CurrentCignaPolicy IP0626

Pulmonary Arterial Hypertension — Phosphodiesterase Type 5 Inhibitors (tadalafil, sildenafil products)

Coverage policy governing use of phosphodiesterase type 5 inhibitors (tadalafil and sildenafil products listed) for pulmonary arterial hypertension (WHO Group 1) and select other uses (Raynaud's phenomenon) for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension — Phosphodiesterase Type 5 Inhibitors (tadalafil, sildenafil products)

Policy CodePolicy IP0626

Change TypeStand‑alone policy createdmultiple content additions/clarifications

Effective Date

Next Review Date

Key ActionObtain and document right heart catheterization confirming WHO Group 1 PAH before initiating therapy and for continuation determinations.

SourceLink

POLICY UPDATE CHANGES

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

Liqrev (sildenafil suspension) was added to the policy with the same criteria as the other PDE5 inhibitors.

Updated confirmation of PAH diagnosis to remove echocardiogram as an option (requires right heart catheterization).

Raynaud's phenomenon criteria were added.

Conditions Not Covered updated to add Erectile Dysfunction and to relocate/update concurrent use contraindication with guanylate cyclase stimulators.

5PDE5 products listed in policy header

1 yearTypical approval duration

<20,000Estimated US patients with PAH

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Coverage and Medical Necessity Criteria

Medical Necessity Criteria — Pulmonary Arterial Hypertension - PDE5 inhibitors

Pulmonary Arterial Hypertension - PDE5 inhibitors are medically necessary when ONE of the following is met (1 or 2).

Overall: Choose 1: FDA-Approved Indication for PAH OR Other supported use (Raynaud's Phenomenon)

1. FDA-Approved Indication - Initial Therapy: Approve for 1 year if the patient meets all of the following

(i-iii)

1.i Diagnosis: a) Patient has had a right heart catheterization; AND b) Results of the right heart catheterization confirm WHO Group 1 PAH

RHC required; echocardiogram is not acceptable

1.ii Prescriber: Medication is prescribed by or in consultation with a cardiologist or a pulmonologist

1.iii Preferred product: Preferred product criteria are met for the requested product(s) as listed in the product-specific tables

See product-specific coverage & step requirements

1.B Continuation (Currently Receiving): Approve for 1 year if the patient meets all of the following

Continuation requires documentation that RHC was performed prior to initiating therapy

1.B.i Diagnosis (currently receiving): a) Patient has had a right heart catheterization (prior to starting therapy); AND b) Results confirm WHO Group 1 PAH

1.B.ii Prescriber (currently receiving): Medication is prescribed by or in consultation with a cardiologist or a pulmonologist

1.B.iii Preferred product (currently receiving): Preferred product criteria are met for the requested product(s) as listed in the product-specific tables

2. Raynaud's Phenomenon: Approve for 1 year if A OR B and C are met

A/B text in source is abbreviated; requires trial of a calcium channel blocker or documentation that CCB is contraindicated, and preferred product criteria met

2.A Trial of CCB: Patient has tried one calcium channel blocker (examples: amlodipine, felodipine, nifedipine)

2.B Contraindication to CCB: According to the prescriber, use of a calcium channel blocker is contraindicated (e.g., right heart failure with decreased cardiac output)

2.C Preferred product: Preferred product criteria are met for the requested product(s) as listed in the product-specific tables

Product-specific Coverage & Step Requirements

Product-specific employer and individual/family plan criteria (step/exception rules)

Adcirca (brand) - Employer Plans: A) Patient meets medical necessity criteria for PAH; AND B) Patient has tried Alyq or generic tadalafil 20 mg tablets; AND C) Patient cannot continue generic tadalafil 20 mg tablets due to a formulation difference in inactive ingredients that, per the prescriber, would result in a significant allergy or serious adverse reaction

Brand override requires documented intolerance to inactive ingredients

Adcirca (brand) - Individual & Family Plans: A) Patient meets medical necessity criteria for PAH; AND B) Patient has tried Alyq or generic tadalafil 20 mg tablets; AND C) Patient cannot continue generic tadalafil 20 mg tablets due to a formulation difference in inactive ingredients that, per the prescriber, would result in a significant allergy or serious adverse reaction

