CurrentUnitedHealthcarePolicy N/A

Prior Authorization/Notification — PAH Agents

Defines UnitedHealthcare pharmacy prior authorization and reauthorization requirements for listed PAH medications (oral, inhaled, and oral suspensions) for members; affects prescribers and pharmacy benefit adjudication.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization/Notification — PAH Agents

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date11/1/2025

Next Review Date

Key ActionObtain prior authorization for listed PAH agents with documentation of the symptomatic diagnosis; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+listed PAH agents included

12 moauthorization duration

Clinical responsereauthorization requirement

PAHprimary covered diagnosis

Coverage and Medical Necessity Criteria

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Initial Therapy (PAH)

Covered when ALL of the following are met

Initial PAH agents: Diagnosis of pulmonary arterial hypertension which is symptomatic

Authorization issued for 12 months

Continuation/Reauthorization

Covered when ALL of the following are met

Reauthorization: Documentation of positive clinical response to therapy

Authorization issued for 12 months

Initial Therapy (Adempas for CTEPH)

Covered when ALL of the following are met

Adempas CTEPH: Diagnosis of inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) which is symptomatic

Authorization issued for 12 months

Initial Therapy (PH‑ILD)

Covered when ALL of the following are met

PH-ILD: Diagnosis of pulmonary hypertension associated with interstitial lung disease which is symptomatic

Authorization issued for 12 months

Certain brand formulations are typically excluded from coverage. Examples called out in the policy include Adcirca, Letairis (brand tablets), Liqrev oral suspension, Opsynvi, and Revatio oral powder for suspension. These branded formulations may be subject to plan-specific exclusion or tried/failed requirements; refer to the member's benefit plan to determine whether a specific brand is covered.

The policy specifies that oral PDE‑5 inhibitors are contraindicated in patients receiving any form of organic nitrates, whether taken regularly or intermittently. In addition, the policy states that concomitant use of oral PDE‑5 inhibitors with Adempas (riociguat) is contraindicated.

Endothelin receptor antagonists (ERAs) require caution in patients with liver disease. The policy notes that ERAs are not recommended in moderate to severe hepatic impairment. Specifically, the Tracleer product label includes a boxed warning for risk of liver injury, and prescribers should weigh benefits versus hepatic risk and monitor for early liver injury that could preclude future use.

The document does not provide additional explicit "not medically necessary" statements beyond the listed exclusions and plan-specific exclusion rules. Where specific formulations are noted as typically excluded, the policy directs readers to plan-specific language for final determination.

Coding and Authorization Duration

No explicit CPT/HCPCS/ICD codes listedmixed

No codes listed

Authorization duration — standard initial/renewal duration

Standard initial authorization durationAuthorization will be issued for 12 months for initial approvals

Standard reauthorization durationReauthorizations are issued for 12 months (documentation of positive clinical response required)

Applies to listed PAH agents12-month authorization applies to listed PAH agents including ERAs, PDE-5 inhibitors, prostacyclin analogs, sGC stimulators and inhaled formulations

Prescriber and Pharmacy Actions

Prior Authorization

Initial authorization – PAH agents

Initial prior authorization is required for PAH agents when the patient has a diagnosis of symptomatic pulmonary arterial hypertension (WHO Group 1). Approvals are issued for 12 months when criteria are met.

Affected products: Adcirca*, Adempas, Alyq, Letairis*, Liqrev oral suspension*, Opsumit, Opsynvi*, Orenitram, Revatio oral powder for suspension*, Tadliq oral suspension, Tracleer, Tyvaso, Tyvaso DPI, Uptravi, Ventavis.
Initial approval criterion: diagnosis of pulmonary arterial hypertension which is symptomatic.
Authorization duration: 12 months.

Prior Authorization

Initial authorization – Adempas (CTEPH)

Initial prior authorization for Adempas for CTEPH requires a diagnosis of inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) that is symptomatic. Approvals are issued for 12 months.

Product: Adempas.
Initial approval criterion: diagnosis of inoperable or persistent/recurrent CTEPH which is symptomatic.
Authorization duration: 12 months.

Prior Authorization

Initial authorization – PH‑ILD (Tyvaso)

Initial prior authorization for Tyvaso or Tyvaso DPI for pulmonary hypertension associated with interstitial lung disease (WHO Group 3) requires a diagnosis of symptomatic PH‑ILD. Approvals are issued for 12 months.

Products: Tyvaso, Tyvaso DPI.
Initial approval criterion: diagnosis of pulmonary hypertension associated with interstitial lung disease which is symptomatic.
Authorization duration: 12 months.

