NICE backs biosimilars with arthritis drug endorsements
pharmafile | January 27, 2016 | News story | Research and Development, Sales and Marketing | DMARDs, NICE, biosimilars, rheumatoid arthritis
NICE has published updated final guidance recommending seven biological disease modifying drugs (DMARDs) for treatment of severe rheumatoid arthritis which has not responded to intensive therapy.
The guidance recommends a combination of biologics is used under these circumstances, starting with the least expensive of the seven of: AbbVie’s Humira (adalimumab); Pfizer’s Enbrel (etanercept); MSD’s Remicade (infliximab) – and Hospira’s and Napp’s biosimilar versions, Inflectra and Rensima respectively; UCB Pharma’s Cimzia (certolizumab pegol); MSD’s Simponi (golimumab); Roche’s RoActemra (tocilizumab); and BMS’ Orencia (abatacept), each in combination with methotrexate.
Biosimilars, copycat versions of biological drugs, are typically 15–30% cheaper than the original drugs, and so are likely to be preferred by prescribing budget holders in under-pressure NHS trusts and clinical commissioning groups.
NICE says its recommendation of Cimzia, Simponi, Orencia and RoActemra is subject to AbbVie, Pfizer, BMS and Roche (respectively) providing them as agreed in their patient access schemes. Humira, Enbrel, Cimzia and RoActemra are also recommended as monotherapies for patients unable to take methotrexate.
The UK regulator also noted that appeals against the guidance had been made unsuccessfully, in some cases arguing that as well as severe rheumatoid arthritis, the drugs should also be indicated for moderate versions of the disease. MSD also appealed the fact that the guidance favoured the cheaper biosimilar versions of Remicade.
Rheumatoid arthritis affects around 400,000 people in the UK, of whom approximately 15% have what is classed as severe disease. The condition is between two and four times more common in women than in men. It can develop at any age, but onset in the UK is most common between 40 and 70 years old.
Professor Carole Longson, director of the NICE’s Health Technology Evaluation Centre, comments: “This guidance considers at what stage it’s clinically and cost effective to start using biological therapies as treatment options for adults with rheumatoid arthritis.
“In recommending them as options for people with severe rheumatoid arthritis after previous treatment with conventional DMARDs has been unsuccessful, this guidance reaffirms our previous recommendations on these drugs and confirms their place as an integral part of the rheumatoid arthritis treatment pathway.”
Joel Levy
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