NORD supports policies that protect patients by reforming step therapy processes.
What is step therapy?
Step therapy, often referred to as “fail first,” is a utilization management practice in which insurers require patients to try one or more alternative medications before gaining access to the treatment originally prescribed by their physician. While step therapy is intended to control health care costs, it is increasingly applied without adequate consideration of a patient’s medical history or the treatment needs identified by their health care provider.
Why it matters
When applied inappropriately, step therapy can delay access to necessary treatment and lead to adverse reactions that harm patients and ultimately increase health care costs. For rare disease patients—many of whom endure years-long diagnostic journeys to identify effective therapies—being forced to retry medications that have already failed or to discontinue successful treatments can jeopardize health outcomes and long-term stability.
What we’re measuring
This measure evaluates whether states have enacted step therapy protections that establish clear and accessible exception processes, require timely insurer decisions, and ensure step therapy protocols are grounded in medical criteria developed by independent clinical experts.
How we grade
States with comprehensive step therapy protections and strong patient safeguards receive higher grades. States with no protections or only minimal safeguards receive lower grades.
Important note
State lawmakers do not have authority over all types of health insurance. This analysis focuses exclusively on state-regulated health insurance plans.
Key patient protections
To date, a majority of states have enacted step therapy protections to help patients access the care and treatment they need in a timely manner. In general, these protections include:
Medical criteria requirement: Step therapy protocols must be based on medical criteria and clinical guidelines developed by independent experts
Clear exception process: A simple and accessible process for providers and patients to challenge the inappropriate use of step therapy
Timely decisions: Defined and expedited timelines for insurer decisions in both emergency and non-emergency situations to prevent treatment delays
Exemption framework: Clear guidelines outlining when patients should be exempt from step therapy, such as when a patient has previously tried and failed the required medication or is stable on a current treatment
Advancing step therapy reform through collaboration
NORD is a member of the State Access to Innovative Medicines (SAIM) Coalition, a collaborative effort that brings together patient advocacy organizations, health care provider societies, and biopharmaceutical companies to advance state policies that improve patient access to innovative medicines. The SAIM Coalition develops policy positions, educational resources, and legislative strategies to help ensure patients nationwide can access the treatments they need.