Alzheimer's drugs seem safe From MMA changes.

Today there are more drugs to treat Alzheimer's disease than five years ago with others in the pipeline. Long term care residents with Alzheimer's generally have access to those drugs, and treatment has improved overall. And awareness of the disease has become widespread, making it easier to gain support for programs that affect such patients.

If it is possible, it seems like a golden age for those who suffer from Alzheimer's disease.

Insuring that the future is brighter than the present, with concerns looming over how the Medicare Modernization Act (MMA) might affect drug accessibility in 2006.

How much the MMA might affect seniors, potentially including those with Alzheimer's, "depends on the income of the individual," said Tom Clark, director of policy and advocacy for the American Society of Consultant Pharmacists in Alexandria, Va. Those who will be most affected are known as "dual eligibles," who receive both Medicare and Medicaid benefits. "Those individuals will lose their Medicaid drug benefits on Jan. 1, 2006."

Though the final recommendations from Center for Medicaid and Medicare Services (CMS) had not yet been released, "Basically we expect the drug benefit will be mediated by private entities," Clark explained. "Congress is putting the dual eligibles in the hands of the private entities."

The prospect of drugs being listed on formularies that list what is--and just as important, what is not--available to patients, portends concern among advocates for seniors. The formularies identify the prescription drugs that are most medically appropriate for patients and cost-effective. Those medications not included on a formulary generally need physician approval.

Groups such as ASCP have expressed concern about drug accessibility when the MMA goes into effect, though the advocacy group's worries have focused more on other drug types.

Given the devastating effect of Alzheimer's, approval of such drugs seems likely. Clark said he believes the formularies would have at least two medications from each of the drug classes. "It looks like they will have pretty good coverage ... compared to some other categories of drugs. That's a positive thing."

Clark added, "A vast proportion of those older adults are in long term settings.... That's where we especially had some question about access to medication."

One of the challenges is that people with Alzheimer's are the least likely to be able to navigate the barriers to access, according to Clark. "These people with Alzheimer's are at the highest risk," he said. They don't necessarily have the ability to fill out forms or call 800 numbers. "This population is at high risk."

Janice Morris, director of nursing at Tanglewood Manor's Memory Garden facility in Jamestown, N.Y., expressed confidence that the MMA wouldn't curtail Alzheimer's care. "I suspect it's not going to have an effect," she said. "My feeling is that with the aging population, they're not really going to have a choice but to supply those medications."

Dan Kuhn is director of education with Mather LifeWays Institute on Aging in Evanston, Ill., and author of "Alzheimer's Early Stages: First Steps for Family, Friends, and Caregivers" (Hunter House, 2003). "I don't think anybody really knows yet (how the MMA will affect access to drugs," Kuhn said. "I think there will be a variety of different classes of drugs. A chemical cocktail if you will."

Kuhn noted that Nemenda, the only one for middle to late-stage Alzheimer's disease, is also used by people in early stages. "Likewise, the other drugs, although approved for early- to middle- (stage Alzheimer's) are being used by people in the late stages.... In the late stages it is difficult to assess if the drug is having a beneficial effect."

He explained that many caregivers ask that the drugs be continued out of fear that there could be a decline if the drug were withdrawn. "On the other hand, decline may happen anyway. There's a real psychological effect for caregivers, even if there's no (noticeable cognitive) improvement for the people with dementia."

When drugs were solely in the hands of private decision makers, perhaps there was not much scrutiny, "but when the Medicare program (begins) supporting all manner of drugs, the true benefit and long term benefit of drugs are going to be closely scrutinized."

Kuhn expressed hope that such scrutiny would lead to more drugs covering the gamut of care for the Alzheimer's patient, but there could be consequences. "If you've got a disorder that lasts years and the government's going to get behind paying drugs for years ... at what point do the drugs stop being useful?"

"There's been some research that even in late stages, these drugs can be beneficial (at) slowing the progression of Alzheimer's (and) reducing behavioral symptoms," Clark said.