Documentation Required

Reauthorization – all agents

Reauthorization for all listed pulmonary hypertension agents requires documentation of a positive clinical response to therapy. Reauthorizations are typically issued for 12 months.

Applies to: Adcirca*, Adempas, Alyq, Letairis*, Liqrev oral suspension*, Opsumit, Opsynvi*, Orenitram, Revatio oral powder for suspension*, Tadliq oral suspension, Tracleer, Tyvaso, Tyvaso DPI, Uptravi, Ventavis.
Required documentation: evidence of positive clinical response (per prescriber notes, objective measures, or other clinical documentation).
Authorization duration: 12 months.

Step Therapy

Exclusion/step therapy note

Some brand formulations are typically excluded from coverage or subject to step-therapy and tried/failed requirements. Refer to member-specific plan benefits for exclusion status and any required prior trials of alternate agents. State mandates, federal requirements, and other utilization management programs may further affect coverage.

Products commonly excluded or requiring trials: Adcirca*, Letairis*, Liqrev oral suspension, Opsynvi*, Revatio oral powder for suspension*.
Check plan-specific formulary/exclusion lists and step therapy rules before submitting prior authorization.
Automated approval/re-approval and supply limits may apply based on prior claim/medication history and diagnosis codes.

Denial Risk

Denial triggers / additional clinical rules

Additional authorization rules: UnitedHealthcare may approve initial or reauthorization requests based on previous claim/medication history, diagnosis codes (ICD‑10), and/or automated claim logic. Supply limitations and other program-level constraints may apply — verify member benefit details.

Automated approvals may be used depending on program or therapeutic class.
Supply limits and other utilization controls can affect approval and quantity limits.

Clinical Background

Pulmonary arterial hypertension (PAH) is a progressive condition characterized by elevated pulmonary vascular pressures that reduce exercise capacity and increase risk of right heart failure. Multiple drug classes are used to treat PAH, including endothelin receptor antagonists (ERAs), phosphodiesterase‑5 (PDE‑5) inhibitors, prostacyclin analogs/agonists, soluble guanylate cyclase (sGC) stimulators and activin signaling pathway agents. Treatments have specific FDA indications by World Health Organization (WHO) group; for example, many agents are indicated for PAH (WHO Group 1), riociguat (Adempas) is indicated for symptomatic inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4), and inhaled therapies such as Tyvaso are indicated for pulmonary hypertension associated with interstitial lung disease (PH‑ILD, WHO Group 3).

Key Terms and Indications

PAH (WHO Group 1) — definition and agents class relevance

DefinitionPulmonary arterial hypertension (PAH, WHO Group 1): a progressive disease with elevated pulmonary vascular pressures treated with ERAs, PDE-5 inhibitors, prostacyclin analogs/agonists, sGC stimulators, and activin signaling ligands to improve exercise capacity and delay clinical worsening

Primary covered diagnosisAuthorization for many listed agents requires a diagnosis of symptomatic PAH (WHO Group 1)

Relevant agent classesEndothelin receptor antagonists (e.g., ambrisentan, bosentan, macitentan), PDE‑5 inhibitors (e.g., sildenafil, tadalafil), prostacyclin analogs (e.g., treprostinil, iloprost), sGC stimulators (riociguat), and prostacyclin receptor agonists (selexipag)

Examples of indicated agentsLetairis, Tracleer, Opsumit, Revatio, Adcirca, Tyvaso, Tyvaso DPI, Uptravi, Ventavis

CTEPH (WHO Group 4) — Adempas indication for inoperable or persistent/recurrent CTEPH

DefinitionChronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4): CTEPH that is inoperable or persistent/recurrent after surgical treatment

Adempas indicationAdempas (riociguat) is indicated for adults with inoperable or persistent/recurrent CTEPH to improve exercise capacity and WHO functional class

Authorization noteInitial authorization for Adempas will be issued for 12 months when diagnosis of symptomatic inoperable or persistent/recurrent CTEPH is documented

PH‑ILD (WHO Group 3) — Tyvaso and Tyvaso DPI indication

DefinitionPulmonary hypertension associated with interstitial lung disease (PH‑ILD, WHO Group 3): pulmonary hypertension occurring in the setting of ILD

Tyvaso/Tyvaso DPI indicationTyvaso and Tyvaso DPI (treprostinil) are indicated to improve exercise ability in pulmonary hypertension associated with interstitial lung disease

Authorization noteInitial authorization for Tyvaso or Tyvaso DPI will be issued for 12 months when symptomatic PH‑ILD is documented

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization/Notification — PAH Agents

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date11/1/2025

Next Review Date

Key ActionObtain prior authorization for listed PAH agents with documentation of the symptomatic diagnosis; approvals issued for 12 months.

SourceLink

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