Prolia® Xgeva® - (Denosumab) - Bone Resorption Inhibitor

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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
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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
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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.
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