CurrentNeighborhood Health Plan of Rhode IslandPolicy Reference number(s) 1651-A

Sildenafil Liqrev Revatio 1651 A Sgm P2024

Defines coverage criteria for sildenafil (Revatio, Liqrev, generic sildenafil oral suspension) for FDA-approved PAH indications in adults and pediatric patients, certain compendial uses (secondary Raynaud's phenomenon and PAH in <1 year olds), prescriber specialty requirement, authorization durations, and continuation criteria. Non-covered uses are experimental/investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySildenafil Liqrev Revatio 1651 A Sgm P2024

Policy CodePolicy Reference number(s) 1651-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization of 12 months may be granted when the listed clinical criteria are met; prescriber must be or consult with a pulmonologist or cardiologist and required hemodynamic confirmation (right heart cath results or echocardiogram for infants) must be documented.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

2Covered indications

1Compendial pediatric group (<1 yr)

1Excluded indications

Coverage Summary

Scope: Defines coverage criteria for sildenafil (Revatio, Liqrev, generic sildenafil oral suspension) for FDA‑approved indications for pulmonary arterial hypertension (PAH) in adults and pediatric patients, select compendial uses (secondary Raynaud's phenomenon and PAH in children <1 year), prescriber specialty requirements, required hemodynamic confirmation, authorization durations, and continuation criteria.

Medical-Necessity Criteria

Pulmonary arterial hypertension (PAH) - Initial Authorization

Authorization of 12 months may be granted for treatment of PAH when ALL of the following criteria are met:

ALL of the following

PAH confirmation
- Pretreatment right heart catheterization with required hemodynamics
  - mPAP: Mean pulmonary arterial pressure (mPAP) > 20 mmHg> 20 mmHg
  - PCWP: Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg≤ 15 mmHg
  - PVR/PVRI: Pulmonary vascular resistance (PVR) ≥ 3 Wood units in adult members or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units x m2 in pediatric members≥ 3 Wood units (PVR) or ≥ 3 WU·m2 (PVRI)
- Infant echo alternative: For infants less than one year of age, PAH was confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.
Prescriber specialty: Medication must be prescribed by or in consultation with a pulmonologist or cardiologist for the diagnosis of PAH.

Secondary Raynaud's phenomenon - Initial Authorization

Authorization of 12 months may be granted for treatment of secondary Raynaud's phenomenon when ALL of the following criteria are met:

ALL of the following

Indication: Member has secondary Raynaud's phenomenon.
Prior inadequate response
- Calcium channel blockers
- Angiotensin II receptor blockers
- Selective serotonin reuptake inhibitors

Compendial pediatric PAH (<1 year) - Initial Authorization

Compendial use may be considered when ALL criteria met:

ALL of the following

Indication: PAH (WHO Group I) in pediatric members less than 1 year of age.
PAH confirmation for infants: PAH confirmation: Doppler echocardiogram if right heart catheterization cannot be performed.
Prescriber specialty: Medication must be prescribed by or in consultation with a pulmonologist or cardiologist.

Continuation of Therapy

Authorization of 12 months may be granted for members currently receiving the medication and demonstrating benefit:

Continuation criteria

Current receipt: Member currently receiving the requested medication through a paid pharmacy or medical benefit.
Documented benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Excluded/Not Medically Necessary Indications

All other indications not listed in Section I (FDA-approved and compendial uses):

Exclusion: All other indications are considered experimental/investigational and not medically necessary.

Provider Actions

Prior Authorization

Prior authorization required for covered indications

Authorization of 12 months may be granted when the listed clinical criteria are met; prescriber must be or consult with a pulmonologist or cardiologist and required hemodynamic confirmation (right heart cath results or echocardiogram for infants) must be documented.

Documentation Required

Document hemodynamic confirmation

Providers must document pretreatment right heart catheterization results (mPAP, PCWP, PVR/PVRI) or Doppler echocardiogram for infants <1 year when catheterization cannot be performed.

Documentation Required

Document prior therapy failure for Secondary Raynaud's

Providers must document inadequate response to at least one listed medication class (e.g., calcium channel blocker, angiotensin II receptor blocker, selective serotonin reuptake inhibitor, alpha blocker, angiotensin-converting enzyme inhibitor, topical nitrates) before approval for secondary Raynaud's phenomenon.

Documentation Required

Continuation requires evidence of benefit

For renewal, providers must document disease stability or improvement to receive an additional 12-month authorization.

Background, Evidence & Definitions

Background: Sildenafil (Revatio, Liqrev, and generic oral suspension) is FDA‑approved for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults and in pediatric patients 1–17 years to improve exercise ability and related hemodynamics. Compendial uses listed in the policy include secondary Raynaud's phenomenon and PAH (WHO Group 1) in pediatric members <1 year of age.

Hemodynamic definitions and WHO classification: The policy references pretreatment right heart catheterization criteria for PAH confirmation: mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units in adults or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units·m2 in pediatrics. The WHO Group 1 PAH classification and its subcategories are included in the policy appendix and referenced guidance.

Product names: The policy specifically names Revatio, Liqrev, and generic sildenafil oral suspension as covered products when criteria are met.

Evidence	Source
Revatio package insert
Revatio [package insert]. Viatris Specialty LLC; January 2023. (Reference list)
Liqrev package insert
Liqrev [package insert]. CMP Pharma, Inc.; April 2023. (Reference list)
Sildenafil generic package inserts
Sildenafil [package insert]. Camber Pharmaceuticals, Inc.; February 2024; Sildenafil for oral suspension [package insert]. Aurobindo Pharma USA, Inc.; January 2024. (Reference list)
Guideline and literature references
ACCF/AHA 2009 expert consensus; CHEST 2014/2019 guideline updates; AHA/ATS 2015 pediatric guidelines; key trials and reviews (e.g., Galiè 2005, Barst 2012/2014) as listed in References section.

Definitions

Definition: PAH (WHO Group 1)Pulmonary arterial hypertension as defined by WHO Group 1 classification (see WHO Classification appendix)

WHO Group 1 includesIdiopathic, heritable, drug-/toxin-induced, and PAH associated with conditions (eg, connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis) and other subgroups listed in the WHO appendix

Hemodynamic confirmation requirementPAH confirmed by right heart catheterization (mPAP >20 mmHg, PCWP ≤15 mmHg, PVR ≥3 WU in adults or PVRI ≥3 WU·m2 in pediatrics) or by Doppler echocardiogram in infants <1 year if catheterization cannot be performed

OpenPayer

Sildenafil Liqrev Revatio 1651 A Sgm P2024

Coverage Summary

Medical-Necessity Criteria

Provider Actions

Coding

Background, Evidence & Definitions

Revision History