CurrentCentenePolicy CP.PCH.51

Propranolol HCl Oral Solution (Hemangeol)

Defines medical necessity criteria, contraindications, dosing, and authorization durations for Hemangeol (propranolol HCl oral solution) for treatment of proliferating infantile hemangioma for Centene-affiliated health plans (Commercial, HIM/ICHRA).

Policy Summary

PayerCentene

PolicyPropranolol HCl Oral Solution (Hemangeol)

Policy CodePolicy CP.PCH.51

Change TypePeriodic review; administrative update

Effective Date03.01.24

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

References reviewed and updated during periodic SDC/P&T reviews.

Added ICHRA line of business.

1FDA-approved Indication

6 monthsStandard approval duration

≥5wMinimum age

≥2kgMinimum weight

4.28 mg/mL

Product concentration

Coverage Summary

Hemangeol (propranolol HCl oral solution) is FDA-approved for the treatment of proliferating infantile hemangioma (IH) requiring systemic therapy. Oral propranolol is the treatment of choice for problematic IHs, and the policy defines medical necessity criteria and authorization durations for Hemangeol for Centene-affiliated plans. Typical authorization/maintenance dosing is continued for an approval duration of 6 months. Rebound growth after treatment has been observed in approximately 10%–25% of children.

Key thresholds / facts

Minimum age≥ 5 weeks

Minimum weight≥ 2 kg

Standard approval duration6 months

Product concentration4.28 mg/mL

FDA‑approved indication count1 (proliferating infantile hemangioma requiring systemic therapy)

Initial Therapy Criteria

I. Initial Approval Criteria - Approval Duration

Approval duration: 6 months6 months

Continuation (Renewal) Criteria

II. Continuation (Renewal) Criteria - Approval Duration

Approval duration: 6 months6 months

Unapproved Indications / Exclusions

Other Diagnoses/Indications

If request does not meet above criteria, follow one of the following (must meet 1 or 2):

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to formulary/no coverage or non-formulary policies per line of business (CP.CPA.190, HIM.PA.33, HIM.PA.103)within 6 months label change
Refer to CP.CPA.190, HIM.PA.33, HIM.PA.103
If requested use (diagnosis, age, dosing) is NOT listed under section III and criterion 1 above does not apply, refer to the off-label use policy for line of business (CP.CPA.09 or HIM.PA.154)not listed under section III
Refer to CP.CPA.09 or HIM.PA.154

III. Diagnoses/Indications NOT authorized

Provider Actions

Prior Authorization

Prior authorization required

Hemangeol requires medical necessity review and approval per this policy prior to coverage; approval durations are 6 months for initial and continuation authorizations.

Documentation Required

Submit supporting documentation

Provider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

Applicable Codes

Product NDC / Drug identifierNDC

No codes listed

Clinical Evidence

10-25%Rebound growth observed after treatment

10%Clinical trial re-treatment rate after 6 months

Oral propranolol is the treatment of choice for problematic infantile hemangiomas that require systemic therapy. The FDA recommends maintaining the maintenance dose for 6 months, though optimal treatment duration is variable and may be longer in practice. Rebound growth has been reported in 10%–25% of children, and in the Hemangeol trial about 10% of patients considered successes at 6 months later required re-treatment.

Definitions

IH: Infantile hemangioma — the most common benign tumors of infancy that may proliferate and sometimes require systemic therapy.

HCl: Hydrochloride — the chemical form in propranolol HCl.

FDA: Food and Drug Administration — the U.S. agency that approved Hemangeol for proliferating IH requiring systemic therapy.

Revision History

2024-01-18review

2Q 2024 annual review: no significant changes; references reviewed and updated.

2024-03-01effective_date

Policy effective date.

2024-05-24review

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

Policy Summary

PayerCentene

PolicyPropranolol HCl Oral Solution (Hemangeol)

Policy CodePolicy CP.PCH.51

Change TypePeriodic review; administrative update

Effective Date03.01.24

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Non-FDA approved indications not addressed in this policy are not covered unless sufficient documentation of efficacy/safety per off-label use policies CP.CPA.09 or HIM.PA.154 or evidence of coverage documents

Documentation Required

Continuation documentation requirements

For renewal, provider must document positive response to therapy and either not having received ≥ 12 months consecutive therapy or documentation of recurrence.

Denial Risk

Off-label / non-FDA uses not covered

Requests for non-FDA approved indications not addressed in this policy will be denied unless sufficient documentation per off-label use policies is provided.

2025-01-13review

2Q 2025 annual review: no significant changes; references reviewed and updated.

2025-05-25review

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

2026-03-30review

2Q 2026 annual review: no significant changes; references reviewed and updated. Added ICHRA line of business.

2026-05-26reviewLatest

2Q 2026 annual review: no significant changes; references reviewed and updated. Added ICHRA line of business (P&T approval).