Revatio tablets (brand) - Employer & Individual: A) Patient meets medical necessity criteria for PAH; AND B) Patient has tried generic sildenafil 20 mg tablets; AND C) Patient cannot continue generic sildenafil 20 mg tablets due to a formulation difference in inactive ingredients that, per the prescriber, would result in a significant allergy or serious adverse reaction

Concurrent use of phosphodiesterase type 5 inhibitors listed in this policy (Adcirca, Alyq, LiQrev, Revatio, and Tadliq) with guanylate cyclase stimulators is contraindicated and therefore not covered. An example of a guanylate cyclase stimulator is riociguat (Adempas).

Use of the PDE5 agents in this policy for erectile dysfunction is not recommended for coverage. Patients should be directed to PDE5 inhibitors that are specifically indicated for erectile dysfunction (for example, sildenafil [Viagra] or tadalafil [Cialis]).

Products, Codes, and Approval Duration

Covered products namedmixedCovered

Adcirca	tadalafil tablets (Eli Lilly/United Therapeutics, generic)
Alyq	tadalafil tablets (Teva, generic)
LiQrev	sildenafil oral suspension (CMP)
Revatio (tablets/suspension)	sildenafil tablets and suspension (Pfizer, generic) — injection not included
Tadliq	tadalafil oral suspension (CMP)

Covered products named - neutral groupingmixed

No codes listed

Approval duration

Typical approval duration1 year

Initial therapy durationApprove for 1 year if initial therapy criteria are met (right heart catheterization confirming WHO Group 1 PAH; prescribed by or in consultation with a cardiologist or pulmonologist; preferred product criteria met)

Continuation (currently receiving) durationApprove for 1 year if prior RHC (performed prior to starting therapy) confirms WHO Group 1 PAH; prescribed by or in consultation with a cardiologist or pulmonologist; preferred product criteria met

Product-specific approval notePreferred product criteria must be met as listed in product-specific tables for the 1-year approval

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

PAH prior authorization

Prior authorization is required for PAH therapies. Approvals require documentation of right heart catheterization confirming WHO Group 1 PAH and that the medication is prescribed by or in consultation with an appropriate specialist (cardiologist or pulmonologist).

Approve initial or current therapy for 1 year when right heart catheterization confirms WHO Group 1 PAH and prescriber is a cardiologist or pulmonologist.

Prior Authorization

Product-specific prior authorization

For brand products (e.g., Adcirca, Revatio tablets) or when requesting a non-tablet formulation, prior authorization requires prior trial of the specified generic tablet product OR documentation of inability to use the generic formulation (for example, documented significant allergy to an inactive ingredient or inability to swallow tablets).

Employer and individual plans: Brand Adcirca requires trial of Alyq or generic tadalafil 20 mg tablets unless prescriber documents intolerance or formulation-related allergy.
Revatio tablets require trial of generic sildenafil 20 mg tablets unless prescriber documents intolerance or formulation-related allergy.

Clinical Background

Pulmonary arterial hypertension (PAH, WHO Group 1) is a progressive, rare disease characterized by elevated pulmonary artery pressures that lead to impaired exercise capacity and increased morbidity and mortality. PAH is defined invasively by right heart catheterization with mean pulmonary arterial pressure >20 mmHg, pulmonary arterial wedge pressure ≤15 mmHg, and pulmonary vascular resistance >2 Wood units. Phosphodiesterase type 5 inhibitors (tadalafil and sildenafil products) improve exercise ability and may delay clinical worsening in adults; some agents have pediatric indications.

Key Definitions and Thresholds

Definition of Pulmonary Arterial Hypertension (PAH)

Hemodynamic definition (mPAP)Mean pulmonary artery pressure (mPAP) > 20 mmHg at rest measured by right heart (cardiac) catheterization

Left-sided filling pressure (PAWP)Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg

Pulmonary vascular resistance (PVR)PVR > 2 Wood units

Required diagnostic methodMeasurements must be obtained by right heart (cardiac) catheterization to confirm WHO Group 1 PAH