CurrentCentenePolicy N/A

Propranolol HCl oral solution (Hemangeol) for infantile hemangioma

Defines medical necessity criteria, approval durations, contraindications, dosing, and continuation requirements for Hemangeol (propranolol HCl oral solution) used to treat proliferating infantile hemangioma for Centene lines of business (Commercial, HIM). Includes references to formulary/non-formulary and off-label policies for other uses.

Policy Summary

PayerCentene

PolicyPropranolol HCl oral solution (Hemangeol) for infantile hemangioma

Policy CodePolicy N/A

Change TypeClarified (no material changes)

Effective DateMar 1, 2024

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.

POLICY UPDATE CHANGES

Policy created per December SDC (adapted from CP PMN.58); references reviewed and updated with P&T approval dates listed through 05.25.

1Covered Indication (proliferating infantile hemangioma)

6 monthsInitial Approval Duration

6 monthsContinued Approval Duration

10-25%Observed rebound growth after therapy

Coverage Summary

Coverage stance: covered_with_criteria for the FDA-approved indication of proliferating infantile hemangioma (IH) requiring systemic therapy. Initial approval duration: 6 months. Continued approval duration: 6 months. Scope: defines medical necessity criteria, approval durations, contraindications, dosing, and continuation requirements for Hemangeol (propranolol HCl oral solution) used to treat proliferating infantile hemangioma for Centene lines of business (Commercial, HIM), with cross-references to formulary/non-formulary and off-label policies for other uses.

Eligibility thresholds and key statistics

Weight>= 2 kg

Corrected age (eligibility)>= 5 weeks

Corrected age (contraindication)Premature infants with corrected age < 5 weeks are contraindicated

Maximum consecutive therapy checkMember has not received >= 12 months of consecutive therapy (< 12 months allows continuation)

Observed rebound growth after therapy10-25% (10% of Hemangeol trial successes after 6 months later required re-treatment)

Initial and continued approval duration6 months

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 >= 5 weeks (corrected age)>= 5 weeks
Interpret corrected age for premature infants per contraindications: premature infants with corrected age <5 weeks are contraindicated.
Weight >= 2 kg>= 2 kg

Other diagnoses/indications (initial)

If request is for other diagnoses/indications, one of the following must be met:

ANY of the following

For drugs on formulary/PDL: follow no coverage criteria policy for relevant line of business (CP.CPA.190 for commercial; HIM.PA.33 for health insurance marketplace/Medicaid)
For drugs NOT on formulary/PDL: follow non-formulary policy (CPCPA.190 for commercial; HIMPA.103 for health insurance marketplace)
If requested use (diagnosis, age, dosing) is not listed under Diagnoses/Indications for which coverage is NOT authorized AND initial criteria do not apply: refer to off-label use policy (CP.CPA.09 for commercial; HIMPA.154 for health insurance marketplace)

Continuation Therapy Criteria

Other diagnoses/indications (continued therapy)

If request is for other diagnoses/indications for continuation, follow one of:

ANY of the following

For drugs on formulary/PDL: follow no coverage criteria policy for relevant line of business (CP.CPA.190 for commercial; HIM.PA.33 for health insurance marketplace/Medicaid)
For drugs NOT on formulary/PDL: follow non-formulary policy (CP.CPA.190 for commercial; HIMPA.103 for health insurance marketplace)
If requested use (diagnosis, age, dosing) is not listed under Diagnoses/Indications for which coverage is NOT authorized AND continued criteria do not apply: refer to off-label use policy (CP.CPA.09 for commercial; HIMPA.154 for health insurance marketplace)

Contraindications / Not Medically Necessary

Contraindications (requests with any of the following will not meet medical necessity): premature infants with corrected age <5 weeks; weight <2 kg; asthma or history of bronchospasm; heart rate <80 beats/min; greater than first-degree heart block; decompensated heart failure; blood pressure <50/30 mmHg; pheochromocytoma; hypersensitivity to propranolol or its excipients.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required with specified criteria

Requests require review against the policy's initial or continued therapy criteria. If criteria are met, approval duration for both initial and continued therapy is 6 months.

Documentation Required

Submit supporting clinical documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that the member has met all approval criteria.

Documentation Required

Document positive response for continuation

For continued approval, documentation must show the member is responding positively to therapy and must show either that the member has not received 12 months or more of consecutive therapy or that there is documented recurrence of the hemangioma.

Denial Risk

Contraindications may lead to denial

Requests for members with listed contraindications will not meet medical necessity and may be denied. Contraindications include: premature infants with corrected age <5 weeks, infants weighing <2 kg, asthma or history of bronchospasm, heart rate <80 bpm, greater than first-degree heart block, decompensated heart failure, blood pressure <50/30 mmHg, pheochromocytoma, and hypersensitivity to propranolol or its excipients.

Billing Rule

Formulary/off-label policy cross-reference

For uses or formulary status not covered by this policy, providers must follow the referenced formulary, non-formulary, or off-label policies listed in this policy.

CP.CPA.190
HIM.PA.33
CPCPA.190
HIMPA.103
CP.CPA.09
HIMPA.154

Clinical Evidence & Guidelines

10% required re-treatment after 6 monthsHemangeol clinical trial: 10% of patients deemed successes after 6 months later required re-treatment (rebound growth)

AAP; Pediatrics 2019; 143(1):e20183475; Pediatrics 2015;136(4):e1060-e1104Guideline references: American Academy of Pediatrics and cited clinical practice guidelines (Pediatrics 2019; 143(1):e20183475; Pediatrics 2015;136(4):e1060-e1104)

Background evidence: Hemangeol is FDA-approved for treatment of proliferating IH that require systemic therapy; oral propranolol is the treatment of choice for problematic IHs requiring systemic therapy. The FDA recommends maintaining the maintenance dose for 6 months. Rebound growth after therapy has been reported in approximately 10–25% of children (clinical trial showed 10% of successes after 6 months later required re-treatment). Relevant guideline references include AAP and other clinical practice guidelines.

Background

Hemangeol (propranolol HCl oral solution) is FDA-approved for the treatment of proliferating infantile hemangioma requiring systemic therapy. Oral propranolol is considered the treatment of choice for problematic IHs that need systemic therapy. The FDA recommends maintaining the maintenance dose for 6 months. Rebound growth has been observed in approximately 10–25% of children; in the Hemangeol trial, 10% of patients deemed successes after 6 months later required re-treatment. Definitions: IH = infantile hemangioma; HCl = hydrochloride; FDA = Food and Drug Administration.

Revision History

12.06.23 (policy created); 02.24 P&T approval; 01.18.24 annual review (no significant changes); 05.24 P&T approval; 01.13.25 annual review (no significant changes); 05.25 P&T approvalpolicy_created_or_reviewedLatest

Policy created per December SDC (adapted from CP PMN.58); references reviewed and updated with P&T approval dates listed through 05.25. Multiple review notes indicate no significant changes during annual reviews.