BlueCross BlueShield of Tennessee Medical Policy Manual

Denosumab

NDC CODE(S)

55513-0710-XX - Prolia 60 mg/1 mL single-use prefilled syringe

 

55513-0720-XX - Prolia 60 mg/1 mL single-use vial

 

55513-0730-XX - Xgeva 120 mg/1.7 mL single-use vial

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prolia® - All indications 60 mg every 6 months
Xgeva®

 

Bone metastases from solid tumors

120 mg every 4 weeks

Giant Cell Tumor of Bone

120 mg subcutaneously 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 every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

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

Lexi-Comp Online. (2016). AHFS DI. Denosumab. Retrieved October 26, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, August). Denosumab. Retrieved October 26, 2016 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium® Denosumab. Retrieved October 26, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, August). Center for Drug Evaluation and Research. Prolia® (denosumab). Retrieved October 26, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf.

U. S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. Xgeva® (denosumab). Retrieved October 26, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320Orig1s177lbl.pdf.

ORIGINAL EFFECTIVE DATE:  11/13/2010

MOST RECENT REVIEW DATE:  2/27/2018

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.

Pharmaceutical Decision Support Tree

Denosumab (Prolia®, Xgeva®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #11

  1. Is the requested agent Prolia® with ALL of the following?

If yes, go to question #3

If no, go to question #5

  1. Does the individual have a diagnosis of osteoporosis if ALL of the following?

If yes, go to question #9

If no, go to question #4

  1. Is there a diagnosis of or a requirement for prevention of osteoporosis in a cancer patient with ALL of the following?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested agent Xgeva® with ALL of the following?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for prevention of skeletal-related events in individuals with bone metastasis from solid tumors?

If yes, go to question #10

If no, go to question #7

  1. Is the request for the treatment of Giant Cell Cancer of the Bone if ALL of the following?

If yes, go to question #10

If no, go to question #8

  1. Is the request for treatment of Hypercalcemia of malignancy if ALL of the following?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for Prolia® for 60 billable units every 6 months for dosage of 60 mg every 6 months for an authorization of 12 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for Xgeva® for any of the following for an authorization of 12 months?

Bone metastases from solid tumors

120 billable units every 4 weeks

120 mg every 4 weeks

Giant Cell Tumor of Bone & Hypercalcemia of malignancy

120 billable units on days 1,8,15 & 29 loading dose (first month only)

120 billable units every 4 weeks maintenance

120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in question 2 through 10?

If yes, go to question #12

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response indicated by improvement in symptoms?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug, e.g., severe symptomatic hypocalcemia?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.