Eisai Ltd, Pfizer UK, Shire Pharmaceuticals and Lundbeck have lodged appeals against the National Institute for Health and Clinical Excellence’s continuing proposal to deny patients with mild forms of Alzheimer’s disease treatment with anti-dementia drugs on the National Health Service.
NICE’s stance on anti-cholinesterase drugs - which are not used to treat the disease itself but help to alleviate some of its symptoms - caused uproar in March last year when it first proposed that their use is not cost-effective under the NHS, as they do not benefit all patients. Products in the firing line include: Aricept (donepezil), marketed by Eisai and its partner Pfizer; Shire’s Reminyl (galantamine); Novartis' Exelon (rivastigmine); and Lundbeck's Ebixa (memantine).
At the time, the ruling was met with a giant wave of protest from all sides of the industry, forcing NICE to reconvene late last year to evaluate the matter further. It then concluded that treatment with anti-cholinesterase therapies be funded only when new patients have moderate-to-severe symptoms, and that Ebixa should not be used at all, as it felt there is not enough evidence to support the drug’s clinical benefit.
In May, the organisation issued its final appraisal determination (FAD), reaffirming its prior ruling to reject these drugs for mild forms of the disease, effectively barring an estimated 72,000 patients in the UK access to them.
This marks a controversial decision which seems to go against the grain of all other treatment strategies that aim to treat a patient as early as possible. “In every other disease, doctors are encouraged, even instructed, to find and treat patients early,” remarked Paul Hooper, Managing Director of Eisai UK. “However, with AD NICE is saying wait until the patients deteriorate before you treat them. It makes no sense medically, it makes no sense economically and it makes no sense in improving the lives of patients and their carers.”
Eisai and Pfizer’s appeal is based on the belief that NICE’s proposal is “fundamentally flawed.” It alleges that the agency has: “Failed to act fairly and in accordance with its own appraisal procedure and prepared guidance which is perverse in the light of the evidence submitted.”
“We are appealing against the fairness and the transparency of the processes NICE used to reach its conclusion on mild Alzheimer's disease – but mainly we are appealing against the perverse nature of that conclusion,” Dr Hooper explained. Olivier Brandicourt, Managing Director of Pfizer UK Ltd, added: “NICE appears to have used an arbitrary decision making process, and have kept details of the model used in their cost effectiveness calculations secret. But aside from this, what it is proposing is contrary to all good clinical practice. Alone in the world, England will be saying patients must lose the chance to fight Alzheimer’s disease at an early stage.”
Among other points, the companies argue that the use of Quality Adjusted Life Years (QALYs) to measure the worth of dementia treatment is “discriminatory and unfair.”
For one, QALYs can discriminate against older people with shorter life expectancies as greater QALY benefits can be gained by treating younger people with longer life expectancies. In addition, they say, in its original appraisal, NICE deemed the use of QALY’s in this setting as inappropriate, and no explanation has been provided as to why a change is justified.
NICE has not yet advised a date for the appeal to be heard. But for how long can NICE hold out against new clinical evidence suggesting that earlier diagnosis of AD could help sufferers stay more like their own selves - the mantra behind the ads for Aricept that are appearing on American TV?