What Is Step Therapy for Biologics?
How it works, when exceptions apply, and how BiologicHealthPlus fights for your coverage
Key Takeaways
- Step therapy requires trying lower-cost medications first before insurance covers a biologic
- Common step therapy requirements: methotrexate failure for RA; conventional immunosuppressants for IBD
- Step therapy exceptions are available when documented clinical reasons exist
- BiologicHealthPlus handles all step therapy documentation and exception requests at no charge
- Many states have passed step therapy protection laws limiting insurer requirements
How Step Therapy Works
Step therapy (also called "fail first") is a cost-management strategy used by insurance companies that requires patients to try one or more less expensive medications before the insurer will cover a more expensive medication like a biologic. The theory is that some patients will respond to cheaper treatments, reducing overall drug spending.
In practice, step therapy can delay access to appropriate treatment — particularly when a biologic is the most medically appropriate first-line therapy for a patient's specific condition and severity.
Common Step Therapy Requirements by Condition
Rheumatoid Arthritis
Most plans require documented failure of conventional DMARDs (typically methotrexate at adequate dose for ≥3 months) before approving a biologic. Some require two DMARD failures.
Crohn's Disease
Many plans require failure of corticosteroids and/or immunomodulators (azathioprine, 6-MP) before approving biologics. Some require corticosteroid dependence as a criterion.
Plaque Psoriasis
Plans may require failure of two conventional therapies (topical steroids, phototherapy, methotrexate, or acitretin) before approving a biologic for psoriasis.
Atopic Dermatitis
Most plans require documented failure of topical corticosteroids and/or topical calcineurin inhibitors before approving Dupixent or Rinvoq for eczema.
How to Get a Step Therapy Exception
Step therapy exceptions can be granted when you or your prescriber can document that:
- You previously tried and failed the required step therapy medication
- The step therapy medication is contraindicated for you (e.g., methotrexate contraindicated in liver disease or pregnancy)
- The step therapy medication caused unacceptable side effects
- Your disease severity requires immediate biologic treatment (e.g., rapidly progressive RA, severe IBD flare)
- You are already stable on the prescribed biologic (prior treatment continuity)
State Step Therapy Protection Laws
Over 30 states have passed step therapy protection laws that limit how insurers can implement step therapy requirements. These laws typically require:
- A clear exception request process with defined timelines
- Exceptions to be granted within 72 hours for urgent cases
- Recognition of previously failed step therapy at another insurer
- No requirement to fail a medication if it is contraindicated
✅ BiologicHealthPlus Fights Step Therapy — Free
We handle all step therapy exception requests, appeals, and documentation gathering. Most patients never have to deal with step therapy directly — we handle it entirely.
Start My Exception Request →Related: Prior authorization guide · Insurance appeals · Benefits verification
📚 Sources & Further Reading
Content developed with reference to leading health organizations, peer-reviewed research, and FDA prescribing information.
Medical Disclaimer: Educational content reviewed by the BiologicHealthPlus Clinical Team. Consult your healthcare provider for personalized advice. Last reviewed: August 2026.