Court Decision Made: NICE Alzheimer’s Drugs Guidance Stands

The High Court ruled that NICE's guidance on three Alzheimer's drugs would standIn an update to the situation concerning NICE’s guidance on three key Alzheimer’s drugs, it has now been announced that the High Court has ruled in favour of the regulatory body, disappointing the campaigners behind the high-profile and landmark court case. Despite this, the National Institute for Health and Clinical Excellence has been ordered to re-define its guidance in respect of assessing cases of Alzheimer’s.

The High Court agreed with NICE’s decision that the three drugs only become cost-effective in advanced cases of Alzheimer’s. However, a revision has been demanded in which NICE must now adapt the current tests designed to establish the severity of individual Alzheimer’s cases. Those against NICE’s decision to modify the terms under which galantamine, rivastigmine and donepezil are provided, had argued that the present tests discriminated against people with learning complications, as well as those not of English tongue.

As covered in the most recent Pharmaceutical International News Item, which provided an informative prequel to this morning’s ruling, the case was spearheaded by drugs firm Eisai, backed by counterpart company Pfizer and the Alzheimer’s Society. The situation, now, is that those people with Alzheimer’s in its early advancement will not be recommended to receive the drugs, which will impact heavily on their carers.

Comment from the main parties involved has already emerged. NICE’s Chief Executive, Andrew Dillon, said of today’s ruling: “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.”

He continued: “Alzheimer's disease is a devastating illness, but the evidence indicates that these drugs are simply not effective for some patients. That is why we also issued advice last year on the broader support that should be provided for people with Alzheimer's disease and those who care for them, creating core standards for the NHS and care homes that will make a real difference for patients and their families."

The Alzheimer’s Research Trust’s Deputy Chief Executive, Harriet Millward, stated in return: "We are devastated that these drugs will remain unavailable on the NHS to people with early-stage Alzheimer's when they might benefit from them. We urgently need to do more research to find better treatments, but research is currently hugely underfunded - we are scraping for every penny to fund vital work."

Further disappointment was evident from charity group Age Concern, whose Director General Gordon Lishman, added: "The drugs can cost as little as Ł2.50 a day per person and could make day-to-day life far more manageable for thousands of people."

Source – Pharmaceutical International’s Editor

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