CurrentCignaPolicy N/A

Hemangeol Prior Authorization with Step Therapy Policy

Defines Cigna's prior authorization and step therapy requirements for Hemangeol (propranolol hydrochloride oral solution 4.28 mg/mL) for treatment of proliferating infantile hemangioma in pediatric patients.

Policy Summary

PayerCigna

PolicyHemangeol Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateNov 13, 2024

Key ActionObtain prior authorization and document a trial of generic propranolol for patients ≥ 6 months before approving Hemangeol.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearinitial approval duration

5 wks–5 mosrecommended initiation window

≥6 monthsstep therapy age threshold

≤5%infant prevalence

Recommended Authorization Criteria

Infantile Hemangioma, Proliferating — Initial

Policy Summary

PayerCigna

PolicyHemangeol Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateNov 13, 2024

Key ActionObtain prior authorization and document a trial of generic propranolol for patients ≥ 6 months before approving Hemangeol.

SourceLink

On This Page

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Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hemangeol. Hemangeol is covered as medically necessary when the Recommended Authorization Criteria are met for the FDA‑approved indication (infantile hemangioma, proliferating). A Step Therapy requirement applies for patients ≥ 6 months of age: a trial of generic propranolol is required prior to approval of Hemangeol.

Applies to Hemangeol (propranolol hydrochloride oral solution 4.28 mg/mL)
Step therapy applies only when patient is ≥ 6 months of age
When step therapy applies, documentation of a trial of generic propranolol is required

Step Therapy

Step Therapy Requirement

When step therapy applies (patients ≥ 6 months), a documented trial of generic propranolol is required before Hemangeol will be authorized. Approvals for the FDA‑approved indication (infantile hemangioma, proliferating) are for up to 1 year when criteria are met.

Patient must be ≥ 6 months of age for the step therapy requirement to apply
If patient is ≥ 6 months, documentation must show trial and inadequate response or intolerance to generic propranolol prior to Hemangeol

Documentation Required

Documentation Required for Prior Authorization and Step Therapy

Document the prior use and outcome of generic propranolol when applicable. Include medication name, dose, duration of trial, reason for discontinuation if any (e.g., adverse effect, lack of efficacy), and relevant clinical notes demonstrating continued need for therapy with Hemangeol. Also provide patient age and diagnosis supporting the FDA‑approved indication.

Required documentation: medication name (generic propranolol), dose, start and stop dates, and treatment response
If propranolol was not tried, document medical rationale why it is not appropriate (e.g., contraindication, intolerance)
Include patient age (to confirm whether step therapy applies) and documentation of diagnosis (infantile hemangioma, proliferating)
Authorization for Hemangeol for the FDA‑approved indication may be granted for up to 1 year when criteria are met

Denial Risk

Non‑Covered Indications

Requests for Hemangeol for any indication not listed in the Recommended Authorization Criteria are considered experimental, investigational, or unproven and are not covered.

Non‑covered: uses outside the FDA‑approved indication (infantile hemangioma, proliferating) or not supported by the authorization criteria
Criteria will be updated as new published data become available

Clinical Background

Infantile hemangiomas are common pediatric vascular tumors that may occur in up to about 5% of infants. They typically appear a few weeks after birth and demonstrate most significant growth during the first months of life; when actively proliferating they can cause disfigurement, functional impairment, or permanent skin changes that may require systemic therapy such as propranolol.

Hemangeol is indicated for proliferating infantile hemangioma requiring systemic therapy, with recommended treatment initiation generally occurring between about 5 weeks and 5 months of age according to the product overview and clinical guidance.

Key Definitions and Contraindications

inv-08: Definition — Proliferating infantile hemangioma (active growth, potential complications)

DefinitionProliferating infantile hemangioma: an infant vascular tumor demonstrating active growth that may cause disfigurement, functional impairment, or permanent skin changes and that requires systemic therapy.

Typical age of onset and growthOnset may occur a few weeks after birth with most significant growth between 1 and 3 months; majority of growth is complete by 5 months.

When systemic therapy is indicatedSystemic therapy (e.g., oral propranolol/Hemangeol) is indicated for proliferating infantile hemangiomas that are problematic due to size, location (e.g., face, periorbital), functional impairment, or risk of permanent skin changes.

Recommended initiation window for HemangeolInitiate treatment between ages 5 weeks and 5 months for proliferating infantile hemangioma requiring systemic therapy.

Natural history relevant to treatment timingMost hemangiomas stop growing and begin involution by 5–12 months; involution is complete by age 4 years in ~90% of patients, which informs timing and duration of therapy.

inv-09: Hemangeol contraindications — prematurity, low weight, asthma/bronchospasm, cardiac conduction issues, etc.

Prematurity (corrected age)Contraindicated in premature infants with corrected age < 5 weeks.

Low weightContraindicated in infants weighing less than 2 kg.

Reactive airway diseaseAsthma or a history of bronchospasm is a contraindication.

Cardiac conduction and functionContraindicated if heart rate < 80 bpm, greater than first‑degree heart block, or decompensated heart failure.

HypotensionContraindicated when blood pressure is < 50/30 mmHg.

PheochromocytomaPheochromocytoma is a listed contraindication to Hemangeol.