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WASHINGTON — Two high-ranking senators have urged the Centers for Medicare and Medicaid Services (CMS) to take a closer look at potential over-prescribing of atypical antipsychotics to nursing home residents.

There are eight atypical antipsychotics approved by the FDA to treat schizophrenia and/or bipolar disorder, including clozapine (Clozaril), aripiprazole (Abilify), and quetiapine (Seroquel).

Atypical antipsychotics are not approved to treat dementia, and must carry black box warnings that elderly people who take atypical antipsychotics have an increased risk of death, compared with those who take placebo pills for dementia.

Still, it’s clear that these drugs are being used in nursing homes to control behavioral problems related to dementia. A 2011 report from the Department of Health and Human Services Office of the Inspector General (OIG) found that 14% of all nursing home residents with Medicare had claims for antipsychotics and 88% of the atypical antipsychotics prescribed off-label were for dementia.

And in 2009 Elli Lilly, the makers of olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia.

In their letter, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.), urged CMS administrator Donald Berwick, MD, to examine the issue of overuse of antipsychotics in nursing homes more closely. The letter is a follow-up to one the senators sent in May after the release of the OIG report, which the senators themselves requested.

The newest letter, sent Aug. 1, requests that CMS investigate what role pharmacy benefit managers — who manage prescription drug coverage for Medicare beneficiaries living in nursing homes — play in fueling the possible overuse of atypical antipsychotics in elderly people in long-term-care facilities.

Pharmacy benefits managers may receive rebates from drug companies for prescribing certain drugs, and CMS should look at their role in “unnecessarily increasing the use of antipsychotic drugs and to subsequently take action to address such practices and curb excess use.”

The letter also urges CMS to consider requiring that physicians, who off-label prescribe drugs with black box warnings to seniors, certify that a Part D provider will cover the drug.

If CMS followed the senators’ advice, Medicare payments for antipsychotics that “lack a medically-accepted indication” should be drastically reduced, the senators said.

“Taking such proactive steps will create disincentives for entities that administer pharmacy benefits to allow these practices to flourish while also providing CMS with clearer means to recoup erroneous payments,” Grassley and Kohl wrote.

A recent study found that the prescription cost for a typical antipsychotic increased from $38 to $41 between 2004 and 2008, while the price tag for an atypical antipsychotic rose from $226 to $323, the researcher found. Overall, the cost of typical antipsychotics in the U.S. was $600 million in 2008, while the cost of atypical drugs reached $9.9 billion.

That same study concluded that atypical antipsychotic use is growing, especially among seniors, and the drugs are increasingly prescribed off-label, sometimes without convincing evidence to support that use.

In 2008, 91% of the prescriptions written for atypical antipsychotics were for circumstances where the evidence for the efficacy was uncertain, the researchers found.

However, a separate study found that after the FDA issued a black box warning about the risks of using the drugs to soothe behavioral problems in dementia patients, there was a decline in prescribing the drugs to patients in the VA medical system.

http://www.medpagetoday.com/Geriatrics/Dementia/28052