"We've learned to view behavior as more a form of communication as opposed to something to manage by drugs," said Niles Frantz, a spokesperson for the Alzheimer's Association based in Chicago. "As a person progresses in the disease ... behavior can speak volumes."

Morris added that people with Alzheimer's are receiving better care now as a result of the improved treatments. "We're not looking at medicating patients to prevent behaviors as much as we were (in the past)," Morris said. This means better quality of life as well as better management of treatment.

The only problem that I see is physicians that are unaware of the availability ... especially the newest one Nemenda," she added. "Some of the physicians are not keeping up with the new medications." She recalled a doctor who initially declined to prescribe Nemenda because he believed it wasn't available in their area, though other residents were already using it.

While studies often show that seniors prefer to remain at home for as long as possible, even those residents of independent living facilities could be better off choosing long term care. "There are a lot that fall through the cracks ... if they don't have close family to encourage them (to check whether Alzheimer's is developing)," Morris said. "There's probably thousands that aren't being treated because they don't know they have the problems."

Kuhn explained that with the potential of residents being admitted to long term care facilities without the benefit of an evaluation, a person's Alzheimer's disease might go undetected. "A lot of people will move into independent living, slipping through the cracks, and they can do quite well with minimal support." Basic needs such as food and housing are in place "but you find even more retirement facilities adding on (assisted living wings)."

"The thing about people living in long term care," Kuhn added, "is that if these residents are put on these medications, they are at least insured of getting them as prescribed.... as opposed to those who are living alone or with family members."

Clark agreed. "People living at home alone, it's quite variable how much support they have," Clark said. Residents of senior communities are more likely to see or dine with others who would recognize the onset of Alzheimer's better than a family member who might consider symptoms simply part of getting older.

With growing awareness of Alzheimer's disease and greater understanding of the medications to treat and care for those with it, the long term care sector will become a beacon of hope for families and residents alike.

WHAT'S OUT THERE

Alzheimer's disease has no known cure, but these five drugs have been approved by the U.S. Food and Drug Administration for treating its related memory problems. Here's what is available:

Memantine (Namenda)--The newest of approved Alzheimer's drugs treats moderate to severe cases, it went on sale this past year. It may block transmission of excessive amounts of glutamate, which is believed to cause neuronal cell dysfunction and cell death. Sold by Forest Laboratories, Inc.

Cholinesterase inhibitors--These drugs block an enzyme that recycles acetylcholine, which appears to improve memory function in early-stage Alzheimer's patients when allowed to accumulate in the brain, or at least slow the disease's progression. The drug's side effects include nausea, vomiting, diarrhea, and stomach ulcers. It can also have adverse interactions with other drugs the patient may be taking.

Donepezil (Aricept)--Approved for mild and moderate stages of Alzheimer's, patients using this drug may demonstrate clearer thinking and maintained physical function. Taken once a day, it is one of the easiest for patients to use. It is sold by Pfizer, Inc.

Galantamine (Reminyl)--May increase neuron sensitivity to acetylcholine, thus enhancing the effect of acetylcholine on the brain in those patients in early or moderate stages of the disease. Like donepezil, galantamine, taken twice a day, has fewer side effects than other drugs. Sold by Janssen, Inc.

Rivastigmine (Exelon)--Believed to block an enzyme that contributes to brain damage during the later stages of Alzheimer's disease, although no clinical studies yet support that view. Available in both liquid and pill form, it must be taken twice a day. Unlike with other Alzheimer's drugs, diarrhea is not listed as a side effect. Sold by Novartis Pharmaceuticals.

Tacrine (Cognex)--This drug prevents acetylcholine both in the body and in the brain, which might help with earlier and mid-stage Alzheimer's patients. Clinical studies, however, have shown more side effects with tacrine than with the others, including possible liver damage. Must be taken four times a day. Sold by First Horizon Pharmaceutical Corp.--MS