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NICE backs biosimilars in rheumatoid arthritis guidance

Seven biologic drugs (DMARDs) and two biosimilars recommended

NICEThe UK's cost-effectiveness body has for the first time included biosimilar drugs in new guidance on the use of biologics in severe rheumatoid arthritis.

The final guidance - published yesterday - recommends seven biologic disease-modifying anti-rheumatic drugs (DMARDs) and two biosimilars and is in line with draft guidance published last September.

The recommended brands are: AbbVie's Humira (adalimumab), Pfizer's Enbrel (etanercept), UCB's Cimzia (certolizumab pegol), MSD/Johnson & Johnson's Simponi (golimumab), Roche's RoActemra (tocilizumab), Bristol-Myers Squibb's Orencia (abatacept) and MSD/J&J's Remicade (infliximab).

Also backed are Napp Pharmaceuticals' Remsima and Pfizer's Inflectra, both of which are biosimilar versions of $10bn-a-year brand Remicade and cost around 10% less than the originator drug at list prices.  However, it is understood that the biosimilars are being supplied at an undisclosed discount to the NHS.

As their name suggests, biosimilars are copies of biologic drugs that are similar but not identical to the original medicine, but are considered therapeutically equivalent.

Importantly, NICE says treatment should be started "with the least expensive drug", taking into account administration costs, the dose needed and the price of the drug per dose, suggesting there will be pressure on NHS prescribers to opt for the cheaper biosimilars.

All the drugs are recommended for use alongside methotrexate, while Humira, Enbrel, Cimzia and RoActemra are also backed for use on their own in patients who cannot tolerate the conventional DMARD.

"This guidance considers at which stage it's clinically and cost effective to start using biological therapies as treatment options for adults with rheumatoid arthritis," said Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE.

The guidance only applies to patients with severe RA who have already tried earlier treatment with methotrexate and other conventional DMARDs as well as short-term corticosteroid therapy.

Article by
Phil Taylor

27th February 2015

From: Regulatory

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