National Alliance on Mental Illness
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July 23, 2001
The Honorable Anthony J. Principi
Dear Secretary Principi:
Thank you for your reply letter regarding the treatment guidelines being developed for schizophrenia. Although it did not address specific concerns raised in NAMI's letter of May 15, the statements about the primary role of clinical judgment in making treatment choices were reassuring. It was also reassuring to see the following statements in your letter and accompanying fact sheet of July 10, sent to several concerned Members of Congress:
Cost containment of the atypical antipsychotic drugs appears to have become an overriding goal of some VA behavioral health programs, even though the cost of antipsychotic medications are overall less than 15% of the cost of treating the illness in most health care settings. Our veterans committee members and staff have received reports that cost-control efforts have resulted in the following unacceptable events:
This type of enforcement of "compliance with guidelines" is common but is usually more subtle and informal - and thus more difficult to document. I believe you will agree that this program of forcing compliance through quantitative goals included in a physician's performance review is chilling. This sort of single-minded attention to cost-savings without regard for the clinical well-being of the individual veteran is exactly the kind of "guideline implementation" we have seen in the past and feared would accompany these new VA "guidelines." Our fears appear to be well-founded.
NAMI understands the VA's concerns about the pricing of pharmaceuticals and the VA's desire to pressure the manufacturer of the more costly antipsychotic to lower the price. But we find it utterly unacceptable for the VA to drag our Nation's veterans with severe mental illnesses into the middle of contractual issues and to use the veterans as leverage to lower acquisition costs.
We believe these guidelines should be suspended until there are better data to examine the complex issues of comparative efficacy, effectiveness, cost-effectiveness, and side effects. At the very least, they should be suspended until the VA develops adequate controls over the implementation of guidelines to assure that clinician judgment regarding choice of medications is respected in practice as well as in theory. In particular, it is evident there would need to be, at a minimum:
We won't reiterate the concerns expressed in our first letter, but have attached it for reference (Attachment 2). We have also attached an outline of concerns about the VA fact sheet accompanying your Congressional letter of the 9th.
We know we share a commitment to providing our veterans with the best available treatment for their illnesses and look forward to continued discussions about the best ways to assure optimal, effective, and cost-effective care.
NAMI Comments on the July 2001 VA Fact Sheet on Treatment Guidelines for Veteran Patients with Schizophrenia
We at NAMI endorse basing treatment on the available scientific evidence and on the needs of the individual veteran. Research, and guidelines based on this research, call for most patients with schizophrenia to receive atypical antipsychotics. Although there is little evidence of overall group differences in effects on psychotic symptoms, there is ample evidence that these atypical antipsychotic agents differ from one another in biological effects and in side effects. There is ample clinical experience to suggest that individual patients may respond to one atypical medication but not another. Thus, clinical judgment plays a vital role in the selection of the most appropriate medication for a particular individual.
However, the fundamental purpose of the proposed VA guidelines is not guidance in selecting the best medication for a particular veteran - rather, the fundamental purpose is to reduce pharmacy costs by producing a shift to prescribing less costly atypical antipsychotic drugs. Such a shift in prescribing could be justified if the atypical antipsychotics were in fact equivalent and interchangeable. As noted above, they are not.
The fact sheet presented by the VA to Congress on July 10 claims that the guidelines are "based on the best existing published medical evidence" and "evidenced based" [sic]. We believe this claim is inappropriate. Medical evidence supports the use of an atypical antipsychotic as the medication of first choice, but current guidelines based on this evidence specifically provide for clinician choice among the atypicals (other than clozapine). The VA guidelines go beyond the medical evidence in that they select preferred atypical medications based solely on cost.
The fact sheet states that "there is no valid medical evidence of the value of one drug over another in managing a disorder." In fact, there is ample evidence of substantial side effect differences among the medications, a vital consideration in the management of schizophrenia and in promoting adherence to treatment.
The fact sheet states: "With respect to strategies involving the use of atypical antipsychotics in VISN 22, VISN officials have informed us that there have been no adverse effects on quality." We would like to know what evidence exists to provide that reassurance.
VA also states that "a number of private and public health care organizations are, in fact, using prioritization systems for the atypical antipsychotic medications similar to those proposed by VA." It is possible that some HMOs and some isolated programs may do so, but we would be interested to know which states and which major health insurance programs do this.
July 24, 2001