National Institute for Health and Clinical Excellence (NICE)
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NICE draft guidance extends treatment options for thousands of people with severe rheumatoid arthritis

New draft guidance from NICE means thousands of people suffering with severe rheumatoid arthritis will have more medicines to choose from.

The draft guidance increases the number of people who will be eligible for  Certolizumab pegol (Cimzia, UCB Pharma), on its own or with another drug, methotrexate, when other drugs haven’t worked or aren’t suitable.

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).

NICE’s draft guidance extends the number of people who can be considered for treatment with certolizumab pegol by now recommending it can be used after a type of DMARD called a TNF inhibitor has been tried and rituximab is not an option.

It is thought that around 580,000 people in England have rheumatoid arthritis, an inflammatory autoimmune disease that usually affects the small joints of the hands and feet causing swelling, stiffness, pain and progressive joint destruction.

About 15% - 87,000 people - have the severe form of the disease.

Professor Carole Longson MBE, director of the centre for health technology evaluation at NICE, said: “Rheumatoid arthritis is a disease for which there is no cure and one that can have a severe impact on quality of life.

“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 is a type of TNF inhibitor – also called a biological DMARD – which works by stopping the body’s immune system attacking the joints. This helps to reduce swelling and joint damage in people with rheumatoid arthritis.

NICE’s draft guidance recommends certolizumab pegol for people with severe active rheumatoid arthritis who: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.

Patient access scheme

A patient access scheme agreed by the Department of Health with the company means the first 12 weeks of treatment are provided free of charge. The cost of the first year of treatment per patient is therefore £6793 and then £9295 yearly for subsequent years.

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