Step Therapy Legislation Increasing

For most health conditions, more than one drug can be used to effectively treat patients. Step therapy is intended to control costs by prescribing the most cost-effective drug treatment before moving to a costlier and riskier drug therapy, only if necessary. If this drug does not produce the best results, a prescriber can “step up” treatment to one of the higher cost drugs for the same condition. The step therapy process has been common practice with nonspecialty prescription drugs for years and is now routinely used with specialty drugs.1

Step therapy has been used to augment prior approval (PA) processes as a method to control utilization and costs of pharmacotherapy by managed care/third party administrators [TPA]. Prior Authorization (PA) remains the best way to not pay or contain rising costs from a managed care perspective.

Patient advocacy groups are leading the movement to enact limitations on mandates of step therapy from health insurers. More than 20 states have enacted legislation in this area, and the advocacy groups have targeted an additional 10 jurisdictions for heightened legislative activity related to step therapy.2

Step therapy challenges today relate to biologics and specialty drugs and the use of copay and coupon programs by manufacturers. Being more selective is probably more useful when looking at certain types of medications and/or conditions for which step therapy can really impact patient care. While there are guidelines and care paths, their utility is limited by the extent to which patient data is shared real-time.

Bills to patients create more pressure for 3rd party management reform along with transparent drug pricing information. Allowing for a truly informed consumer as to the cost, not price, of their treatment or drug is being heavily promoted in this election cycle. The system as a whole around reimbursement and value across HCP stakeholders needs alignment to the care outcomes being sought by plan sponsors and patients as purchasers of care.

Drug pricing remains timely as an important policy aspect as newer generation personalized therapies with biologics, gene and molecular therapies emerge at million dollar price points that is not sustainable for any purchaser of care let alone a payer for care. 


  1. Integrated Pharmacy Benefits for Specialty Pharmaceuticals: Access and Management; Access Market Intelligence
  2. Laws in 20 States Address Insurance-Mandated Step Therapy, 2019-07-18 15:00:00, Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA