CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY

Prior authorization policy for coverage of Adcirca, Alyq, Liqrev, Revatio (tablets and suspension only), and Tadliq for PAH (WHO Group 1) and Raynaud's phenomenon, including required documentation, prescriber specialty, approval durations, and not-covered uses.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY

Policy CodePolicy N/A

Change TypeAddition and clarification

Effective Date

Next Review DateOct 15, 2025

Key ActionObtain prior authorization and provide documentation of right heart catheterization confirming WHO Group 1 PAH; ensure medication is prescribed by or in consultation with a cardiologist or pulmonologist.

SourceLink

POLICY UPDATE CHANGES

Liqrev was added to the policy with the same criteria as other PDE5 inhibitors.

Clarified that for patients currently receiving the requested PDE5 inhibitor, the right heart catheterization requirement refers to an RHC prior to starting therapy for WHO Group 1 PAH.

Annual revision on 10/02/2024 noted 'No criteria changes.'

5Drugs in policy

1 yearApproval duration

WHO Group 1Primary covered diagnosis

ContraindicatedConcurrent use with guanylate cyclase stimulators

Coverage Summary

This prior authorization policy covers phosphodiesterase type 5 (PDE5) inhibitors — Adcirca, Alyq, Liqrev, Revatio (tablets and suspension only), and Tadliq — for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise ability, and for selected use in Raynaud's phenomenon; it specifies required documentation, prescriber specialty, approval durations, and uses that are not covered.

Policy key attributes

Drugs in policy5

Approval duration for covered indications1 year

Primary covered diagnosisWHO Group 1

Concurrent use with guanylate cyclase stimulatorsContraindicated

Last review / Next review2024-10-02 / 2025-10-15

Coverage / Medical Necessity Criteria

Coding

Drugs covered under this policymixedCovered

Adcirca	tadalafil tablets (Eli Lilly/United Therapeutics, generic)
Alyq	tadalafil tablets (Teva, generic)
Liqrev	sildenafil oral suspension (CMP)
Revatio	sildenafil tablets and suspension (Pfizer, generic). Note: Revatio injection is not included in this policy
Tadliq	tadalafil oral suspension (CMP)

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Adcirca, Alyq, Liqrev, Revatio (tablets and suspension only), and Tadliq. Approvals are provided for the durations noted in the policy (approve for 1 year when criteria are met).

Documentation Required

Right heart catheterization documentation required

Documentation of a right heart catheterization (RHC) and results confirming WHO Group 1 PAH is required for initiation of therapy and for patients currently receiving the requested PDE5 inhibitor. Note: for patients already receiving a WHO Group 1 PAH medication, a previously provided RHC submitted for another WHO Group 1 PAH medication may satisfy this documentation requirement.

Background and Evidence

PDE5 inhibitors (Adcirca, Alyq, Liqrev, Revatio, Tadliq) are indicated for PAH (WHO Group 1) to improve exercise ability; Revatio additionally carries a pediatric PAH indication for patients 1 to 17 years old. Clinical guidelines (CHEST 2019 and ESC/ERS 2022) recognize a prominent role for PDE5 inhibitors in PAH management. Tadalafil and sildenafil have some supporting data for Raynaud's phenomenon (often in patients with scleroderma), but evidence is limited and guidelines recommend calcium channel blockers first-line for Raynaud's in systemic sclerosis.

Source	Reference summary
Policy references	Product prescribing information and clinical guidelines (CHEST 2019, ESC/ERS 2022) and systematic reviews for Raynaud's phenomenon

WHO Group 1 PAH is defined by right heart catheterization as a resting mean pulmonary artery pressure mPAP > 20 mmHg, pulmonary arterial wedge pressure PAWP ≤ 15 mmHg, and pulmonary vascular resistance PVR > 2 Wood units.

Revision History

2023-10-11material_addition

Liqrev was added to the policy with the same criteria as other PDE5 inhibitors.

2023-10-11material_clarification

Clarified that for patients currently receiving the requested PDE5 inhibitor, the right heart catheterization requirement refers to an RHC prior to starting therapy for WHO Group 1 PAH.

2024-10-02annual_revisionLatest

Annual revision noted: No criteria changes.