Correspondence
Effect of a Prior-Authorization Requirement on the Use of Nonsteroidal Antiinflammatory Drugs
N Engl J Med 1995; 333:1289-1290November 9, 1995
- Article
To the Editor:
Smalley et al. (June 15 issue)1 effectively demonstrate that prior-authorization requirements are cost effective with regard to expenditures for nonsteroidal antiinflammatory drugs (NSAIDs). They correctly state that NSAIDs are similar in efficacy, but they incorrectly claim equivalence in safety.
Two of the listed generic preparations (fenoprofen and phenylbutazone) have higher rates of severe organ toxicity than other NSAIDs.2,3 Fenoprofen causes interstitial nephritis more frequently than other NSAIDs that are either in the same chemical class as fenoprofen or in a different class.3 Phenylbutazone is well known to have a much higher risk of causing potentially irreversible bone marrow suppression than any other NSAID. This severe toxicity has relegated phenylbutazone to the realm of historical interest.4
It is conceivable that the requirement that providers obtain prior approval before prescribing preparations that are not available in a generic form would provide an incentive to use more toxic agents, if these drugs were on lists of approved medications.
In the current rush to adopt more cost-containment measures, we need to ensure that effective safety controls are also in place that require prior authorization before an equally efficacious, but more toxic, preparation is used. Alternatively, medications such as fenoprofen and phenylbutazone should be eliminated from the list of drugs approved for insurance reimbursement.
4 ReferencesDavid F. Lehmann, M.D., Pharm.D.
State University of New York Health Science Center, Syracuse, NY 132101
Smalley WE ,Griffin MR ,Fought RL ,Sullivan L ,Ray WA . Effect of a prior-authorization requirement on the use of nonsteroidal antiinflammatory drugs by Medicaid patients. N Engl J Med 1995;332:1612-1617
Full Text | Web of Science | Medline2
Insel PA. Analgesic–antipyretics and antiinflammatory agents: drugs employed in the treatment of rheumatoid arthritis and gout. In: Gilman AG, Rall TW, Nies AS, Taylor P, eds. Goodman and Gilman's the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press, 1990:654-5.
3
Garella S ,Matarese RA . Renal effects of prostaglandins and clinical adverse effects of nonsteroidal anti-inflammatory agents. Medicine (Baltimore) 1984;63:165-181
CrossRef | Web of Science | Medline4
Flower RJ, Moncada S, Vane JR. Analgesic-antipyretics and antiinflammatory agents: drugs employed in the treatment of gout. In: Gilman AG, Goodman LS, Gilman A, eds. Goodman and Gilman's the pharmacological basis of therapeutics. 6th ed. New York: Macmillan, 1980:698-700.
To the Editor:
With respect to the article by Smalley et al., what criteria did the Medicaid nurse use in overruling the prescribing decision of the treating physician? What accounted for the sudden decrease in the use of prescription NSAIDs? Was it fewer prescriptions or more rejections? How much of the saving was merely a transfer of the expense to Medicaid patients, who bought nonreimbursable, nonprescription alternatives?
I presume that patient outcomes were not measured because they were considered unimportant in comparison with the financial benefits.
Harvey S. Frey, M.D., Ph.D.
552 12th St., Santa Monica, CA 90402Author/Editor Response
The authors reply:
To the Editor: As suggested by Dr. Lehmann, the prior-authorization policy altered the patterns of use of specific NSAIDs. The most pronounced change was a marked increase in the use of ibuprofen (from a 5.2-day supply per person-year of Medicaid enrollment in the year before the implementation of the prior-authorization policy to a 7.2-day supply per person-year in the two years after implementation). Recent epidemiologic data suggest that this change should be beneficial, since ibuprofen is consistently associated with relatively low rates of upper gastrointestinal bleeding,1 the most common serious toxic effect of NSAIDs.
Other changes are more difficult to evaluate, because they involve drugs with an excess of case reports of certain adverse effects2 but without confirmatory, well-controlled studies. The use of diclofenac (for which there are case reports of hepatotoxicity) decreased from 0.6 to 0.4 day per person-year, the use of piroxicam (reports of dermatologic reactions) decreased from 2.5 to 0.4 day, the use of indomethacin (reports of interference with antihypertensive drugs) increased from 0.7 to 0.9 day, and the use of fenoprofen (reports of interstitial nephritis) increased from 0.9 to 1.8 days. The use of phenylbutazone (which can cause blood dyscrasias) was rare before and after the policy change (0.02 day in each period). Without epidemiologic data from well-controlled studies, the overall clinical effects of such changes (some seemingly favorable and some unfavorable) cannot be assessed, which emphasizes the need to collect better quantitative data on the relative safety of drugs in the same therapeutic class.3
We speculated that the decrease in the overall use of NSAIDs, noted by Dr. Frey, was related to the moderate efficacy of these compounds. This speculation is reinforced by recent reevaluations of treatments for musculoskeletal pain, which now recommend a decreased role for NSAIDs,4 and by suggestions of a recent trend of decreasing NSAID use over time.5 With regard to patient outcomes, we agree with Dr. Frey that these are an important end point. We did assess the use of medical care for the management of musculoskeletal conditions and found no evidence of poorer control after the implementation of the prior-authorization policy. Unfortunately, in our retrospective study, conducted years after the policy was implemented, we could not directly evaluate patients before and after the policy was implemented. This limitation underscores the need to make provisions for an evaluation of the effects of policy changes when they are implemented, particularly as policies to modify the delivery of health care become more common.
5 ReferencesWalter E. Smalley, M.D.
Marie R. Griffin, M.D., M.P.H.
Wayne A. Ray, Ph.D.
Vanderbilt School of Medicine, Nashville, TN 37232-26371
Langman MJ ,Weil J ,Wainwright P , et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994;343:1075-1078
CrossRef | Web of Science | Medline2
Brooks PM ,Day RO . Nonsteroidal antiinflammatory drugs -- differences and similarities. N Engl J Med 1991;324:1716-1725
Full Text | Web of Science | Medline3
Ray WA ,Griffin MR ,Avorn J . Evaluating drugs after their approval for clinical use. N Engl J Med 1993;329:2029-2032
Full Text | Web of Science | Medline4
Brandt KD . Should osteoarthritis be treated with nonsteroidal anti-inflammatory drugs? Rheum Dis Clin North Am 1993;19:697-712
Web of Science | Medline5
Gabriel SE ,Fehring RA . Trends in the utilization of non-steroidal anti-inflammatory drugs in the United States, 1986-1990. J Clin Epidemiol 1992;45:1041-1044
CrossRef | Web of Science | Medline
