NICE guidance for severe RA includes biosimilars for Merck & Co., Johnson & Johnson's Remicade

The UK's National Institute for Health and Care Excellence published final guidance Tuesday recommending several biological disease modifying drugs (DMARDs) as options for treating severe rheumatoid arthritis (RA), including two biosimilar therapies. Specifically, NICE recommends AbbVie's Humira (adalimumab), Pfizer's Enbrel (etanercept), UCB's Cimzia (certolizumab pegol), Merck & Co. and Johnson & Johnson's Simponi(golimumab), Roche's RoActemra (tocilizumab) and Bristol-Myers Squibb's Orencia (abatacept). The guidance also covers Merck and Johnson & Johnson's Remicade (infliximab), as well as Napp Pharmaceuticals' Remsima and Pfizer's Inflectra, both of which are Remicade biosimilars, with NICE stating that "treatment should be started with the least expensive drug."

The agency said the recommendation is for the drugs to be used along with methotrexate for severe RA that has been unresponsive to intensive therapy with a combination of conventional DMARDs, adding that the guidance does not extend to treating moderately active disease. Additionally, Humira, Cimzia, Enbrel and RoActemra were recommended for use as monotherapy in patients unsuitable for methotrexate. NICE also noted that for Cimzia, Simponi, RoActemra and Orencia, its recommendation is contingent on the drugmakers providing the products as agreed in their patient access schemes.

"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," said Carole Longson, director of NICE's Health Technology Evaluation Centre. She added that "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."

According to NICE, the NHS list price for Remsima and Inflectra is about 378 pounds ($543) per 100‑mg vial, adding that negotiated prices for the biosimilars were even lower, compared with about 420 pounds ($603) for the same quantity of Remicade. NICE also provided estimates indicating that the other RA drugs recommended in the final guidance would have higher annual costs, ranging from 9156 pounds ($13 148) for Simponi to 15 725 pounds ($22 578) for Orencia, than either Remsima or Inflectra, which the agency calculated would cost approximately 9064 pounds ($13 016) in the first year, and then 7931 pounds ($11 389) after that.

Earlier this month, Samsung Bioepis, a joint venture between Biogen and Samsung Biologics, said the EU approved its Enbrel biosimilar Benepali, making it the first follow-on version of the Amgen drug cleared in the region. The European Commission approved Inflectra in 2013, which made it the first biosimilar monoclonal antibody therapy authorised in the EU.

For more information on biosimilars, see The Future of Biosimilars 2015.

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