Healthy Skepticism Library item: 11208

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Publication type: news

DATAMONITOR: High Court ruling on Alzheimer's drugs may have global implications for patient power
PharmaLive 2007 Aug 8
http://pharmalive.com/news/index.cfm?articleID=465454&categoryid=43

Full text:

LONDON, Wednesday August 8 2007- Patients are no longer happy to settle for what their doctors or their health provider tell them is good enough. The recent unprecedented High Court challenge of the UK government drug watchdog the National Institute for Health and Clinical Excellence’s (NICE) decision not to fund treatment for patients with mild Alzheimer’s disease is a prime example of increasing patient power.

The few available Alzheimer’s drugs that can delay the progress of the disease are not available on the NHS for patients in early stages of the disease, and the patient group Alzheimer’s Society together with the drug makers Eisai and Pfizer are challenging NICE’s decision. If the Court’s ruling, scheduled to be announced on August 10, quashes NICE’s decision and forces it to reconsider the status of Alzheimer’s drugs, it will have huge implications not only for Alzheimer’s sufferers in the UK, but also for patient empowerment in the UK and worldwide. According to Datamonitor senior pharmaceutical analyst Dr Tijana Ignjatovic*, this could be a pivotal moment that sets a precedent that would undoubtedly motivate other patients to start legal action over other refused drugs.

Patient power is rising

Patient power is the patients’ will to be involved in decisions regarding their healthcare. Ever since the success of the US HIV/AIDS patient advocacy groups in the eighties, patients have been motivated not to settle for second best but to demand access to the best possible treatments available. The ease of access to healthcare information via the internet has only made this process easier, says Dr Ignjatovic. “Patients are now in a position to find out information about new treatments from sources other then their doctors.

”The rising patient power is mirrored by the rise in numbers of patient advocacy groups worldwide, and more specifically by the recent example of patients’ success in getting the new, expensive breast cancer drug Herceptin to be widely available on the NHS,” she says.

Drug rationing in UK motivating patients to lobby for access to new drugs

While US patients are generally thought to be the most empowered, the rationing of drugs in the UK has resulted in an environment that specifically fosters patient groups focussed on lobbying for wider and fairer access to drugs. Established in 1999 with the purpose of erasing the ‘postcode lottery’ (variation in drug coverage by area), NICE reviews the newly approved drugs and decides whether they will be available on the NHS based on their cost-effectiveness. Several recent decisions not to fund certain drugs, including acetylcholine esterase inhibitors for mild and severe cases of Alzheimer’s disease, have met with widespread public disapproval and attracted a great deal of public attention.

Alzheimer’s disease is a highly emotive condition as it affects the elderly population, resulting in mental decline, dependence on carers and ultimately death. This has played an important role in ensuring vigorous public debate around this issue and ultimately, the High Court challenge of NICE’s decision. Demographic changes resulting in an ageing population also mean the disease is on the rise. Most people have heard of or know someone who has or had Alzheimer’s and can relate to it, so this keeps the issue in the public eye, Dr Ignjatovic says. ”For lots of people losing their memory means losing their independence and dignity, and that prospect scares them.”

Following two years of campaigning and several appeals against NICE’s decision, the patient groups, Alzheimer’s Society and Eisai and Pfizer – manufacturers of one of the denied drugs – are now challenging NICE’s decision in the High Court. While Eisai and Pfizer are the main claimants, the Alzheimer’s Society is acting as an interested party in the judicial review. In their case against NICE the claimants have asserted that NICE’s cost-effectiveness analysis of Eisai’s Alzheimer’s drug Aricept, costing ?.50 per day per patient, was flawed as it underestimated the cost of long-term care and failed to recognise the impact on the quality of life of carers. Furthermore, the claimants asserted that as these drugs can delay the need for long-term stay in care homes they should be available to patients with a mild, and not only moderate, form of the disease. NICE defended its cost-effectiveness analysis, saying it took into account the price of drugs, benefit for patients and social value they bring. NICE also accused the Alzheimer’s Society of acting in the interest of the drug producers. The Alzheimer’s Society denied these allegations, stating that although the charity has accepted funding from these companies its involvement in the legal proceedings was funded by charitable donations. Eisai and Pfizer have stated that they are working together with the charity because they have the shared interest of doing what is best for the patients.

The Court is expected to announce its decision on August 10. Although the Court cannot decide whether the drug should be available on the NHS or not, it does have the power to quash NICE’s latest decision and to force it to reconsider the case.

Recently, several other drugs have received a negative opinion from NICE, including the colorectal cancer drugs Avastin and Erbitux. These drugs, which are available in the US, France and other European countries, can extend the life of colorectal patients by four months in 50% of patients. However, while NICE acknowledged the clinical effectiveness of these drugs it judged that the treatments, costing over ?,000 per patient, were not cost-effective. So far three patients have successfully challenged their Primary Care Trusts’ decisions not to fund their Avastin or Erbitux treatment. This is also reminiscent of the Herceptin case. Giving patients access to life-saving treatments should be a priority of any national health provider, says Dr Ignjatovic. “However, the question of how the cash-strapped NHS can realistically do this in a sustainable manner remains unanswered,” she says.

Court’s decision might be pivotal moment for patients

If the Court rules in favour of NICE, it is unlikely it will put a brake on the patients’ motivation to continue fighting for access to the best possible treatments, says Dr Ignjatovic. “But if the Court quashes NICE’s decision and forces it to reconsider, it could be a watershed moment for all patients in the UK and beyond. It would also be a serious blow to NICE as it is already facing a lot of criticism and is undergoing a parliamentary inquiry over its decisions and speed of review.

“This case could pave the way for other law suits from patients demanding access to drugs.”