CampaignsHealthcare RationingNICE delivers devastating news for severe rheumatoid arthritis in England and Wales NICE delivers devastating news for severe rheumatoid arthritis in England and Wales
21/08/2007
Orencia, a drug that reduces pain and slows progression of rheumatoid arthritis in moderate to severe cases has been rejected as "not cost-effective" in draft guidance from the National Institute for Health and Clinical Excellence (NICE). The news comes as a blow to the UK's 40,000 sufferers, of whom around 30% fail to respond to the standard drug treatment - anti-TNFs.
The National Rheumatoid Arthritis Society (NRAS) said that Orencia could potentially benefit 12,000 people in the UK alone, although manufacturers Bristol-Myers Squibb estimate the number at around 3,500. Ailsa Bosworth, NRAS Chief Executive of NRAS: “This is extremely bad news for people living with severe rheumatoid arthritis in the UK and a potential step backwards in the management of the condition, if this decision is not reversed.
“Denying patients the option of Orencia leaves some of them with the unacceptable choices of being put back onto treatments they have already failed on, or palliative care, taking large doses of steroids which have extremely unacceptable side effects such as osteoporosis when given over the long term.
"We are talking about a relatively small number of patients who have a very aggressive and severe form of rheumatoid arthritis. They will have failed all other treatment options before they are recommended for Orencia. Approximately 30% of patients fail on anti-TNF, and similar number on rituximab, therefore patients need more choice of agents that work in different ways to combat this complex and terrible disease”.
“From a cost perspective only those who attain sufficient benefit will remain on treatment. If there is no response then treatment can be stopped very quickly so minimising cost. The guidance recommends denying our most severely ill rheumatoid arthritis sufferers one less vital step in their treatment pathway. We simply cannot accept that individuals should be denied the chance of at least regaining some quality of life and condemning them to a life of pain and disability, which could be equally as expensive to the NHS.”
The drug, whose brand name is Orencia, and generic name is abatacept, is an injectable, synthetic (man-made) protein. The immune system is responsible for protecting the body against foreign invaders - for example, infectious agents such as bacteria. In patients with rheumatoid arthritis, however, the immune system attacks and destroys normal tissue in and around the joints, causing pain, inflammation and damage to bone and cartilage.
T-lymphocytes are important cells of the immune system. Patients with rheumatoid arthritis have increased numbers of T-lymphocytes within the joints that are inflamed: they are “activated,” that is, they multiply and release chemicals that promote the destruction of tissues surrounding the joints and cause the signs and symptoms of rheumatoid arthritis.
Abatacept acts like an antibody and attaches to a protein on the surface of T-lymphocytes, thereby preventing the activation of the T-lymphocytes and blocking both the production of new T-lymphocytes and the production of the chemicals that destroy tissue and cause the symptoms and signs of arthritis. Abatacept slows the damage to bones and cartilage and relieves the symptoms and signs of arthritis and was approved by the FDA in December, 2005.
A NICE spokeswoman said an independent advisory committee had decided the drug was not a cost effective option after carrying out a detailed assessment. The draft Nice guidance is now open to consultation, and final guidance is not expected until the end of the year.
For more information call the National Rheumatoid Arthritis Society on 0845 458 3969, or visit the website linked below.