CurrentCentenePolicy CP.PHAR.193

Iloprost (Ventavis) — Pulmonary Arterial Hypertension

Covers medical necessity criteria, dosing, and continuation requirements for iloprost (Ventavis) for treatment of pulmonary arterial hypertension (WHO Group 1) for Centene-affiliated health plans and affected lines of business.

Policy Summary

PayerCentene

PolicyIloprost (Ventavis) — Pulmonary Arterial Hypertension

Policy CodePolicy CP.PHAR.193

Change TypeNo material changes

Effective Date03.16

Next Review Date

Key ActionPrior authorization required; submit documentation showing member meets all approval criteria including specialist involvement and prior therapy history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

45 mcg/daymax daily dose

6-9 INH/daytypical frequency

12 monthsstandard approval

WHO Group 1indicated population

Coverage Criteria for Iloprost (Ventavis)

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Initial PAH criteria: 1. Diagnosis of pulmonary arterial hypertension (PAH).

From Initial Approval Criteria A.1

Initial PAH criteria: 2. Prescribed by or in consultation with a cardiologist or pulmonologist.

From Initial Approval Criteria A.2

Initial PAH criteria: 3. Failure of a calcium channel blocker (see Appendix B), unless the member meets ONE of: (a) inadequate response or contraindication to acute vasodilator testing; (b) contraindication to or clinically significant adverse effects from calcium channel blockers.

From Initial Approval Criteria A.3

Initial PAH criteria: 4. Requested dose does not exceed 45 mcg per day.<= 45 mcg/day

From Initial Approval Criteria A.4

Continuation Therapy - Pulmonary Arterial Hypertension

Continued coverage when ALL of the following are met:

Continuation PAH criteria: 1. Member meets ONE of the following: (a) currently receiving the medication via the Centene benefit or previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations.

From Continued Therapy II.A.1

Continuation PAH criteria: 2. Member is responding positively to therapy (clinical improvement or stability as documented in chart notes).

From Continued Therapy II.A.2

Continuation PAH criteria: 3. If request is for a dose increase, the new dose does not exceed 45 mcg per day.<= 45 mcg/day

From Continued Therapy II.A.3

Other indications / off-label handling

When requested use is not listed in III and recent label change does not apply:

Alternate processing: Refer to the appropriate formulary/non‑formulary or off‑label policy depending on whether the drug is on the formulary/PDL and the line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/no coverage; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary; CP.CPA.09, HIM.PA.154, CP.PMN.53 for off‑label processing).

From Other diagnoses/indications section II.B

Non‑FDA approved indications are not authorized under this policy unless the requestor provides sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies. For Commercial lines of business reference CP.CPA.09, for Health Insurance Marketplace reference HIM.PA.154, and for Medicaid reference CP.PMN.53 (or other evidence of coverage documents) when submitting off‑label justification and supporting clinical information.

Coding and Dose Limits

No specific CPT/HCPCS/ICD-10 codes listed in this sectionmixed

No codes listed

Referenced HCPCSHCPCS

Q4074

Iloprost, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, up to 20 mcg

Maximum daily dose

Maximum daily dose45 mcg/day

Documented in initial approval criteriaDose must not exceed 45 mcg per day for initial therapy

Continuation therapy limitIf dose increase requested during continuation, new dose must not exceed 45 mcg/day

Dosing frequency

Typical dosing frequency6 to 9 inhalations per day with at least 2 hours between doses

Starting and titration regimenStart 2.5 mcg per inhalation, titrate to 5 mcg if well tolerated

Dose timing requirementAllow ≥2 hours between inhalations to meet dosing schedule

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of therapy. Initial and continuation requests must meet the clinical criteria and specialist involvement requirements outlined in the policy. Approval durations vary by line of business — see approval duration rules below.

Prior authorization required for initial and continued therapy
Specialist involvement: prescribed by or in consultation with a cardiologist or pulmonologist

Documentation Required

Required Documentation and Denial Risk

Provider must submit supporting documentation such as office chart notes, lab results, or other clinical information demonstrating the member meets all approval criteria. Requests that lack sufficient documentation to show the member meets approval criteria, or requests for non‑FDA indications without adequate off‑label justification, may be denied.

Acceptable documentation: office notes, diagnostic testing/results, treatment history, consultation notes
Insufficient documentation may result in denial

Note

Authorization Duration Changes

Approval durations have been updated. Commercial initial and continued approvals are revised to 12 months or the duration of the request, whichever is less. Medicaid and HIM initial and continued approvals are 12 months.

Medicaid/HIM — 12 months
Commercial — 12 months or duration of request, whichever is less

Billing Rule

Billing and Coding Documentation

When submitting claims, document coding per the policy guidance. Inclusion or exclusion of codes in the policy does not guarantee coverage; providers should reference current professional coding guidance before claim submission.

Q4074 — Iloprost, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, up to 20 mcg
Inclusion/exclusion of codes does not guarantee coverage; verify current coding guidance

Background

Iloprost (Ventavis) is a synthetic prostacyclin analog indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1). It is used to improve exercise tolerance and symptoms and to prevent clinical deterioration in patients with PAH; pivotal studies primarily included patients with NYHA/WHO functional class III–IV and etiologies such as idiopathic/heritable and connective tissue disease–associated PAH. Prescribing information and clinical guidelines should be consulted for complete clinical details and administration guidance.

Definitions and Terms

Iloprost (Ventavis)

DrugIloprost (Ventavis) — a synthetic prostacyclin analog

IndicationIndicated for treatment of pulmonary arterial hypertension (PAH; WHO Group 1)

Clinical goalsTo improve exercise tolerance, symptoms (NYHA class), and prevent clinical deterioration

PAH (WHO Group 1)

DefinitionPulmonary arterial hypertension (PAH) — WHO Group 1 pulmonary hypertension as classified by WHO

Context in policyReferenced as the indicated population for Ventavis coverage criteria

WHO classification referenceGroup 1: PAH (other groups include PH due to left heart disease, lung disease/hypoxemia, CTEPH, and multifactorial mechanisms)

Q4074 (HCPCS)

HCPCS codeQ4074

DescriptionIloprost, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, up to 20 mcg

Coding noteCodes are informational; inclusion/exclusion does not guarantee coverage — verify current coding guidance when submitting claims

Policy Revision History

2026-01-? or 1Q 2026 (documented 11.17.25 with P&T 02.26)annual_reviewLatest

1Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication; references reviewed and updated.

2025-01-? or 1Q 2025 (documented 11.08.24 with P&T 02.25)annual_review

1Q 2025 annual review: Appendix B updated per Clinical Pharmacology—removed commercially unavailable branded products, updated dosing regimens, and clarified drugs used for off‑label indications; references reviewed and updated.

2024-01-? or 1Q 2024 (documented 10.03.23 with P&T 02.24)annual_review

1Q 2024 annual review: removed commercially unavailable branded products from Appendix B; references reviewed and updated.