Step therapy (also called "fail first") is an insurance requirement that you try one or more lower-cost medications before your plan will cover a more expensive drug. Understanding step therapy protocols helps you navigate the process, know your rights, and work with your doctor to get the medication you need.
Key Facts
Check Your Specific Plan's Formulary
Coverage varies by plan. Use our formulary checker tool to look up your exact copay and restrictions.
Open Formulary CheckerSources and standards behind this page
Drug coverage in the United States is governed by published rules rather than by any one insurer's summary, and the sources below are the primary ones. They are linked so a reader can check a claim without taking this page's word for it.
- FDA Orange Book publishes the therapeutic-equivalence ratings that decide whether a generic may be substituted for a brand-name drug.
- FDA generic drug facts sets out what "generic equivalent" means and what a manufacturer must prove.
- CMS prescription drug coverage defines the rules a Medicare drug plan formulary must follow and how it may change mid-year.
- Medicare.gov drug coverage (Part D) states what a Part D plan is required to offer a member.
- CMS prescription drug appeals documents the coverage-determination and exception process when a drug is denied.
This page describes how coverage and formularies work. It is not medical advice, and a reader's own plan documents and prescriber decide what applies to them.
Frequently Asked Questions
In most cases, yes. If you have documentation (pharmacy records, medical records) showing you previously tried and failed the required step therapy drug, your doctor can submit this to your insurer to bypass the requirement. Many states have laws requiring insurers to accept prior trial evidence from previous plans.
Ask your doctor to submit a step therapy exception request with clinical justification. Valid reasons include previous adverse reactions, drug interactions with your other medications, medical conditions that make the step drug inappropriate, or documented prior trial failure. If denied, appeal the decision and consider contacting your state insurance commissioner.
No, they are related but different. Prior authorization is a one-time approval process for a specific drug. Step therapy is a specific type of utilization management that requires trying cheaper drugs first. A drug can require prior authorization without step therapy, step therapy without separate PA, or both.
Related Resources
Get Formulary and Coverage Updates
Subscribe to receive alerts on formulary changes, new drug approvals, and insurance coverage updates.