Denosumab
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, 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 function and survive. By interrupting that action, denosumab diminishes bone resorption.
Examples of preparations of denosumab are Prolia® and Xgeva®.
REFER TO DECISION SUPPORT TREE
POLICY
Denosumab (i.e., Prolia®) for the treatment of osteoporosis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Denosumab for the prevention of skeletal-related events (e.g., to increase bone mass) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Denosumab for the prevention/treatment of other conditions/diseases including, but not limited to, bone metastases from multiple myeloma is considered investigational.
MEDICAL APPROPRIATENESS
Denosumab is considered medically appropriate if ANY ONE of the following criteria are met:
For treatment of osteoporosis if ALL of the following:
Administration by a healthcare professional
Requested agent is Prolia®
Individual is a postmenopausal woman with ALL of the following:
High risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture)
Has failed or is intolerant to other available osteoporosis therapy, including an oral agent
For prevention of skeletal-related events (e.g., to increase bone mass) if ANY ONE of the following criteria are met:
Diagnosis of bone metastases with ALL of the following:
Administration by a healthcare professional
Bone metastases are from ANY ONE of the following:
Breast cancer
Prostate cancer that is castrate-resistant (i.e., hormone refractory)
Other solid tumors (e.g., non-small cell lung cancer [NSCLC], thyroid carcinoma [follicular, Hürthle cell, medullary or papillary carcinomas])
Requested agent is Xgeva®
Diagnosis of nonmetastatic prostate cancer with ALL of the following:
Administration by a healthcare professional
Receiving androgen deprivation therapy
High risk for fracture (e.g., osteopenia, history of fracture, multiple risk factors for fracture)
Requested agent is Prolia®
Diagnosis of breast cancer with ALL of the following:
Administration by a healthcare professional
Receiving adjuvant aromatase inhibitor therapy
High risk for fracture (e.g., osteopenia, history of fracture, multiple risk factors for fracture)
Requested agent is Prolia®
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies withTennessee 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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of denosumab in the treatment/prevention of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2011, November). AHFS DI. Denosumab. Retrieved November 17, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, October). Denosumab. Retrieved November 17, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Denosumab Retrieved November 17, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2011, June). Center for Drug Evaluation and Research. Prolia® (denosumab). Retrieved September 20, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf.
U. S. Food and Drug Administration. (2010, November). Center for Drug Evaluation and Research. Xgeva® (denosumab). Retrieved January 14, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/13/2010
MOST RECENT REVIEW DATE: 2/22/2012
ID_BT
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®)
Does the individual have a diagnosis of bone metastasis from multiple myeloma?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Is the requested agent Prolia® and is to be administered by a healthcare professional?
If yes, go to question #3
If no, go to question #6
Does the individual have a diagnosis of osteoporosis and ALL of the following?
Individual is a postmenopausal woman
Has a high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture)
Failure of or intolerance to other available osteoporosis therapy, including an oral agent
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #4
Does the individual have a diagnosis of nonmetastatic prostate cancer and ALL of the following?
Is receiving androgen deprivation therapy
Is at high risk of fracture (e.g., osteopenia, history of fracture, multiple risk factors for fracture)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a diagnosis of breast cancer and ALL of the following?
Is receiving adjuvant aromatase inhibitor therapy
Is at high risk of fracture (e.g., osteopenia, history of fracture, multiple risk factors for fracture)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #6
Is the request for Xgeva® to be administered by a healthcare professional to an individual with a diagnosis of bone metastases from ANY ONE of the following?
Breast cancer
Prostate cancer that is castrate-resistant (i.e., hormone refractory)
Other solid tumors [e.g., non-small cell lung cancer (NSCLC), thyroid carcinoma (follicular, Hürthle cell, medullary or papillary carcinomas)]
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.