REVIEW REQUEST FOR Prolia® Xgeva® - Bone Resorption Inhibitor Provider Data Collection Tool Based on Medical Policy DRUG.00055 Policy Last Review Date: 05/07/2015 Request Date: / Initial Request Buy and bill Policy Effective Date: 05/11/2015 Provider Tool Effective Date: 05/11/2015 / Subsequent Request Individual’s Name: Date of Birth: / / Individual’s Phone Number: Insurance Identification Number: Primary Diagnosis: Diagnosis Code(s) (if known): Ordering Provider Name & Specialty: Individual’s Weight (lbs) (kg) Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Servicing Provider Name & Specialty (If different than Ordering Provider): Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Place of Service: Home Office Dialysis Center Outpatient Hospital Ambulatory Infusion Ambulatory Infusion Center Other: Drug Name/HCPCS Code (if known) Dose to be administered: Prolia® J0897 Xgeva® J0897 Other: When did the individual first start this drug? Frequency (Days, Wks, Months) / / Duration: Start Date For This Request: (Weeks) / / (mg) Other This provider data collection tool is for medical necessity review requests for the use of Denosumab (Prolia®, Xgeva®) for the treatment of individuals with osteoporosis, treatment induced bone loss, bone metastases, giant cell tumor of the bone, hypercalcemia of malignancy and for all other indications. Please check all of the following that apply to the individual REVIEW REQUEST FOR Prolia® Xgeva® - Bone Resorption Inhibitor Provider Data Collection Tool Based on Medical Policy DRUG.00055 Policy Last Review Date: 05/07/2015 Policy Effective Date: 05/11/2015 Provider Tool Effective Date: 05/11/2015 Denosumab (Prolia®) 1. Osteoporosis Request is for Prolia®) for treatment of osteoporosis (defined as a T score -2.5 or less) Individual is a postmenopausal woman (greater than or equal to 18 years of age) Individual is a man (greater than or equal to 18 years of age) (Please check all of the following that apply to the individual) either man or woman Individual has had at least one osteoporotic (minimal trauma) fracture Individual has failed or is intolerant to other available osteoporosis therapies (for example, bisphosphonates). Individual has two or more risk factors for osteoporotic fracture: (If checked, identify the risk factors that apply to the individual) hypogonadism or premature ovarian failure low body mass smoking rheumatoid arthritis alcohol intake of 3 or more drinks/day vitamin D deficiency low calcium intake hyperkyphosis parental hip fracture multiple falls medication: anticoagulants, anticonvulsants, cancer chemotherapeutic drugs, gonadatropin-releasing hormone agonists, (glucocorticoid daily dosage equivalent to 5mg or greater of prednisone for at least 3 months); Other 2. Breast Cancer Request is for Prolia® treatment of bone loss in an adult woman (greater than or equal to 18 years of age) receiving adjuvant aromatase inhibitor therapy for breast cancer. Please check all that apply: Individual has had at least one osteoporotic (minimal trauma) fracture Individual has one or more of the following risk factors for osteoporotic fracture: low body mass smoking rheumatoid arthritis alcohol intake of 3 or more drinks/day vitamin D deficiency low calcium intake hyperkyphosis parental hip fracture multiple falls medication: anticoagulants, anticonvulsants or glucocorticoid daily dosage equivalent to 5mg or greater of prednisone for at least 3 months Other Page 2 of 4 REVIEW REQUEST FOR Prolia® Xgeva® - Bone Resorption Inhibitor Provider Data Collection Tool Based on Medical Policy DRUG.00055 Policy Last Review Date: 05/07/2015 Policy Effective Date: 05/11/2015 Provider Tool Effective Date: 05/11/2015 3. Prostate Cancer For the treatment of bone loss in an adult (greater than or equal to 18 years of age) man receiving androgen deprivation therapy for non-metastatic prostate cancer Please check all that apply: Individual has had at least one osteoporotic (minimal trauma) fracture Individual has one or more of the following risk factors for osteoporotic fracture: low body mass smoking rheumatoid arthritis alcohol intake of 3 or more drinks/day vitamin D deficiency low calcium intake hyperkyphosis parental hip fracture multiple falls medication: anticoagulants, anticonvulsants or glucocorticoid daily dosage equivalent to 5mg or greater of prednisone for at least 3 months Other 4. Other Indications for Prolia not specified above ) (Please submit all supporting documents including labs, progress notes, imaging, etc., for review.) Denosumab (Xgeva®) 1. Bone Metastases Xgeva® will be used as preventive therapy for skeletal-related events in an adult (greater than or equal to 18 years of age) with bone metastases (Please identify the metastases source below) Solid tumors (excluding multiple myeloma and prostate cancer) Castration-recurrent prostate cancer Other 2. Hypercalcemia of Malignancy (HCM) Xgeva® will be used to treat HCM, defined as an albumin-corrected serum calcium level greater than 12.5 mg/dL Individual is an adult (greater than or equal to 18 years of age) Individual is refractory to recent (within last 30 days) treatment with intravenous bisphosphonate therapy (for example, pamidronate, zoledronic acid) 3. Giant Cell Tumor of the Bone Page 3 of 4 REVIEW REQUEST FOR Prolia® Xgeva® - Bone Resorption Inhibitor Provider Data Collection Tool Based on Medical Policy DRUG.00055 Policy Last Review Date: 05/07/2015 Policy Effective Date: 05/11/2015 Provider Tool Effective Date: 05/11/2015 Xgeva® will be used to treat localized or metastatic giant cell tumor of the bone (GCTB) (If checked answer the following) Tumor is unresectable Surgical resection is likely to result in severe morbidity Individual is an adult (greater than or equal to 18 years of age) Individual is a skeletally mature adolescent (defined by at least 1 mature long bone [for example: closed epiphyseal growth plate of the humerus]) 4. Other Indications for Xgeva not specified above (Please submit all supporting documents including labs, progress notes, imaging, etc., for review.) This request is being submitted: Pre-Claim Post–Claim. If checked, please attach the claim or indicate the claim number I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its designee may perform a routine audit and request the medical documentation to verify the accuracy of the information reported on this form. / / Name & Title of Provider or Provider Representative Completing Form Date & attestation (Please Print)* *The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization management services on behalf of your health benefit plan or the administrator of your health benefit plan. Page 4 of 4