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:
- Opsumit Prescribing Information. Actelion Pharmaceuticals US, Inc. Titusville, NJ. July 2022
Last review date: March 1, 2024