OPSUMIT (macitentan)

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