CurrentMass General Brigham Health PlanPolicy N/A

Tyvaso (treprostinil inhalation) prior authorization

Defines prior authorization, specialty pharmacy, and coverage criteria for Tyvaso (treprostinil inhalation solution and DPI) for members of the Mass General Brigham Health Plan across applicable commercial and MassHealth UPPL plans.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTyvaso (treprostinil inhalation) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative revision

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization; approvals are generally granted for 12 months and require documentation by or in consultation with a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

Policy was switched from SGM to Custom effective 01/01/2024 following review on 12/13/2023.

12 monthstypical approval duration

Specialtydesignation

Commercial/Exchange, MassHealth UPPLplans covered

RHC criteriahemodynamic confirmation

Coverage Criteria for Tyvaso (treprostinil inhalation)

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Initial Therapy

Covered when ONE of the following is met:

Initial or current therapy: (1) Member is new to the plan and is currently receiving the requested medication (excluding product obtained only as samples or via manufacturer patient assistance programs).

Continuation described separately in policy; prior authorization required.

New initiation meeting clinical and diagnostic criteria

Diagnosis: Member has either WHO Group 1 pulmonary arterial hypertension (PAH) OR pulmonary hypertension associated with interstitial lung disease (WHO Group 3).
See WHO Group definitions in Appendix.
Hemodynamic confirmation
- Right heart catheterization criteria: Pretreatment right heart catheterization demonstrating all of: mPAP > 20 mmHg; PCWP < 15 mmHg; PVR per policy threshold.
  Document lists PVR value (typographic '23 Wood units' likely intended as ≥3 Wood units); use recorded catheterization values.
- Alternative for infants: For infants <1 year of age, pulmonary hypertension may be confirmed by Doppler echocardiogram when right heart catheterization cannot be performed.

Continuation of Therapy

Covered when ALL of the following are met:

Continuation criteria: (1) Member is currently receiving the requested medication AND (2) Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Provider must document clinical benefit; requests from members new to the plan who only received samples or assistance may not be granted.

The policy covers use of treprostinil inhalation (Tyvaso) for indications beyond FDA-approved uses only as specified in the coverage criteria. The FDA-approved indications are: 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. Uses outside these FDA-labeled indications are considered experimental/investigational and are not covered under this policy.

Use of treprostinil inhalation for indications not listed in the FDA-approved indications above (that is, other than PAH — WHO Group 1 and PH-ILD — WHO Group 3) is considered not medically necessary and will not be authorized.

Coding and Hemodynamic Criteria

Covered CPT Codesmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in document

Hemodynamic thresholds for PH confirmation — right heart catheterization

Mean pulmonary arterial pressure (mPAP)Pretreatment right heart catheterization showing mPAP > 20 mmHg

Pulmonary capillary wedge pressure (PCWP)Pretreatment right heart catheterization showing PCWP < 15 mmHg

Pulmonary vascular resistance (PVR)Pretreatment right heart catheterization showing PVR ≥ 3 Wood units (document text shows 'PVR 23 Wood units' which appears to be typographic)

Alternate diagnostic method for infants <1 yearFor infants <1 year, PH may be confirmed by Doppler echocardiogram if right heart catheterization cannot be performed

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required; typical 12-month approvals

Prior authorization is required for Tyvaso; approvals are generally granted for 12 months. Continued authorization may be granted for members currently receiving the medication if they demonstrate benefit (disease stability or improvement).

Approvals will be granted for 12 months.
Members currently receiving the requested medication may be authorized if experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Step Therapy

Step therapy designation noted (no specifics)

The policy lists Step Therapy as a program type for this medication, but the document does not provide specific step requirements or sequence details.

Documentation Required

Required clinical documentation and specialist involvement

Document that the medication is prescribed by or in consultation with a pulmonologist or cardiologist and that pulmonary hypertension is confirmed per policy definitions (right heart catheterization results or Doppler echocardiogram for infants <1 year when catheterization cannot be performed).

Prescription must be by or in consultation with a pulmonologist or cardiologist.
PH confirmation: pretreatment right heart catheterization with mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR as stated; or Doppler echocardiogram for infants <1 year if catheterization cannot be performed.

Denial Risk

New-to-plan members must already be receiving therapy

Requests for members new to the plan who are not currently receiving the medication (including those who only obtained samples or product via manufacturer patient assistance programs) may not be granted.

Authorization may be granted for members new to the plan only if they are currently receiving treatment with the requested medication; exclusions apply for samples or manufacturer patient assistance program supply.

Definitions: WHO Groups

WHO Group 1 (PAH) and Group 3 (PH-ILD) — definitions and included conditions

WHO Group 1 (Pulmonary arterial hypertension, PAH)Includes idiopathic PAH, heritable PAH, drug- and toxin-induced PAH, and PAH associated with conditions such as connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis, and others

WHO Group 1 — clinical contextIndication supported by FDA: treatment of PAH to improve exercise ability; pivotal studies primarily included patients with NYHA/Functional Class III and etiologies like idiopathic or heritable PAH or PAH associated with connective tissue diseases

WHO Group 3 (PH due to lung diseases and/or hypoxia)Includes PH associated with interstitial lung disease and other lung diseases: obstructive lung disease, restrictive lung disease, hypoxia without lung disease, mixed patterns, and developmental lung disorders

WHO Group 3 — clinical contextIndication supported by FDA: treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability; trial populations included idiopathic interstitial pneumonia, IPF, CPFE, and WHO Group 3 connective tissue disease

Background

Treprostinil inhalation (Tyvaso) is FDA-approved for two specific indications: (1) to improve exercise ability in patients with Pulmonary arterial hypertension (PAH; WHO Group 1), with pivotal trials predominantly including patients with NYHA/WHO Functional Class III and etiologies such as idiopathic, heritable, or connective tissue disease–associated PAH; and (2) to improve exercise ability in patients with Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), with studies primarily including etiologies such as idiopathic interstitial pneumonia, idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, and WHO Group 3 connective tissue disease.