Drugmakers Win Appeal Against UK Watchdog

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ariceptPharma won a “stunning victory” over the National Institute for Health and Clinical Excellence, or NICE, which a UK Court of Appeal ruled had acted unfairly in refusing to allow Pfizer and Eisai full access to a computer model that was used to assess cost-effectiveness of their Aricept drug for Alzheimer’s, The Times of London reports.

NICE had decided that the drug shouldn’t be prescribed on the NHS to patients with mild Alzheimer’s disease, because it wasn’t worth the $5-a-day price tag. But Eisai and Pfizer, which jointly market Aricept, were put at a disadvantage during their appeal because NICE refused access to the data. The ruling doesn’t require NICE to make Aricept more widely available, but the drugmakers will now get full details of the computer model so they can a new submission.

“Today’s decision is a damning indictment of the fundamentally flawed process used by the NICE to deny people with Alzheimer’s disease access to drug treatments,” Neil Hunt of the Alzheimer’s Society tells Reuters, adding that curbs on drug access should now be urgently reviewed.

But NICE ceo Andrew Dillon warns that longer approval times may be in store. “The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result,” he tells Reuters. Since 1999, NICE has measured the cost-effectiveness of new treatments, and its actions are closely watched by other governments and insurers, the wire service notes.

The organization plays a key role in rationing healthcare, but its decisions have often proved controversial. Drugmakers see NICE as a fourth hurdle for drugs that have already been proved safe, effective and of good quality. Generally, NICE recommends that med costing more than $60,000 per quality-adjusted life year, or QALY, shouldn’t be used. A QALY is a statistical measure of a person’s state of health, with one QALY equal to one year of perfect health or two years of half-perfect health.

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  1. For every life an airbag saves, it costs over a million dollars. Mammograms cost $175k/QALY (in 1996 dollars!). Is 60k/QALY a fair bar to set for drugs in 2008?

    FYI: seatbelts reign supreme at <$100/QALY (in 96 dollars). So buckle up.

  2. Opinions about drugs are different depending on whose interest is involved.
    About a year ago I attended a lecture by a physician whose specialty was
    Alzheimer’s disease. The audience included physicians, pharmacists and nurses.
    The lecturer asked the audience, “how long do you think the average patient
    stays on Aricept?” The audience gave answers that ranged from 6 months to
    3+ years.
    The lecturer then show a slide of a study of about 1,500 patients who were on Aricept. The graph showed a starting point for patients on the drug and those that were not on the drug. The patients NOT on the drug showed no improvement and their line declined downward on approximate a 30 degree angle. The patients on Aricept showed that patients improved and was defined by a line going up at a 45 degree angle and reached the highest point just after 3 months of drug use.

    Then the patients on the drug slowly declined and their line in a slow decent of about a 60 degree angle, met the line of the patients not on the drug.

    We can discuss how much money should be spent on QAL all day long, but
    if a drug is not therapeutically effective, should money be spent and should
    seniors be exposed to the potential of about 22 common adverse reactions of Aricept or any other drug?

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