Eisai to appeal as High Court bid fails

Campaigners have failed in their High Court bid to make the NHS fund Alzheimer's drugs for those with the early stages of the disease.

However, the campaigners won a partial victory as NICE will have to reconsider guidance to people with learning disabilities and those whose first language is not English.

The Court upheld NICE's decision that the drugs are only cost-effective later on in the disease. It also found that NICE did appropriately take into account the benefits the drugs bring to carers, that it appropriately reflected the costs of long term care in its calculations, that it did not breach principles of procedural fairness by providing a 'read only' version of the economic model, and that it was not irrational in concluding there is no cumulative benefit to patients after six months treatment with the drugs.

Japanese drug company Eisai, manufacturer of Alzheimer's drug Aricept (donepezil), is to appeal the decision, as it is disappointed, along with marketing partner Pfizer, that the detailed calculations over how NICE reached its decision have still not been revealed.

Dr Paul Hooper, Managing Director of Eisai UK, said: "The guidance NICE has issued is morally reprehensible. They are denying patients access to early treatment and that is wrong.

"NICE have got it wrong and they have got it wrong under a shroud of secrecy, seeking to keep their computer model non-transparent." 

Dr Hooper said the companies were seeking leave to appeal against the High Court decision.

"Of course we have a commercial interest, but this is about patients, not profits. For NICE to deny treatment to patients with mild Alzheimer's disease is disgraceful," he said.

"Our guidance stands and the drugs continue to be recommended only for people with moderate Alzheimer's disease, but the court has asked us to clarify our guidance when it is used for certain groups.  It was always our intention that people with learning disabilities or people whose first language is not English should have equal access to the drugs in the moderate stage of Alzheimer's disease.  We will reissue our guidance to the NHS to make this crystal clear," said NICE CEO Andrew Dillon.

Keiron Sparrowhawk, a partner at pricing strategy consultancy Pricespective, believes the ruling still has some implications.

"NICE's [method] doesn't make sense. It is particularly true in this instance, when there is a clinical condition with an unmet need, as there is no other treatment available for people with early stage Alzheimer's," explains Sparrowhawk.

According to Sparrowhawk, the ruling has questioned the use of cost-effectiveness in pricing decisions.

"The cost-effectiveness [model] was set up by academics years ago, and since then there has been no change in the QUALY GBP30,000 threshold. That means we are measuring the value of life less than it was 10-20 years ago when it was introduced," stated Sparrowhawk.

"The threshold has been questioned and shows they can't use [certain] measures in a set scientific way. They can't rubber stamp every condition with the same qualifications," concludes Sparrowhawk.

NICE ruled in March 2005 that all drug treatments for Alzheimer's disease, Pfizer and Eisai's Aricept, Novartis' Exelon (rivastigimine tartrate) and Shire's Reminyl (galantamine), should not be prescribed on the NHS because of cost. Following overwhelming public condemnation from the public, healthcare professionals and campaigners, NICE changed its position to allow limited access to the treatments.