Industry news: Court decision could have major implications for Alzheimer's patients in SA

The United Kingdom's NICE - founded in 1999 - is a publicly funded organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. NICE guidance is developed by a number of independent advisory groups made up of health professionals, representatives from the National Health Service (NHS), patients, their careers and the public. NICE is mandated to produce guidance in three areas of health; namely; public health, health technologies and clinical practice.

In 2006 NICE and the Social Care Institute for Excellence (SCIE) made public announcement on their guidelines (NICE/SCIE, 2006). These guidelines covered the whole trajectory of Alzheimer's disease from the earliest recognition of dementia to the end of life care. The guidelines were the first to be developed jointly by health and social care disciplines, and made considerable impact beyond England's borders. Health service regulators world-wide continuously consult NICE for their assessment of the benefits of medical interventions, thus influencing access for anti-dementia drugs as well as the general treatment and care of the disease.

We in South Africa are similarly affected by the NICE guidelines and from time to time our own local Health Administrators and Medical Health Schemes keep close scrutiny and monitor international trends in this regard.

NICE's recent decision to curtail the use of cholinesterase inhibitors in Alzheimer's disease (AD) therefore drew widespread criticism and court action. The background and build-up to this situation is most intriguing.

Although, NICE had approved the use of acetylcholinesterase inhibitors donepezil, rivastigmine and galantamine for the treatment of Alzheimer's disease by the NHS in 2001, this decision was amended four years later when NICE pronounced that treatment will not be including newly diagnosed Alzheimer's disease patients.

In what appeared to be a change of heart, NICE requested extra patient data from manufacturers for further consideration. After making its considerations, NICE made an announcement early the following year that treatment will be confined only to moderate AD and will exclude mild AD patients. The institute defined moderate as a Mini Mental State Examination (MMSE) score of 20 – 10 out of 30. A consultation period then followed this announcement.

Later in the year, it became very clear that NICE would not relent on its position after announcing that it was going to stick by its earlier decision and not extend Alzheimer's therapy on patients in the mild phase of AD. Following this, Eisai and Pfizer along with other manufacturers and organisations including the Alzheimer's Society and the Royal College of Psychiatrists appealed this decision, only to be dismissed by NICE.

Consequently, in November 2006 Eisai and Pfizer then once again challenged NICE and called on the institute to fulfil the following:

Withdraw the current Final Appraisal Determination (FAD) and postpone issuing the new guidance
Disclose a fully transparent working version of the calculations used in the cost-effectiveness model for independent evaluation and comment
Develop a new FAD using both a more accurate cost-effectiveness model and data.

A month later, NICE officially issued its new Guidance disallowing the use of acetylcholinesterase inhibitors in newly diagnosed mild Alzheimer's disease patients. Following this, Eisai with the full support of Pfizer, confirmed an application for Judicial Review submission early in 2007. The High Court granted permission to proceed to judicial review on all grounds including procedural fairness, irrationality and human rights/discrimination.

The Judicial Review hearing duly commenced at the High Court in June this year and early last month the High Court upheld the claims of discrimination while dismissing procedural fairness and irrationality. The High Court further ordered NICE to produce a draft amendment to its recently published guidance document.

What makes this litigation remarkable is that this is the first time that NICE has been challenged in the Courts, and marks a major victory for the many critics of the process by which NICE reaches its often controversial clinical decisions.

Those of us who have clinically researched or either prescribed and experienced the efficacy of the acetylcholinesterase inhibitors in AD, and the support for these medicines by caregivers and AD patients in the early stages, welcome the above decision. Research has confirmed the importance of both the early detection and earliest treatment of AD. Treatment not only delays the progression of the illness, but helps maintain the patient at a higher level of functioning. This treatment benefit is ongoing and extends into the severe phase of the illness where placement in a frail care facility may be delayed by as much as two years. To, therefore, restrict the use of acetylcholinesterase inhibitors to the moderate phase of AD only, is discriminatory and denies these patients the right to proper care. It will be important to keep a close watch on the developments to see how this is going to impact on other markets such as South Africa, which have for years used NICE guidelines as a benchmark.