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The Mental Health America (NMHA) has declared that prescription formularies often increase health care costs and undermine the quality of patient care. In response, the NMHA has created an advocacy campaign to educate the public, media, and policymakers about these dangers.
One of the most recent challenges to providing optimal mental health treatment in this age of managed care is restrictive formularies, lists of medications participating doctors can prescribe without preapproval. Created to lower costs for health plans, these formularies may actually increase treatment costs as well as the suffering of people with mental illness, according to a recent position statement issued by the NMHA, which is based in Alexandria, Va.
Although new medications may represent treatment advances, restrictive formularies make it harder for people with mental illness to have access to these drugs because they require doctors to try older, less-expensive medications first.
"They fail on economic and moral grounds," said Michael Faenza, president and CEO of the NMHA. "We would not tolerate fail-first treatment plans for diabetes or cancer, and we should not tolerate them because an individual has a mental illness like depression or schizophrenia. Particularly for people with severe mental illnesses, those most likely to require medication, improper treatment and delayed recovery predict a worse future outcome."
Lawrence Kline, M.D., chair of APA's Council on Economic Affairs, agreed. "I'm very concerned about restrictive pharmacy rules," he said. "Doctors are literally being compelled to substitute drugs that are not similar-and this is being done solely to save money. Patients experience certain risks when these substitutions are made, and it's really very dangerous in some situations."
APA's position statement on restrictive formularies and therapeutic drug substitutions was approved by the Board of Trustees in December 1997. The Association stated its opposition to the use of restrictive therapies and advocated that prescribing physicians must have the authority to override any formulary restrictions when necessary for the benefit of patients and that peer review procedures should not include inappropriate or excessive administrative burdens.
The NMHA's policy states that it opposes restrictive formularies on the grounds that they restrict access to medically necessary medications, fail to achieve their intended purpose of reducing costs, prolong suffering, and reduce patients' potential for full recovery. Where restrictive formularies are already in place, the NMHA proposes that there should be no "fail-first" policies; that prior authorization should be timely and efficient so as not to delay access to medication or deter the prescriber from ordering medications that will have optimal benefits; and that management of consumer information during the prior authorization process should be consistent with the NMHA's Standards for Responsible Management of Consumer Information.
In addition to issuing it's position statement, the NMHA is organizing an effort to assess Medicare formularies on a state-by-state basis. State mental health associations (MHA's) are building a grass-roots advocacy campaign involving citizen, family, mental health, and disability organizations. As a result of the state MHA efforts in California, the Medicaid program there expanded its formulary to include newer antipsychotic medications (such as Risperdal, Clozaril, Seroquel, and Zyprexa) at the first diagnosis. Rusty Selix, executive director of the California MHA, credits the success to the grass-roots advocacy campaign and to the research literature supporting the cost efficiency of these drugs.
In New York, a postcard campaign and a number of meetings with the state Office of Mental Health, the Governor's office, and key legislators helped the New York State MHA defeat a provision that would have resulted in a list of "unapprovable drugs" in the Medicaid system. The MHA is now concerned that the state is considering requiring prior authorization for psychiatric medications other than antipsychotics in special-needs plans.
Restrictive formularies have become increasingly common in the last few years. They are instituted and managed by health maintenance organizations or pharmaceutical benefits managers (PBM's), which may be part of the HMO or a separate organization. PBM's may manage mental health medications alone, or they may manage prescription benefits for both physical and mental health needs.
Many PBM's are influenced by the trend of "step-care therapy." In a step-care approach, health care providers follow a sequence of treatments for a given condition, starting with the least-expensive intervention and proceeding to more expensive options only when there is treatment failure. Unfortunately, this trend has reduced access to newer and more effective antipsychotic medications. For those with schizophrenia, extensive side effects from older medications often cause patients to discontinue use, resulting in relapse. According to the NMHA, newer, more effective antipsychotic medications should be made available for people with schizophrenia before their condition worsens.
The step-care approach also creates problems for people taking selective serotonin reuptake inhibitors (SSRI's). Patients may be given the least-expensive SSRI, even if they have had success with a different SSRI or another class of antidepressants. In other situations, patients are forced off effective medications and prescribed cheaper ones.
Not all restrictive formularies employ fail-first policies, but some of those that don't require complex paperwork or time waiting on the phone for prior authorization. Prescribing physicians report that these processes are exceedingly burdensome and that they deter them from using nonformulary drugs. Despite regulations requiring that the review of prior authorization requests be timely, patients and clinicians often find that this process slows access to needed drugs.
Another problem confronting psychiatrists and other physicians is pressure from HMO's to cut costs. Even when a physician or psychiatrist is able to prescribe other drugs, as some HMO's claim, the fact is that in most cases companies maintain records of costs generated by doctors and use those records to make decisions about which doctors to retain on their plans, said Kline.
"These kinds of things have a powerful effect inducing doctors to prescribe cheaper medicine," he said. The public, he added, is not aware of these pressures on their doctors.
Indeed the problems associated with restrictive formularies are not always easy for physicians to identify. Psychiatrists participating in carveouts may find that the carveout organization understands the rationale for a particular treatment, but the parent HMO may be attempting to keep medication costs as low as possible. For example, Kline said, he had a patient who was doing very well on a particular antidepressant, and her insurance company has not yet approved a renewal of her prescription. The carveout knows that changing prescriptions could cause her to end up hospitalized and that treatment would ultimately be more expensive, but the parent company has other concerns, such as keeping current costs down.
"Because of the fact that one company is at risk for part of the care and the other for something else, there is conflict," said Kline.
Restrictive formularies are ensconced in a complex system comprising HMO's, drug companies, the federal government, physicians, and patients, all with different goals and needs. Moreover, the structure of HMO's and PBM's varies in the private and the public sectors. The Substance Abuse and Mental Health Services Administration (SAMHSA) has funded a study by the Lewin Group to determine the extent of the problem and the issues involved, and to conduct a preliminary survey of data sources.
According to Razmic Gregorian, Ph.D., an associate at the Lewin Group, the organization has only recently begun the study. Gregorian said that public health care is fragmented by carveouts as well as a lack of clarity about who pays for medications-state Medicaid budgets or state Medicaid pharmacy budgets? There is then a whole different set of problems to explore in the private sector. "It is a moving, fragmented target," he said.
Both the NMHA and APA agree that restrictive formularies create dangers for patients needing medication and that there is a better way to address concerns about patient care as well as cost. As Kline said, "The solution is not to put the patient in the middle."