CurrentNeighborhood Health Plan of Rhode IslandPolicy 1650-A

Tyvaso (treprostinil inhalation/powder)

Defines coverage criteria for Tyvaso (treprostinil inhalation solution and DPI inhalation powder) for treatment of pulmonary arterial hypertension (PAH, WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD, WHO Group 3), including prescriber specialty requirements, diagnostic confirmation, approval durations, and continuation criteria. All other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso (treprostinil inhalation/powder)

Policy CodePolicy 1650-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization required; approval may be granted for 12 months when criteria are met (WHO Group 1 or PH-ILD diagnosis and diagnostic hemodynamic confirmation).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

2Covered Indications

12 moAuth Duration (initial/cont)

3-4Hemodynamic thresholds

Coverage Summary

Scope: This policy covers Tyvaso (treprostinil inhalation solution) and Tyvaso DPI (treprostinil inhalation powder) for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability and for pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). Coverage is provided with criteria and prior authorization requirements. All other indications are considered experimental/investigational and not medically necessary.

Initial Therapy Criteria (Pulmonary Hypertension)

Pulmonary Hypertension (PH) — Initial Authorization

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

ALL of the following

ONE of
- WHO Group 1 class of pulmonary hypertension (refer to Appendix)
- Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3)
ONE of
- ALL of the following
  - Mean pulmonary arterial pressure (mPAP) > 20 mmHg> 20 mmHg
  - Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg≤ 15 mmHg
  - Pulmonary vascular resistance (PVR) > 2 Wood units> 2 Wood units
    For pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units x m^2 is also acceptable
- For infants less than one year of age, PH was confirmed by Doppler echocardiogram if right heart catheterization cannot be performed

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title": "Pulmonary Hypertension (PH) — Initial Authorization"

ref": "b1_0"

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 12 months may be granted for members currently receiving the requested medication who are experiencing benefit

ALL of the following

Member has an indication listed in the coverage criteria section and is currently receiving the requested medication through a paid pharmacy or medical benefit
Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement

Unproven / Not Covered Indications

Indications Not Covered

All other indications beyond those listed are not covered

ALL of the following

Any indication other than: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability, or treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability
These other indications are considered experimental/investigational and not medically necessary

Denial Risk

Not medically necessary for other indications

Claims for any indication other than WHO Group 1 pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) will be considered experimental/investigational and denied as not medically necessary.

Provider Actions & Requirements

Prior Authorization

Authorization required for Tyvaso

Prior authorization is required for Tyvaso. Approval may be granted for up to 12 months when the member meets the coverage criteria (WHO Group 1 PAH or PH-ILD diagnosis with required diagnostic confirmation).

Documentation Required

Diagnostic confirmation documentation

Document pretreatment diagnostic confirmation of pulmonary hypertension. Provide results of a pretreatment right heart catheterization including mean pulmonary arterial pressure (mPAP), pulmonary capillary wedge pressure (PCWP), and pulmonary vascular resistance (PVR). For infants under one year of age when catheterization cannot be performed, provide Doppler echocardiogram evidence of PH.

Mean pulmonary arterial pressure (mPAP) > 20 mmHg
Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
Pulmonary vascular resistance (PVR) > 2 Wood units
For pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units × m² is acceptable
For infants <1 year, Doppler echocardiogram if catheterization cannot be performed

Documentation Required

Prescriber specialty requirement

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

Documentation Required

Continuation documentation

For continuation of therapy, document that the member is currently receiving the requested medication through a paid pharmacy or medical benefit and provide evidence of benefit from therapy as shown by disease stability or disease improvement to support a 12‑month authorization.

Background & Definitions

Background: Tyvaso (treprostinil) is FDA-approved for treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability and for pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms. Use of Tyvaso for indications beyond these FDA-approved PAH (Group 1) and PH-ILD (Group 3) populations is considered experimental/investigational and not medically necessary.

Term	Definition
{"text":"PAH","status":""},{"text":"Pulmonary arterial hypertension (WHO Group 1)","status":""}
{"text":"PH-ILD","status":""},{"text":"Pulmonary hypertension associated with interstitial lung disease (WHO Group 3)","status":""}

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso (treprostinil inhalation/powder)

Policy CodePolicy 1650-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization required; approval may be granted for 12 months when criteria are met (WHO Group 1 or PH-ILD diagnosis and diagnostic hemodynamic confirmation).

SourceLink

On This Page

Tyvaso (treprostinil) inhalation solution	product referenced; includes brand and generic, all dosage forms and strengths unless otherwise stated
Tyvaso DPI (treprostinil) inhalation powder	product referenced; includes brand and generic, all dosage forms and strengths unless otherwise stated

OpenPayer

Tyvaso (treprostinil inhalation/powder)

Coverage Summary

Initial Therapy Criteria (Pulmonary Hypertension)

Continuation Therapy Criteria

Unproven / Not Covered Indications

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History