OPSUMIT (macitentan)

SELF-ADMINISTRATION - Oral

Diagnosis considered for coverage:
  • Pulmonary Arterial Hypertension (PAH): Treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH
Coverage Criteria:

For diagnosis of pulmonary arterial hypertension (PAH):

  • Dose does not exceed 10 mg once daily, AND
  • Diagnosis of PAH, AND
  • PAH is symptomatic, AND
  • One of the following (A or B):
    • A) Diagnosis of PAH was confirmed by right heart catheterization, or
    • B) Patient is currently on any therapy for the diagnosis of PAH, AND
  • Prescribed by or in consultation with a cardiologist or pulmonologist
Reauthorization Criteria:

For diagnosis of pulmonary arterial hypertension (PAH):

  • Dose does not exceed 10 mg once daily, AND
  • Documentation of positive clinical response to therapy
Coverage Duration: 
  • Initial: 6 months
  • Reauthorization: 1 year
Dosing:
  • 10 mg tablets once daily
  • Dose does not exceed 10 mg per day
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: 
  • Contraindications: Pregnancy (may cause fetal harm)
    • Available for females through the Macitentan REMS program
Policy Updates:
  • 2/24/2020 – New policy approved by P&T.
  • 3/01/2024 – Policy updated, reauthorization criteria added.
References:
  1. Opsumit Prescribing Information. Actelion Pharmaceuticals US, Inc. Titusville, NJ. July 2022

Last review date: March 1, 2024