Anthem Blue Cross California Denosumab agents Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of denosumab which is approved for the treatment of individuals with osteoporosis, glucocorticoid- induced osteoporosis, treatment induced bone loss, bone metastases, multiple myeloma, giant cell tumor of the bone, hypercalcemia of malignancy and for all other indications as applicable. Denosumab (Prolia, Xgeva) is a subcutaneous, fully human monoclonal antibody that is specifically designed to target the human receptor activator of nuclear factor kappa-B ligand (RANKL). The American College of Endocrinology (AACE/ACE) (2020) osteoporosis treatment guidelines stratify initial treatment based on risk status. For those at high risk/no prior fractures, initial therapy options include bisphosphonates (alendronate, risedronate, or zoledronic acid) or denosumab. For those at very high risk/prior fractures, initial therapy options are denosumab, abaloparatide, teriparatide, romosozumab, or zoledronic acid. The Endocrine Society osteoporosis guideline update (2020) recommends initial therapy with bisphosphonates (alendronate, risedronate, zoledronic acid, or ibandronate) or alternatively denosumab for those at high risk. Osteoporosis may be diagnosed by bone mineral density (BMD) testing indicating a T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population. It also may be clinically diagnosed based on a history of a fragility fracture (low trauma fracture). Higher risk for fracture may be defined as: 1. 2. 3. History of osteoporotic fracture; or Multiple risk factors for fractures, including but not limited to: Prior low-trauma fracture as an adult, advanced age, gender, ethnicity, low bone mineral density (T-score -1.0 to-2.5), low body weight (<57.6kg), family history of osteoporosis, use of glucocorticoids (daily dosage equivalent to 5 mg or greater prednisone for at least 3 months), current cigarette smoking, excessive alcohol consumption (3 or more drinks per day), secondary osteoporosis (such as rheumatoid arthritis), early menopause, height loss of kyphosis, fall risk and low calcium intake; or Failure or intolerance to other osteoporosis therapies. A failure of other osteoporosis therapies, otherwise known as refractory disease, may be defined as a decline in BMD while on therapy (≥5%) or a fragility fracture while on therapy. AACE/ACE (2020) recommends obtaining a baseline axial (lumber spine and hip; 1/3 radius if indicated) dual-energy X-ray absorptiometry (DXA) and after treatment initiation, repeat DXA every 1 to 2 years until findings are stable. Depending on clinical circumstances, follow-up DXA every 1 to 2 years or less frequently can be continued thereafter. Successful response to osteoporosis therapy is considered when BMD is stable or increasing with no evidence of new fractures or vertebral fracture progression. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Prolia (denosumab) Initial requests for Prolia (denosumab) may be approved when the following criteria are met: I. AND Individual is 18 years of age or older; 1 II. III. IV. V. OR VI. VII. VIII. IX. OR X. OR XI. XII. XIII. Individual is a male or postmenopausal female with a diagnosis of osteoporosis (defined as a bone mineral density (BMD) T- score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)); AND Individual has had at least one osteoporotic (minimal trauma) fracture; OR Individual has two or more risk factors for osteoporotic fracture; OR Individual has failed, is intolerant to or has a medical contraindication to other available osteoporosis therapies (for example, bisphosphonates); Individual has glucocorticoid-induced osteoporosis (defined as a bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture)) and is initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5mg or greater of prednisone and expected to remain on glucocorticoids for a least 6 months; AND Individual has had at least one osteoporotic (minimal trauma) fracture; OR Individual has two or more risk factors for osteoporotic fracture; OR Individual has failed, is intolerant to or has a medical contraindication to other available osteoporosis therapies (for example, bisphosphonates); Individual is a postmenopausal (natural or induced) female receiving adjuvant aromatase inhibitor therapy for treatment of breast cancer; Individual is a male receiving androgen deprivation therapy for non-metastatic prostate cancer; AND Individual has had at least one osteoporotic (minimal trauma) fracture; OR Individual has one or more additional risk factors for osteoporotic fracture. Continuation Request for Prolia (denosumab) may be approved if the following criterion is met: I. II. There is clinically significant response to therapy (including but not limited to confirmation of no new fractures or reduction of fractures, or no worsening vertebral fractures, or no clinically significant adverse reaction); AND If individual has been on therapy ≥ 24 months of treatment, a repeat BMD demonstrates a stable or increase in BMD. Xgeva (denosumab) Requests for Xgeva (denosumab) may be approved when the following criteria are met: I. II. OR III. IV. OR V. Individual is 18 years of age or older; AND Individual is using for the prevention of skeletal-related events with one of the following conditions: A. Multiple myeloma; OR B. Bone metastases from solid tumor other than prostate cancer; OR C. Bone metastases from castration resistant/recurrent prostate cancer; Individual is 18 years of age or older; AND Individual is using for the treatment of hypercalcemia of malignancy (defined as an albumin-corrected serum calcium level greater than 12.5 mg/dL (3.1 mmol/L)) and is refractory to recent (within last 30 days) treatment with intravenous bisphosphonate therapy (such as pamidronate or zoledronic acid); Individual is using for the treatment of localized or metastatic giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity; AND A. B. Individual is 18 years of age or older; OR Individual is a skeletally mature adolescent (defined by at least one mature long bone [for example; closed epiphyseal growth plate of the humerus]). Request for denosumab agents (Prolia, Xgeva) may not be approved when the above criteria are not met and for all other indications. Quantity Limits Denosumab Agents Quantity Limit Drug Limit 2 Prolia (denosumab) 60 mg/1 mL prefilled syringe Xgeva (denosumab) 120 mg/1.7 mL vial* 60 mg (1 prefilled syringe) every 6 months 1 vial per 28 days Override Criteria *Xgeva (denosumab): Requests for increased quantities may be approved for one (1) month, only during the first month of therapy for two (2) additional 120 mg doses for the diagnosis of Giant Cell Tumor of Bone or Hypercalcemia of Malignancy Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J0897 Injection, denosumab, 1 mg [Prolia, Xgeva] ICD-10 Diagnosis C00.0-C39.9 Malignant neoplasms C40.00-C41.9 C43.0-C60.9 C61 C62.00-C75.9 C76.0-C76.8 C79.51 Malignant neoplasm of bone and articular cartilage Malignant neoplasms Malignant neoplasm of prostate Malignant neoplasms Malignant neoplasm of other and ill-defined sites Secondary malignant neoplasm of bone C90.00-C90.32 Multiple myeloma and malignant plasma cell neoplasms D48.0 E83.52 Neoplasm of uncertain behavior of bone and articular cartilage [specified as GCTB] Hypercalcemia M81.0-M81.8 Osteoporosis without current pathological fracture M85.80-M85.9 Other specified disorders of bone density and structure [osteopenia] N95.1 Z08 Menopausal and female climacteric states Encounter for follow-up examination after completed treatment for malignant neoplasm Z51.11-Z51.12 Encounter for antineoplastic chemotherapy and immunotherapy Z78.0 Postmenopausal status NOS Z79.51-Z79.52 Long term (current) use of steroids Z79.811 Z79.899 Long term (current) use of aromatase inhibitors Other long term (current) drug therapy [prophylactic drug therapy] Z85.00-Z85.45 Personal history of malignant neoplasms Z85.46 Z85.47-Z85.59 Z85.810-Z85.9 Z87.310 Personal history of malignant neoplasm of prostate Personal history of malignant neoplasms Personal history of malignant neoplasms Personal history of (healed) osteoporosis fracture M80.00XA- M80.88XS Osteoporosis with current pathological fracture Document History Revised: 08/18/2023