CurrentNeighborhood Health Plan of Rhode IslandPolicy 1650-A

Tyvaso (treprostinil) inhalation therapy for pulmonary hypertension

Defines coverage and authorization criteria for Tyvaso (treprostinil) inhalation solution and DPI for treatment of pulmonary arterial hypertension (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso (treprostinil) inhalation therapy for pulmonary hypertension

Policy CodePolicy 1650-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for 12 months when all coverage criteria are met and ensure medication is prescribed by or in consultation with a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

WHO Group 1 & 3covered PH groups

mPAP >20; PVR >2hemodynamic threshold

Pulmonologist/Cardiologistprescriber

Coverage and Medical Necessity Criteria

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inv-01: Initial Therapy (Pulmonary Hypertension)

Authorization of 12 months may be granted for treatment of PH when ALL of the following criteria are met:

Initial Authorization for PH: Member has either WHO Group 1 pulmonary arterial hypertension (PAH) OR pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3).12-month authorization

See FDA-approved indications for Tyvaso (treprostinil) inhalation formulations.

Hemodynamic confirmation of PH

Confirmation method
- Pretreatment right heart catheterization showing mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units (for pediatric members PVRI > 3 Wood units·m2 is acceptable).
- For infants < 1 year of age, PH confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.

Prescriber requirement: Medication is prescribed by or in consultation with a pulmonologist or cardiologist.12-month authorization

inv-02: Continuation of Therapy

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Continuation: Member is currently receiving the requested medication through a paid pharmacy or medical benefit and is experiencing benefit from therapy as evidenced by disease stability or disease improvement.12-month authorization

Continuation requires documentation of clinical benefit.

All indications for Tyvaso (treprostinil inhalation solution or DPI) beyond the FDA‑listed uses—treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability and treatment of pulmonary hypertension associated with interstitial lung disease (PH‑ILD; WHO Group 3) to improve exercise ability—are considered experimental/investigational and not medically necessary. The supporting trials establishing effectiveness were conducted primarily in patients with NYHA/WHO Functional Class III symptoms and the listed etiologies.

Use of Tyvaso for any indication not listed among the FDA‑approved indications (PAH/WHO Group 1 and PH‑ILD/WHO Group 3) is not medically necessary and may be denied.

Hemodynamic Thresholds and Definitions

Hemodynamic thresholds

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Pediatric pulmonary vascular resistance index (PVRI)> 3 Wood units·m2 (acceptable for pediatric members)

Hemodynamic confirmation of PH

Required diagnostic testPretreatment right heart catheterization showing hemodynamic criteria

mPAP threshold> 20 mmHg

PCWP threshold≤ 15 mmHg

PVR threshold> 2 Wood units (PVRI > 3 Wood units·m2 acceptable for pediatrics)

Prior Authorization, Prescriber Requirements, and Documentation

Prior Authorization

Prior authorization — 12-month approvals

Authorization of 12 months may be granted for treatment of pulmonary hypertension (PH) when ALL of the following criteria are met. Continuation requests may be approved for 12 months if the member is currently receiving Tyvaso and is experiencing clinical benefit (disease stability or improvement).

Authorization duration: 12 months
Continuation: 12 months with evidence of clinical benefit

Note

Prescriber specialty requirement

This medication must be prescribed by or in consultation with a pulmonologist or cardiologist.

Documentation Required

Required Diagnostic Documentation

Documented confirmation of pulmonary hypertension is required prior to approval. Acceptable diagnostic documentation includes either: (1) pretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units (for pediatric members PVRI > 3 Wood units·m2 is also acceptable); or (2) for infants <1 year of age when catheterization cannot be performed, a diagnostic Doppler echocardiogram. Also document WHO Group classification (Group 1 PAH or Group 3 PH‑ILD) and relevant RHC results where available.

Required: Pretreatment right heart catheterization results — mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units (PVRI > 3 Wood units·m2 for pediatric)
Acceptable alternative for infants <1 year: Doppler echocardiogram if RHC cannot be performed
Required: Documentation of WHO Group (Group 1 PAH or Group 3 PH‑ILD) and supporting clinical details

Denial Risk

Experimental/Investigational Indications

Use of Tyvaso for indications other than FDA‑approved PAH (WHO Group 1) and PH‑ILD (WHO Group 3) — including any other forms of pulmonary hypertension — is considered experimental/investigational and not medically necessary.

Policy Background

This policy addresses inhaled treprostinil for pulmonary hypertension. The FDA‑approved scope includes two populations: pulmonary arterial hypertension (PAH; WHO Group 1), where treatment is indicated to improve exercise ability (studies predominantly enrolled patients with NYHA/WHO Functional Class III and etiologies such as idiopathic, heritable, or connective tissue disease‑associated PAH), and pulmonary hypertension associated with interstitial lung disease (PH‑ILD; WHO Group 3), where effectiveness was shown in patients with interstitial lung disease etiologies including idiopathic pulmonary fibrosis and combined pulmonary fibrosis and emphysema. Coverage and authorization are limited to these disease contexts.