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NICE approves UCB Pharma’s Cimzia

New guidance could significantly extend the patient population it could treat

UCB Pharma has received a boost after NICE recommended its TNF inhibitor Cimzia for people with severe rheumatoid arthritis (RA) who have not responded to other drugs.

The draft guidance states that Cimzia (certolizumab pegol) can be used on its own or in combination with methotrexate when other drugs have not worked or are not suitable to treat the incurable inflammatory autoimmune disease.

It is already recommended for NHS use to treat severe RA which has not responded to conventional disease-modifying anti-rheumatic drugs (DMARDs).

But this new guidance significantly extends the number of patients who could now be eligible for Cimzia, which is already a star performer for UCB.

Around 580,000 people in England are thought to suffer from RA, which usually affects the small joints of the hands and feet causing swelling, stiffness, pain and progressive joint destruction. It severely affects quality of life.

About 15% of sufferers have the severe form of the disease and Cimzia can now be used after other TNF inhibitors have been tried and Roche's big-seller MabThera/Rituxan (rituximab) cannot be used.

Cimzia works by stopping the body's immune system attacking the joints - this in turn helps to reduce swelling and joint damage.

NICE insists that treatment should only continue if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at six months. If this is not maintained, then treatment should be withdrawn.

Professor Carole Longson, director of NICE's centre for health technology evaluation, said: “NICE already recommends a number of drugs as possible options for severe RA 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 RA will be able to manage their condition more effectively so they can lead as full and active a life as possible.”

The drug costs £6,793 per patient during the first year and then £9,295 each year after that. UCB has agreed a patient access scheme which sees it providing the first 12 weeks of treatment free of charge.

Article by
Adam Hill

12th July 2016

From: Regulatory



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