. Affecting 0.5% to 1% of adults2, with 75% of new diagnoses in people of working age3, the impact on patients, healthcare systems and society as a whole is considerable4. Failure to adequately control RA results in pain, disability, inability to work as well as comorbidities extending beyond joint symptoms. Over the last two decades treatment options for RA have changed beyond recognition. The development of advanced therapies, including biologics that target specific inflammatory pathways to control RA, dramatically improved outcomes. They have changed rheumatology clinics from places of disability and despair to places of optimism. In the late 1990’s, the rheumatology department I rotated through had responsibility for 40 inpatient beds for people affected by RA, admitted for rehabilitation. In 2018 as a consultant rheumatologist, I do not have a ward as my patients are managed almost entirely as outpatients. Whilst this is clearly positive, it is still no time for complacency. We know that for the best outcomes, we need to establish people with RA on effective treatments as soon as possible.
New internationally accepted guidelines recommend early aggressive treatment strategies, with escalation to advanced therapies for those that do not respond well enough to intensive treatment with conventional drugs. This treat to target approach, aiming to put patients into disease remission, is vital to reduce the burden of inflammation-mediated damage. Recently published NICE guidelines embrace this treat to target approach5. However this has not been reflected in their health technology appraisals which guide national reimbursement, a source of frustration for patients and clinicians.
We currently face a situation where NICE documents conflict with each other: the overarching RA guideline advocates a treat to target approach aiming for remission, whilst individual drug guidelines restricts our most effective treatment options to only the worst cases.
For a patient to be permitted access to an advanced therapy for RA, there is a requirement to wait until the disease state is severe6,7. This target is based upon criteria set in 2001. Numerous clinical trials have enrolled patients with less severe disease and demonstrated efficacy. Clinically the decision to save our best medications until the disease has reached severe levels is counterintuitive and contrary to European and American guidelines. However it would be wrong to cast judgement on the UK position as the situation is a result of sensible commissioning strategies over many years. The challenge to systems is the growing spend on biologic drugs. In 2007-08 biologics accounted for 2.8% of the total NHS prescribing expenditure of £11.4 billion; by 2016-17 this increased to 7.4% of a £17.4 billion budget8.
Cost savings resulting from optimised treatment help balance these costs. Improved disease control reduces the need for acute hospital admissions: hospital bed-days due to RA-related admissions in the NHS fell from 93,434 in 2006-07 to 29,327 in 2016-17, a significant financial gain8. In addition, preventing disease progression can have an impact outside of the direct health system thereby benefitting wider society. RA has huge impact upon work, with 40-50% stopping work within 5 years of diagnosis, and far greater numbers reporting a reduction in performance at work9.
Combining these cost savings with the vast reductions in costs of advanced therapies provides an opportunity for change. No one ever expected improving healthcare to be cheap. Clinicians, managers and policy makers all ultimately want the same – to improve the lives of patients. Now is the time to capitalise on the changing pharmaceutical market and offer patients in the NHS access to the best possible therapy when it is needed.
NHS England. NHS set to save £150 million by switching to new versions of most costly drug https://www.england.nhs.uk/2018/10/nhs-set-to-save-150-million-by-switching-to-new-versions-of-most-costly-drug/
Kvien, T.K. Pharmacoeconomic (2004) 22(Suppl 1): 1. https://doi.org/10.2165/00019053-200422001-00002
National Audit Office Services for people with Rheumatoid arthritis https://www.nao.org.uk/wp-content/uploads/2009/07/0809823.pdf
Boonen, A. & Severens, J.L. Clin Rheumatol (2011) 30(Suppl 1): 3. https://doi.org/10.1007/s10067-010-1634-9
NICE Guideline [NG100] 2018 Rheumatoid arthritis in adults: management https://www.nice.org.uk/guidance/ng100
Zoltán Kaló, Zoltán Vokó, Andrew Östör, Emma Clifton-Brown, Radu Vasilescu, Alysia Battersby & Edward Gibson (2017) Patient access to reimbursed biological disease-modifying antirheumatic drugs in the European region, Journal of Market Access & Health Policy, 5:1, 1345580, DOI: 10.1080/20016689.2017.1345580 https://www.tandfonline.com/doi/pdf/10.1080/20016689.2017.1345580
Putrik P, Ramiro S, Kvien TK, et al. Ann Rheum Dis 2014;73:2010–2021. https://ard.bmj.com/content/annrheumdis/73/11/2010.full.pdf
Mark D Russell, Marwan Bukhari, James Galloway; The price of good health care, Rheumatology, , key235, https://doi.org/10.1093/rheumatology/key235
Verstappen SM, Bijlsma JW, Verkleij H, et al. Overview of work disability in rheumatoid arthritis patients as observed in cross-sectional and longitudinal surveys. Arthritis Rheum 2004;51(3):488-97. https://onlinelibrary.wiley.com/doi/full/10.1002/art.20419
Date of preparation: February 2019