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.
     

Last review date: September 1, 2024

Rite Aid Pharmacy Patients: All Rite Aid pharmacies nationwide are closing! Please be on the lookout for information from Rite Aid pharmacies about their bankruptcy and store closures. Call your Rite Aid pharmacy for questions about your prescriptions and new pharmacy options. WHA is here to help as well. Contact Us via Phone