CurrentCignaPolicy IP0626

Pulmonary Arterial Hypertension - Phosphodiesterase Type 5 Inhibitors

Coverage criteria for phosphodiesterase type 5 inhibitors (tadalafil and sildenafil products) for treatment of 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

Policy CodePolicy IP0626

Change TypeMaterial and operational revisions (criteria split, added product, diagnostic confirmation update)

Effective DateJan 15, 2025

Next Review Date

Key ActionObtain and document right heart catheterization confirming WHO Group 1 PAH and submit with prior authorization; ensure specialist prescriber or consultation and trial of preferred generic products when required.

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 other PDE5 inhibitors.

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

Raynaud's phenomenon criteria were added as an other-use indication with supportive evidence.

Conditions Not Covered clarified to include concurrent use with guanylate cyclase stimulators and erectile dysfunction (not recommended).

5+PDE5 products listed (brand and generics)

1 yearTypical approval duration

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

COVERAGE CRITERIA

Covered when ONE of the following is met (1 or 2):

1. Pulmonary Arterial Hypertension (WHO Group 1)

A) Initial Therapy
- i. Diagnostic confirmation: Patient has had a right heart catheterization; AND results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH.
  Echocardiogram is not acceptable for confirmation per updated criteria.
- ii. Prescriber requirement: Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.
- iii. Preferred product criteria: Preferred product criteria are met for the product(s) as listed in the below table(s).
B) Currently Receiving the Requested Phosphodiesterase Type 5 (PDE5) Inhibitor
- i. Diagnostic confirmation (prior to start): Patient has had a right heart catheterization; AND results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH.
  This refers to prior to starting therapy with a medication for WHO Group 1 PAH.
- ii. Prescriber requirement: Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.
- iii. Preferred product criteria: Preferred product criteria are met for the product(s) as listed in the below table(s).

2. Raynaud's Phenomenon (other use with supportive evidence)

A/B prior therapy: A) Patient has tried one calcium channel blocker; OR B) According to the prescriber, use of a calcium channel blocker is contraindicated.
Examples of contraindications include right heart failure and decreased cardiac output; examples of calcium channel blockers include amlodipine, felodipine, and nifedipine.
C. Preferred product criteria: Preferred product criteria are met for the product(s) as listed in the below table.

3. Employer and Individual Plan product-specific rules: Brand tablet approval requires trial of generic and documentation of intolerance to inactive ingredients; suspensions require trial of tablets or documentation of inability to swallow or need for alternate dosing.

Specific product-level step and exception rules detailed per Employer and Individual and Family Plans sections.

Concurrent use of phosphodiesterase type 5 (PDE5) 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 inhibitors included in this policy for treatment of erectile dysfunction is not recommended and not covered. Patients requiring treatment for erectile dysfunction should be prescribed PDE5 agents specifically indicated for ED (for example, sildenafil tablets [Viagra] or tadalafil tablets [Cialis]).

Any use of these PDE5 inhibitors outside the covered indications described in this policy (that is, outside WHO Group 1 pulmonary arterial hypertension and the specified Raynaud's phenomenon criteria) is considered experimental, investigational, or unproven and is not covered.

Covered Products and Coding

Covered NDC/HCP CODESNDCCovered

(Not specified)

NDC/HCPCS codes not specified in source policy — list of covered products shown below; contact payer for billing codes.

Generic Trial Requirements

Generic trial requirement (tablets)Trial of generic sildenafil 20 mg (for sildenafil products) or trial of Alyq or generic tadalafil 20 mg (for tadalafil products) required prior to brand formulation unless exception documented.

Exceptions to generic trialException allowed if prescriber documents inability to use generic due to formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) that would cause significant allergy or serious adverse reaction.

Oral suspension exceptionsFor Revatio, LiQrev, sildenafil suspension, and Tadliq suspensions: alternative to prior trial is allowed if patient cannot swallow tablets or requires a dose not available as tablets; otherwise trial of generic sildenafil 20 mg or generic tadalafil 20 mg (as applicable) required.

Prescriber and Administrative Requirements

Documentation Required

Prior Authorization Required — Diagnostic & Prescriber Documentation

Prior authorization is required. Approvals are contingent on documentation confirming WHO Group 1 PAH (right heart catheterization with confirmatory results) and that the medication is prescribed by or in consultation with a cardiologist or pulmonologist. For initial therapy or continuation therapy, approvals are for up to 1 year when all medical necessity criteria are met.

Right heart catheterization with results confirming WHO Group 1 PAH required
Prescriber = cardiologist or pulmonologist, or consultation with one
Approval duration: up to 1 year

Step Therapy

Step Edits and Trials — Generic First

Step-therapy requirements apply for brand products and alternative formulations. Before approving brand Adcirca (tadalafil) or Revatio (sildenafil) tablets, the patient must have tried the specified generic products. For oral suspensions or other non-tablet formulations, a trial of generic tablets is generally required unless the patient cannot swallow tablets or requires a dose not available in tablet form.

Background

Pulmonary arterial hypertension (PAH; WHO Group 1) is a progressive disease of the pulmonary arterioles that increases pulmonary vascular resistance and impairs exercise capacity. PAH is defined hemodynamically by mean pulmonary arterial pressure > 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg, and pulmonary vascular resistance > 2 Wood units measured by right heart catheterization. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil and tadalafil formulations) act on the nitric oxide–cGMP pathway to promote pulmonary vasodilation and are indicated to improve exercise ability in patients with WHO Group 1 PAH; some formulations have pediatric labeling.

Definitions

Pulmonary arterial hypertension (PAH) definition (inv-13)

Hemodynamic diagnostic criteriaPulmonary arterial hypertension (PAH) is defined by mean pulmonary artery pressure (mPAP) > 20 mmHg at rest, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units measured by cardiac catheterization.

Diagnostic modality requiredMeasurements must be obtained by cardiac catheterization (right heart catheterization) to confirm the hemodynamic criteria.

WHO classificationPAH is classified within WHO Group 1 pulmonary hypertension.

Indications (inv-14)

Primary indicated populationWHO Group 1 PAH (adults) — tadalafil and sildenafil products are indicated to improve exercise ability.

Agents indicated for PAH