Patient Navigation: Understanding Step Therapy Mandates


This article defines “step therapy,” provides helpful information on the patient impact of step therapy programs, and includes resources to learn more about step therapy.


What is step therapy?

Step therapy is a utilization management technique for drugs that prevents the patient from accessing prescribed treatment and instead mandates a therapy as dictated by the insurance plan. In laymen terms, it means trying “less expensive” drug options before “stepping up” to a more costly drug therapy. Step therapy plans could dictate that a patient begin treatment with a cost-effective drug before progressing to a more costly drug therapy if the initial treatment is proven ineffective. Some providers refer to this as a “fail first” plan.


How does step therapy impact me?

Step therapy is more prevalent in commercial plans and may or may not impact you depending on your particular health plan. If your health plan implements a step therapy mandate, you may have to utilize other medication before receiving approval for a more expensive therapy. You will have to document the ineffectiveness of the preferred, less expensive therapy before being permitted to switch. In some limited cases a doctor’s intervention may allow an override of the step therapy program.

For many chronic and rare conditions, a less-expensive (often “generic”) medication may not exist. In this scenario, a health plan may prioritize the most cost-effective medication as the starting step for medication. The health plan may dictate medication choices based on cost savings and may even deem some of the products as interchangeable. Significant documentation is encouraged in order to appeal to use another medication. This can become problematic especially if you change to a new health plan which has instituted a step therapy program; despite perhaps a long history of using a particular medication, the plan could dictate a medicine change.

For government programs such as Medicare and Medicaid, step therapy programs are less prevalent, but caution must be taken when selecting plans. Because Medicare Advantage (MA) plans are managed by commercial payors, they may be more at risk of implementing step therapy programs, but the MA plans must adhere to Part B guidelines for factor medications and must ensure they do not disrupt ongoing Part B drug therapies for beneficiaries. Under new policy guidelines, step therapy can only be applied to new prescriptions or administration of Part B drugs for beneficiaries who are not actively receiving the affected medication. This means that no beneficiary currently receiving drugs under part B will have to change their medication.


What can BioMatrix do to help with a problem with step therapy?

If you’re facing step therapy, our access team at BioMatrix can help you navigate the process. We can help you identify, collect, and submit the documentation required by your health plan and can help file for an exception in order to maintain or return to your original therapy.


Where can I learn more about step therapy?

The Alliance for Patient Access has created a succinct overview for understanding step therapy. Scan the QR code or visit the link to watch.



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