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NICE rejects Orencia for arthritis

NICE says that Bristol-Myers Squibbís rheumatoid arthritis drug Orencia should not be made available on the NHS because it is too expensive

Guidelines issued by the National Institute for Health and Clinical Excellence (NICE) have said that Bristol-Myers Squibbís (BMS) rheumatoid arthritis (RA) drug Orencia (abatacept) should not be made available on the NHS because it is too expensive.

The draft recommendation said: "Having examined the cost effectiveness analyses on abatacept against a range of comparators, the committee concluded that abatacept could not be considered a cost effective use of NHS resourcesî

The EU Commission approved Orencia for use in May 2007, and BMS launched the drug in the US, its home market, in 2006. BMS disputed that Orencia was not cost-effective, highlighting that the average annual cost of GBP 9,337 (USD 18,900) was similar to that of rival drugs.

Orencia, in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one anti-tumour necrosis factor (TNF) inhibitor. The drug could help more than 3,585 sufferers, according to analysts.

Until Orencia, only three anti-TNF drugs have been available to RA sufferers. Swiss pharmaceutical company Roche's cancer drug MabTherea (rituximab), which targets a slightly later stage of the inflammation cascade, won an RA licence in the EU in 2006, though only for the severe stage of the disease.

MabThera, J&Jís Remicade (infliximab) and Orencia are infusions through an IV, but the established treatments take around two hours to administer, while Orencia can be given in just half an hour. Abbottís Humira (adalimumab) and Amgen and Wyethís Enbrel (etanercept) are both given by injection in a hospital setting.

Tumour necrosis factor-alpha (TNF-alpha) inhibitors have created a world-wide market worth approximately USD 8bn in 2005, according to IMS data. Industry analysts say that anti-TNFs and novel biological agents will drive the RA market to more than USD 10bn by 2015, as doctors see positive long-term efficiency and side-effect profiles of biologicals over traditional RA treatments.

2nd August 2007

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