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NICE pushes biosimilars in rheumatoid arthritis guidance

Published on 03/09/15 at 10:18am

NICE has published final draft guidance confirming its recommended treatment options for rheumatoid arthritis. 

For the first time copycat, or biosimilar, versions of rheumatoid arthritis drugs are recommended alongside their original reference products. Two biosimilar versions of Merck’s monoclonal antibody Remicade (infliximab) – Inflectra from Hospira UK and Remsima from Napp Pharmaceuticals are recommended as options for suitable patients.

Hospira and Napp both launched their biosimilar versions of infliximab in the UK in February. Biosimilars are chemically and physiologically indistinct from their original, reference products. But as the drugs they are reproducing are large, complex biological molecules the dramatic price reductions seen with generic versions of drugs are not achievable. However, they are expected to be between 20 and 30% cheaper than their reference products, so offer potentially significant savings in prescribing costs.

The positioning of biosimilars in the guidance is welcomed by the Uk trade body that represent generic manufacturers and suppliers.

Warwick Smith, director general of the British Generic Manufacturers Association (BGMA), says: “We welcome NICE’s Final Appraisal Determination which recommends biosimilar infliximab as an option for the treatment of severe rheumatoid arthritis following a Multiple Technology Appraisal.

"NICE also recommends that treatment should be started with the least expensive medicine, which is likely to be the biosimilar. This opens the way for significant savings for the NHS and an increase in the number of patients who can be treated within existing budgets.”

The draft guidance also recommends: AbbVie’s Humira (adalimumab), Pfizer’s Enbrel (etanercept), UCB Pharma’s Cimzia (certolizumab pegol), Merck’s Simponi (golimumab) Roche’s RoActemra (tocilizumab) and Bristol-Myers Squibb’s Orencia (abatacept). RoActemra has been newly approved for use in the NHS as a monotherapy, while Cimzia, Simponi and Orencia had all previously been approved for this purpose.

The draft guidance states that treatment should be started with the least expensive drug, taking into account administration costs, required dose and product price per dose. This applies to the use of biosimilars ahead of branded products

Each is recommended in combination with methotrexate, as options for treating severe forms of the condition, where a patient has not responded to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs (DMARDs).

The recommendation of Cimzia, Simponi, Orencia and RoActemra is subject to their manufacturers providing them with the discount agreed in their patient access schemes.

Adalimumab, etanercept, certolizumab pegol or tocilizumab are also recommended as monotherapy for people who cannot take methotrexate. The draft guidance also includes recommendations about when treatment with biological DMARDs should be continued or withdrawn.

Rheumatoid arthritis affects around 400,000 people in the UK, of whom approximately 15% have what is classed as severe disease.

Professor Carole Longson, director of the health technology evaluation centre at NICE says: “This draft guidance considers at what stage it’s clinically and cost effective to start using biological therapies as treatment options for adults with RA.

“In recommending them as clinically and cost effective treatment options for people with severe RA after previous treatment with conventional DMARDs has been unsuccessful, this draft guidance reaffirms our previous guidance on these drugs and confirms their place as an integral part of the RA treatment pathway.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. 

Joel Levy

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