CurrentMass General Brigham Health PlanPolicy N/A

Tyvaso (treprostinil inhalation solution/powder)

Prior authorization policy for Tyvaso (treprostinil inhalation solution and Tyvaso DPI powder) under the pharmacy benefit for Commercial/Exchange members, with specialty pharmacy requirement and clinical criteria for initiation and continuation focused on pulmonary arterial hypertension (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (WHO Group 3).

Policy Summary

PayerMass General Brigham Health Plan

PolicyTyvaso (treprostinil inhalation solution/powder)

Policy CodePolicy N/A

Change TypeAdministrative/classification update

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization required for Tyvaso under the pharmacy benefit; approvals granted per the clinical criteria and for up to 12 months; specialty pharmacy fill required.

SourceLink

POLICY UPDATE CHANGES

Reviewed at Dec P&T, switched from SGM to Custom.

2Covered Indications (FDA-approved)

12Approval Duration

Commercial/ExchangePlan Applicability

SpecialtyDispensing Requirement

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This policy covers prior authorization under the pharmacy benefit for Tyvaso (treprostinil inhalation solution and Tyvaso DPI powder) for Commercial/Exchange members, requires specialty pharmacy dispensing, and is designated as covered_with_criteria.

Covered Indications / FDA-Approved Indications

Covered when indication matches FDA-approved uses:

Treatment of Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability (studies predominately included NYHA Functional Class III and idiopathic/heritable or connective tissue disease–associated PAH)

Treatment of Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability (studies predominately included idiopathic interstitial pneumonia, IPF, CPFE, and WHO Group 3 connective tissue disease)

All other indications are considered experimental/investigational and not medically necessary

Initial Therapy Criteria

Authorization Criteria (New to Plan or New Start)

Authorization may be granted when ALL of the following are met:

ALL of the following

Specialist prescribing/consultation: Medication is prescribed by or in consultation with a pulmonologist or cardiologist
Documentation of specialist involvement required
Member diagnosis
- WHO Group 1 pulmonary arterial hypertension (PAH)
- WHO Group 3: Pulmonary hypertension associated with interstitial lung disease (WHO Group 3)
PH confirmation (one required)
- Right heart catheterization
  - mPAP > 20 mmHg> 20 mmHg
  - PCWP ≤ 15 mmHg≤ 15 mmHg
  - PVR ≥ 3 Wood units≥ 3 Wood units
- Infants < 1 year alternative: For infants < 1 year, PH confirmed by Doppler echocardiogram if right heart catheterization cannot be performed

ref":

Hemodynamic thresholds for PH confirmation

Mean Pulmonary Arterial Pressure (mPAP)> 20 mmHg

Pulmonary Capillary Wedge Pressure (PCWP)≤ 15 mmHg

Pulmonary Vascular Resistance (PVR)≥ 3 Wood units

Continuation Therapy Criteria

Continuation of Therapy

Authorization may be granted for members currently receiving the requested medication when ALL of the following are met:

Member is currently receiving the requested medication

Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement

Approvals are granted per the clinical criteria for a duration of up to 12 months.

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required

Prior authorization required for Tyvaso under the pharmacy benefit; approvals granted per the clinical criteria.

Approvals up to 12 months
Specialty pharmacy fill required

Documentation Required

Specialist involvement

Medication must be prescribed by or in consultation with a pulmonologist or cardiologist. Document specialist involvement with the request.

Documentation Required

Hemodynamic confirmation

Provide pretreatment right heart catheterization results showing mean pulmonary arterial pressure (mPAP), pulmonary capillary wedge pressure (PCWP), and pulmonary vascular resistance (PVR). For infants <1 year, provide Doppler echocardiogram confirming pulmonary hypertension if catheterization cannot be performed.

Billing Rule

Specialty pharmacy requirement

This medication has been designated specialty and must be filled at a contracted specialty pharmacy.

Denial Risk

Not medically necessary for other indications

Requests for indications outside the FDA‑approved uses (PAH, WHO Group 1, and pulmonary hypertension associated with interstitial lung disease, WHO Group 3) are considered experimental/investigational and will be denied as not medically necessary.

Clinical Evidence

Evidence sources include the Tyvaso package insert (Tyvaso PI March 2021) and the Tyvaso DPI package insert (Tyvaso DPI PI May 2022). Clinical studies supporting FDA approval evaluated the indicated populations described in the labeling: PAH (WHO Group 1) with predominately NYHA Functional Class III and idiopathic/heritable or connective tissue disease–associated PAH, and PH-ILD (WHO Group 3) including idiopathic interstitial pneumonia, IPF, and CPFE.

Definitions

WHO Group 1 (PAH): Pulmonary arterial hypertension including idiopathic, heritable, drug/toxin-induced, and PAH associated with conditions such as connective tissue diseases, HIV, portal hypertension, and congenital heart disease.

WHO Group 3 (PH due to lung disease and/or hypoxia): Pulmonary hypertension due to lung diseases and/or hypoxia, including obstructive and restrictive lung diseases, other mixed lung disease patterns, hypoxia without lung disease, and developmental lung disorders; this includes PH associated with interstitial lung disease.