National Institute for Clinical Excellence (NICE) Provisionally Recommends Merck Sharp & Dohme's New Drug, Simponi, for Rheumatoid Arthritis

In draft guidance, published today (13 May), the National Institute for Health and Clinical Excellence (NICE) provisionally recommends golimumab (Simponi) as an option for treating rheumatoid arthritis in specific circumstances where previous treatments haven't worked.

Golimumab in combination with methotrexate is provisionally recommended for adults whose rheumatoid arthritis has responded inadequately to conventional disease-modifying antirheumatic drugs (DMARDs) only, including methotrexate. In this case, golimumab is an option if it is used as described for other tumour necrosis factor (TNF) inhibitor treatments - adalimumab, etanercept and infliximab - covered by NICE technology appraisal 130, and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.

For adults whose rheumatoid arthritis has responded inadequately to other DMARDs, including a TNF inhibitor, golimumab in combination with methotrexate is also provisionally recommended as a treatment option. In this situation golimumab can be used only as described for other TNF inhibitor treatments in NICE technology appraisal guidance 195 (which covers the use of adalimumab, etanercept, infliximab, rituximab and abatacept after the failure of a TNF inhibitor), and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.

Golimumab is a treatment for moderate to severe active rheumatoid arthritis in adults where the response to DMARD therapy including methotrexate has been inadequate. This draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance. NICE has not yet issued final guidance to the NHS. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: "This draft guidance sets out the circumstances where golimumab could be a treatment option for people with rheumatoid arthritis for whom previous treatments have not worked. Finding ways to relieve pain, improve mobility and reduce long-term damage are the aims in treating rheumatoid arthritis. 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."

About the guidance

1. Further information on the NICE appraisal 'Golimumab for the treatment of rheumatoid arthritis after failure of previous disease-modifying anti-rheumatic drugsĀ“.

2. NICE currently recommends a range of treatments for rheumatoid arthritis: adalimumab, etanercept, infliximab, rituximab, abatacept, tocilizumab and certolizumab pegol.

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