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Last NICE Word on Alzheimer's Meds


UK Health Institute leaves guidance unchanged in case against Eisai and Pfizer; more research on NICE methodology needed.

The protracted battle in the UK over access to Alzheimer's drugs has finally ended, with the National Institute for Health and Clinical Excellence (NICE) issuing its final technology appraisal for the medicines, which was updated in the light of the court case against Eisai and Pfizer, manufacturers and distributors of Aricept (donezepil).

NICE said it will uphold its original decision to ban the reimbursement of Aricept, plus Exelon (rivastigmine, Novartis) and Reminyl (galantamine, Shire), for patients in the early stages of Alzheimer's. The companies had objected to NICE's refusal to release the model it used to make the decision, and the Court of Appeal said last year that NICE must hand over a fully executable version of its model-not just the read-only version initially supplied.

A consultation with stakeholders resulted in a few minor changes being made to the model, and NICE's independent advisory committee decided that these changes would not make enough difference to the cost-effectiveness of the drugs. As a result, the guidance is being left unchanged, and the drugs will be available on the National Health Service for only those patients who have the moderate form of the disease-not those for whom the disease is mild.

Eisai and Pfizer have decided not to continue the appeal, citing NICE's decision to carry out a review of the guidance as part of its normal work schedule, which it would do as soon as possible as long as no further appeals were received.

As part of the appeal process, Eisai commissioned United BioSource Corporation to carry out an independent assessment of NICE's model; its team was led by the academic who developed the original economic model which was modified by NICE in its appraisal process. UBC found several inconsistencies, including a disconnect between the actual cost of care and the model's assumptions-those with the mild form of the disease do not require anything like as much care as those with moderate Alzheimer's, but the model assumed it was the same. It also only looked at six-month trials, not longer ones where greater benefit would be evident.

The whole episode throws into sharp focus the difficult task NICE has in deciding which treatments to recommend for reimbursement, and which to reject. With a limited amount of money to pay for medicines, health technology assessments must provide a rational method for deciding which are most important, and therefore should be covered by NHS. Yet every time NICE rejects a drug, there is an outcry from patients, advocacy groups, and industry who believe that their drugs should be reimbursed.

NICE is now working with the Medical Research Council (MRC)-one of the government-funded bodies that pays for academic research within the UK-to develop new methodologies to underpin its decision-making process. MRC has called for research proposals, and has £2 million to spend on projects. The two bodies have worked together to identify NICE's research priorities in response to the House of Commons Health Select Committee's 2008 report that pointed out the need for better methodologies.

Several areas where research is needed have been identified; these include analysis and design of effectiveness studies; synthesis of evidence from patients, the public, and stakeholders; economic analysis and uncertainty; measurement and valuation of benefits; and decision making at NICE. This may encompass putting new measures into the estimation of quality-adjusted life years (QALYs), and the use of disease-specific measures in decision making. Another important aspect would be the identification of important benefits and hindrances that are not captured by QALY calculations, and working out how these factors could influence the decision process. MRC believes that this research may also be relevant to other decision-making bodies, notably the Medicines and Healthcare products Regulatory Agency.

"NICE is tasked with making some of the most difficult decisions in public life, decisions that have an impact on the millions of people who use the NHS," said NICE clinical and public health director Peter Littlejohns. "It's therefore vital for people to continue to have confidence not just in the guidance we produce, but also in the processes and methods we use to produce it. Of particular importance are the issues around how we measure health related quality of life."