CurrentCentenePolicy CP PHAR.197

Sildenafil (Revatio, Liqrev)

Clinical policy governing medical necessity criteria, dosing limits, prior authorization and continuation criteria for sildenafil (Revatio, Liqrev) for treatment of pulmonary arterial hypertension (PAH) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicySildenafil (Revatio, Liqrev)

Policy CodePolicy CP PHAR.197

Change TypeClarifiedRevised

Effective Date2003-16

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

RT4: updated PAH criteria to include newly FDA approved pediatric age expansion and updated adult PAH dosing per revised PI; updated HCPCS codes and Appendix B (03.08.23).

1Q 2025 annual review clarified criteria also applies to brand Revatio and Liqrev and updated Appendix B per Clinical Pharmacology.

1Primary covered indication (PAH WHO Group 1)

3HCPCS codes referenced

3Formulations available

Coverage Summary

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Background: Sildenafil (Revatio, Liqrev) is a phosphodiesterase-5 inhibitor indicated for treatment of pulmonary arterial hypertension (PAH; WHO Group 1) in adults and in pediatric patients ages 1–17 years to improve exercise ability and, in younger pediatric patients, pulmonary hemodynamics; dosing varies by age, weight and formulation.

Scope/Subject: Clinical policy governing medical necessity criteria, dosing limits, prior authorization and continuation criteria for sildenafil (Revatio, Liqrev) for treatment of PAH across Commercial, HIM, and Medicaid lines of business (Policy number: CP PHAR.197).

Policy status and stance: CURRENT status; coverage position is covered_with_criteria — sildenafil is medically necessary for PAH when the specified initial and continued therapy criteria are met, including specialist prescribing and dose limits.

Brief background sentence: Dosing and formulation-specific limits are included in the policy (tablet, oral suspension, IV) and were updated to reflect pediatric age expansion and adult dosing in recent reviews.

Dose maxima (formulation / age-weight)

Adult oral maximum daily dose240 mg/day

Adult IV maximum daily dose30 mg/day

Pediatric <20 kg oral maximum daily dose30 mg/day

Pediatric 20 to <45 kg oral maximum daily dose60 mg/day

Medical Necessity Criteria

Initial Approval Criteria

Sildenafil (Revatio, Liqrev) is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of pulmonary arterial hypertension (PAH; WHO Group 1).
Prescribed by or in consultation with a cardiologist or pulmonologist.
Exception to CCB failure requirement
- Inadequate response or contraindication to acute vasodilator testing.
- Contraindication or clinically significant adverse effects to calcium channel blockers are experienced.
If request is for brand Revatio or Liqrev, member must use generic sildenafil unless generic is contraindicated or clinically significant adverse effects are experienced.
Dose limits
- Adult oral formulation: does not exceed 240 mg per day (divided doses).240 mg/day
- Adult intravenous formulation: does not exceed 30 mg per day.30 mg/day
- Pediatric oral formulation: body weight < 20 kg: does not exceed 30 mg per day (divided doses).30 mg/day
- Pediatric oral formulation: body weight 20 kg to < 45 kg: does not exceed 60 mg per day (divided doses).60 mg/day

Continued Therapy (Renewal) Criteria

Continued therapy is approved when ALL of the following are met:

ALL of the following

Member status: Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria.
Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state addendums).
Member is responding positively to therapy (clinical response).
Dose increase constraint: If request is for a dose increase, new dose does not exceed the same dose limits as initial therapy (adult and pediatric maxima as above).

Other Diagnoses / Indications (Non-PAH)

Coverage for other diagnoses/indications requires meeting one of the following:

ANY of the following

For drugs on formulary (commercial/marketplace) or PDL (Medicaid): follow the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial; HIM.PA.33 for marketplace; CP PMN.255 for Medicaid).
For drugs NOT on formulary/PDL: follow the non-formulary policy for relevant line of business (CP PMN.16 for Medicaid; CP.CPA.190 or HIM.PA.103 as referenced).
If requested use is not specifically listed under Diagnoses/Indications not authorized AND initial approval criterion 1 does not apply: refer to off-label use policy for the relevant line of business (CP.CPA.09 commercial; HIM.PA.154 marketplace; CPPMN.53 Medicaid).

