Denosumab (Prolia®, Xgeva®) is a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL), a protein that is essential for the formation, function, and survival of osteoclasts. Denosumab (Prolia, Xgeva) prevents RANKL from activating its receptor, receptor activator of nuclear factor κ B (RANK), on the surface of the osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
Denosumab (Prolia)
Denosumab (Prolia) may be considered medically necessary for ANY of the following indications:
Denosumab (Prolia) is considered experimental/investigational when all of the criteria specified above are not met, or for the treatment of all other indications, and therefore non-covered. There is a lack of evidence based literature to confirm the efficacy and safety for any other indication.
J0897 |
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Denosumab (Xgeva)
Food and Drug Administration (FDA) Indications
Denosumab (Xgeva) may be considered medically necessary for ANY of the following indications:
National Comprehensive Cancer Network (NCCN) Indications
Denosumab (Xgeva) may be considered medically necessary for ANY of the following indications:
Denosumab (Xgeva) is considered experimental/investigational when all of the criteria specified above are not met, or for the treatment of all other indications, and therefore non-covered. There is a lack of evidence based literature to confirm the efficacy and safety for any other indication.
J0897 |
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Note: NCCN recognizes that the use of a bisphosphonate (oral/IV) or denosumab is acceptable to maintain or improve bone mineral density and reduce risk of fractures in postmenopausal (natural or induced) individuals receiving adjuvant endocrine therapy.
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Note: Therapy with denosumab (Prolia, Xgeva) is appropriate for continuation when an individual shows stability or improvement in their condition.
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NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
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All individuals should be monitored for hypocalcemia and denosumab (Prolia, Xgeva) is contraindicated for individuals with hypocalcemia.
Covered Diagnosis Codes for Denosumab (Prolia)
C61 |
M80.00XA |
M80.00XD |
M80.00XG |
M80.00XK |
M80.00XP |
M80.00XS |
M80.011A |
M80.011D |
M80.011G |
M80.011K |
M80.011P |
M80.011S |
M80.012A |
M80.012D |
M80.012G |
M80.012K |
M80.012P |
M80.012S |
M80.019A |
M80.019D |
M80.019G |
M80.019K |
M80.019P |
M80.019S |
M80.021A |
M80.021D |
M80.021G |
M80.021K |
M80.021P |
M80.021S |
M80.022A |
M80.022D |
M80.022G |
M80.022K |
M80.022P |
M80.022S |
M80.029A |
M80.029D |
M80.029G |
M80.029K |
M80.029P |
M80.029S |
M80.031A |
M80.031D |
M80.031G |
M80.031K |
M80.031P |
M80.031S |
M80.032A |
M80.032D |
M80.032G |
M80.032K |
M80.032P |
M80.032S |
M80.039A |
M80.039D |
M80.039G |
M80.039K |
M80.039P |
M80.039S |
M80.041A |
M80.041D |
M80.041G |
M80.041K |
M80.041P |
M80.041S |
M80.042A |
M80.042D |
M80.042G |
M80.042K |
M80.042P |
M80.042S |
M80.049A |
M80.049D |
M80.049G |
M80.049K |
M80.049P |
M80.049S |
M80.051A |
M80.051D |
M80.051G |
M80.051K |
M80.051P |
M80.051S |
M80.052A |
M80.052D |
M80.052G |
M80.052K |
M80.052P |
M80.052S |
M80.059A |
M80.059D |
M80.059G |
M80.059K |
M80.059P |
M80.059S |
M80.061A |
M80.061D |
M80.061G |
M80.061K |
M80.061P |
M80.061S |
