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NICE set to recommend seven biologics for severe rheumatoid arthritis

List includes Roche's RoActemra and biosimilars Inflectra and Remsima
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NICE is poised to recommend seven biologics for rheumatoid arthritis (RA), including two biosimilars of the blockbuster drug Remicade.

The new final draft updated guidance includes recommendations for three versions of infliximab - Janssen/Merck Sharp & Dohme's Remicade is backed, but so are two biosimilar versions of the $8bn a year blockbuster.

Marketed by Hospira as Inflectra and Napp Pharmaceuticals' as Remsima, the infliximab biosimilars had appeared to be recommended ahead of Remicade.

Remicade costs £419 for a 100ml vial while both biosimilars are priced at £377, which represents a 10% discount, and the new guidance still notes that “treatment should be started with the least expensive drug”.

However, NICE has now noted that the exact cost of Remicade “may vary in different settings because of negotiated procurement discounts”. Meanwhile, the government's Commercial Medicines Unit has negotiated confidential prices for the two biosimilars that NICE said are “lower than the list price”.

NICE's other new final draft recommendations for severe RA also include AbbVie's Humira (adalimumab), Pfizer's Enbrel (etanercept), UCB Pharma's Cimzia (certolizumab pegol), Merck Sharp & Dohme's Simponi (golimumab) and Roche's RoActemra (tocilizumab).

Biologics are used by around 60% of patients who do not respond to conventional disease-modifying anti-rheumatic drugs (cDMARDs) and are often given in combination with methotrexate. However, more than a third of RA patients are unable, or do not wish to take methotrexate.

Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE, said: “In recommending [these biological therapies] as clinically and cost effective treatment options for people with severe RA after treatment with conventional DMARDs has been unsuccessful, this draft guidance reaffirms our previous guidance on these drugs and confirms their place as an integral part of the RA treatment pathway.”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 RoActemra recommendation from NICE brings England and Wales in line with Scotland, where the drug has been available as monotherapy or combination therapy with methotrexate to Scottish patients for a year.

Senam Beckley-Kartey, immunology country medical leader at Roche, said: “We are delighted that NICE, as part of its re-assessment of seven biologics currently available on the NHS, has decided to widen access to RoActemra for patients with severe RA and extend its use into the monotherapy setting."

Rheumatoid arthritis is a chronic, progressive and incurable disease that affects over 690,000 adults in the UK with prevalence increasing. 

The estimated cost to the UK economy from sick leave and work-related disability from RA is £1.8bn each year, while RA treatment cost the NHS £560m a year.

Article by
Nikhil Patel

9th September 2015

From: Regulatory



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