CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Sildenafil Drug Quantity Management Policy - Per Rx

Defines Cigna's quantity limits and exception criteria for sildenafil products (tablets and oral suspensions) used for pulmonary arterial hypertension and Raynaud's phenomenon; applies to Cigna-administered health benefit plans and participating providers.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Sildenafil Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 10, 2025

Key ActionSubmit documentation supporting diagnosis, prescribed dose (including weight for pediatric dosing), and inability to swallow tablets when requesting quantity exceptions; approved exceptions are granted for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20 mg TIDrecommended adult dose (typical)

Max 90Revatio (20 mg) max per Rx

112 mLRevatio suspension bottle

122 mLLiQrev suspension bottle

1 yearapproval duration

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Coverage Criteria for Sildenafil (Revatio, LiQrev)

Sildenafil 20 mg tablets (Revatio, generic) - dosing above standard

Approve quantity greater than standard limits when the following condition is met:

Tablet dosing exception: If the patient is prescribed greater than 20 mg three times daily for pulmonary arterial hypertension (PAH) or Raynaud's phenomenon, approve a quantity sufficient for a 30-day supply at retail or a 90-day supply at home delivery.>20 mg TID

Applies to tablets only

Sildenafil 10 mg/mL oral suspension (Revatio) and LiQrev 10 mg/mL suspension - exception criteria

Approve quantities above listed limits when ALL of the following are met:

Oral suspension exception: A) Patient meets ONE of: i. diagnosis of pulmonary arterial hypertension (PAH) OR ii. diagnosis of Raynaud's phenomenon; AND B) patient is prescribed greater than 10 mg three times daily; AND C) patient is unable to swallow a 20 mg sildenafil tablet (Revatio, generic).>10 mg TID for suspension

Round up to whole package sizes when calculating supply (examples provided in policy).

Approval of additional quantities of sildenafil (Revatio, generic) or LiQrev is NOT recommended for use in erectile dysfunction or sexual dysfunction. Requests for quantities beyond the stated limits for these indications will not be approved.

Any exception request that does not meet the specific quantity exception criteria in this policy is considered not medically necessary and will not be approved. Quantity limits in the Drug Quantity Limits section apply at point of service unless the documented clinical criteria for an exception are satisfied.

Referenced Product Codes and Dosing Thresholds

Referenced product codesNDC | mixed

NDCs not listed

Policy references Revatio and LiQrev but does not list specific NDCs in document.

Pediatric weight-based dosing thresholds — sildenafil (Revatio, generic)

≤ 20 kg10 mg three times daily (10 mg TID)

20–45 kg20 mg three times daily (20 mg TID)

> 45 kgStart 20 mg TID; may titrate to a maximum of 40 mg three times daily based on symptoms and tolerability

Provider Actions, Documentation, and Denial Conditions

Prior Authorization

Quantity exception review and approval duration

Approvals for quantity exceptions that meet criteria are provided for a duration of 1 year. At the point of sale, default drug quantity limits will apply unless an approved exception is in place.

Approval duration: 1 year
Default quantity limits apply at point of sale

Denial Risk

Denial if quantity rule not met

If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the listed criteria. Exceptions that do not meet the specified criteria are considered not medically necessary and may be denied.

Coverage determined by criteria when quantity rule not met
Exceptions not meeting criteria = not medically necessary (denial risk)

Background

Sildenafil (Revatio, generic) and LiQrev are phosphodiesterase type 5 (PDE5) inhibitors indicated for treatment of pulmonary arterial hypertension (PAH; WHO Group I) to improve exercise capacity and, in pediatric patients, pulmonary hemodynamics. The policy criteria address tablet and oral suspension formulations and specify dosing-based exceptions (for example, >20 mg three times daily for tablets or >10 mg three times daily for suspension) and circumstances such as inability to swallow tablets that support use of the oral suspension.

Definitions and Clinical Circumstances

PAH (pulmonary arterial hypertension) — definition and indication context

DefinitionPulmonary arterial hypertension (PAH) — WHO Group I disease for which sildenafil products are indicated to improve exercise ability and delay clinical worsening.

Age considerationsRevatio (sildenafil) is indicated for PAH in adults and in patients 1–17 years; LiQrev lacks pediatric labeling due to marketing exclusivity.

Indications covered by this policyQuantity exceptions may be approved for PAH (WHO Group I) when criteria in the policy are met (e.g., dose or formulation requirements).

Unable to swallow a tablet — supporting definition for oral suspension approval

Definition of inability to swallow tabletsClinical circumstance where the patient is unable to swallow a 20 mg sildenafil tablet (Revatio, generic), supporting use of oral suspension when documented and other criteria are met.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Sildenafil Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 10, 2025

SourceLink

On This Page

Documentation Required

Required supporting documentation

Submit claims with the appropriate diagnosis and procedure codes and include supporting documentation to justify any quantity exception (e.g., diagnosis of PAH or Raynaud's phenomenon, documentation of inability to swallow tablets, and prescribed dosing). Lack of supporting documentation may result in denial.

Include diagnosis (PAH or Raynaud's phenomenon) when applicable
Document inability to swallow tablets for suspension approvals
Provide prescribed dose and quantity calculations to support requested quantity

Billing Rule

Provider action highlight

Provider must request a quantity exception when the prescribed amount exceeds the listed retail or home-delivery maximums. Use the specified criteria for sildenafil 20 mg tablets and 10 mg/mL oral suspensions to support the request; round quantities to accommodate whole package sizes as noted in the criteria.

For sildenafil 20 mg tablets: approve greater than 20 mg three times daily only when criteria met
For 10 mg/mL suspensions: approve greater than 10 mg three times daily only when ALL criteria A–C are met
Round up quantities to whole package sizes per the policy note

Oral suspension quantity exceptions require documentation that the patient is unable to swallow a 20 mg tablet as part of meeting the ALL criteria for suspension approval.

Related dosing thresholdOral suspension approvals apply when the patient is prescribed greater than 10 mg three times daily (suspension dosing >10 mg TID).