CurrentmhnPolicy CP.PHAR.193

Iloprost (Ventavis)

This policy governs prior authorization and coverage criteria for Ventavis (iloprost) inhalation for treatment of pulmonary arterial hypertension (PAH) for members under the payer's Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyIloprost (Ventavis)

Policy CodePolicy CP.PHAR.193

Change TypeNo material changes

Effective DateMar 16, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

45 mcg/daymax daily dose

12 monthsapproval duration

6-9/daydosing frequency

Ampules 10 & 20product availability

1 listedbilling code

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Coverage Criteria

Initial Therapy (PAH)

Covered when ALL of the following are met

Initial Approval for PAH: 1. Diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1).

Initial Approval for PAH: 2. Drug is prescribed by or in consultation with a cardiologist or pulmonologist.

Initial Approval for PAH

Exceptions to calcium channel blocker trial: a. Inadequate response to acute vasodilator testing or contraindication to acute vasodilator testing.
Exceptions to calcium channel blocker trial: b. Contraindication to calcium channel blockers or clinically significant adverse effects to calcium channel blockers are experienced.

Initial Approval for PAH: 4. Dose requested does not exceed 45 mcg per day.

Continuation Therapy (PAH)

Covered when ALL of the following are met

Continued Therapy for PAH

Current therapy or prior approval: a. Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria.
Continuity of care: b. Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations.

Continued Therapy for PAH: 2. Member is responding positively to therapy.

Continued Therapy for PAH: 3. If the request is for a dose increase, the new dose does not exceed 45 mcg per day.

Other Diagnoses/Indications

Other indications — meet one of the following

Other/Label Change or Off-label: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., newly approved indication, age expansion, new dosing), refer to the appropriate no-coverage or non-formulary policy for the relevant line of business as specified in the policy (see policy references).

Other/Label Change or Off-label: 2. If the requested use (diagnosis, age, dosing regimen) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use or no‑coverage policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that apply to members.

Requests for use of iloprost (Ventavis) for indications not listed in this policy are not authorized if adequate supporting clinical evidence is not provided or if the off‑label/non‑formulary approval processes are not followed. Such uses must follow the applicable off‑label or non‑formulary policies and include the required documentation to be considered for coverage.

Coding

Codingmixed

No explicit CPT/HCPCS/NDC codes listed in this part

Document does not list specific billing codes in the provided sections.

Informational drug HCPCS codeHCPCS

Q4074

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

inv-09: Maximum daily dose — 45 mcg/day

Maximum daily dose45 mcg/day

Dosing frequency (PAH)6–9 inhalations per day with at least 2 hours between doses

Starting dose2.5 mcg inhalation, titrate to 5 mcg if tolerated

inv-10: Iloprost unit dose strength — up to 20 mcg

Unit dose strength (informational HCPCS description)Iloprost unit dose form, up to 20 mcg per unit (Q4074)

Available ampule strengths (product availability)Ampules 10 & 20 mcg/mL

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Ventavis (iloprost) is medically necessary only when the criteria in the Initial and Continued Therapy sections are met. Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Prior authorization required for Ventavis (iloprost).
Provider must submit supporting documentation (office notes, labs, or other clinical information).

Step Therapy

Calcium Channel Blocker Trial Requirement

Failure of a calcium channel blocker is required unless the member has an inadequate response to acute vasodilator testing or has a contraindication or intolerance to calcium channel blockers (see Appendix B for therapeutic alternatives).

Calcium channel blocker trial required unless inadequate acute vasodilator response or contraindication/intolerance.
Refer to Appendix B for therapeutic alternatives.

Background

Iloprost (Ventavis) is a synthetic prostacyclin analog indicated for the treatment of pulmonary arterial hypertension (PAH; World Health Organization Group 1) to improve exercise tolerance, symptoms (functional class), and to delay clinical worsening. Clinical studies establishing effectiveness predominantly included patients with NYHA/WHO functional class III–IV disease and populations such as idiopathic/heritable PAH and PAH associated with connective tissue disease.

Definitions

inv-20: Iloprost (Ventavis) — Iloprost (Ventavis): synthetic prostacyclin analog used as an inhaled prostacyclin pathway agonist for vasodilation in PAH.

Drug class and mechanismSynthetic prostacyclin analog; prostacyclin pathway agonist causing pulmonary vasodilation

Formulation and routeInhalation (Ventavis)

Indication (WHO Group)Treatment of pulmonary arterial hypertension (PAH), WHO Group 1

Clinical effectImproves exercise tolerance, symptoms (NYHA class), and prevents deterioration

inv-21: PAH / WHO Group 1 — PAH: pulmonary arterial hypertension, WHO Group 1 pulmonary hypertension.

DefinitionPulmonary arterial hypertension (PAH): WHO Group 1 pulmonary hypertension