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February 28, 2017

Step Therapy—Clinical Algorithms, Legislation, and Optimal Prescribing

Author Affiliations
  • 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
  • 2Harvard Medical School, Boston, Massachusetts
JAMA. 2017;317(8):801-802. doi:10.1001/jama.2016.20619

Increasing prescription drug costs impose economic burdens for patients and payers and are reflected in substantial increases in insurance premiums for individuals and employers and budget stress for public programs. One widely used approach to control prescription costs is “step therapy”: requiring patients to try a less expensive drug for a given condition before a more expensive option can be approved. Authorization of the second-line agent may require attestation by the prescriber that the patient took the initial medication and had adverse effects or inadequate clinical benefit. Such clinical algorithms are often sensible and evidence based and can improve the quality of care. But sometimes they are not, because of limited evidence, inadequate attention to the underlying evidence, or an emphasis on cost containment rather than patient outcomes. The economic stakes can be high, because manufacturers’ promotion to both prescribers and patients is usually aimed at encouraging use of more costly second-line agents.