CurrentHealth NetPolicy CP PMN.58

Propranolol HCl oral solution (Hemangeol) for proliferating infantile hemangioma

Defines medical necessity criteria, initial and continued therapy requirements, contraindications, dosing guidance, formulary redirection to generic propranolol oral solution for Medicaid line of business, and approval durations for Hemangeol (propranolol HCl oral solution) for treatment of proliferating infantile hemangioma (IH).

Policy Summary

PayerHealth Net

PolicyPropranolol HCl oral solution (Hemangeol) for proliferating infantile hemangioma

Policy CodePolicy CP PMN.58

Change TypeTemplate/redirectcontraindication updates

Effective DateMay 1, 2014

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

Redirected to generic propranolol oral solution for Medicaid line of business and removed Commercial and HIM lines of business (per December SDC).

Contraindications updated per product labeling during 2Q 2023 annual review.

1FDA approved indication

2Key safety contraindications listed

6Initial/renewal approval duration (months)

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Coverage summary: Hemangeol (propranolol HCl oral solution) is covered with criteria for the FDA‑approved indication of treatment of proliferating infantile hemangioma (IH) requiring systemic therapy. Initial approval requires diagnosis of proliferating IH, weight ≥ 2 kg, and use of generic propranolol HCl oral solution unless contraindicated; approval duration is 6 months. Continued therapy requires documentation of response and meeting the policy renewal criteria. Effective date: 05.01.14; last review: 05.25.

Key thresholds and approvals

Weight for treatment>= 2 kg

Maximum consecutive therapy before renewal consideration< 12 months (continued therapy criterion ambiguous)

Initial/renewal approval duration6 months

FDA approved indicationtreatment of proliferating infantile hemangioma requiring systemic therapy

Initial Therapy Criteria

Initial Approval Criteria

Hemangeol is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of proliferating infantile hemangioma (IH).
Age: (source text incomplete; policy indicates age/gestational age considerations; see contraindications for corrected age < 5 weeks).
Document appears to intend a minimum corrected gestational age of ≥5 weeks; source text for initial age criterion is incomplete.
Weight ≥ 2 kg.>= 2 kg
Member must use generic propranolol HCl oral solution, unless contraindicated or clinically significant adverse effects are experienced.
Policy redirects to generic propranolol oral solution for Medicaid line of business.

Approval duration: 6 months.

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Member must meet ALL of the applicable continued therapy criteria:

Member must meet one of the following (A or B):

A. Proliferating Infantile Hemangioma (must meet all):
- Member is currently receiving medication via Centene benefit or has previously met initial approval criteria.
- Member is responding positively to therapy.
  Documentation that member is responding positively to therapy is required for continuation.
- Member has not received ≥ 12 months of consecutive therapy.< 12 months
  Criterion wording in source is ambiguous; likely means member has not yet received ≥12 months of consecutive therapy.
- ONE of:
  - Member continues therapy per continuity of care regulations (if enrolled in state/product with such regulations).
    Refer to state specific addendums for continuity of care.
  - Documentation supports recurrence of hemangioma.
B. Other diagnoses/indications (must meet 1 or 2):
- For drugs on the formulary/PDL, follow no coverage criteria policy CP PMN.255 for Medicaid or relevant line of business; if a recent label change (within 6 months) is not reflected, refer to the specified policies.
- For drugs NOT on the formulary/PDL, refer to non-formulary policy CP PMN.16 for Medicaid.
- If requested use is not listed under Diagnoses/Indications Not Authorized and initial criterion does not apply, refer to off-label use policy CP.PMN.53 for Medicaid.

Approval duration: 6 months.

Provider Actions

Prior Authorization

Submission of clinical documentation required

Provider must submit clinical documentation (for example, office chart notes, laboratory results, or other relevant clinical information) that demonstrates the member meets all approval criteria for propranolol HCl oral solution therapy. Submit documentation with the prior authorization request to support the diagnosis, weight/age criteria, and other required elements for coverage.

Billing Rule

Redirect to generic propranolol oral solution

The policy redirects Medicaid members to the generic propranolol HCl oral solution: members must use the generic propranolol oral solution unless contraindicated or clinically significant adverse effects occur. This redirection to the generic product applies to the Medicaid line of business per the policy revisions.

Documentation Required

Evidence of response required for continuation

For continued therapy, documentation that the member is responding positively to propranolol treatment is required to authorize ongoing coverage. Include clinical evidence of response in the renewal request.

Clinical Evidence & Background

Background: Hemangeol (propranolol HCl oral solution) is FDA‑approved for treatment of proliferating infantile hemangioma requiring systemic therapy. Oral propranolol is the treatment of choice for problematic IHs that require systemic therapy; maintenance dosing and clinical trial data support a maintenance duration of 6 months, although optimal duration is individualized and rebound growth can occur in a subset of patients.

Evidence sources: Hemangeol Prescribing Information (Pierre Fabre, June 2021) and the American Academy of Pediatrics clinical practice guideline (Pediatrics 2019; 143(1):e20183475) are cited as primary sources of supporting information and guidance.

Background - key facts

FDA approval indicationtreatment of proliferating infantile hemangioma

Typical therapy duration6 months (individualized)

Revision History

12.06.23redirection

Per December SDC, policy removed Commercial and HIM lines of business, added redirection to generic propranolol oral solution for Medicaid; references reviewed and updated.

02.24P&T approval

P&T approval recorded for the December 2023 redirection to generic propranolol oral solution.

05.23P&T approval

2Q 2023 annual review: no significant changes; contraindications updated per product labeling and references reviewed and updated; P&T approval 05.23.

01.26.21references reviewed

2Q 2021 annual review: no significant changes; references revised and updated for HIM line of business (off-label use reference change to HIMPA.154); P&T approval 05.21.

01.31.22references reviewed

2Q 2022 annual review: no significant changes; references reviewed and updated; P&T approval 05.22. Template changes to other diagnoses/indications and continued therapy section applied 10.07.22.

01.18.24annual review

2Q 2024 annual review: no significant changes; references reviewed and updated; P&T approval 05.24.

01.13.25annual reviewLatest

2Q 2025 annual review: no significant changes; references reviewed and updated; P&T approval 05.25.