Bosentan
Policy governs coverage of bosentan (Tracleer and generics) for treatment of pulmonary arterial hypertension (WHO Group 1) including FDA-approved adult and pediatric indications; requires prescriber specialty and specific diagnostic confirmation. Other uses are considered experimental/investigational and not medically necessary.
No material clinical or coverage changes were made in this update.
Coverage Summary
Policy governs coverage of bosentan (Tracleer and generics) for treatment of pulmonary arterial hypertension (WHO Group 1). Coverage is limited to the FDA‑approved PAH indications: in adults to improve exercise ability and decrease clinical worsening, and in pediatric patients aged 3 years and older to improve pulmonary vascular resistance. Prior authorization is required and may be granted for 12 months when all diagnostic confirmation and prescriber specialty criteria are met. Bosentan must be prescribed by or in consultation with a pulmonologist or cardiologist. All other indications, including non‑Group 1 pulmonary hypertension and other non‑FDA‑approved or non‑compendial uses, are considered experimental/investigational and are not covered.
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