Arthritis Foundation Step Therapy Legislative Position Statement

Arthritis Foundation Position Statement on Step Therapy/Fail First


An increasing number of insurers are utilizing step therapy or fail first policies that require patients to try and fail one or more formulary covered medications before providing coverage for the originally prescribed non-formulary or non-preferred medication.


Step therapy or “fail first” is the practice by insurers of requiring patients to test use of a safe lower cost drug or service before permitting more expensive drugs or services. Step therapy is an established benefit management tool that is used by commercial carriers, self-insured employers, Medicare Advantage/Part D programs, and Medicaid.

When a patient changes insurers or a drug they are currently taking is moved to a non-preferred status patients may be put through the step therapy process again. Some step therapy protocols impose these requirements on stable patients.

Arthritis Foundation Position

The Arthritis Foundation supports legislation that provides limitations on step therapy/fail first protocols and believes the following provisions are essential to protect patients:

  • Permit a prescriber to override the step therapy when patients are stable on a prescribed medication.
  • Permit a physician to override the step therapy if the physician expects the treatment to be ineffective based on the known relevant physical characteristics of the patient and the known characteristics of the drug regimen; will cause or will likely cause an adverse reaction by or physical harm to the patient; or is not in the best interest of the patient, based on medical necessity.
  • Require health insurance plans to incorporate step therapy approval and override processes in their preauthorization applications.
  • Prohibit insurers from requiring insured patients from having to fail a prescription medication more than once.
  • Limit any single step therapy protocol to a maximum of 60 days.
  • In circumstances where an insured is changing health insurance plans, the new plan may not require the patient to repeat step therapy when that person is already being treated for a medical condition by a prescription drug provided that the drug is appropriately prescribed and is considered safe and effective for the patient’s condition.
  • When a health insurance plan changes formulary design, the plan cannot limit or exclude coverage for a drug for an insured if the drug previously had been approved for coverage by the plan for a medical condition of the person and the plan’s prescribing provider continues to prescribe the drug for the medical condition.

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