High Court's ruling on
Alzheimer's drugs may have global implications for patient power
The recent High Court challenge to
UK drug watchdog the National Institute for Health and Clinical Excellence's
decision not to fund treatment for patients with mild Alzheimer's disease is a
prime example of increasing patient power. If the court's ruling quashes the
decision, it will have huge implications not only for Alzheimer's sufferers in
the UK, but also for patient empowerment worldwide.
Patient power is the patients' will to be involved in decisions regarding
their healthcare. 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 UK National Health Service (NHS).
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 focused 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), the National Institute for Health and
Clinical Excellence (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 to the NICE's
decision. Demographic changes resulting in an ageing population also mean that
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.
Following two years of campaigning and several appeals against the NICE's
decision, the patient groups, the Alzheimer's Society and Eisai and Pfizer -
manufacturers of one of the denied drugs - are now challenging the 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 the NICE, the claimants have asserted that the NICE's
cost-effectiveness analysis of Eisai's Alzheimer's drug Aricept, costing
GBP2.50 per day per patient, was flawed as it underestimated the cost of
long-term care and failed to recognize 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.
The NICE defended its cost-effectiveness analysis, saying that it took into
account the price of drugs, benefit for patients and social value they bring.
The 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, 2007. Although
the court cannot decide whether the drug should be available on the NHS or
not, it does have the power to quash the NICE's latest decision and to force
it to reconsider the case.
Recently, several other drugs have received a negative opinion from the NICE,
including 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 the
NICE acknowledged the clinical effectiveness of these drugs, it judged that
the treatments, costing over GBP10,000 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. However, the
question of how the cash-strapped NHS can realistically do this in a
sustainable manner remains unanswered.
Court's decision might be pivotal moment for patients
If the court rules in favor of the NICE, it is unlikely that this will put a
brake on patients' motivation to continue fighting for access to the best
possible treatments. However, if the court quashes the 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 the 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
lawsuits from patients demanding access to drugs.
Related research:
Patient Empowerment: empowered patients can change healthcare outcomes and
impact the pharmaceutical industry
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - Competition
for the anti-TNF failure patient population increases
Monoclonal Antibodies Report Part I
