CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sildenafil-Revatio

Defines clinical coverage criteria, prescriber requirements, authorization duration, and indications (FDA-approved and compendial) for Revatio/Liqrev/sildenafil for PAH (adult and pediatric) and secondary Raynaud's phenomenon. Covers continuation criteria and diagnostic confirmation requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySildenafil-Revatio

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionAuthorization of 12 months may be granted when required diagnostic confirmation and prescriber specialty requirements are met (see PAH and Secondary Raynaud's criteria).

SourceLink

POLICY UPDATE CHANGES

No material changes: This brief indicates has_material_change=false and provides no policy changes.

2Covered Indications (FDA/Compendial)

12Authorization Duration (months)

1Prescriber Specialties Required

Coverage Summary

This policy covers sildenafil (Revatio/Liqrev) for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) in adults and in pediatric patients aged 1–17 years per FDA labeling, and also covers compendial use for PAH in pediatric members less than 1 year of age and for secondary Raynaud's phenomenon when criteria are met. Prescriptions for PAH must be from or in consultation with a pulmonologist or cardiologist. Authorization may be granted for a duration of 12 months when the policy criteria are satisfied.

Provider Actions / Prior Authorization

Prior Authorization

Authorization required for covered indications

Authorization of 12 months may be granted when required diagnostic confirmation and prescriber specialty requirements are met (see PAH and Secondary Raynaud's criteria).

Documentation Required

Diagnostic confirmation documentation

Document pretreatment right heart catheterization results (mPAP, PCWP, PVR) or Doppler echocardiogram for infants <1 year when RHC cannot be performed.

Documentation Required

Prior therapy documentation for secondary Raynaud's

Document inadequate response to at least one listed medication class (e.g., calcium channel blockers, ARBs, SSRIs, alpha blockers, ACE inhibitors, topical nitrates).

Documentation Required

Prescriber specialty requirement

Ensure prescription is from or in consultation with a pulmonologist or cardiologist for PAH diagnoses.

Denial Risk

Non-covered indications

Claims for indications other than FDA-approved indications and listed compendial uses are at risk for denial as experimental/investigational and not medically necessary.

Clinical Evidence & References

Primary product labeling references and cited trials/guidelines include: Revatio and Liqrev package inserts (2023–2024) and sildenafil product labeling; key clinical trials and reports such as Barst et al., Galiè et al., Rubin et al., STARTS-2 (Barst et al. 2014), and additional guideline and review references supporting use in PAH and secondary Raynaud's phenomenon.

Background and Definitions

Revatio/Liqrev (sildenafil) is FDA-indicated for PAH (WHO Group I) in adults to improve exercise ability and delay clinical worsening, and for pediatric patients aged 1 to 17 years to improve exercise ability (or pulmonary hemodynamics in those too young for testing). Compendial uses listed include secondary Raynaud's phenomenon and PAH in pediatric members less than 1 year of age. The policy references hemodynamic diagnostic criteria required from pretreatment right heart catheterization: mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units (with pediatric PVRI > 3 Wood units·m² acceptable). For infants <1 year, a Doppler echocardiogram may confirm PAH if right heart catheterization cannot be performed. The document also references the WHO classification of pulmonary hypertension (Group 1 = PAH) and related guidance.

Term	Definition
PAH
Pulmonary arterial hypertension, WHO Group 1 pulmonary hypertension.
RHC
Right heart catheterization; required pretreatment hemodynamics include mPAP, PCWP, and PVR as specified.
PVRI
Pulmonary vascular resistance index; used for pediatric members (threshold > 3 Wood units x m^2).

Diagnostic Hemodynamic Thresholds

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Pulmonary vascular resistance index (PVRI) - pediatric> 3 Wood units x m^2

Revision History

policy_statusLatest

CURRENT — Policy defines coverage for Revatio/Liqrev (sildenafil) for treatment of pulmonary arterial hypertension (PAH) in adults and pediatric patients 1–17 years and compendial uses including secondary Raynaud's phenomenon and PAH in pediatric members <1 year when listed criteria are met. Authorization of 12 months may be granted when diagnostic, prescriber specialty, and prior therapy criteria (for secondary Raynaud's) are satisfied. Policy notes diagnostic hemodynamic thresholds (mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units; PVRI > 3 Wood units·m2 for pediatrics) and permits Doppler echocardiogram confirmation for infants <1 year if right heart catheterization cannot be performed.

notesLatest

No dated revision entries provided in the brief; document-level changes list not supplied.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySildenafil-Revatio

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionAuthorization of 12 months may be granted when required diagnostic confirmation and prescriber specialty requirements are met (see PAH and Secondary Raynaud's criteria).

SourceLink

On This Page

OpenPayer

Sildenafil-Revatio

Coverage Summary

Applicable Codes

Provider Actions / Prior Authorization

Clinical Evidence & References

Background and Definitions

Revision History