Prior Auth Protocol

Prior Authorization Protocol

KANUMA^TM (sebelipase alfa)

NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

FDA Approved Indications:
- For use in the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of Lysosomal Acid Lipase (LAL) deficiency
Coverage is Not Authorized For:
- Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
General Information:
- LAL deficiency includes Wolman disease and cholesteryl ester storage disease.
Therapeutic Alternatives:

Drug Dosing Regimen Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Kanuma	Rapidly progressive LAL deficiency presenting within the first 6 months of life: 1 mg/kg IV once weekly. May increase to 3 mg/kg IV once weekly if suboptimal clinical response. Pediatric and adult patients with LAL deficiency: 1 mg/kg IV every other week	Length of Benefit HNCA: 6 months or to member's renewal date, whichever is longer

Product Availability:

Single-use Vial: 20 mg/10 mL (2 mg/mL)
References:

1. Kanuma [Prescribing Information]. Cheshire, CT: Alexion Pharmaceuticals Inc; December 2015.
2. Burton, BK et al. A phase 3 trial of sebelipase alfa in lysosomal acid lipase deficiency. N Engl J Med 2015;373:1010-20.

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.