Do US Managed Care Organizations Restrict Coverage More Than the Food and Drug Administration Label?

OBJECTIVES: Medical Policies (MPs) are developed by US payers to assist the administration of health benefits, particularly in situations where there are multiple treatment options for a specific indication. The most widely known mechanisms used by US payers to determine appropriateness of coverage include step-therapy (SP), prior authorization (PA), and quantity limits (QL). Our goal is to understand if Managed Care Organizations (MCOs) tighten health plan management of drugs when compared to the FDA label.

METHODS: Secondary research identified MPs for N=6 drugs from N=3 therapy areas (spinal muscular atrophy [SMA], psoriasis, and systemic lupus erythematosus [SLE]). Drugs included: Spinraza and Zolgensma (SMA); Sotyktu and Otezla (psoriasis); and Benlysta and Saphnelo (SLE). We reviewed N=18 CDs (one for each drug) from N=3 MCOs (United Healthcare, Anthem Blue Cross Blue Shield, and Aetna).

RESULTS: All three MCOs explored in this research restrict coverage more than the FDA label. While United Healthcare is the only insurer not requiring PA for Spinraza, its coverage is contingent upon 5 diagnosis requirements besides those of the FDA label. Regarding Zolgensma, all MCOs require PA to start treatment. For psoriasis, MCOs require not only PA but also have QL implemented for both Otezla and Sotyktu. Coverage of SLE is also more restrictive than FDA label, with PA requested by all MCOs, and QL and ST implemented by United Healthcare and Anthem Blue Cross Blue Shield. No specific pattern of coverage restriction was identified in this research.

CONCLUSIONS: MCO coverage criteria are typically more restrictive than the FDA label, which can contribute to challenges for US physicians when prescribing drugs, as well as patients when accessing them. Additional real-world analysis of claims data should be performed to examine the implications of these restriction mechanisms implemented by payers to US patients.