It is looking likely that patients with rheumatoid arthritis will get access to Merck Sharpe and Dohme's Simponi on the National Health Service, after cost regulators provisionally recommended funding for the drug.
The National Institute for Health and Clinical Excellence has issued draft guidance endorsing the drug as a treatment option for patients with RA, but only in specific circumstances when other treatment's have failed, just as MSD announced its launch in the country.
More specifically, it ruled that Simponi (golimumab) in combination with methotrexate is a cost-effective option for adults whose disease has not responded well to both conventional and other disease-modifying antirheumatic drugs (DMARDs), when used as per the other tumour necrosis factor inhibitor treatments already available on the NHS – Amgen/Pfizer's Enbrel (etanercept), Johnson & Johnson/Merck's Remicade (infliximab) and Abbott Laboratories Humira (adalimumab).
In addition, in all circumstances the drug is only being backed for funding by NICE if MSD provides the 100mg dose of Simponi at the same price as the 50mg version, to boost its cost-effectiveness.
The decision will come as a relief to the firm given that, in preliminary recommendations published in October last year, the Independent Appraisal Committee said it was 'minded' not to recommend the drug and sought additional information from the manufacturer as part of the consultation to gage whether Simponi could have a place on the NHS in the setting.
"Finding ways to relieve pain, improve mobility and reduce long-term damage are the aims in treating rheumatoid arthritis," said the Institute's Health Technology Evaluation Centre Director Carole Longson. "NICE has already recommended seven biological treatment options for patients living with this very disabling disease; these provisional recommendations indicate that golimumab could be another option,” she said.
Simponi is a human monoclonal antibody that works by preventing the binding of TNF to its receptors to neutralise its activity, and is the first once-monthly, self-administered, subcutaneous anti-TNF to be licensed for the management of RA, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Therapy with SImponi costs around £9,155 per patient per year but, as MSD points out, a report by the National Audit Office has estimated that the annual cost of RA due to sick leave and work related disability is around £1.8 billion.
Furthermore, the economic cost of musculoskeletal disorders - including RA, PsA and AS - is estimated to account for the fifth-highest area of NHS spending.
Professor Peter Taylor, Head of Clinical Trials and Campus Dean, Imperial College, London, said he is excited by the UK launch of Simponi "as it represents a valuable additional choice for the treatment of these debilitating rheumatoid conditions, and any new therapy that improves quality of life for patients is most welcome".