Diagnoses/Indications Not Authorized

Coverage is not authorized for:

Non-FDA approved indications that are not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policies is provided.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required with specialist involvement

Prescriptions must be written by or in consultation with a cardiologist or pulmonologist. The policy requires prior authorization for sildenafil (Revatio, Liqrev) as part of the coverage criteria; documentation should demonstrate specialist involvement.

Prescriber must be a cardiologist or pulmonologist, or document consultation with one.
Prior authorization is implied by the policy and should be obtained per plan requirements.

Documentation Required

Submit documentation supporting criteria

Submit clinical documentation that supports all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results, and other clinical information demonstrating diagnosis, prior treatments, and current clinical status.

Office chart notes documenting diagnosis of PAH and specialist involvement.
Laboratory results and objective testing relevant to PAH evaluation and response.
Other clinical information (e.g., prior therapy history, adverse reactions, consultation notes).

Billing Rule

Generic-first requirement for brands

Requests for branded Revatio or Liqrev require use of generic sildenafil first. The member must trial generic sildenafil prior to coverage of the brand unless the generic is contraindicated or the member experiences clinically significant adverse effects.

Brand products Revatio or Liqrev: trial of generic sildenafil required unless contraindicated or significant adverse effects occur.

Documentation Required

Demonstrate positive response for continued therapy

For continued therapy, providers must document that the member is responding positively to treatment. If requesting a dose increase, documentation must show the member’s response and the new dose must remain within the policy-specified maximums for the applicable age, weight, and formulation.

Evidence of clinical response to therapy (symptom improvement, functional status, objective measures).
If increasing dose, new total daily dose must not exceed policy maxima (e.g., adult oral 240 mg/day; adult IV 30 mg/day; pediatric weight-based maxima).

Background and Evidence

Sildenafil is indicated for pulmonary arterial hypertension (WHO Group 1) in adults to improve exercise ability and delay clinical worsening; Revatio and Liqrev are also indicated in pediatric patients 1 to 17 years for PAH with dosing that varies by age, weight, and formulation.

Formulations available include tablet (20 mg), oral suspension (10 mg/mL) (Liqrev), and single-use vial for IV (10 mg/12.5 mL); dosing recommendations differ by formulation and patient weight.

Dosing examples and maxima from the policy: adults (tablet/oral suspension) 20–80 mg PO TID with a maximum of 240 mg/day; adult IV 10 mg TID (30 mg/day max); pediatric oral dosing by weight: <20 kg: 10 mg PO TID (max 30 mg/day), 20 kg to <45 kg: 20 mg PO TID (max 60 mg/day), and ≥45 kg ranges up to adult dosing (policy lists 20–40 mg PO TID).

Definitions: PAH = Pulmonary arterial hypertension (WHO Group 1).

Definitions: PDL = Preferred Drug List.

Supporting evidence

FDA Prescribing Information referencesRevatio PI Jan 2023; Liqrev PI Apr 2023

Guideline citationsCHEST 2019 update; 2015 AHA/ATS pediatric guidelines; 2022 ESC/ERS guidelines

Revision History

03.08.23revised

RT4: updated PAH criteria to include newly FDA approved pediatric age expansion; updated adult PAH dosing per revised PI; updated HCPCS codes and Appendix B (material change).

05.09.23revised

RT4: added new oral suspension formulation Liqrev to policy (added Liqrev formulation and related dosing/HCPCS updates).

02.25clarifiedLatest

1Q 2025 annual review: clarified policy/criteria also applies to brand Revatio and Liqrev and updated Appendix B per Clinical Pharmacology; references reviewed and updated; P&T Approval Date = 02.25.

J3490	Unclassified drugs
J8499	Prescription oral non-chemotherapeutic, Not Otherwise Specified drug
C9399	Unclassified drug or biologicals

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