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Documentations Requirements for Boniva, Zometa, Reclast, Prolia and Xgeva


Bisphosphonate therapy:

The following bisphosphonate injections (administered IV) are considered medically reasonable and necessary when administered as outlined below. The coverage of IV bisphosphonates must be supported in the medical record. The documentation should include the following information:

• Criteria for the diagnosis of osteoporosis, and
• History of treatment as related to progression of disease and ongoing risk factors, and
• Description of treatment failure of oral or self administered drugs for osteoporosis as applicable to the patient that supports IV therapy in lieu of standard oral treatment protocol.
• An indication that the serum creatinine was measured prior to the administration of the drug.
• An indication that the oral health of the patient was discussed

Boniva®

The documentation must clearly state why IV Boniva® is being given as opposed to the oral form of the drug. Documentation should demonstrate if one of the following apply:

• Patient has a diagnosis of esophageal stricture, achalasia, or other severe esophageal dysmotility disorder; OR
• Patient has a history of severe malabsorption making use of oral bisphosphonates ineffective; OR
• Patient has an inability to stand or sit upright for 60 minutes; OR
• Patient had adverse side effects secondary to oral form of the drug that required the withdrawal of the oral from of the medication.
• An indication that the serum creatinine was measured before Bonica® was administered
• An indication that the patient does not have severe renal impairment (patients with severe renal impairment with serum creatinine >200 ┬Ámol/L [2.3 mg/dL] or creatinine clearance measured or estimated <30 mL/min should not receive Boniva® injection)
• Documentation to support that the drug was administered per IV route by a healthcare professional with a 3mg/3 mL bolus over 15 to 30 seconds every three months

Reclast® - All patients

• An indication that the patient received adequate hydration prior to treatment
• An indication that the patient has a creatinine clearance of ≥35 mL/min or better
• Documentation to support that the drug was administered one time in a year per IV route by a healthcare professional with 5 mg Reclast® infused IV over no less than 15 minutes given over a constant infusion rate with a 10 mL normal saline flush of the IV line following the infusion

Reclast® for Glucocorticoid-Induced Osteoporosis in Men and Women (must meet above criteria also)

• An indication that the patient is either initiating or continuing to take system glucocorticoids in a daily dosage of 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months
• An indication that the patient is taking at least 1200 mg calcium and 800-1000 IU vitamin D per day

Reclast® for Women or Men with Osteoporosis

• An indication that the patient is taking at least 1200 mg calcium and 800-1000 IU vitamin D per day

Reclast® for Paget’s Disease

• An indication that the patient has been instructed to take 1500 mg elemental calcium daily in divided doses (750 mg two times per day, or 500 mg three times per day) and 800 IU vitamin D per day, particularly in the 2 weeks following the administration of Reclast®

• An indication that the patient has one of the following:

o An elevated serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or
o The patient is symptomatic, or
o The patient is at risk for complications from the disease, to induce remission (normalization of serum alkaline phosphotase) prior to treatment with Reclast®

Reclast® for Re-Treatment of Paget’s Disease

• An indication that the patient is experiencing a relapse based on serum alkaline phosphatase, or
• An indication that the patient has failed to achieve normalization of their serum alkaline phosphatase, or
• An indication that the patient has symptoms as dictated by current standard medical practice.

Zometa®

• An indication that the patient is not on any other bisphosphonate medication(s)
• Documentation to support that the drug was administered per IV route by a healthcare professional with a dosage amount not exceeding 4 mg administered for no less than 15 minutes
• An indication that the renal status of the patient has been monitored

Zometa® for Hypercalcemia of Malignancy

• An indication that the patient has an albumin-corrected serum calcium of ≥ 12 mg/dL (3.0 mmol/L)
• The date of the last treatment must be indicated

Zometa® for Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors

• An indication that for the patient with a creatinine clearance of > 60 mL/min, a 4 mg IV infusion over no less than 15 minutes was administered every 3-4 weeks by a healthcare provider
• An indication that the patient was coadministered oral calcium supplements of 500 mg and a multiple vitamin containing 400 IU of vitamin D per day

Prolia™

Prolia™ for Women with Postmenopausal Osteoporosis

• An indication that the patient meets the definition of high risk for fracture, or
• An indication that the patient has failed or is intolerant of other available osteoporotic therapy
• An indication that the patient received a single dose of 60 mg SQ Prolia™ which was administered by a healthcare professional into the upper arm, the upper thigh or the abdomen once in 6 months
• An indication that the patient was instructed to take 1000 mg of calcium and at least 400 IU of vitamin D per day

Xgeva™

Xgeva™ for the prevention of skeletal-related events in patients with Bone Metastasis from solid tumors

• An indication that the patient received a single dose dose of 120 mg SQ Xgeva™ which was administered by a healthcare professional into the upper arm, the upper thigh or the abdomen once every 4 weeks
• An indication that the patient is taking calcium and vitamin D supplements as necessary to treat or prevent hypocalcemia


Utilization Guidelines

It is expected that these services would be performed as indicated by current literature and/or standards of practice and should follow the guidelines for administration and safety found in the FDA approved labels for these drugs. When services are performed in excess of established parameters, they may be subject to medical review for medical necessity.

