OPSYNVI (macitentan/tadalafil)

OPSYNVI (macitentan/tadalafil)

Self-Administration – oral tablets

Diagnosis considered for coverage:

Pulmonary Arterial Hypertension (PAH): Indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III). Macitentan reduces the risk of clinical worsening events and hospitalization. Tadalafil improves exercise ability.
 

Coverage Criteria:

For diagnosis of PAH :

• One of the following: 
  • Diagnosis of pulmonary arterial hypertension was confirmed by right heart catheterization OR
  • Patient is currently on any therapy for the diagnosis of pulmonary arterial hypertension; 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:

• One 10 mg/20 mg or 10 mg/40 mg tablet taken orally once daily with or without food
• For patients who are treatment-naïve to any PAH specific therapy or transitioning from ERA monotherapy:
  • The recommended starting dose is one 10 mg/20 mg tablet taken orally once daily for one week. If tolerated, up titrate to one 10 mg/40 mg tablet taken orally once daily as the maintenance dose.
• For patients transitioning from PDE5 inhibitor monotherapy or PDE5 inhibitor and ERA therapy in combination:
  • The recommended dose is one 10 mg/40 mg tablet taken orally once daily.

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: 

• Opsynvi is the first single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
• Signs and symptoms of PAH include exertional dyspnea, fatigue, syncope, elevated jugular-vein pressure, and pedal edema
• Right heart catheterization is required for diagnosis of PAH and provides an assessment of pulmonary hemodynamics and cardiac output
• Patients are generally treated based on a risk assessment with therapy typically beginning with dual therapy (i.e. endothelin receptor antagonists plus PDE5 inhibitors)
• Opsynvi is available via REMS program and carries a boxed warning for embryofetal toxicity.  Most warnings are related to concomitant use with other drugs that may increase the patient’s risk of hypotension.
   

Policy Updates:

• 09/01/2024 – New policy for Opsynvi approved by WHA P&T Committee. (P&T, 08/20/2024)
   

References:

1. Opsynvi Prescribing Information. Actelion Pharmaceuticals US, Inc. Titusville, NJ. April 2024.