When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
When coverage of sebelipase alfa (KanumaŽ) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.
Camarena C, Aldamiz-Echevarria LJ, Polo B, et al. Update on lysosomal acid lipase deficiency: Diagnosis, treatment and patient management. Med Clin (Barc). 2017 May 10;148(9):429.e1-429.e10.
Elsevier’s Clinical Pharmacology Compendium. Sebelipase alfa. [ClinicalKey Web site]. 01/06/2016. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed April 15, 2020.
Kanuma (Sebelipase alfa). Prescribing Information. New Haven, CT: Alexion Pharmaceuticals Inc; 2015. Available at: https://kanuma.com/hcp . Accessed April 15, 2020.
Lexi-Drugs Compendium. Sebelipase alfa. [Lexicomp Online Web site]. 11/16/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed April 15, 2020.
MicromedexŽ Healthcare Series [Internet database]. DRUGDEXŽ Evaluations. Sebelipase alfa (KanumaŽ). Greenwood Village, CO: Thomson Micromedex. 11/06/2019. Available at:
http://www.micromedexsolutions.com/micromedex2/librarian. Accessed April 15, 2020.
National Institutes of Health (NIH). Genetics Home Reference. LIPA Gene. Reviewed 02/2017. Available at: https://ghr.nlm.nih.gov/gene/LIPA#conditions . Accessed April 15, 2020.
Reiner Z, Guardamagna O, Nair D, etc. Lysosmal acid lipase deficiency: An under-recognized cause of dyslipidaemia and liver dysfunction. Atherosclerosis.2014; 235:21-30.
US Food and Drug Administration. Sebelipase alfa (KanumaŽ). Product Information. 12/2015. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ or http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125561s000lbl.pdf. Accessed April 15, 2020.
Policy: 07.00.20f:Routine Costs Associated with Qualifying Clinical Trials
Policy: 08.00.15f:Off-label Coverage for Prescription Drugs and/or Biologics