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Letter to VA Secretary Anthony Principi Regarding Access to Medications for Veterans

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July 23, 2001

The Honorable Anthony J. Principi
Secretary
U.S. Department of Veterans' Affairs
801 Vermont Ave., N.W.
Washington, D.C. 20420

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:

• "... I can assure you that the recommendations under development will continue to place clinician assessment of patient needs as the first consideration in the prescription of antipsychotic medication."
• "The proposed guideline and existing VISN guidelines assume the selection of atypical antipsychotic therapy must and will be based on physicians' assessment of clinical circumstances and patient needs."
• "... no patients who are currently being effectively treated with an atypical antipsychotic will have their medications changed as a result of the proposed guidelines."
• "... the proposed guidelines do not restrict a treating physician from prescribing any specific atypical antipsychotic that may best meet a patient's needs, based on the physician's clinical assessment."
• "Atypical antipsychotic prescribing will continue to be driven by clinical needs of patients as determined by their treating psychiatrist."

Unfortunately, actual events have not been reassuring. Although in theory the central role of clinical judgment is recognized in your draft guidelines, in practice there is ample evidence that the VA's schizophrenia guidelines are focused on cost-cutting rather than optimal clinical care. As we feared, some parts of the Veterans Administration are implementing pharmacy guidelines in a way that is inconsistent with your letter, inconsistent with the draft guidelines, and most importantly, inconsistent with good evidence-based clinical care for our Nation's veterans. Policies are being implemented that do not serve the best interests of our Nation's veterans.

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:

• Patients stabilized on the more costly atypical during an inpatient stay have been switched to a less expensive product soon after discharge, in direct contrast to VA assurances.
• Physicians' prescribing of the more costly atypical has been actively discouraged, both formally and informally. Pharmacists have called physicians to ask that they change their prescriptions to a less costly drug to comply with the "guidelines."
• Specific plans have been outlined to monitor physician practices, to assure that the more costly medication is prescribed less often, and to punish those who continue to prescribe the medication, believing it represents the best alternative for their particular patients.

Unfortunately, many of these instances have been documented informally, in part because VA staff report some concern about possible reprisals if they are publicly associated with these disclosures. Fortunately for our advocacy cause, one of the VA service chiefs was indiscrete enough to put his enforcement plan into writing (please see Attachment 1).

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:

• a directive forbidding the collection and use of individual physician prescribing profiles
• a directive forbidding the introduction of cost-containment criteria into performance reviews
• a formal monitoring program to examine all instances in which a less expensive medication is substituted for a more expensive medication to assure that stable patients are not switched
• a formal program by which violations of these directives by overzealous pharmacy or behavioral science managers could be reported without fear of reprisal

These constraints will help assure that treatment decisions are made by the veteran and the clinician, with the individual veteran's interests being the first and foremost concern.

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.

Sincerely,

Rex Cowdry, M.D.,	Andrew Sperling, J.D
Medical Director	Policy DirectorPolicy Director

cc:	The Honorable Rodney Frelinghuysen
	The Honorable Marcy Kaptur
	The Honorable David Hobson
	The Honorable Joseph Knollenberg
	House VA-HUD Appropriations Subcommittee
	Senate VA-HUD Appropriations Subcommittee
	The Honorable Thomas Garthwaite, M.D.
	Laurent Lehmann, M.D.

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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.

• In the public sector, we are not aware of any state that has implemented the type of restrictive guidelines that VA is proposing. Florida, Oregon, Kentucky, Hawaii, Missouri, Tennessee and Arizona have implemented preferred drug lists but exempt mental health drugs. Texas has implemented the Texas Medication Algorithm Project (TMAP) which supports open access to all atypical antipsychotic medications that are effective for treatment of a specific disorder. Within the algorithm, TMAP does not favor one specific medication over another. It is clinical judgement and patient preference and acceptance that determine the choice. The state of Texas follows TMAP and uses medication cost as a basis for choice only if there is no clinical reason to prefer one drug over another.
• In most private healthcare plans, tiered co-pays are commonly used rather than restricting access to atypical medications. We know of no private plan that has implemented a restrictive policy that requires a patient to utilize the type of "step therapy" that VA is proposing for the use of atypical antipsychotics, and would be interested in any that could be identified.

In any case, the existence of isolated instances do not justify a wide-ranging VA policy. Within the past two years, isolated Medicaid and VA programs have proposed putting patients back on conventional antipsychotics, complete with a markedly increased risk of tardive dyskinesia. I believe we would all agree that these proposals were irresponsible and possibly unethical. The fact that someone interested in cutting costs will propose a plan does not make it right.

July 24, 2001 

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