WHA

WINREVAIR (sotatercept-csrk)

Office-Administration – subcutaneous injection 

Diagnosis considered for coverage:

Pulmonary Arterial Hypertension (PAH): Indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events.
 

Coverage Criteria:

For diagnosis of PAH:

  • Diagnosis of pulmonary arterial hypertension; AND
  • Pulmonary arterial hypertension is symptomatic; AND
  • Patient is currently on at least two therapies indicated for the treatment of pulmonary arterial hypertension from the following different mechanisms of action, unless there is a contraindication or intolerance: 
    • Endothelin receptor antagonists (i.e., bosentan, ambrisentan or macitentan) 
    • Phosphodiesterase 5 inhibitors (i.e., Tadalafil or sildenafil); AND
  • Prescribed by or in consultation with a pulmonologist or cardiologist
Reauthorization Criteria:

For diagnosis of PAH:

  • Patient demonstrates positive clinical response to therapy
Coverage Duration:
  • Initial: 6 months
  • Reauthorization: 1 year
Dosing:

For diagnosis of PAH:

  • WINREVAIR is administered once every 3 weeks by subcutaneous injection according to patient body weight. The starting dose of WINREVAIR is 0.3 mg/kg.
  • Obtain hemoglobin (Hgb) and platelet count prior to the first dose of WINREVAIR. Do not initiate treatment if platelet count is <50,000/mm3 (<50 x 109/L).
  • Injection volume should be rounded to the nearest 0.1 mL.
  • After verifying acceptable Hgb and platelet count, increase to the target dose of 0.7 mg/kg. Continue treatment at 0.7 mg/kg every 3 weeks unless dosage adjustments are required.
  • Check Hgb and platelet count before each dose for the first 5 doses, or longer if values are unstable. Thereafter, monitor Hgb and platelet count periodically.
  • For treatment delays lasting >9 weeks, restart treatment at 0.3 mg/kg, and escalate to 0.7 mg/kg after verifying acceptable Hgb and platelet count.
     
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 
  • WINREVAIR is intended for use under the guidance of a healthcare professional. Patients and caregivers may administer WINREVAIR when considered appropriate and when they receive training and follow-up from the healthcare provider (HCP) on how to reconstitute, prepare, measure, and inject WINREVAIR.
  • WINREVAIR is the first FDA-approved activin signaling inhibitor therapy for PAH that works by modulating vascular remodeling.
  • Right heart catheterization is required for diagnosis of PAH and provides an assessment of pulmonary hemodynamics and cardiac output.
  • The addition of WINREVAIR treatment to currently available background therapy improved exercise capacity in patients with PAH.
  • Current treatment usually involves initial combination therapy with PDE5 inhibitor in combination with ERAs, with addition of prostacyclin analogues or riociguat for more advanced disease.
     
Policy Updates:
  • 09/01/2024 – New policy for Winrevair approved by WHA P&T Committee. (P&T, 08/20/2024)
     
References:
  1. Winrevair Prescribing Information. Merck Sharp & Dohme LLC. March 2023.

Last review date: September 1, 2024