CurrentCignaPolicy IP0626

Pulmonary Arterial Hypertension Phosphodiesterase Type 5 Inhibitors

Defines prior authorization, medical necessity criteria, documentation requirements, preferred-product rules and product-specific exceptions for PDE5 inhibitors used for WHO Group 1 pulmonary arterial hypertension and for Raynaud's phenomenon; lists conditions not covered and product-specific interchangeability rules for employer and individual plans.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension Phosphodiesterase Type 5 Inhibitors

Policy CodePolicy IP0626

Change TypeMultiple revisions (new policy, additions, documentation updates)

Effective DateJun 1, 2024

Next Review Date

Key ActionPrior Authorization is required; submit documentation of right heart catheterization confirming WHO Group 1 PAH and ensure prescription is by or in consultation with a cardiologist or pulmonologist.

POLICY UPDATE CHANGES

New stand-alone policy created; criteria previously housed in Pulmonary Hypertension Therapy class policy.

Updated confirmation of PAH diagnosis to remove echocardiogram as an option; added Raynaud's Phenomenon criteria; added Erectile Dysfunction to Conditions Not Covered and updated concurrent use statement.

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

Added a policy statement and a documentation statement; for initial therapy added documentation to the right heart catheterization requirement.

2Primary Covered Indications

2Not Covered Uses (examples)

1Required Diagnostic Test (RHC)

Coverage Summary

Scope: This policy addresses coverage for phosphodiesterase type 5 (PDE5) inhibitors including Adcirca (tadalafil tablets), Alyq (tadalafil tablets), LiQrev (sildenafil oral suspension), Revatio (sildenafil tablets and suspension), Tadliq (tadalafil oral suspension), and generics. The primary covered indication is WHO Group 1 Pulmonary Arterial Hypertension (PAH), with Raynaud's Phenomenon listed as an additional use with supportive evidence. The overall coverage stance is mixed (medically necessary for specified indications and not medically necessary for others).

Prior Authorization is required for Adcirca, Alyq, LiQrev, Revatio (tablets and suspension only), Tadliq and generics, and approvals are typically provided for the specified duration (commonly 1 year).

Thresholds and Quick Facts

Policy IdentifierIP0626

Effective Date2024-06-01

Last Review Date2025-01-15

Right Heart Catheterization Confirmation ThresholdDiagnosis of WHO Group 1 PAH confirmed by right heart catheterization: mPAP >20 mmHg, PAWP ≤15 mmHg, PVR >2 Wood units (documentation required)

Required Specialist ConsultationMedication must be prescribed by or in consultation with a cardiologist or pulmonologist

Approval Duration / Quick NoteApprovals generally for 1 year when criteria met; documentation of RHC required for initiation and may be considered met if previously provided for a different WHO Group 1 PAH medication

Medical Necessity Criteria

Medically Necessary

Pulmonary Arterial Hypertension - Phosphodiesterase Type 5 Inhibitors are considered medically necessary when ONE of the following is met (1 or 2):

Product-specific Preferred / Employer & Individual Plan Criteria

Product coverage for brand formulations includes step through generics or specific conditions for suspensions; criteria differ by Employer and Individual/Family plans as specified below.

Adcirca (tadalafil tablets) - Employer & Individual Plans

Patient meets the above medical necessity criteria
Patient has tried Alyq or generic tadalafil 20 mg tablets
Patient cannot continue to use generic tadalafil 20 mg tablets due to a formulation difference in the inactive ingredients which, per the prescriber, would result in a significant allergy or serious adverse reaction

Revatio tablets (sildenafil) - Employer & Individual Plans

Conditions Not Covered (Not Medically Necessary)

Use of these PDE5 inhibitors for the following is considered not medically necessary:

ALL of the following

Concurrent use with guanylate cyclase stimulators (e.g., Adempas/riociguat) — contraindicated
Erectile Dysfunction — coverage is not recommended; patients should use PDE5 inhibitors indicated for erectile dysfunction (e.g., Viagra, Cialis)
Any other use not listed as medically necessary in this policy

Coding

Policy Identifiermixed

IP0626

Coverage Policy Number

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Adcirca, Alyq, LiQrev, Revatio (tablets and suspension only), Tadliq and generics. Approvals are typically provided for 1 year.

Documentation Required

Right Heart Catheterization Documentation

Documentation of a right heart catheterization and results confirming WHO Group 1 PAH is required for initiation of therapy. The hemodynamic criteria are: mean pulmonary artery pressure (mPAP) > 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units measured by cardiac catheterization. For patients currently receiving the requested PDE5 inhibitor, prior documentation of RHC provided for a different WHO Group 1 PAH medication may be considered to meet this requirement.

Background, Evidence & Definitions

Background: Tadalafil and sildenafil PDE5 inhibitors are indicated for WHO Group 1 PAH to improve exercise ability; some agents (sildenafil formulations) also have indications to delay clinical worsening and for pediatric use. Clinical guidelines recognize PDE5 inhibitors as important therapies in PAH management.

