Q5161, Injection, denosumab-kyqq (aukelso/bosaya), biosimilar, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Initial therapy: documentation of the diagnosis relevant to the requested indication (e.g., osteoporosis, glucocorticoid-induced osteoporosis, non-metastatic prostate cancer receiving ADT, breast cancer receiving aromatase inhibitor therapy, multiple myeloma, bone metastases from solid tumor, giant cell tumor of bone, hypercalcemia of malignancy, systemic mastocytosis with bone pain and osteoporosis/osteopenia).
- Evidence of 'high risk for fracture' where required (examples given in policy: history of osteoporotic fracture, multiple risk factors for fracture, failure or intolerance to other osteoporosis therapy).
- For indications requiring prior bisphosphonate therapy failure/intolerance/contraindication: documentation of history of intolerance, contraindication, or treatment failure to oral bisphosphonates and/or IV bisphosphonates as specified (policy examples: pamidronate, zoledronic acid).
Key Coverage Criteria
- Jubbonti (denosumab-bbdz), Prolia (denosumab), and Stoboclo (denosumab-bmwo): Treatment of postmenopausal patients with osteoporosis or to increase bone mass in patients with osteoporosis at high risk for fracture when all of the following criteria are met: Initial Therapy; Diagnosis of osteoporosis; Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy); [...]
- Jubbonti (denosumab-bbdz), Prolia (denosumab), and Stoboclo (denosumab-bmwo): Reauthorization/Continuation of Care for postmenopausal osteoporosis: Documentation of positive clinical response to therapy; Dosing in accordance with FDA labeling; Authorization for no more than 12 months.
- Jubbonti, Prolia, and Stoboclo: Treatment of glucocorticoid-induced osteoporosis in patients at high risk for fracture when all of the following criteria are met: Initial Therapy; Diagnosis of glucocorticoid-induced osteoporosis; Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy); Dosing in accordance with FDA labeling; Authorization for no more than [...]
- Jubbonti, Prolia, and Stoboclo: Reauthorization/Continuation of Care for glucocorticoid-induced osteoporosis: Documentation of positive clinical response to therapy; Dosing in accordance with FDA labeling; Authorization for no more than 12 months.
- Jubbonti, Prolia, and Stoboclo: Increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer when all of the following criteria are met: Initial Therapy; Diagnosis of non-metastatic prostate cancer; Patient is receiving androgen deprivation therapy; One of the following (for Medicare reviews, refer to the CMS section): (a) Both: history of intolerance to oral bisphosphonate therapy AND history of failure, contraindication, or [...]
- Jubbonti, Prolia, and Stoboclo: Reauthorization/Continuation of Care for androgen deprivation therapy population: Patient is receiving androgen deprivation therapy; Documentation of positive clinical response to therapy; Dosing in accordance with FDA labeling; Authorization for no more than 12 months.
11 Active Policies
UHC-POL-denosumab-prolia-xgeva, Denosumab
UMR-POL-UMR-denosumab-prolia-xgeva, Denosumab
SUREST-POL-SUREST-denosumab-prolia-xgeva, Denosumab
BCBSIL-RX501.140, Denosumab and Biosimilars for Non-Oncologic Indications
BCBSMT-RX501.140, Denosumab and Biosimilars for Non-Oncologic Indications
Related Codes
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