M80.062A |
M80.062D |
M80.062G |
M80.062K |
M80.062P |
M80.062S |
M80.069A |
M80.069D |
M80.069G |
M80.069K |
M80.069P |
M80.069S |
M80.071A |
M80.071D |
M80.071G |
M80.071K |
M80.071P |
M80.071S |
M80.072A |
M80.072D |
M80.072G |
M80.072K |
M80.072P |
M80.072S |
M80.079A |
M80.079D |
M80.079G |
M80.079K |
M80.079P |
M80.079S |
M80.08XA |
M80.08XD |
M80.08XG |
M80.08XK |
M80.08XP |
M80.08XS |
M80.80XA |
M80.80XD |
M80.80XG |
M80.80XK |
M80.80XP |
M80.80XS |
M80.811A |
M80.811D |
M80.811G |
M80.811K |
M80.811P |
M80.811S |
M80.812A |
M80.812D |
M80.812G |
M80.812K |
M80.812P |
M80.812S |
M80.819A |
M80.819D |
M80.819G |
M80.819K |
M80.819P |
M80.819S |
M80.821A |
M80.821D |
M80.821G |
M80.821K |
M80.821P |
M80.821S |
M80.822A |
M80.822D |
M80.822G |
M80.822K |
M80.822P |
M80.822S |
M80.829A |
M80.829D |
M80.829G |
M80.829K |
M80.829P |
M80.829S |
M80.831A |
M80.831D |
M80.831G |
M80.831K |
M80.831P |
M80.831S |
M80.832A |
M80.832D |
M80.832G |
M80.832K |
M80.832P |
M80.832S |
M80.839A |
M80.839D |
M80.839G |
M80.839K |
M80.839P |
M80.839S |
M80.841A |
M80.841D |
M80.841G |
M80.841K |
M80.841P |
M80.841S |
M80.842A |
M80.842D |
M80.842G |
M80.842K |
M80.842P |
M80.842S |
M80.849A |
M80.849D |
M80.849G |
M80.849K |
M80.849P |
M80.849S |
M80.851A |
M80.851D |
M80.851G |
M80.851K |
M80.851P |
M80.851S |
M80.852A |
M80.852D |
M80.852G |
M80.852K |
M80.852P |
M80.852S |
M80.859A |
M80.859D |
M80.859G |
M80.859K |
M80.859P |
M80.859S |
M80.861A |
M80.861D |
M80.861G |
M80.861K |
M80.861P |
M80.861S |
M80.862A |
M80.862D |
M80.862G |
M80.862K |
M80.862P |
M80.862S |
M80.869A |
M80.869D |
M80.869G |
M80.869K |
M80.869P |
M80.869S |
M80.871A |
M80.871D |
M80.871G |
M80.871K |
M80.871P |
M80.871S |
M80.872A |
M80.872D |
M80.872G |
M80.872K |
M80.872P |
M80.872S |
M80.879A |
M80.879D |
M80.879G |
M80.879K |
M80.879P |
M80.879S |
M80.88XA |
M80.88XD |
M80.88XG |
M80.88XK |
M80.88XP |
M80.88XS |
M81.0 |
M81.6 |
M81.8 |
M85.9 |
M89.9 |
M94.9 |
Z79.811 |
Z87.310 |
Z87.311 |
Z87.312 |
Z87.81 |
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Covered Diagnosis Codes for Denosumab (Xgeva)
C33 |
C34.00 |
C34.01 |
C34.02 |
C34.10 |
C34.11 |
C34.12 |
C34.2 |
C34.30 |
C34.31 |
C34.32 |
C34.80 |
C34.81 |
C34.82 |
C34.90 |
C34.91 |
C34.92 |
C40.00 |
C40.01 |
C40.02 |
C40.10 |
C40.11 |
C40.12 |
C40.20 |
C40.21 |
C40.22 |
C40.30 |
C40.31 |
C40.32 |
C40.80 |
C40.81 |
C40.82 |
C40.90 |
C40.91 |
C40.92 |
C41.0 |
C41.1 |
C41.2 |
C41.3 |
C41.4 |
C41.9 |
C50.011 |
C50.012 |
C50.019 |
C50.021 |
C50.022 |
C50.029 |
C50.111 |
C50.112 |
C50.119 |
C50.121 |
C50.122 |
C50.129 |
C50.211 |
C50.212 |
C50.219 |
C50.221 |
C50.222 |
C50.229 |
C50.311 |
C50.312 |
C50.319 |
C50.321 |
C50.322 |
C50.329 |
C50.411 |
C50.412 |
C50.419 |
C50.421 |
C50.422 |
C50.429 |
C50.511 |
C50.512 |
C50.519 |
C50.521 |
C50.522 |
C50.529 |
C50.611 |
C50.612 |
C50.619 |
C50.621 |
C50.622 |
C50.629 |
C50.811 |
C50.812 |
C50.819 |
C50.821 |
C50.822 |
C50.829 |
C50.911 |
C50.912 |
C50.919 |
C50.921 |
C50.922 |
C50.929 |
C61 |
C64.1 |
C64.2 |
C64.9 |
C65.1 |
C65.2 |
C65.9 |
C73 |
C79.51 |
C79.52 |
C90.00 |
C90.01 |
C90.02 |
C90.10 |
C90.11 |
C90.12 |
C90.20 |
C90.21 |
C90.22 |
C90.30 |
C90.31 |
C90.32 |
C96.20 |
C96.21 |
C96.22 |
C96.29 |
D47.02 |
D48.0 |
E83.52 |
Z85.528 |
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.
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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.