NICE issues draft guidance recommending drugs for rheumatoid arthritis

In final draft updated guidance published today, UK medicines cost watchdog the National Institute for Health and Care Excellence (NICE) confirms its recommendations for treatment options for people with rheumatoid arthritis.

The draft guidance recommends adalimumab (Humira, AbbVie), etanercept (Enbrel, Pfizer), infliximab (Remicade, Merck & Co, as well as biosimilars Inflectra, Hospira UK; Remsima, Napp Pharmaceuticals ), certolizumab pegol (Cimzia, UCB Pharma), golimumab (Simponi, Merck & Co) tocilizumab (RoActemra, Roche) and abatacept (Orencia, Bristol-Myers Squibb), each in combination with methotrexate, as options for treating severe rheumatoid arthritis where disease has not responded to intensive therapy with a combination of conventional DMARDs.

Some subject to discounts

In the case of certolizumab pegol, golimumab, abatacept and tocilizumab the recommendation is subject to the companies providing them with the discount agreed in their patient access schemes. The draft guidance states that treatment should be started with the least expensive drug (taking into account administration costs, dose needed and product price per dose).

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 The draft guidance also includes recommendations about when treatment with biological DMARDs should be continued or withdrawn.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 is an incurable chronic systemic inflammatory autoimmune disease in which the synovial joints (such as those in the hands and feet) become inflamed, causing pain, swelling and stiffness. The disease affects around 400,000 people in the UK, of whom approximately 15% have severe disease. It is about two–four times more common in women than in men. It can develop at any age, but the peak age of onset in the UK is about 40–70 years. Rheumatoid arthritis is associated with increased mortality and increasing disability and can have a severe effect on quality of life.

Carole Longson, director of the Health Technology Evaluation Centre at the NICE, said: “This draft guidance considers at what stage it’s clinically and cost effective to start using biological therapies as treatment options for adults with RA.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.