The National Institute for Health and Clinical Excellence has now ruled definitively on arthritis drug Orencia – a ruling towards which campaigners have reacted furiously. Orencia was covered in a previous Pharmaceutical International News Item, at which point NICE had issued initial guidance highlighting the drug as representing poor value for money. Now, the UK’s medicinal regulator has rejected Orencia on the basis of its cost. Although conceding that its benefit to arthritis patients is evident, the decision focused on the fact that, per person, a yearly course of the treatment works out to £9,333.

Orencia, or abatacept, is designed to be used by arthritis patients in whom previous drugs have proved ineffective. According to the National Rheumatoid Arthritis Society (NRAS), 3,500 patients fall into this category.

The society’s Director of Operations, Lynn Love, said she was unable to comprehend how NICE arrived at the decision. She continued: “Abatacept is for people who have failed on other biologic agents. Whatever the price, we are talking about so few people who will now have nowhere else to go except back on to treatments which have already failed."

Rheumatoid Arthritis is a condition suffered by approximately 400,000 UK residents. A number in the region of 40,000 have it in its severe state.

Bristol-Myers Will Appeal Against NICE’s Orencia Ruling

Orencia is manufactured by Bristol-Myers Squibb. It believes its product, if approved,  would have been applicable to around 3,585 arthritis patients. Describing the company’s feelings concerning NICE’s ruling, the firm’s Vice President, Frank  Pasqualone, said it was “disappointed”. He continued: "[The drug] has been shown to be an effective option for patients with severe rheumatoid arthritis for whom treatment with other biologic therapies is not working. We will be appealing against this decision."

A NICE spokeswoman stated that the body had given approval for anti-TNF agent Humira (adalimumab) earlier this week. In respect of abatacept, she added, its refusal was due to its intended use in patients with late stage arthritis, and as a substitute for the more cost effective Mabthera (rituximab).

"Abatacept can cost about twice as much as rituximab, but offers similar benefits”, a statement issued by NICE read, adding: ”Based on this evidence, abatacept could not be considered a good use of NHS resources."

Source – Pharmaceutical International’s Health Reporter

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