CurrentUnitedHealthcarePolicy 2026 P 1076-18

Prior authorization criteria for pulmonary arterial hypertension (PAH) agents (pharmacy benefit)

UnitedHealthcare pharmacy prior authorization and reauthorization criteria for specified PAH agents (oral, inhaled, and combination products) when billed under the pharmacy benefit; includes PAH (WHO Group 1), CTEPH (Adempas) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) for specified inhaled treprostinil products.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization criteria for pulmonary arterial hypertension (PAH) agents (pharmacy benefit)

Policy CodePolicy 2026 P 1076-18

Change TypeAdditionclarification

Effective DateMay 1, 2026

Next Review Date

Key ActionProviders must obtain prior authorization for the listed PAH medications and supply documentation of symptomatic diagnosis for initial approvals and evidence of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Added Yutrepia to coverage criteria and to the list of products typically excluded from coverage.

Clarified that criteria apply only to oral suspension formulations of sildenafil citrate and that IV sildenafil is not covered under the pharmacy benefit.

18named PAH products listed

12initial authorization duration

12reauthorization duration (standard stated)

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Prior Authorization Criteria for PAH, CTEPH, and PH-ILD Agents

Initial Authorization — PAH (WHO Group 1) agents

Approved when the following criterion is met:

ALL of the following

Medication requested is one of: Adcirca (tadalafil), Adempas (riociguat), Alyq (tadalafil), Letairis (ambrisentan), Liqrev (sildenafil) oral suspension, Opsumit (macitentan), Opsynvi (macitentan/tadalafil), Orenitram (treprostinil), Revatio (sildenafil) oral powder for suspension, Tadliq (tadalafil) oral suspension, Tracleer (bosentan), Tyvaso (treprostinil inhalation solution), Tyvaso DPI (treprostinil dry powder inhaler), Uptravi (selexipag), Ventavis (iloprost inhalation solution), or Yutrepia (treprostinil)
List reflects products managed under this pharmacy PA program; some brand formulations may be typically excluded—see exclusion footnote.
Diagnosis of symptomatic pulmonary arterial hypertension (WHO Group 1)
Clinical documentation of symptomatic PAH required.

Reauthorization — PAH (WHO Group 1) agents

Approved for continued therapy when the following criterion is met:

ALL of the following

Documentation of positive clinical response to the specific PAH therapy
Positive response not explicitly defined numerically; provider documentation required.

Initial Authorization — Adempas for CTEPH (WHO Group 4)

Approved when the following criterion is met:

ALL of the following

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

Reauthorization — Adempas for CTEPH

Approved for continued therapy when the following criterion is met:

ALL of the following

Documentation of positive clinical response to Adempas therapy
Positive response not explicitly defined numerically; provider documentation required.

Initial Authorization — PH associated with interstitial lung disease (PH-ILD)

Approved when the following criterion is met for inhaled treprostinil products:

ALL of the following

Medication requested is Tyvaso, Tyvaso DPI, or Yutrepia (inhaled treprostinil formulations)
Diagnosis of pulmonary hypertension associated with interstitial lung disease which is symptomatic

Reauthorization — PH-ILD inhaled treprostinil

Approved for continued therapy when the following criterion is met:

ALL of the following

Documentation of positive clinical response to Tyvaso, Tyvaso DPI, or Yutrepia therapy
Positive response not explicitly defined numerically; provider documentation required.

Relevant Medications and Formulation Notes

Relevant medications (named products managed by policy)mixedCovered

Adcirca	tadalafil (brand) — oral PDE-5 inhibitor
Adempas	riociguat — sGC stimulator
Alyq	tadalafil — oral PDE-5 inhibitor
Letairis	ambrisentan — endothelin receptor antagonist (ERA)
Liqrev	sildenafil oral suspension — oral PDE-5 inhibitor (suspension)
Opsumit	macitentan — ERA
Opsynvi	macitentan/tadalafil — combination ERA + PDE-5 inhibitor
Orenitram	treprostinil — oral prostacyclin analog
Revatio (suspension)	sildenafil oral powder for suspension — oral PDE-5 inhibitor (suspension)
Tadliq	tadalafil oral suspension

1–10 of 16

1/2

Formulation-specific note — typically excluded brandsmixedNot Covered

specified brands

Brand Adcirca, Letairis, Liqrev oral suspension, Opsynvi, Revatio oral powder for suspension, and Yutrepia are typically excluded from coverage; plan specifics determine exclusion status and any 'tried/failed' requirements.

Actions, Requirements, and Operational Notes for Providers

Prior Authorization

Prior authorization required for listed PAH agents

Prior authorization required for the listed PAH agents; initial approvals are issued for 12 months when criteria are met. Affected products include: Adcirca; Adempas; Alyq; Letairis; Liqrev (sildenafil) oral suspension; Opsumit; Opsynvi; Orenitram; Revatio (sildenafil) oral powder for suspension; Tadliq oral suspension; Tracleer; Tyvaso; Tyvaso DPI; Uptravi; Ventavis; and Yutrepia.

Initial authorizations are issued for 12 months subject to meeting the listed clinical criteria.

Documentation Required

Clinical documentation required for approval and reauthorization

Clinical documentation must substantiate a symptomatic diagnosis for initial approval (PAH, CTEPH, or PH‑ILD as applicable). For reauthorization, providers must document a positive clinical response to the specific PAH therapy.

Initial: documentation of symptomatic pulmonary arterial hypertension, symptomatic inoperable or persistent/recurrent CTEPH for Adempas, or symptomatic PH‑ILD for inhaled treprostinil formulations.
Reauthorization: documentation of positive clinical response to the specific therapy (per prescriber assessment such as exercise ability, symptoms, WHO functional class, or hemodynamics).

