TYVASO (treprostinil)

TYVASO (treprostinil)

Self-Administration – oral inhalation

Diagnosis considered for coverage:

• Indicated for the treatment of PAH (WHO Group I) to improve exercise ability.

• Indicated for the treatment of pulmonary hypertension associated with ILD (PH-ILD; WHO Group 3) to improve exercise ability

Coverage Criteria:

1. For the diagnosis of Pulmonary Arterial Hypertension (PAH):

   • One of the following:

     • Tyvaso: Dose does not exceed 12 breaths per treatment session (72 mcg) four times daily

     • Tyvaso DPI: Dose does not exceed 64 mcg per treatment session four times daily; AND

   • Prescribed by or in consultation with a pulmonologist or cardiologist; AND

   • Diagnosis of Pulmonary Arterial Hypertension; AND

   • Documentation supporting pulmonary arterial hypertension is symptomatic

2. For the diagnosis of Pulmonary Hypertension associated with Interstitial Lung Disease (ILD):

   • One of the following:

     • Tyvaso: Dose does not exceed 12 breaths per treatment session (72 mcg) four times daily

     • Tyvaso DPI: Dose does not exceed 64 mcg per treatment session four times daily; AND

   • Prescribed by or in consultation with a pulmonologist or cardiologist; AND

   • Diagnosis of pulmonary hypertension associated with interstitial lung disease confirmed by diagnostic test(s) (e.g., right heart catheterization, doppler echocardiogram, computerized tomography imaging)

Reauthorization Criteria:

1. For the diagnosis of Pulmonary Arterial Hypertension (PAH):

   • One of the following:

     • Tyvaso: Dose does not exceed 12 breaths per treatment session (72 mcg) four times daily

     • Tyvaso DPI: Dose does not exceed 64 mcg per treatment session four times daily; AND

   • Documentation of a positive clinical response to therapy

2. For the diagnosis of Pulmonary Hypertension associated with Interstitial Lung Disease (ILD):

   • One of the following:

     • Tyvaso: Dose does not exceed 12 breaths per treatment session (72 mcg) four times daily

     • Tyvaso DPI: Dose does not exceed 64 mcg per treatment session four times daily; AND

   • Documentation of a positive clinical response to therapy

Coverage Duration:

 
•    Initial: 6 months
•    Reauthorization: 1 year

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.

Policy Updates:

• 11/15/2022 – Updated policy and format
• 04/2019 - Last reviewed

References:

1. Tyvaso Prescribing Information. United Therapeutics Corp. Research Triangle Park, NC. March 2021.
2. Tyvaso DPI Prescribing Information. United Therapeutics Corporation. Research Triangle Park, NC. May 2022.