Patient groups and manufacturers express their disappointment in the High Court’s decision over Alzheimer’s drugs,while a new report claims that NICE is actually approving too many treatments.
The High Court’s decision to uphold NICE guidance that Alzheimer’s drugs should only be funded for moderate-stage disease has been received by patient groups and manufacturers with ‘disappointment’.
However, a recent report by The King’s Fund and City University has claimed that NICE, which is currently also the subject of a health select committee inquiry, is approving too many treatments and its cost effectiveness assessments are too generous.
“It is deeply disturbing that a public body, required to use rigorous standards of evidencebased decision-making, can simply guess at vital data.This is simply unacceptable.”
Neil Hunt, Chief Executive, Alzheimer’s Society
Eisai, who requested the judicial review of NICE’s decision, with support from Pfizer and the Alzheimer’s Society, is delighted with the court’s conclusion that the current tests used to assess the disease are discriminatory to people with learning difficulties or who speak English as a second language. NICE has been asked to rewrite its guidance in this area.
Although other claims, that some of NICE’s conclusions were irrational and that NICE had breached the principles of procedural fairness by not making its cost effectiveness model public, were not upheld. Eisai is planning to appeal the decision.
Response to the original guidance
In January 2006, NICE proposed that Eisai and Pfizer’s Aricept, Novartis’ Exelon and Shire’s Reminyl should only be used to treat Alzheimer’s patients in the moderate stages of the disease, despite approving them for mild Alzheimer’s in 2001.
During the consultation period over 9000 people protested against the draft guidance, the biggest ever response to a consultation. NICE, however, stated its intention to publish the guidelines anyway, provoking an appeal from Eisai, the Alzheimer’s Society and The Royal College of Psychiatrists, which demanded that NICE make the mathematical model used to reach the decision available. NICE responded that it was unable to reveal its model as it was provided by a third party and this would be a breach of confidence.
In November 2006, the Alzheimer’s Society co-ordinated nationwide demonstrations against NICE’s decision that drugs that cost just £2.50 per patient per day are not cost effective. In the same month, Eisai and Pfizer requested that NICE postpone the guidance, disclose its cost effectiveness model and develop a new Final Appraisal Document based on more accurate data. Despite this, the FAD was issued at the end of the month, stating that the NHS should not fund treatment for early-stage sufferers of Alzheimer’s disease. In response, Eisai and Pfizer applied for and were granted a judicial review by the High Court, on procedural grounds, based on NICE’s refusal to make its model public, and on grounds of irrationality and discrimination against certain patient groups.
“Insulting and devastating”
Despite general approval that NICE’s guidance was found to be discriminatory by the High Court, there was widespread disappointment that the other claims were dismissed.
Neil Hunt, Chief Executive of the Alzheimer’s Society, described the news as “insulting and devastating,” adding:“People will be forced to deteriorate before they get the treatment they need. Is this the sort of society we want to live in?”
He went on to challenge NICE’s role:“To retain its authority as a public body it must command the confidence of the public.The result of this case must call into question whether NICE has lost that confidence.We hope the health select committee inquiry will address the gaping holes in the NICE process.”
However, the Alzheimer’s Society’s involvement in the case has provoked criticism that it has undermined its own authority as a public body and a charity. Professor Iain Chalmers, a member of NICE’s research and development committee, wrote in the British Medical Journal that he was disappointed by the charity’s “close alliance” with drug makers and its role in bringing NICE to a judicial review. He said that the Society should indicate clearly on its website what support it receives and from which sources.
||“We remain disappointed that NICE has not been required to reveal details of the calculations used to determine the value of treatment in patients with mild Alzheimer’s disease. We will continue to pursue access to these calculations through the courts and Information Commissioners office.”
Dr Paul Hooper,
The Alzheimer’s Society responded: “To suggest a fictitious alliance with drug manufacturers is an insult to thousands of people across the nation who took to the streets in support of the campaign.The only alliance the Alzheimer’s Society has in this case is with the 30 patient and professional organisations that opposed this decision.” Adding that the information Iain Chalmers requested is actually already available on the website.
The Alzheimer’s Society will be working with the DH to develop the first ever National Dementia Strategy, which aims to increase awareness of the disease, improve early diagnosis and provide higher quality treatment.
Is NICE ‘too generous’?
Another criticism of the court’s decision, voiced by the ABPI, among others, was that NICE relies heavily on quality-adjusted life year (QALY) assessments, which assess the cost of an extra year of good health, and does not consider the full value of a treatment to society at large.
To be deemed cost effective a new treatment needs to provide one QALY for £20,000 or less, although NICE has approved treatments with a QALY cost up to £30,000 or even higher. Research from the Kings Fund and City University has indicated that this threshold is actually too high, as it does not reflect the prices PCTs are willing to pay – most PCTs impose a limit of £12,000 per QALY in circulatory disease, for example.
The King’s Fund and City University’s report stated that if newer treatments are funded, it could mean there will be limited funds for more effective ones. However, a lower QALY threshold will mean that many more treatments will be rejected by NICE, most likely provoking ever more outraged reactions from patient groups.
Cost effectiveness is an ongoing issue and a key factor in the health select committee inquiry. A health select committee inquiry into NICE in 2002 explored similar issues of cost-effectiveness and affordability and reached the conclusion that NICE had become a scapegoat for funding disputes. It concluded in paragraph 134:“with so many competing interests vying for attention and funding in an area where resources are finite, it is not sufficient to have implicit healthcare prioritisation.We feel that NICE has been laid open to unfair criticism in respect of the 'rationing' debate, as a consequence of the lack of clarity in policy here.”
The 2002 health select committee report also concluded in paragraph 107 that there was a need for “decisions about the affordability of NICE's recommendations to be seen to be made entirely separately from NICE's decisions about clinical and cost-effectiveness.”
Had the High Court upheld all three grounds for the judicial review, this case could have signalled a new era in patient power, as seemed to be heralded by the success of the Herceptin campaign. As it is, the court’s decision is likely to set a precedent for any future disputes over NICE decisions. At least until the latest select committee reaches its own conclusions.