This functionality is implemented using Javascript. It cannot work without it, etc...

Estamos cargando la información...

Saltar al contenido

XGEVA® (denosumab) Prevention Therapy Related Events In Patients With Bone Metastasis From Solid Tumors and Tumor Therapy Bone Giant Cell Unresectable

Xgeva®
Xgeva may be considered medically necessary in patients 13 years and older for the treatment of giant cell tumor of bone whose tumor is unresectable or for whom surgical resection is not recommended; and if the conditions below are met.

Xgeva may also be considered medically necessary in patients 18 years of age and older who have bone metastases from solid tumors, multiple myeloma or hypercalcemia due to malignancy; and if the conditions below are met.

Xgeva may be considered investigational for all other patients and for all other indications.

Prior-Approval Requirements

Age 13 years of age or older

Diagnosis

Patient must have the following:

1. Giant cell tumor of bone

a. Tumor is unresectable or surgical resection is not recommended

b. Pre-existing hypocalcemia must be corrected prior to initiating therapy

c. NO concurrent use with another RANKL-inhibitor

Age 18 years of age or older

Diagnoses

Patient must have ONE of the following:

1. Bone metastases from solid tumors

2. Multiple myeloma

AND ALL of the following for BOTH indications:

a. At high risk for skeletal-related events

b. Pre-existing hypocalcemia must be corrected prior to initiating therapy

3. Hypercalcemia of malignancy

a. Disease must have relapsed or progressed after bisphosphonate therapy

AND the following for ALL indications:

a. NO concurrent use with another RANKL-inhibitor

Prior – Approval Renewal Requirements

Age 13 years of age or older

Diagnosis

Patient must have the following:

1. Giant cell tumor of bone

a. NO concurrent use with another RANKL-inhibitor

Age 18 years of age or older

Diagnoses

Patient must have ONE of the following:

1. Bone metastases from solid tumors

2. Multiple myeloma

3. Hypercalcemia of malignancy

AND the following for ALL indications:

a. NO concurrent use with another RANKL-inhibitor

Xgeva® is not considered for payment under the following circumstances:

There is documentation of:

1 evidence of uncorrected hypocalcemia in before receiving treatment.

2. the patient presents hypersensitivity to the product or any of its components.

3. evidence of less than 3 months life expectancy.

4. the patient is being treated with intravenous or oral bisphosphonates or Prolia®.

5. the patient has history or have real evidence of that patient present osteonecrosis of the jaw.

6. evidence of active dental condition or any condition of the jaw that required oral surgery or another procedure invasive dental planned or recent.

Prolia®:

III. Initial Approval Criteria

Patient must be supplementing with 1,000 mg of calcium and at least 400 IU of vitamin D daily; AND
· Patient is at least 18 years of age; AND
· Patient must not have hypocalcemia; AND
· Patient must be at a high risk for fracture**; AND

Pregnancy ruled out prior to starting therapy in women of child-bearing potential; AND
Coverage is provided in the following conditions:

Osteoporosis in Men and Women †

· Women only: Patient must be post-menopausal; AND
· Patient has a documented diagnosis of osteoporosis indicated by one or more of the following:
o Hip DXA (femoral neck or total hip) or lumbar spine T-score ≤-2.5 and/or forearm DXA 33% (one-third) radius; OR
o T-score ≤-1 or low bone mass and a history of fragility fracture to the hip or spine or

T-score between -1 and -2.5 with a FRAX 10-year probability for major fracture ≥20% or hip fracture ≥3%; AND
· Documented treatment failure or ineffective response± to a minimum (12) month trial on previous therapy with bisphosphonates (oral or IV) such as alendronate, risedronate, ibandronate, or zoledronic acid; OR
· Patient has a documented contraindication* or intolerance to BOTH oral bisphosphonates AND intravenous (IV) bisphosphonates such as alendronate, risedronate, ibandronate, or zoledronic acid

Glucocorticoid-Induced Osteoporosis †
· Patient will be initiating or is continuing systemic glucocorticoid therapy at a daily dosage equivalent to ≥ 7.5 mg of prednisone and is expected to remain on glucocorticoid therapy for at least 6 months; AND
o Documented treatment failure or ineffective response± to a minimum (12) month trial on previous therapy with bisphosphonates (oral or IV) such as alendronate, risedronate, ibandronate, or zoledronic acid; OR
o Patient has a documented contraindication* or intolerance to BOTH oral bisphosphonates AND intravenous (IV) bisphosphonates such as alendronate, risedronate, ibandronate, or zoledronic acid

Osteoporosis treatment and prevention in prostate cancer patients †
· Documented Hip DXA (femoral neck or total hip) or lumbar spine T-score ≤-1 (or patient meets the diagnostic criteria for osteoporosis above); AND
· Patient must be receiving androgen deprivation therapy for nonmetastatic prostate cancer

Osteoporosis treatment and prevention in breast cancer patients †
· Patient must be receiving adjuvant aromatase inhibitor therapy for breast cancer ±Ineffective response is defined as one or more of the following:
– Decrease in T-score in comparison with baseline T-score from DXA scan
– Patient has a new fracture while on bisphosphonate therapy

High risk for fractures include, but are not limited to, one or more of the following:
– History of an osteoporotic fracture as an adult
– Parental history of hip fracture
– Low BMI
– Rheumatoid arthritis
– Alcohol intake (3 or more drinks per day)
– Current smoking
– History of oral glucocorticoids ≥5 mg/d of prednisone (or equivalent) for >3 months (ever) *Examples of contraindications to oral bisphosphonate therapy include the following:
– Documented inability to sit or stand upright for at least 30 minutes
– Documented pre-existing gastrointestinal disorder such as inability to swallow, Barrett’s esophagus, esophageal stricture, dysmotility, or achalasia

† FDA Approved Indication(s)

787-277-6653 787-474-6326