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 service.
Elsevier’s Clinical Pharmacology Compendium. isatuximab-irfc (Sarclisa®). 03/06/2020. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed March 10, 2020.
Lexi-Drugs Compendium. isatuximab-irfc (Sarclisa®). 03/09/2020. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 10, 2020.
National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. isatuximab-irfc (Sarclisa®). [NCCN Web site]. 2020. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed March 24, 2020.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Multiple Myeloma. V.3.2020. 03/10/2020. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf [via free subscription]. Accessed March 24, 2020.
National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients - Multiple Myeloma. 2019. [NCCN Web site]. Available at: https://www.nccn.org/patients/guidelines/content/PDF/myeloma-patient.pdf [via free subscription]. Accessed March 10, 2020.
National Institutes of Health. Clinical trials: Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)(NCT02990338). [ClinicalTrials Web site]. last updated 03/05/2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02990338?term=NCT02990338&draw=2&rank=1 . Accessed March 10, 2020.
Rajkumar SV. Multiple myeloma: Clinical features, laboratory manifestations, and diagnosis. [UpToDate Web Site]. Updated 01/09/2020. Available at: http://www.uptodate.com/home [via subscription only]. Accessed March 10, 2020.
Rajkumar SV. Multiple myeloma: Treatment of relapsed or refractory disease. [UpToDate Web site]. 01/28/2020. Available at: http://www.uptodate.com/contents/treatment-of-relapsed-or-refractory-multiple-myeloma?source=search_result&search=daratumumab&selectedTitle=4%7E10. Accessed March 4, 2020.
Truven Health Analytics. Micromedex® DrugDex® Compendium. isatuximab-irfc (Sarclisa®). 03/04/2020. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed March 10, 2020.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. isatuximab-irfc (Sarclisa®) prescribing information and approval letter [FDA Web site]. 03/02/2020. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed March 2, 2020.
C90.00 Multiple myeloma not having achieved remission
C90.01 Multiple myeloma in remission
C90.02 Multiple myeloma in relapse
Policy: 08.00.15f:Off-label Coverage for Prescription Drugs and/or Biologics
Policy: 08.00.73l:Bortezomib (Bortezomib for Injection, Velcade®)
Policy: 08.01.05f:Carfilzomib (Kyprolis™)
Policy: 08.01.29e:Daratumumab (Darzalex™)