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Seth Ginsberg: Step Therapy's Effect on Patients


Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains how "fail-first" policies, or step therapy, affect patients.


What are fail-first policies, and how do they affect patients?

“Fail first” is a term often used to describe a health insurance utilization management strategy called step therapy. Step therapy is a program put into place by a patient’s health insurance provider. It encourages the use of less costly yet effective medications before more costly medications are approved for coverage. In some specific instances, step therapy can be an appropriate way to reduce cost, however when applied to more complex diseases and conditions, it can be unethical, prolong suffering, exacerbate disease, and increase cost.

Most of the time, the problem with step therapy is that it unilaterally applies a one-size fits all policy to individual patients without regard to their specific medical history. A doctor may have prescribed a more expensive, more complex medication—like a biologic—to her patient for specific reasons. For an insurance company to reject the prescription and require a patient to try something different, first, is problematic, to say the least. For example, in many cases, a patient may have already tried the less expensive medication and either not responded to it or experienced an adverse event. But if they are new to their health insurance plan, that history may be disregarded. This puts the health of the person at risk by delaying and/or preventing effective treatment. State legislatures across the country as well as Congress are addressing this issue by reforming the appeals process to bypass a step therapy procedure or accelerate an appeal. Legislation provides specific criteria with which a physician can use justify an appeal and puts in place response time requirements that insurers must comply with when answering appeal submissions from patients and providers.

Fail-first policies intrude on the patient/physician relationship and lead to:

  • Prolonged illness
  • Unstabilized care and the potential for permanent damage to occur
  • Higher overall healthcare costs
  • Additional lost productivity
  • Reduction in patient quality of life
  • Forcing patients to sometimes take drugs that are not FDA approved for their condition

Our organization has been a leader in helping people understand fail-first practices, educating policy makers and regulators about fail-first practices, and keeping the public updated on each state’s approach to fail first. The web site for that information is www.FailFirstHurts.org.

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