Winrevair™
Drug - Winrevair™ (sotatercept-csrk) [Merck & Co., Inc.]
January 2025
Therapeutic area - PAH Agents, Injectable
Initial approval criteria
- Patient is ≥ 18 years of age; AND
- Patient has a diagnosis of pulmonary arterial hypertension (PAH) World Health Organization (WHO) Group 1; AND
- Patient’s diagnosis has been confirmed by right heart catheterization (medical records required); AND
- Patient’s mean pulmonary arterial pressure is > 20 mmHg; AND
- Patient has a pulmonary capillary wedge pressure ≤ 15 mmHg; AND
- Patient has a pulmonary vascular resistance ≥ 2 Wood units; AND
- Patient’s WHO functional class is II or greater; AND
- Patient has been stable on background PAH therapy for ≥ 90 days and will continue background PAH therapy during treatment with sotatercept-csrk (Please note: Background therapy refers to combination therapy consisting of drugs from ≥ 2 of the following drug classes: endothelin receptor antagonists [ERA], phosphodiesterase type-5 [PDE5] inhibitor [PDE5i], soluble guanylate cyclase stimulator, and/or prostacyclin analogue or receptor agonist); AND
- A negative pregnancy test prior to starting therapy, if applicable; AND
- If applicable, use an effective method of contraception during treatment and for ≥ 4 months after the final dose; AND
- Prescriber attestation hemoglobin (Hgb) and platelets will be monitored as appropriate; AND
- Patient does NOT have a baseline platelet count < 50 x 109/L; AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.
Renewal criteria
- Patient must continue to meet the above criteria; AND
- Patient must have disease improvement and/or stabilization OR improvement in the slope of decline (e.g., 6-minute walk distance); AND
- Patient has NOT experienced any treatment-restricting adverse effects (e.g., erythrocytosis, severe thrombocytopenia, serious bleeding)
Quantity limits
- 1 kit per 21 days; kits include either one or two 45 mg or 60 mg vials with accompanying sterile water for injection in prefilled syringes
- Patient’s body weight (in kg) must be submitted at time of request
Questions?
Provider Call Center (844) 575-7887