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Health Affairs, 22, no. 5 (2003): 261-263
doi: 10.1377/hlthaff.22.5.261-a
© 2003 by Project HOPE
 
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Letters

Evidence Needed Before Action

The Reforming States Group reminds us that North American policymakers "cannot wait for articles evaluating new approaches to appear in peer-reviewed journals" before making key policy decisions. Several proposals, such as creating standardized assessments of drug efficacy, are useful innovations. However, the authors’ upbeat conclusions about the savings gained (with no harm to patients) from using preferred drug lists (PDLs) and the improved outcomes resulting from prior authorization (PA)—two of the most common cost-control approaches—are not supported by the extant research. Our group has studied the effects of Medicaid drug cost containment policies for twenty years. Previous research by us and others yields evidence-based conclusions that contrast starkly to those of the authors. For example, because of the hassle factor, Medicaid PA policies can practically eliminate use of "nonpreferred" drugs, even appropriate ones.1 Although some PA policies may have reduced costs of symptomatic treatments (such as nonsteroidal anti-inflammatory drugs) without harmful effects, no data exist to support the safety of current expansions of PA to highly effective drugs for severe illness such as schizophrenia and depression.2 Research has established that other types of drug reimbursement restrictions can raise costs and institutionalization without providers’ being aware of these effects.3 The authors cite our and others’ research on reference pricing (RP) in British Columbia to support the safety of PA.4 These RP policies are not relevant, however, because they involved cost sharing, not bureaucratic obstacles to access. Also, most patients were automatically exempted from the policy because of their specific conditions.

Rather than complying with the time-honored principle of erring on the side of public health, these policymakers appear to want to act first in the absence of safety data, extend cost cutting to vulnerable chronically ill, and make unsubstantiated claims regarding efficacy and safety. A true innovation would be to allocate 3 percent of the drug savings for objective evaluation of the policy impacts of such massive social experiments on costs and health.

Stephen B. Soumerai and Alyce S. Adams

Harvard University and Harvard Pilgrim Health Care, Boston, Massachusetts

NOTES

  1. B.S.Bloom and J. Jacobs, "Cost Effects of Restricting Cost-Effective Therapy," Medical Care 23, no. 7 (1985): 872–880.[CrossRef][ISI][Medline]
  2. W.E.Smalley et al., "Effect of a Prior Authorization Requirement on the Use of Nonsteroidal Antiinflammatory Drugs by Medicaid Patients," New England Journal of Medicine 332, no. 24 (1995): 1612–1617.[Abstract/Free Full Text]
  3. S.B.Soumerai et al., "Effects of Medicaid Drug-Payment Limits on Admission to Hospitals and Nursing Homes," New England Journal of Medicine 325, no. 15 (1991): 1072–1077[Abstract]; and S.B.Soumerai et al., "Effects of Limiting Medicaid Drug-Reimbursement Benefits on the Use of Psychotropic Agents and Acute Mental Health Services by Patients with Schizophrenia," New England Journal of Medicine 334, no. 10 (1994): 650–655.
  4. S.Schneeweiss et al., "Outcomes of Reference Drug Pricing for Angiotensin-Converting Enzyme Inhibitors in British Columbia," New England Journal of Medicine 346, no. 11 (2002): 822–829.[Abstract/Free Full Text]

The authors respond:

Far from being "radical," as Marjorie Powell writes, our suggestions for improving states’ purchasing of prescription drugs derive from the principle that states should help to create a more functional market for drugs. We believe that PhRMA’s members should compete with each other on quality and price. Moreover, the policies we recommend have long been used by private-sector purchasers, including Soumerai’s and Adams’ employer, which has PA and a tiered copayment for brand-name drugs selected based on "relative safety, effectiveness and cost."1

Buying drugs smarter by creating incentives for competition among makers of equivalent drugs is good business and public health practice—not government price control. A major reason for increased drug costs is that most states don’t know the price they are paying for a drug until after purchase. Many states rely on pharmacy benefit managers (PBMs) to decide which drugs are bought and in what quantity. PBMs have no commitment to taxpayers and close ties to drug company sales staff. This purchasing system threatens public health. Unchecked prescription drug cost increases diminish access to and affordability of care for Medicaid patients. In many states leading consumer groups, notably AARP, agree and have endorsed PDLs.

