HEMANGEOL, Propranolol HCl Form

Propranolol HCl oral solution (Hemangeol®) is a beta-adrenergic blocker.
FDA Approved Indication(s) Hemangeol oral solution is indicated for the treatment of proliferating infantile hemangioma (IH) requiring systemic therapy. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Hemangeol is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Proliferating Infantile Hemangioma (must meet all):

1. Diagnosis of proliferating IH;
   2. Age ≥ 5 weeks;
   3. Weight ≥ 2 kg;
   4. Member must use generic propranolol HCl oral solution, unless contraindicated or clinically significant adverse effects are experienced. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
2. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or

3. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
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   CLINICAL POLICY Propranolol HCl Oral Solution
   II. Continued Therapy A. Proliferating Infantile Hemangioma (must meet all):

4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. Member meets one of the following (a or b): a. Member has not received ≥ 12 months of consecutive therapy; b. Documentation supports recurrence of hemangioma. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or

6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HCl: hydrochloride IH: infantile hemangioma Appendix B: Therapeutic Alternatives
   Dosing Regimen Drug Name Propranolol HCl oral solution* 1 mg/kg/day PO initially in 2 to 3 divided doses, titrated to a target dose of 2 to 3 Dose Limit/ Maximum Dose See regimen Page 2 of 6

   CLINICAL POLICY Propranolol HCl Oral Solution
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose mg/kg/day initially in 2 to 3 divided doses, unless there are comorbidities (e.g., PHACE syndrome, progressive ulceration) or adverse reactions that require a lower dose Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. *off-label Appendix C: Contraindications/Boxed warnings • Contraindication(s): premature infants with corrected age of less than 5 weeks, infants weighing less than 2 kg, asthma or history of bronchospasm, heart rate less than 80 beats/min, greater than first degree heart block, decompensated heart failure, blood pressure less than 50/30 mmHg, pheochromocytoma, hypersensitivity to propranolol or its excipients • Boxed warning(s): none reported Appendix D: Management of IH
   • IHs are the most common benign tumors of infancy. While they often involute after proliferation, there are some that rapidly develop life-threatening complications, resulting ulceration, functional impairment, underlying abnormalities, or permanent disfiguration. Oral propranolol is the treatment of choice for problematic IHs that require systemic therapy.
   • Although the most dramatic improvement using propranolol for IH occurs within 3 to 4 months of initiation of therapy, the optimal treatment duration has not been established:
   o The FDA recommends the maintenance dose be maintained for 6 months. This is likely based on the clinical trial for approval which evaluated patients after 6 months of treatment. o The American Academy of Pediatrics indicates that many continue therapy until patients reach an age when IH would normally begin to regress without treatment- often until at least 8 to 12 months of age, which, in most studies, equated to 3 to 12 months of therapy. • While Hemangeol is effective, rebound growth has been observed in 10% to 25% of children. In the Hemangeol clinical trial, 10% of patients deemed successes after 6- months of therapy later required re-treatment for recurrence. V. Dosage and Administration
   Indication Proliferating IH Dosing Regimen 0.15 mL/kg (0.6 mg/kg) PO twice daily, increase to 0.3 mL/kg (1.1 mg/kg) twice daily after 1 week, then to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily after 2 weeks Maximum Dose See regimen Page 3 of 6

   CLINICAL POLICY Propranolol HCl Oral Solution
   VI. Product Availability
   Oral solution: 4.28 mg/mL VII.