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A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them-Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review-the first time one of NICE's decisions had been challenged in this way-and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands.
A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them—Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review—the first time one of NICE's decisions had been challenged in this way—and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands.
The successful challenge concerned discrimination, because the way the severity of the Alzheimer's is assessed can discriminate against some patients. The other two points, that the decision was irrational and that the procedure used to make it was unfair, failed. This has left the companies disappointed, not least because they are unable to challenge the ban on drugs for patients in the mild stages of disease because NICE will not disclose the model it uses to assess them.
"We're greatly disappointed about this," says Paul Hooper, managing director of Eisai UK. "Our health economists say that the only way we can challenge it in an informed fashion is to have an active version of the model. What you see here is very bad for medicine—and science in general. Were the industry to publish something like this and not be transparent in how it works, I'm sure we would get completely hammered!" Even the scientist who developed the model said in his witness statement to the court that had he known NICE was not going to allow access to the model, he never would have cooperated in the first place. And he has said that while the model may have been state-of-the-art when he first proposed it back in the early 1990s, NICE put it back another 10 years with the simplifications it made.
Richard Barker, director general of the Association of the British Pharmaceutical Industry (ABPI), agrees that the model should be disclosed. "I can see no reason at all why there should not be complete transparency in these models," he says. "We can all disagree about the answers, but there should be nothing murky about how the calculations are done."
Hooper says that the companies would like to challenge two of NICE's major assumptions: They want to look at the mortality figures that have been used, and they also want to adapt the model to include the one-year placebo-controlled trial data that NICE consistently refuses to consider. He adds that the costs NICE has used are more than a decade old and have not been indexed to modern-day prices; Eisai and Pfizer would like to determine what would happen to the cost–versus–quality-of-life assessments if the costs were updated.
It remains debatable whether such crude quality-of-life figures are an appropriate way of assessing a drug's effectiveness, says ABPI's Barker. "Even if we knew the models were accurate, they are only a partial assessment of the value of a medicine," he says. "In the case of Alzheimer's, there are many factors that we believe should be taken into account and haven't, some of which NICE isn't allowed even to consider. It ignores what seems like common sense to you or me in terms of taking care of people whose cognition is declining and thus allowing those who would otherwise have to look after them to return to the workplace. These are things that really should be taken into account, too, and the system should be changed."
Eisai and Pfizer are now looking into whether they have a good enough legal case to apply for leave to appeal the decision. If it is granted, the appeal is likely to be several months away. But with the ground swell of public opinion in the United Kingdom being that NICE is not recommending all the medicines it should, this will likely be only the first of many such legal challenges.
Sarah Houlton is Pharmaceutical Executive's global correspondent. She can be reached at firstname.lastname@example.org