NICE draft guidance backs UCB's Cimzia for severe RA

The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending Belgian drugmaker UCB’s (Euronext: UCB) Cimzia (certolizumab pegol), on its own or in combination with methotrexate, as an option for thousands of people with severe rheumatoid arthritis when other drugs haven’t worked or aren’t suitable.

The cost-effectiveness watchdog for England and Wales, NICE already recommends certolizumab pegol for treating severe rheumatoid arthritis which has not responded to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs (DMARDs). The draft guidance extends the number of people who can be considered for treatment with certolizumab pegol by now recommending its use after a type of DMARD called a TNF inhibitor has been tried and rituximab is not an option.

The draft guidance recommends certolizumab pegol for people with severe active rheumatoid arthritis who:
• have had an inadequate response to, or are unable to take DMARDs, at least one of which must have been a TNF inhibitor; and
• are unable to take the drug rituximab.

Treatment with certolizumab pegol should be continued only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months. The draft guidance recommends that treatment with certolizumab pegol should be withdrawn if a moderate EULAR response is not maintained after the initial response.

“Rheumatoid arthritis is a disease for which there is no cure and one that can have a severe impact on quality of life,” said Carole Longson, director of the NICE Centre for Health Technology Evaluation, adding: “NICE already recommends a number of drugs as possible options for severe rheumatoid arthritis after treatment with a TNF inhibitor has failed and where rituximab is not an option. We hope that adding certolizumab pegol to this list will mean that people with severe rheumatoid arthritis will be able to manage their condition more effectively so they can lead as full and active a life as possible.”

Certolizumab pegol costs £6,793 ($8,824) per patient during the first year and then £9,295 yearly for subsequent years. This cost takes into account a patient access scheme agreed by the Department of Health with the company which provides the first 12 weeks of treatment free of charge.