Embargoed Until:
April 1, 2008
12:00 a.m. Eastern Time



Christopher Fleming

Treatment Gaps And Other Disruptions Increased After Maine Medicaid Program Instituted A “Prior Authorization” Requirement For Certain Schizophrenia Drugs

Researchers Say That Findings Should Caution States and Part D Plans Considering Adopting Similar Policies

Bethesda, MD -- Schizophrenia patients in Maine’s Medicaid program were subjected to more frequent interruptions in treatment when the state began requiring physicians to seek prior authorization (PA) or follow a step-therapy algorithm before prescribing certain schizophrenia medications not on the program’s preferred drug list, researchers report in a Health Affairs Web Exclusive published today. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.3.w185

Maine’s PA policy, which was in effect for eight months in 2003 and 2004 and covered patients newly receiving one of a class of drugs known as atypical antipsychotics (AAs), increased the number of patients starting on preferred drugs within this class. However, many patients experienced treatment gaps or other treatment disruptions, which suggests that they responded poorly to the preferred drug they were initially prescribed. In the end, the PA policy appeared to do a poor job of lowering Maine’s cost of treating patients with schizophrenia, report Stephen Soumerai, a professor in the Department of Ambulatory Care and Prevention at Harvard Medical School and Harvard Pilgrim Health Care, and coauthors. However, the team could not measure the administrative costs of filing PA requests, or the confidential rebates received from manufacturers of preferred drugs.

The researchers say their results raise concerns about the burgeoning number of PA programs for antipsychotic medications: Maine itself introduced a different PA program in 2007 for patients newly starting nonpreferred AAs, and an additional 15 states have implemented PA programs for AAs in recent years. All told, 40 percent of state Medicaid programs, as well as one-third of Medicare Part D prescription drug plans, restrict the prescription of AAs through PA requirements.

As the name implies, PA policies generally allow physicians to prescribe nonpreferred drugs by requesting authorization from the state Medicaid program or other payer. However, as Soumerai and his colleagues point out, “Physicians may tend to switch to prescribing preferred medications because requesting a PA is a time-consuming process, even if they have concerns about the appropriateness of the medication for a specific patient.” In addition, patients with chronic mental illnesses such as schizophrenia are likely to be ill-equipped to negotiate administrative barriers such as PAs, the researchers write.

“PA programs may well make sense for drug classes where patients generally have a constant response to most or all members of the class. However, given the tremendous variation in individual responses to different AAs, as well as the devastating impact treatment disruptions can have on schizophrenia patients, a policy that pushes all schizophrenia patients toward a limited number of preferred AAs is likely to do more harm than good. It would be better to focus on ensuring that all AAs are prescribed for evidence-based applications such as treating schizophrenia and bipolar disorder, and not for clinically questionable applications such as treating dementia,” Soumerai said.

Maine’s PA Policy Resulted In More Treatment Discontinuities
Than In Neighboring New Hampshire, But Not Lower Costs

Maine’s PA policy was in effect from July 2003 through February 2004, when it was replaced with a provider education policy following numerous case reports of adverse events associated with the PA policy. Soumerai and his colleagues looked at the number of “treatment discontinuities” suffered by patients during the eight months the PA policy was in effect; they compared the experiences of patients who began taking AAs between July 2003 and February 2004, and were thus subject to the PA policy, with the experiences of identically defined patients who began taking the drugs in the previous year.

Patients subject to the PA policy were 29 percent more likely than prepolicy patients to suffer any sort of “treatment discontinuity,” a category including not only treatment gaps but also switches from one drug to another and the addition of other drugs to patients’ treatment regimens. About two-thirds of discontinuities were gaps in therapy of longer than 30 days, a strong predictor of acute psychotic episodes and hospitalization.

To help determine whether this increase in treatment discontinuities resulted from the implementation of Maine’s PA policy, as opposed to other factors, Soumerai and colleagues looked at Medicaid and Medicare records from neighboring New Hampshire, which did not institute such a PA policy while Maine’s policy was in effect. In New Hampshire, the researchers found no increase in treatment discontinuities among patients who started taking AAs after July 2003, as compared to patients who began taking the medications after July 2002.

“The fact that treatment discontinuities did not increase in New Hampshire suggests that the increase we saw in Maine really did stem from the PA policy,” said Soumerai.

In the eight months Maine’s PA policy was in effect, the researchers found a slight leveling of the upward trend in average monthly AA medication cost of $2.33 per patient per month. However, New Hampshire, which again did not institute a PA policy for AAs, experienced an even bigger decrease in cost trends; in the Granite State, per patient per month costs were $3.58 less than would have been predicted from cost trends prior to July 2003.

After the embargo lifts, the article by Soumerai and colleagues will be available online at



Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org.


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