CurrentNeighborhood Health Plan of Rhode IslandPolicy 1650-A

Tyvaso Sgm 1650 A P2024A_R

Defines coverage criteria, prescriber specialty, diagnostic confirmation, and authorization duration for Tyvaso (treprostinil) inhalation products (solution and DPI) for pulmonary hypertension indications (WHO Group 1 PAH and PH-ILD/Group 3). All other indications are considered experimental/investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso Sgm 1650 A P2024A_R

Policy CodePolicy 1650-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain authorization for 12 months when all coverage criteria are met and document diagnostic hemodynamic confirmation and prescriber specialty prior to initiation or continuation.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy provisions.

2Covered Indication Categories (WHO Group 1 and PH-ILD/Group 3)

12 monthsAuthorization Duration

3Hemodynamic Thresholds Required

Coverage Summary

Defines coverage criteria for Tyvaso (treprostinil) inhalation products (inhalation solution and Tyvaso DPI) for pulmonary hypertension indications, limited to PAH (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). Policy requires that the medication be prescribed by or in consultation with a pulmonologist or cardiologist, diagnostic confirmation by hemodynamic criteria (pretreatment right heart catheterization or Doppler echo for infants <1 year when catheterization cannot be performed), and authorizations may be granted for 12 months when all criteria are met.

Pulmonary Hypertension (PH) — Initial Authorization

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

ref_origination_date_time_stamp_unparsed_returns_blank_ref_field_only_REF_DO_NOT_EDIT__ref_changed_to_ref_field_in_output__ref_b0_1_ONLY_echo_exact_ref_FROM_PROMPT__do_not_add_extra_text_or_characters__ref_b0_1_is_required_to_match_prompt_ref_exactly__ref_b0_1_do_not_change_this_line_REF_b0_1_b0_1_do_not_remove_this_line_OR_modify_it_but_it_must_be_exactly_the_ref_value_provided_in_prompt_repeated_here_as_echo_for_validation_purposes__ref_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1

refable_id_or_token_echoed_from_prompt_ref_field__MUST_MATCH_EXACT__DO_NOT_CHANGE__ref_b0_1_ONLY_echo_exact_REF_VALUE_FROM_PROMPT__ref_b0_1___b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1

ref_b0_1_b0_1_DO_NOT_EDIT_THIS_FIELD_REF_b0_1_ONLY_echo_exact_FROM_PROMPT__ref_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1_b0_1

title_origination_field_echo_REF_b0_1_ONLY_do_not_change__Pulmonary Hypertension (PH) 6 Initial Authorization

ref_b0_1_original_echo_must_match_prompt_ref_EXACTLY_b0_1

ref_b0_1_echo_duplicate_field_do_not_modify_b0_1

title_must_equal_prompt_title_Pulmonary Hypertension (PH) 6 Initial Authorization

title

Pulmonary Hypertension (PH) — Initial Authorization

ref

b0_1

Excluded / Not Covered Indications

All other indications not listed under FDA-approved indications or compendial uses are considered:

Excluded indications: All other indications not listed under FDA-approved indications or compendial uses are considered experimental/investigational and not medically necessary.

ref": "b0_3

title":

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Authorization for 12 months must be obtained prior to initiation or continuation of therapy when the policy criteria are met.

Documentation Required

Diagnostic confirmation required

Require documentation of pretreatment right heart catheterization results showing hemodynamics, or for infants <1 year when catheterization cannot be performed, Doppler echocardiogram results. Provider documentation must include the following thresholds:

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·m^2

Documentation Required

Prescriber specialty or consultation required

Medication must be prescribed by or in consultation with a pulmonologist or cardiologist. The provider must document specialist involvement (prescribing specialist or consultation notes) in the medical record.

Documentation Required

Documentation for continuation

For renewal, require documentation that the member is currently receiving the requested medication through a paid pharmacy or medical benefit and is demonstrating disease stability or improvement (e.g., clinical notes, functional status, exercise tolerance, or objective testing).

Clinical Evidence & References

Primary sources: Tyvaso package insert (May 2022); Tyvaso DPI package insert (November 2023). Guideline/classification references: Simonneau et al., Eur Respir J. 2019 and multiple Eur Respir J. 2024 publications cited in the policy. Policy also references the WHO classification of pulmonary hypertension in its appendices.

Hemodynamic thresholds required

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Pulmonary vascular resistance index (PVRI) — pediatrics> 3 Wood units x m^2

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTyvaso Sgm 1650 A P2024A_R

Policy CodePolicy 1650-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain authorization for 12 months when all coverage criteria are met and document diagnostic hemodynamic confirmation and prescriber specialty prior to initiation or continuation.

SourceLink

On This Page

OpenPayer

Tyvaso Sgm 1650 A P2024A_R

Coverage Summary

Applicable Codes & Document IDs

Provider Actions & Requirements

Clinical Evidence & References

Background

Revision History