States attempt to rein in use of new antipsychotics
Attempting to stem the rapidly increasing cost of pharmaceuticals, some state Medicaid programs are searching for ways to limit or restrict the use of new antipsychotic medications that have a better safety profile than older drugs.
Though access to so-called atypical antipsychotics appears to be greater than access to two physical health medications used for comparison in a November 1999 study by the Bazelon Center for Mental Health Law in Washington, DC. The national advocacy group says efforts at restrictions are continuing, with more states likely to try for them.
The movement in Medicaid toward managed care arrangements "has the potential for expanding the use of closed formularies," says the Bazelon report. The center’s advocates also are worried about the increasing use of pharmacy benefit managers to control pharmaceutical treatment and Medicaid incentives that restrict access to atypical antipsychotics. The reason states pursue restrictions on the mental health drug benefit seems clear — the combined effect of increasing utilization of such drugs with their higher cost has led to a sharp rise in expenditures for the drugs. In 1997, retail sales of antipsychotics increased 63%, faster than for any other drug group, the Bazelon Center reports. Two of the newest antipsychotics — Risperdal, with sales of $364 million, and Zyprexa, with sales of $334 million — led the growth.
States’ Medicaid spending for the drugs reflect that picture, the center says. As an example, the Florida Medicaid program, one of the nine states in the Bazelon survey, spends 20% of its medication budget on just 12 drugs, five of which are high-cost psychiatric medications. And in Massachusetts, Medicaid’s highest drug expenditures are nearly all for psychiatric drugs.
In general, the atypical antipsychotics are two to three times more expensive than older medications, Bazelon reports. For instance, the pharmaceutical cost of one year of treatment for an adult patient on Zyprexa is $1,700 more than treatment with thioridazine hydrochloride, the generic version of Mellaril.
The survey was conducted to address concerns of state policy-makers, mental health care providers and consumers, and mental health advocates about the need for appropriate and timely access to and coverage of the new atypical antipsychotics for the Medicaid population. The study reviewed Medi caid programs in Connecticut, Florida, Hawaii, Illinois, Iowa, New Mexico, Texas, Utah, and Wyoming and looked at use of six drugs, including four atypical antipsychot ics (clozapine, Zyprexa, Seroquel, and Risperdal). The two drugs for physical health conditions (Azactam and Prilosec) were chosen because of their higher price and improved outcomes when compared with older medications.
The nine states were chosen because they have a range of prior approval use and different delivery systems, including fee-for-service, mental health managed care carveouts, and integrated managed care arrangements such as HMOs.
Only one plan requires prior approval for all atypical antipsychotics. In the two states that allow the integrated managed care organizations to employ restrictive formularies, only one plan requires one or two failures before the studied physical and mental health medications can be prescribed.
The Bazelon report notes that the report’s finding are limited by the nonrandom sampling, the small number of states studied, and whether the two physical-health medications are compar - able to the atypical antipsychotics.
The National Alliance for the Mentally Ill (NAMI) says the problem has appeared so far only in "a few isolated Medicaid programs. NAMI notes that a number of other states have proposed either higher regulated formularies or "first-fail policies" in which patients must first fail on an older drug before a newer one can be prescribed.
NAMI’s policy is to "strongly oppose measures that limit the availability and right of individuals with brain disorders to receive treatment with new generation’ medications," NAMI deputy executive director for public policy Clarke Ross tells State Health Watch. The organization’s position statement says professional judgment and informed consumer choice should determine the choice of medications, and the choice of treatment should be based on knowledge of effectiveness and side effects, consistent with existing treatment guidelines. "NAMI members are committed to work to identify and remove any barriers that prevent persons with severe brain disorders from receiving the right medication, at the right dose, at the right frequency, and for the right duration."
NAMI helps chapters in states with proposed restrictions advocate against limits. So far, the states have backed down, Mr. Ross says. He says those opposing the restrictions argue that state Medicaid officials don’t choose drugs to be used in fighting cancer or other diseases and, similarly, should not choose specific mental health drugs. He says advocates also point out that restricting use of newer antipsychotics may not be cost-effective because studies show that their use can result in lower overall treatment costs through reduced hospital expenditures.
NAMI arms its advocates with a 1998 letter from Sally K. Richardson, then director of HCFA’s Center for Medicaid and State Operations, suggesting that states update their formularies to reflect the advantages of the atypical antipsychotics in reduced side effects and increased patient compliance because of the reduced side effects. Included with her letter was a research summary from the director of the National Institute of Mental Health (NIMH) that indicated the atypical medications "will be effective for a broad range of symptoms of schizophrenia, with substantial improvement in side effect profiles." The NIMH research said there was no scientific justification for applying a fail-first policy and said it could be "ill-advised since, for many people with schizophrenia, their first exposure to antipsychotic medication may have life-long implications for compliance with treatment."
Contact Mr. Ross at (703) 524-7600. The Bazelon report, Medicaid Formulary Policies: Access to High-Cost Mental Health Medications, is available at http://bazelon.org/ formulary.html.
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