Specialty Drug Clinical Criteria
| Drug Category | Clinical Criteria | Savings Potential |
|---|---|---|
| TNF inhibitors (RA) | Prior methotrexate trial; PA required | 15–25% |
| GLP-1 agonists (diabetes/obesity) | BMI threshold; prior lifestyle intervention; PA required | 20–30% |
| Oncology drugs | Biomarker testing; clinical trial eligibility; PA required | 10–20% |
| MS drugs | Diagnosis confirmation; PA required | 10–15% |
| Rare disease drugs | Genetic confirmation; specialist attestation; PA required | 5–10% |
Evidence-Based Criteria
Specialty drug clinical criteria must be evidence-based — grounded in clinical guidelines and peer-reviewed evidence. Criteria that are purely financially motivated — requiring step therapy for drugs where step therapy is not clinically appropriate — are both ineffective and potentially harmful. Work with a clinical pharmacist to develop evidence-based criteria for each specialty drug category.
MHPAEA and Specialty Drugs
Compliance Note
MHPAEA requires that prior authorization and step therapy requirements for mental health and substance use disorder drugs be no more restrictive than for medical/surgical drugs. If your plan requires step therapy for antidepressants but not for cardiovascular drugs, you may have a MHPAEA violation. Review specialty drug clinical criteria for MHPAEA compliance.