Boniva®

• Boniva® injection must be administered by intravenous route only by a healthcare professional
• The recommended dose of Boniva® injection is 3 mg/3 mL IV bolus over 15 to 30 seconds once every three months
• Patients with severe renal impairment with serum creatinine >200 ┬Ámol/L (2.3 mg/dL) or creatinine clearance measured or estimated <30 mL/min should not receive Boniva® injection
• Patients taking Boniva® must receive supplemental calcium and vitamin D

Reclast®

• Reclast® contains the same active ingredient found in Zometa®. A patient that is already receiving Zometa® should not be treated with Reclast®.
• Patients must receive adequate hydration prior to the administration of Reclast®
• For patients with creatinine clearance ≥35 mL/min the recommended dose of Reclast® is 5 mg infused intravenously once a year over no less than 15 minutes given over a constant infusion rate with a 10 mL normal saline flush of the IV line following the infusion

Glucocorticoid-Induced Osteoporosis

• The recommended regimen is a 5 mg of Reclast® IV infused once a year over no less than 15 minutes given over a constant infusion rate with a 10 mL normal saline flush of the IV line following the infusion.
• An average of at least 1200 mg calcium and 800-1000 IU vitamin D per day is recommended for patients with glucocorticoid-induced osteoporosis receiving Reclast®.

Osteoporosis in Postmenopausal Women and Men

• For treatment of osteoporosis in postmenopausal women and men, 5 mg of Reclast® IV infused once a year over no less than 15 minutes given over a constant infusion rate is recommended with a 10 mL normal saline flush of the IV line following the infusion.
• 1200 mg calcium and 800-1000 IU vitamin D per day.

Paget’s Disease

• The recommended dose is 5 mg of Reclast® IV infused once a year over no less than 15 minutes given over a constant infusion rate with a 10 mL normal saline flush of the IV line following the infusion.
• To reduce the risk of hypocalcemia, all patients with Paget’s disease should receive 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 IU vitamin D daily, particularly in the 2 weeks following the administration of Reclast®.

Zometa®

• Zometa® contains the same active ingredient found in Reclast®. A patient that is already receiving Zometa® should not be treated with Reclast®.
• A single dose of Zometa® should not exceed 4mg and must be given intravenously for no less than 15 minutes.
• Retreatment with Zometa® 4 mg may be considered if serum calcium does not return to normal or remain normal after treatment.
• It is recommended that a minimum of 7 days elapse before re-treatment to allow for full response to the initial dose.
• Renal function must be carefully monitored in all patients receiving Zometa® and possible deterioration in renal function must be assessed prior to re-treatment with Zometa®

Hypercalcemia of Malignancy

• Zometa® is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected serum calcium ≥ 12 mg/dL [3.0 mmol/L].
• The maximum recommended dose of Zometa® for this indication is 4 mg dose given as a single-dose IV infusion over no less than 15 minutes.
• Patients should have their serum creatinine assessed prior to each treatment.
• Patients should be adequately hydrated prior to the administration of Zometa®.
• Retreatment may be considered if serum calcium does not return to normal or remain normal after the initial treatment.
• A minimum of 7 days should elapse prior to retreatment to allow for full response to the initial dose.

Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors

• The recommended dose of Zometa® for these indications for patients with creatinine clearance >60 mL/min is 4 mg infused over no less than 15 minutes every 3 to 4 weeks.
• Patients should take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of Vitamin D daily.

Monoclonal Antibodies - RANK ligand (RANKL) Inhibitors:

Prolia™

Postmenopausal Women with Osteoporosis at High Risk for Fracture

• Prolia is a single dose 60 mg subcutaneous (SQ) injection administered by a healthcare professional into the upper arm, the upper thigh, or the abdomen once every six months.
• Patients receiving Prolia™ are instructed to take 1000 mg of calcium and at least 400 IU of vitamin D per day.

Xgeva™

Prevention of Skeletal-Related Events in Patients with Bone Metastisis from Solid Tumors

• Xgeva™ is a single dose of 120 mg SQ injection administered by a healthcare professional into the upper arm, the upper thigh, or the abdomen once every 4 weeks.
• Patients receiving Xgeva™ should take calcium and vitamin D as necessary to treat or prevent hypocalcemia.

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