Denial Risk

Exclusion/plan-specific coverage may deny brand formulations

Some brand formulations are typically excluded from coverage and may be denied or subject to tried/failed requirements depending on the member's benefit plan; verify member-specific benefits prior to prescribing.

Brands commonly listed as typically excluded include Adcirca, Letairis, Liqrev oral suspension, Opsynvi, Revatio oral powder for suspension, and Yutrepia.
Exclusion status and any tried/failed requirements are determined by the member's specific plan.

Billing Rule

Pharmacy vs medical benefit applicability

Oral suspension formulations of sildenafil (e.g., Liqrev, Revatio suspension products) are managed under the pharmacy benefit per this policy; the intravenous (IV) formulation of sildenafil is not covered under the pharmacy benefit and may be managed under the medical benefit if applicable.

Policy note: criteria apply only to oral suspension formulations of sildenafil citrate; the IV formulation is not self‑administered and is therefore not covered under the pharmacy benefit.

Clinical and Therapeutic Context

Pulmonary arterial hypertension (PAH) is a progressive disease characterized by elevated pulmonary vascular pressures that lead to ventricular dysfunction, reduced exercise capacity, risk of right‑sided heart failure, and increased mortality. Multiple therapeutic classes target distinct pathways implicated in PAH pathogenesis to improve exercise ability, delay clinical worsening, and reduce hospitalizations. These classes include endothelin receptor antagonists (ERAs), phosphodiesterase‑5 (PDE‑5) inhibitors, prostacyclin analogs, soluble guanylate cyclase (sGC) stimulators, and activin signaling pathway agents (references to specific agents provided below).

Representative ERAs managed by this program include Letairis (ambrisentan), Tracleer (bosentan), and Opsumit (macitentan), which are indicated to improve exercise capacity and reduce clinical worsening in PAH. Oral PDE‑5 inhibitors listed include Revatio/Liqrev (sildenafil), Adcirca/Alyq/Tadliq (tadalafil), which are indicated to improve exercise ability and, for some formulations, pulmonary hemodynamics. Prostacyclin pathway agents include inhaled products Ventavis (iloprost), Tyvaso (treprostinil inhalation solution), Tyvaso DPI, and the newly added Yutrepia, as well as oral treprostinil (Orenitram) and the prostacyclin receptor agonist Uptravi (selexipag); these agents are used to improve exercise tolerance and delay disease progression in PAH.

Adempas (riociguat) is a soluble guanylate cyclase (sGC) stimulator indicated for adults with PAH (WHO Group 1) to improve exercise capacity and WHO functional class and to delay clinical worsening. Adempas is also specifically indicated for adults with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve exercise capacity and functional class. Separate coverage criteria apply for Adempas when used for CTEPH.

Inhaled treprostinil products—Tyvaso, Tyvaso DPI, and Yutrepia—carry indications both for PAH (WHO Group 1) and for pulmonary hypertension associated with interstitial lung disease (PH‑ILD, WHO Group 3) to improve exercise ability; the policy includes specific criteria for PH‑ILD use.

Policy Changes and Notes

2026-01additionLatest

Added Yutrepia (treprostinil) to the coverage criteria and to the list of products typically excluded from coverage; no change to coverage logic (administrative).

effective 2026-05-01effective_date

Policy effective date updated to 2026-05-01 for Program 2026 P 1076-18.

2024-08addition

Added Opsynvi (macitentan/tadalafil) to the criteria for PAH and to additional information.

2024-02annual_review/addition

Added Liqrev oral suspension for PAH and updated exclusion footnote; updated background and references.

2022-12addition

Added Tadliq oral suspension for PAH; updated background and references.

Scope, System Limitations, and Plan Considerations

This prior authorization program applies to specified PAH agents billed under the pharmacy benefit and requires providers to obtain authorization for listed products; initial approvals are issued for 12 months and reauthorizations are similarly authorized based on meeting reauthorization criteria. UnitedHealthcare may use automated approval and re‑approval processes that rely on prior claims/medication history, diagnosis codes, and claim logic; the use and scope of automated processes vary by program and therapeutic class.

State mandates, federal regulatory requirements, and the member’s specific benefit plan may modify coverage and apply additional requirements. In particular, several branded formulations—such as Adcirca, Letairis, Liqrev oral suspension, Opsynvi, Revatio oral powder for suspension, and Yutrepia—are noted as typically excluded from coverage and may be subject to tried/failed requirements or denial depending on plan specifics. Providers should verify member benefits and plan exclusions before submitting requests.

Operationally, this policy applies only to the pharmacy‑managed formulations identified in the criteria (for example the oral suspension formulations of sildenafil). Intravenous sildenafil is not covered under the pharmacy benefit and may be managed under the medical benefit where applicable. Providers must document a symptomatic diagnosis for initial approvals (PAH, CTEPH, or PH‑ILD as applicable) and must provide documentation of a positive clinical response to the specific therapy for reauthorization.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization criteria for pulmonary arterial hypertension (PAH) agents (pharmacy benefit)

Policy CodePolicy 2026 P 1076-18

Change TypeAdditionclarification

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Prior authorization criteria for pulmonary arterial hypertension (PAH) agents (pharmacy benefit)

Prior Authorization Criteria for PAH, CTEPH, and PH-ILD Agents

Relevant Medications and Formulation Notes

Actions, Requirements, and Operational Notes for Providers

Clinical and Therapeutic Context

Defined Terms Used in This Policy

Policy Changes and Notes

Scope, System Limitations, and Plan Considerations

Quick Policy Metrics