PAH is a rare, progressive disorder classified as Group 1 pulmonary hypertension and is definitively diagnosed by right heart catheterization using hemodynamic criteria (mean pulmonary artery pressure > 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg, pulmonary vascular resistance > 2 Wood units), and it leads to increased right heart workload and impaired activity.

Evidence	Detail
PAH definition (hemodynamics)	mPAP > 20 mmHg, PAWP ≤ 15 mmHg, PVR > 2 Wood units measured by cardiac catheterization
[{"text":"PAH definition (hemodynamics)","status":""},{"text":"mPAP > 20 mmHg, PAWP 64 15 mmHg, PVR > 2 Wood units measured by cardiac catheterization","status":"covered"}]

Definitions

TermWHO Group 1 PAH

DefinitionPulmonary arterial hypertension defined by right heart catheterization hemodynamics consistent with PAH

Hemodynamic CriteriamPAP >20 mmHg, PAWP ≤15 mmHg, PVR >2 Wood units measured by cardiac catheterization

Link to Threshold

Revision History

2024-06-01added

New stand-alone policy created; LiQrev was added with the same criteria as other phosphodiesterase type 5 inhibitors.

2024-06-01revised

Updated confirmation of PAH diagnosis to remove echocardiogram as an option; Raynaud's Phenomenon criteria added; Erectile Dysfunction added to Conditions Not Covered and concurrent use statement relocated/updated.

2025-01-15clarified

Clarified that for patients currently receiving a requested PDE5 inhibitor, the right heart catheterization requirement refers to RHC prior to starting therapy for WHO Group 1 PAH; initial therapy RHC documentation requirement added and preferred product requirement for currently receiving patients was removed.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension Phosphodiesterase Type 5 Inhibitors

Policy CodePolicy IP0626

Change TypeMultiple revisions (new policy, additions, documentation updates)

Effective DateJun 1, 2024

Next Review Date

On This Page

Patient meets the above medical necessity criteria

Patient has tried generic sildenafil 20 mg tablets

Patient cannot continue to use generic sildenafil 20 mg tablets due to a formulation difference in the inactive ingredients which, per the prescriber, would result in a significant allergy or serious adverse reaction

Revatio suspension (sildenafil) - Employer & Individual Plans

Patient meets the above medical necessity criteria
ANY of the following
- Patient has tried generic sildenafil 20 mg tablets
- Patient cannot swallow or has difficulty swallowing generic sildenafil 20 mg tablets
- Patient requires administration of a dose that cannot be obtained with generic sildenafil 20 mg tablets

LiQrev suspension (sildenafil) - Employer & Individual Plans

Patient meets the above medical necessity criteria
ANY of the following
- Patient has tried generic sildenafil 20 mg tablets
- Patient cannot swallow or has difficulty swallowing generic sildenafil 20 mg tablets
- Patient requires administration of a dose that cannot be obtained with generic sildenafil 20 mg tablets

Sildenafil suspension (generic) - Employer & Individual Plans

Patient meets the above medical necessity criteria
ANY of the following
- Patient has tried generic sildenafil 20 mg tablets
- Patient cannot swallow or has difficulty swallowing generic sildenafil 20 mg tablets
- Patient requires administration of a dose that cannot be obtained with generic sildenafil 20 mg tablets

Tadliq suspension (tadalafil) - Employer & Individual Plans

Patient meets the above medical necessity criteria
ANY of the following
- Patient has tried Alyq or generic tadalafil 20 mg tablets
- Patient cannot swallow or has difficulty swallowing Alyq or generic tadalafil 20 mg tablets
- Patient requires administration of a dose that cannot be obtained with generic tadalafil 20 mg tablets

Denial Risk

Denial if Off-Label or Contraindicated Use

Claims for uses outside the policy's listed medically necessary indications (for example, erectile dysfunction) or for concurrent use with guanylate cyclase stimulators (e.g., riociguat/Adempas) will be denied as not medically necessary or are contraindicated.

Documentation Required

Specialist Prescriber Requirement

The medication must be prescribed by or in consultation with a cardiologist or a pulmonologist.

Step Therapy

Preferred Product / Step-through Requirements

Many brand product approvals require a trial of the specified generic (for example, generic tadalafil 20 mg or generic sildenafil 20 mg) prior to approval. Exceptions to the step-through requirement include inability to swallow or difficulty swallowing the generic, need for a dose that cannot be obtained with the generic, or a significant allergy/serious adverse reaction to inactive ingredients in the generic per the prescriber.

Required trial examples: generic tadalafil 20 mg or generic sildenafil 20 mg tablets.
Exceptions: swallowing difficulty, dosing needs not met by generic strengths, allergy to inactive ingredients.

Denial Risk

Denial if Off-Label or Contraindicated Use

Uses outside the policy's listed medically necessary indications (including erectile dysfunction) or concurrent use with guanylate cyclase stimulators (e.g., riociguat/Adempas) are contraindicated and will be denied as not medically necessary.

Right heart catheterization confirmation: diagnosis must be confirmed by RHC per policy thresholds (documentation required)

2025-11-15addedLatest

Added a policy statement and a documentation statement; for initial therapy added documentation to the right heart catheterization requirement; updated Conditions Not Covered.