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NICE Not Playing Nice With Alzheimer's

By Rich Duprey – Updated Nov 15, 2016 at 6:25PM

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British authority proposes limiting availability of treatments because of cost.

In January, the United Kingdom's National Institute for Health and Clinical Excellence (NICE), the organization that determines what drugs the government will and will not pay for, created a firestorm of controversy when it decided to limit the availability of various drugs used to treat Alzheimer's patients because it said they weren't cost-effective.

That put NICE at odds with the tens of thousands of patients who found the drugs to be very effective at improving their cognitive functioning. It was also at odds with NICE's own policy, promulgated in 2001, which said not only that patients ought to be treated as early as possible in the diagnosis continuum, but also that these drugs in particular were approved.

Apparently, what's past is simply prologue, because NICE is no longer playing nice. It has now said that it will refuse to pay for the use of these drugs in severe cases of Alzheimer's. Again, an alliance of patients, practitioners, and drug manufacturers is preparing to oppose the change. If the past is any indication, NICE may again have to back down. It's not that it's saying the drugs are ineffective -- just that they cost too much for the government to pay for, considering the benefits they deliver.

Four drugs would be affected by the decision: Rivastigmine, which is sold by Novartis (NYSE:NVS) as Exelon; Ebixa, which is Lundberg's trade name for memantine and which is sold by Forest Labs (NYSE:FRX) as Namenda; donepezil, manufactured by Eisai as Aricept; and galantamine, which is known as Razadyne and is made by Johnson & Johnson (NYSE:JNJ) and Shire Pharmaceuticals (NASDAQ:SHPGY). All had been approved for treating Alzheimer's patients at various stages of the disease. Some were approved for mild to moderate forms of the illness, while others were prescribed for moderate to severe symptoms. Patients have generally reported a slowing of the progression of the disease; there is no cure for Alzheimer's. The outcry caused NICE to back down, and treatment was permitted to continue.

It's true that these drugs are expensive. Approximately 1 million of the 4.5 million Alzheimer's patients in the U.S. alone use Aricept, the No. 1 prescribed treatment, or similar drugs, at a cost of more than $1 billion per year. According to a UCLA research report, health-care costs over a six-month period for a person recently diagnosed with Alzheimer's who still retains high cognitive functions total nearly $20,000. For someone with severe dementia, that cost rises to $35,000 during the same period. Some studies have put the cost as high as $50,000 per patient. The average lifetime costs of treating someone with Alzheimer's is approximately $174,000, while the annual direct and indirect costs for caring for all Alzheimer's patients approaches $100 billion.

More importantly, considering the debate in Britain, the costs associated with treatment are far lower than the costs of no treatment at all. In a Swedish study published in 2005, treatment decreased formal care costs by 123,600 Swedish kronor (approximately $16,949 at current exchange rates). After taking into account the costs of just the one drug (memantine), the total savings were 100,528 kronor (roughly $13,785) per patient.

When NICE originally proposed limiting the costly Alzheimer's treatments, doctors vocally expressed their intent to prescribe the drugs, recognizing the benefits their patients received. The organization anticipated some of the backlash this time around, saying that the rules will effect only newly diagnosed patients, and that those already under a doctor's care will still be able to have access to the drug treatments.

"Some or none" seems to be a hard choice to make, but denying access to all hardly seems the right prescription.

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Fool contributor Rich Duprey owns shares of Eisai but does not own any of the other stocks mentioned in this article. The Motl ey Fool has a disclosure policy.

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