Contrary to Powell’s assertion, our proposals are grounded in an evidence-based understanding of the value of drugs to patients. These policies ensure that publicly funded programs receive value for money and achieve positive patient outcomes. The "less than one-eighth of Medicaid spending in 2001" that she trivializes amounts to more than $30 billion and continues to escalate rapidly.2 Most PDLs and PA programs have simplified mechanisms to assure that patients can get their drugs dispensed as prescribed by their physician. Indeed, Medicaid law requires that appeals be resolved within twenty-four hours and that at least a seventy-two-hour supply of a covered drug be dispensed in an emergency.3 We would not suggest that because one drug company is sued for manipulation of prices, improper arrangements with PBMs, fraudulent marketing, or interference with the introduction of competing generics, all drug companies act in the same way. Similarly, PhRMA should not imply that the Florida program it sued is representative of all state PA programs.

Soumerai and Adams make claims unrelated to our proposals. For example, in our experience many Medicaid PA programs exempt antipsychotics from the PDL. Similarly, we are not proposing "other types of drug reimbursement restrictions" that raise costs. Moreover, they misleadingly imply that we urge action that contradicts research (including research results of theirs that they admit have not yet been published). In quoting us, Soumerai and Adams omitted essential words. We wrote that policymakers’ responsibilities to the public often require them to act before new approaches to policy have been thoroughly evaluated. But we also urged that "timely information about successful strategies for improving quality and reducing expenses be developed and disseminated."

We also disagree with Soumerai and Adams’ opinion that reference drug policy in British Columbia is irrelevant to the United States. The provincial system includes a special authorization process for accessing nonreference drugs within the reference categories. This is analogous to the method used in accessing drugs that are not in the PDL. It also is analogous to the hospital formulary process that serves as the cornerstone of rational drug therapy across North America.

Finally, we question whether the "time-honored" approach to public health that Soumerai and Adams advocate has ever existed outside the discourse of theorists. We prefer practice to abstraction. We also prefer protecting vulnerable people from losing coverage to erring in ways that effectively protect the status quo. Hence, we recommend policies for states’ purchase of prescription drugs that promise to avoid the negative public health consequences of eliminating from the Medicaid program many vulnerable people with serious chronic diseases.

Reforming States Group Steering Committee

c/o Milbank Memorial Fund, New York, New York

NOTES

  1. Harvard Pilgrim Online, "Pharmacy Program," www.harvardpilgrim.org (7 July 2003).
  2. S.Dale and J. Verdier, State Medicaid Prescription Drug Expenditures for Medicare-Medicaid Dual Eligibles, Task Force on the Future of Health Insurance, Issue Brief no. 627 (New York: Commonwealth Fund, April 2003).
  3. 42 U.S.C. 1396r-8(d)(5).


A Reforming States Group member responds:

Powell and Soumerai and Adams assume that every physician is blessed with encyclopedic knowledge and can take time to consider all of the drug options available to every patient. Perhaps this can be done at Harvard Medical School, but it is a bit much to ask of your average country doctor who is paid $30 a visit to administer a goulash of drugs to Medicaid patients with major medical problems. The collective knowledge behind PDLs and PA techniques, continuously evaluated in light of changing evidence, is far superior to what any one person can know or understand.

PhRMA seems to prefer that all therapeutic information be delivered through TV images and commissioned sales representatives and that drug costs be eliminated from medical decision making. Powell argues that the more money we spend on drugs, the more we may save in other areas of health care. Those of us on the front lines of state budget writing hear this argument so often that we are hardened to it. Primary care doctors ask for more money so that they can see more patients, make better decisions, and keep people out of the hospital. Chiropractors and naturopaths fill our hearing rooms with patients who fervently believe that we can cut prescription drug costs if we increase access to alternative medicine.

Maine has a network of volunteer drivers who provide free transportation to thousands of Medicaid patients living in remote areas. The state pays these drivers only a modest mileage reimbursement. Several weeks ago we cut the mileage rate. Many witnesses testified that with reduced transportation services, people will go without treatment, get sick at home, and increase costs to Medicaid by much more than we will save in mileage payments. We cold-heartedly cut the cost anyway. PhRMA needs to reenter the real and brutal world of public health care economics. If Congress lacks the courage to usher them into it, then state legislatures must do the triage for them.

Peter Mills

Maine House of Representatives, District 108, Cornville, Maine


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