CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sildenafil (Revatio/Liqrev) — Coverage Criteria for Pulmonary Arterial Hypertension and Secondary Raynaud's Phenomenon

Covers medical benefit authorization criteria for sildenafil (Revatio/Liqrev) for treatment of pulmonary arterial hypertension (PAH) in adults and pediatric patients, and for secondary Raynaud's phenomenon; applies to prescribers and members under the payer's benefit when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySildenafil (Revatio/Liqrev) — Coverage Criteria for PAH and Secondary Raynaud's

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when PAH (WHO Group 1) is confirmed with required hemodynamics and the medication is prescribed by or in consultation with a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

WHO Group 1PAH group required for coverage

PVR ≥ 3hemodynamic threshold (adults)

PVRI ≥ 3hemodynamic threshold (pediatrics)

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PAH - Initial therapy authorization

Authorization of 12 months may be granted when ALL of the following are met:

PAH group: Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1

Refer to Appendix for subtypes

PAH confirmation: PAH was confirmed by either (i) pretreatment right heart catheterization with specified hemodynamics OR (ii) for infants < 1 year, Doppler echocardiogram if catheterization cannot be performedmPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)

Hemodynamic thresholds required

Prescriber specialty: Medication must be prescribed by or in consultation with a pulmonologist or cardiologist

Secondary Raynaud's phenomenon

Authorization of 12 months may be granted when ALL of the following are met:

Prior therapy failure: Member has had an inadequate response to one of: calcium channel blockers, angiotensin II receptor blockers, selective serotonin reuptake inhibitors, alpha blockers, or topical nitrates

Step therapy requirement

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 experiencing benefit when ALL of the following are met:

Current therapy: Member is currently receiving the requested medication through a paid pharmacy or medical benefit

Clinical benefit: Member is experiencing benefit from therapy as evidenced by disease stability or improvement

All indications other than the listed FDA-approved indications and compendial uses are considered experimental/investigational and not medically necessary.

Use of sildenafil for any indication not included in the FDA-approved indications or the policy’s listed compendial uses (for example, beyond pulmonary arterial hypertension and secondary Raynaud’s phenomenon and the specified pediatric compendial use) is considered not medically necessary and will be denied as experimental/investigational.

Coding, Hemodynamic Thresholds, and Definitions

No explicit codes providedmixed

no codes listed

Policy lists no explicit CPT/HCPCS/ICD-10/NDC codes

inv-07: Mean pulmonary arterial pressure (mPAP) — > 20 mmHg.

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Measurement contextRecorded from pretreatment right heart catheterization

PurposeRequired hemodynamic threshold to confirm PAH for authorization

inv-08: Pulmonary capillary wedge pressure (PCWP) — ≤ 15 mmHg.

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Measurement contextRecorded from pretreatment right heart catheterization

PurposeDistinguishes pre-capillary PAH from post-capillary PH

inv-09: Pulmonary vascular resistance (PVR) — ≥ 3 Wood units (adults).

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

Measurement contextCalculated from pretreatment right heart catheterization in adult patients

PurposeHemodynamic threshold required to confirm PAH in adults for authorization

inv-10: Pulmonary vascular resistance index (PVRI) — ≥ 3 Wood units·m2 (pediatrics).

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

Measurement contextUsed for pediatric patients as part of pretreatment right heart catheterization criteria

PurposeAge-adjusted hemodynamic threshold to confirm PAH in pediatric patients for authorization

inv-17: WHO Group classifications — references to WHO Group 1 (PAH) and appendix of subcategories.

WHO Group 1 (PAH)Includes idiopathic, heritable, drug- and toxin-induced, and PAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis, long-term responders to calcium channel blockers, PVOD/PCH involvement, and persistent PH of the newborn

Reference for classificationPolicy requires member has PAH defined as WHO Group 1 (see Appendix for subtypes)

Use in criteriaWHO Group 1 classification is required for authorization of sildenafil for PAH

Provider Actions, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval may be granted for up to 12 months when all specified criteria are met (see PAH diagnostic documentation and prescriber specialty requirements).

Authorization duration: up to 12 months when criteria met

Denial Risk

Experimental/Investigational Exclusions

Use of the medication for indications other than FDA‑approved or listed compendial uses (including indications not in the policy's Compendial Uses list) is considered experimental or investigational and is not medically necessary.

Documentation Required

PAH Diagnostic Documentation Required

Documentation must confirm diagnosis of pulmonary arterial hypertension (PAH) when seeking authorization for PAH. For adults, provide pretreatment right heart catheterization results showing all of the following: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg; pulmonary vascular resistance (PVR) ≥ 3 Wood units. For pediatric patients, provide a pulmonary vascular resistance index (PVRI) ≥ 3 Wood units·m2. For infants less than one year of age when right heart catheterization cannot be performed, a confirming Doppler echocardiogram is acceptable. Include relevant study reports and dates.

Documentation Required

Prescriber Specialty Documentation

Record that the medication is prescribed by or in consultation with a pulmonologist or cardiologist for the diagnosis of pulmonary arterial hypertension (PAH). Include the consulting specialist's name, specialty, and contact information in the submission.

Definitions and Classifications

inv-17: WHO Group classifications — list of referenced WHO Group 1 and subcategories of pulmonary hypertension etiologies.

WHO Group 1 — PAH subcategories1.1 Idiopathic; 1.2 Heritable; 1.3 Drug- and toxin-induced; 1.4 PAH associated with connective tissue diseases, HIV infection, portal hypertension, congenital heart diseases, schistosomiasis; 1.5 Long-term responders to calcium channel blockers; 1.6 PVOD/PCH involvement; 1.7 Persistent PH of the newborn

Other WHO groups listed in AppendixGroup 2: PH due to left heart disease; Group 3: PH due to lung diseases/hypoxia; Group 4: PH due to pulmonary artery obstruction (including chronic thromboembolic PH and other obstructions); Group 5: PH with unclear/multifactorial mechanisms

Appendix purposeDefines etiologies and classifications to identify appropriate patients for PAH therapy