BlueCross BlueShield of Tennessee Medical Policy Manual

Denosumab

NDC CODE(S)

55513-0710-XX - Prolia 60 MG/ML SOLN (AMGEN)

 

55513-0730-XX - Xgeva 120 MG/1.7ML SOLN (AMGEN)

DESCRIPTION

Denosumab is a monoclonal antibody that is specific for the receptor activator of nuclear factor kappa-B ligand (RANKL).  RANKL is a soluble protein essential for the formation, function and survival of osteoclasts, those cells responsible for bone resorption.

In osteoporosis and other conditions, the balance of bone remodeling is disturbed: Osteoclasts break down more bone than osteoblasts are able to form.  This leads to decreased bone mass and bone strength.  When RANKL binds to denosumab it is inhibited from binding with and activating RANK, receptor activator of nuclear factor kappa-B.  RANK, located on the surface of osteoclasts and their precursors, must be activated to form new osteoclasts and for those present to survive and function to break down bone.  By interrupting that action, denosumab diminishes bone resorption. 

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prolia®  
All indications 60 mg subcutaneously by a health care provider every 6 months
Xgeva®  
Bone metastases from solid tumors and Multiple Myeloma 120 mg subcutaneously by a health care provider every 4 weeks
Giant Cell Tumor of Bone 120 mg subcutaneously by a health care provider every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy
Hypercalcemia of malignancy

120 mg subcutaneously by a health care provider every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 months and may be renewed.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of denosumab for the treatment or prevention of other conditions or diseases.

SOURCES

Camacho, P.M., Petak, S.M., Binkley, N. et al, American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis - 2016. Endocr Pract. 2016;Sep 2; 22(Suppl 4):1-42.

Cosman, F., De Beur, S.J., LeBoff, M.S., Lewiecki, E.M, et al, Clinicians Guide to Prevention and Treatment of Osteoporosis – 2014 Osteoporosis International  2014;25(10):2359-81.

Lexi-Comp Online. (2018). AHFS DI. Denosumab. Retrieved August 2, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, July). Denosumab. Retrieved August 2, 2018 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium® Denosumab. Retrieved August 2, 2018 from the National Comprehensive Cancer Network.

National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2014.

U. S. Food and Drug Administration. (2018, May) Center for Drug Evaluation and Research. Prolia® (denosumab). Retrieved August 2, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s178lbl.pdf.

U. S. Food and Drug Administration. (2018, June). Center for Drug Evaluation and Research. Xgeva® (denosumab). Retrieved August 2, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320Orig1s177lbl.pdf.

ORIGINAL EFFECTIVE DATE:  11/13/2010

MOST RECENT REVIEW DATE:  9/11/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit   1 mg = 1 billable unit

AGENT

DIAGNOSIS

MAXIMUM UNITS

Prolia

All indications

60 billable units every 6 months

Xgeva

Giant Cell Tumor of Bone; Hypercalcemia of malignancy

Loading Dose:

120 billable units on days 1, 8, 15, and 29

Maintenance:

120 billable units every 4 weeks

Bone metastases from solid tumors; Multiple Myeloma:

120 billable units every 4 weeks