Reclast®, Zometa® (zoledronic acid) prior authorization
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Criteria and prior authorization requirements for Reclast® and Zometa® (zoledronic acid) for Alaska Medicaid members, including indications, denial reasons, duration, and quantity limits.
No material clinical or coverage changes in this revision.
Coverage Criteria for Reclast® and Zometa® (Zoledronic acid)
Reclast (zoledronic acid) approval
Covered when ALL of the following are met:
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Indications for Reclast
- a Treatment of osteoporosis in postmenopausal woman: Either (i) prior to therapy, DXA T-score ≤ -2.5 at the femoral neck or spine or osteoporotic vertebral fracture confirmed by radiographic imaging OR (ii) high risk of fracture defined as a recent low-trauma hip fracture
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- b Prevention of osteoporosis in postmenopausal woman: T-score < -1.0 at the femoral neck, spine, or total hip AND either a 10-year probability of hip fracture ≥ 3% per FRAX OR a 10-year probability of a major osteoporosis-related fracture ≥ 20% per FRAX
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- c Treatment of male with osteoporosis: Male with osteoporosis; if hypogonadal, is receiving testosterone but remains at high risk for fracture or has a contraindication to testosterone
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- d Glucocorticoid-induced osteoporosis: Initiating or continuing systemic glucocorticoids in a daily dosage equivalent to ≥ 7.5 mg prednisone and expected to remain on glucocorticoids ≥ 12 months
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- e Paget's disease: Treatment of Paget's disease when the member is symptomatic, at risk for complications, or serum alkaline phosphatase is ≥ 2 times the upper limit of the age‑specific normal reference range
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Zometa (zoledronic acid) approval
Covered when ALL of the following are met:
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Indications for Zometa
- a Hypercalcemia of malignancy: Hypercalcemia of malignancy defined as an albumin‑corrected calcium ≥ 12 mg/dL
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- b Multiple myeloma: Multiple myeloma when used in conjunction with antineoplastic therapy and calcium plus vitamin D supplementation
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- c Bone metastases from solid tumors: Bone metastases from solid tumors when used in conjunction with antineoplastic therapy and calcium plus vitamin D supplementation
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Patients with uncorrected pre-existing hypocalcemia are excluded from coverage until the hypocalcemia has been corrected with adequate calcium and vitamin D supplementation.
Requests that do not meet the listed approval criteria are considered not medically necessary and will be denied.
Coding, Age & Clinical Thresholds
| J3489 | Zoledronic acid, not otherwise specified (HCPCS listed) |
Prior Authorization, Step Requirements, and Denial Triggers
Prior authorization required for Reclast and Zometa
Prior authorization is required for Reclast® and Zometa®. Approvals are granted only when the member meets the specific clinical indications listed for each product; initial approval is for 12 months and reauthorization may be granted for up to 12 months. Quantity limits apply: Reclast—one infusion not exceeding 5 mg; Zometa—one infusion not exceeding 4 mg. HCPCS code J3489 applies.
- Approvals granted per the listed clinical indications for Reclast and Zometa.
- Initial Approval: 12 months; Reauthorization Approval: up to 12 months.
- Quantity limits: Reclast 1 infusion ≤5 mg; Zometa 1 infusion ≤4 mg.
- Billing HCPCS: J3489
Reclast requires prior oral bisphosphonate contraindication or inadequate response
For Reclast®, the member must have a contraindication to or an inadequate response to oral bisphosphonate therapy before Reclast will be approved.
Required references — consult product package inserts
Refer to the Reclast® and Zometa® package inserts for full cautions and prescribing information. Provider must consult the manufacturers' labeling linked in the policy when considering therapy.
- Reclast package insert: https://www.novartis.us/sites/www.novartis.us/files/reclast.pdf?campaign=uehcd
- Zometa package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf
Denial triggers — unmet criteria or uncorrected hypocalcemia
Requests will be denied if the approval criteria are not met or if the patient has pre-existing hypocalcemia that has not been corrected with adequate supplementation of calcium and vitamin D.
- Denial triggers: failure to meet approval criteria.
- Denial trigger: uncorrected pre-existing hypocalcemia despite supplementation with calcium and vitamin D.
Background
Zoledronic acid is an intravenous bisphosphonate that inhibits osteoclastic bone resorption and is marketed as Reclast® and Zometa®. Reclast is used primarily for osteoporosis indications (treatment and prevention, including postmenopausal and glucocorticoid‑induced osteoporosis, male osteoporosis, and Paget’s disease), while Zometa is used for oncologic indications such as hypercalcemia of malignancy, adjunctive therapy in multiple myeloma, and management of bone metastases from solid tumors.
Definitions
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