CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tyvaso (treprostinil inhalation) coverage for pulmonary hypertension

Defines indications, prescriber requirements, and authorization criteria for Tyvaso (treprostinil inhalation solution and DPI) for members with pulmonary hypertension, including PAH (WHO Group 1) and PH-ILD (WHO Group 3). Affects prescribing pulmonologists/cardiologists and payers' authorization processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso (treprostinil inhalation) coverage for pulmonary hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document pretreatment right heart catheterization results and prescriber specialty (pulmonologist or cardiologist) to support coverage for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

WHO Group 1 & 3covered pulmonary hypertension groups

Pulmonologist or cardiologistprescriber specialty requirement

RHC thresholdshemodynamic criteria

1650-Ainternal reference number

Coverage Criteria for Tyvaso (treprostinil inhalation)

Initial and continuation therapy criteria

Covered when ALL of the following are met for PAH (WHO Group 1) or PH-ILD (WHO Group 3):

Indication: Member has an FDA‑approved or compendial indication: pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability OR pulmonary hypertension associated with interstitial lung disease (PH‑ILD; WHO Group 3) to improve exercise ability.

Studies establishing effectiveness predominantly included NYHA/functional class III PAH and etiologies such as idiopathic/heritable PAH and connective tissue disease–related PAH; PH‑ILD evidence included IIP/IPF/CPFE and WHO Group 3 connective tissue disease.

Prescriber: Medication must be prescribed by or in consultation with a pulmonologist or cardiologist.

Diagnostic confirmation (adults): Pretreatment right heart catheterization demonstrating all of: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) < 15 mmHg; and pulmonary vascular resistance (PVR) ≥ 3 Wood units (PVRI ≥ 3 Wood units·m2 in pediatric patients).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso (treprostinil inhalation) coverage for pulmonary hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document pretreatment right heart catheterization results and prescriber specialty (pulmonologist or cardiologist) to support coverage for up to 12 months.

SourceLink

On This Page

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Coding and Hemodynamic Criteria

Internal referencemixed

1650-A

Reference number for Tyvaso policy document

inv-05: Pulmonary vascular resistance — thresholds

Pulmonary vascular resistance (adults)>= 3 Wood units

Pulmonary vascular resistance index (pediatrics)PVRI >= 3 Wood units·m2

ContextUsed as part of pretreatment right heart catheterization to confirm pulmonary hypertension

inv-06: Mean pulmonary arterial pressure — threshold

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

ContextPart of pretreatment right heart catheterization criteria to confirm pulmonary hypertension

Use in infantsDoppler echocardiogram may be used for infants <1 year if RHC cannot be performed

inv-07: Pulmonary capillary wedge pressure — threshold

Pulmonary capillary wedge pressure (PCWP)< 15 mmHg

ContextRequired finding on pretreatment right heart catheterization to classify pre-capillary PH

Relation to other measuresInterpreted alongside mPAP (>20 mmHg) and PVR (>=3 Wood units)

inv-14: Hemodynamic confirmation of PH — RHC criteria

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)< 15 mmHg

Pulmonary vascular resistance (PVR/PVRI)>= 3 Wood units (adults); PVRI >= 3 Wood units·m2 (pediatrics)

inv-15: PH-ILD (WHO Group 3) — definition and examples

DefinitionPulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3)

Examples of ILD included in evidenceIdiopathic interstitial pneumonia (IIP), including idiopathic pulmonary fibrosis (IPF)

Additional examplesCombined pulmonary fibrosis and emphysema (CPFE) and WHO Group 3 connective tissue disease-associated ILD

Prescriber Requirements and Authorization Actions

Prior Authorization

Prior Authorization Duration

Prior authorization may be granted for up to 12 months when criteria and documentation support benefit.

Documentation Required

Prescriber Specialty

Must be prescribed by or in consultation with a pulmonologist or cardiologist.

Documentation Required

Continuation Documentation

Authorization of 12 months may be granted for members who are currently receiving the requested medication through a paid pharmacy or medical benefit and who are experiencing benefit from therapy as evidenced by disease stability or disease improvement. Documentation must show the member is currently receiving the medication via a paid benefit and provide objective or clinical evidence of benefit (disease stability or improvement).

Documentation Required

Hemodynamic Confirmation

Documentation of pretreatment right heart catheterization is required showing all of the following: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) < 15 mmHg; and pulmonary vascular resistance (PVR) ≥ 3 Wood units in adults (or PVRI ≥ 3 Wood units·m2 in pediatric patients). For infants <1 year, Doppler echocardiogram confirmation is acceptable when right heart catheterization cannot be performed.

Denial Risk

Non-covered Indications

Use for indications other than FDA-approved and compendial uses (including indications not supported by referenced clinical studies) is considered experimental/investigational and not covered.

Definitions

inv-14: Hemodynamic confirmation of PH — RHC criteria (definition)

Hemodynamic confirmation (definition)Pretreatment right heart catheterization demonstrating mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR >= 3 Wood units (PVRI >= 3 Wood units·m2 in pediatric patients)

Alternative for infantsFor infants <1 year, Doppler echocardiogram may be used if RHC cannot be performed

PurposeRequired to confirm pulmonary hypertension prior to initiating therapy

inv-15: PH-ILD (WHO Group 3) — definition and examples

PH-ILD definitionPulmonary hypertension associated with interstitial lung disease (WHO Group 3)

Included ILD typesIdiopathic interstitial pneumonia (IIP) including idiopathic pulmonary fibrosis (IPF)

Other examplesCombined pulmonary fibrosis and emphysema (CPFE) and connective tissue disease-related ILD

OpenPayer

Tyvaso (treprostinil inhalation) coverage for pulmonary hypertension

Coverage Criteria for Tyvaso (treprostinil inhalation)

Coding and Hemodynamic Criteria

Prescriber Requirements and Authorization Actions

Background and Clinical Context

Definitions