CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ventavis (iloprost) — Coverage Criteria for Pulmonary Arterial Hypertension

Covers clinical authorization criteria for Ventavis (iloprost) for treatment of pulmonary arterial hypertension (WHO Group 1) for members of Neighborhood Health Plan of Rhode Island when prescriber and clinical criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVentavis (iloprost) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic documentation including WHO Group 1 classification and confirmatory testing (right heart catheterization results or Doppler echocardiogram for infants) and prescriber specialty information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

WHO Group 1indicated PH group

NYHA III-IVpopulation studied

Pulmonologist/Cardiologistrequired prescriber

Coverage criteria for Ventavis (iloprost)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVentavis (iloprost) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Initial PAH treatment

Authorization may be granted when ALL of the following are met:

PAH indication: Member has pulmonary arterial hypertension defined as WHO Group 1.

refer to Appendix for subgroup details

Diagnostic confirmation: PAH confirmed by either (1) pretreatment right heart catheterization with specified hemodynamic thresholds OR (2) for infants <1 year, Doppler echocardiogram when catheterization cannot be performed.

Right heart catheterization thresholds: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units in adults or PVRI ≥ 3 Wood units·m2 in pediatrics.

Coding and diagnostic thresholds

No explicit codes listedmixed

No codes listed

inv-06: mPAP — mean pulmonary arterial pressure threshold

mPAP thresholdMean pulmonary arterial pressure (mPAP) > 20 mmHg

ContextRequired as part of pretreatment right heart catheterization confirming PAH (WHO Group 1)

UseApplies to adults and pediatric diagnostic RHC criteria unless alternative pediatric index used

inv-07: PCWP — pulmonary capillary wedge pressure threshold

PCWP thresholdPulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg

ContextRequired as part of pretreatment right heart catheterization confirming PAH (WHO Group 1)

PurposeHelps distinguish pre-capillary PAH from post-capillary pulmonary hypertension

inv-08: PVR (adults) — pulmonary vascular resistance threshold

PVR threshold (adults)Pulmonary vascular resistance (PVR) ≥ 3 Wood units

Measurement contextMeasured during pretreatment right heart catheterization to confirm PAH (WHO Group 1)

Relation to PVRIAdults use PVR; pediatrics use indexed PVRI threshold

inv-09: PVRI (pediatrics) — indexed pulmonary vascular resistance threshold

PVRI threshold (pediatrics)Pulmonary vascular resistance index (PVRI) ≥ 3 Wood units·m2

Age applicationSpecified for pediatric patients as part of pretreatment right heart catheterization criteria

CorrespondencePVRI replaces PVR threshold for indexed assessment in children

inv-16: Right heart catheterization diagnostic criteria for PAH — mPAP, PCWP, PVR

mPAP diagnostic criterionMean pulmonary arterial pressure (mPAP) > 20 mmHg

PCWP diagnostic criterionPulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg

PVR/PVRI diagnostic criterionPVR ≥ 3 Wood units in adults or PVRI ≥ 3 Wood units·m2 in pediatric patients

inv-17: Alternative diagnostic approach for infants <1 year — Doppler echocardiogram when RHC cannot be performed

Alternative for infants <1 yearDoppler echocardiogram may be used to confirm PAH when right heart catheterization cannot be performed

Age limitationApplies to infants less than one year of age

ContextUsed only if pretreatment right heart catheterization is not feasible

Required provider actions and documentation

Prior Authorization

Prior authorization — 12‑month approvals when listed criteria for PAH diagnosis and confirmation are met; continuation criteria

Prior authorization required. Approval may be granted for up to 12 months when criteria for a diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1) and confirmatory testing are met. Continuation approvals may be granted for 12 months for members currently receiving the medication who demonstrate clinical benefit (disease stability or improvement).

Authorization duration: up to 12 months
Continuation: 12 months if currently receiving medication and demonstrating benefit

Documentation Required

Provider action / documentation required

Provider must complete all required documentation and submit supporting diagnostic test results and clinical notes with the prior authorization request.

Include documentation of WHO Group 1 classification and confirmatory testing results
Include clinical assessment of symptoms/NYHA class and treatment history

Documentation Required

Diagnostic documentation required — documentation of PAH diagnosis including WHO Group 1 classification and confirmatory testing

Documentation of the PAH diagnosis is required. This must demonstrate WHO Group 1 classification and confirmatory testing as described in the diagnostic criteria: either pretreatment right heart catheterization meeting hemodynamic thresholds or, for infants <1 year when catheterization cannot be performed, Doppler echocardiogram.

Right heart catheterization results: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)
If <1 year old and catheterization not possible: Doppler echocardiogram confirming PAH

Note

Prescriber specialty — prescription by or consultation with a pulmonologist or cardiologist is required

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

Prescriber specialty: pulmonologist or cardiologist (prescription or documented consultation)

Denial Risk

Non‑approved indications — Use for indications other than FDA-approved PAH (WHO Group 1) or compendial uses is experimental/investigational and not medically necessary

Use for indications other than FDA‑approved PAH (WHO Group 1) or compendial uses is considered experimental/investigational and not medically necessary.

Non‑approved indications are not covered

Background

Pulmonary arterial hypertension (PAH, WHO Group 1) is a progressive vascular disease characterized by elevated pulmonary arterial pressures and resulting impairment in exercise tolerance and symptoms measured by New York Heart Association (NYHA) functional class. Ventavis is indicated to improve a composite outcome including exercise tolerance, symptoms (NYHA class), and prevention of clinical deterioration. Clinical trials establishing effectiveness primarily enrolled patients with NYHA Functional Class III–IV and etiologies such as idiopathic or heritable PAH or PAH associated with connective tissue disease.

Definitions and diagnostic criteria

inv-16: Right heart catheterization diagnostic criteria for PAH — mPAP > 20 mmHg, PCWP ≤ 15 mmHg, PVR threshold

Right heart catheterization criteria summarymPAP > 20 mmHg

Supporting thresholdPCWP ≤ 15 mmHg

Resistance thresholdPVR ≥ 3 Wood units in adults (PVRI ≥ 3 Wood units·m2 in pediatrics)

inv-17: Alternative diagnostic approach for infants <1 year — Doppler echocardiogram may be used when RHC cannot be performed

Echocardiogram as alternativeDoppler echocardiogram may confirm PAH for infants <1 year when right heart catheterization cannot be performed

Clinical scopeSpecified only for infants less than one year of age

Diagnostic roleServes as confirmatory testing when RHC is not feasible prior to treatment authorization