CurrentAlaska MedicaidPolicy N/A

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.

Policy Summary

PayerAlaska Medicaid

PolicyReclast®, Zometa® (zoledronic acid) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets indication-specific criteria and, for Reclast, has contraindication to or inadequate response to oral bisphosphonates.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial approval duration

5 mgReclast max

4 mgZometa max

J3489HCPCS

Coverage Criteria for Reclast® and Zometa® (Zoledronic acid)

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CurrentAlaska MedicaidPolicy N/A

Reclast®, Zometa® (zoledronic acid) prior authorization

Customize your policy alerts

Sign up for all Alaska Medicaid policy alerts

Know when Alaska Medicaid releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Criteria and prior authorization requirements for Reclast® and Zometa® (zoledronic acid) for Alaska Medicaid members, including indications, denial reasons, duration, and quantity limits.

Policy Summary

PayerAlaska Medicaid

PolicyReclast®, Zometa® (zoledronic acid) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets indication-specific criteria and, for Reclast, has contraindication to or inadequate response to oral bisphosphonates.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial approval duration

5 mgReclast max

4 mgZometa max

J3489HCPCS

Coverage Criteria for Reclast® and Zometa® (Zoledronic acid)

Reclast (zoledronic acid) approval

Covered when ALL of the following are met:

Reclast general: Patient is 18 years of age or older

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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
chunk 4
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
chunk 4
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
chunk 4
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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Prior bisphosphonate requirement: Patient has a contraindication to or has had an inadequate response to oral bisphosphonate therapy

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Not on Zometa: Patient is not currently receiving therapy with Zometa

chunk 4

Zometa (zoledronic acid) approval

Covered when ALL of the following are met:

Zometa general: Patient is 18 years of age or older

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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

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

HCPCSHCPCS

J3489

Zoledronic acid, not otherwise specified (HCPCS listed)

inv-06: Age — >= 18 years

Age requirementMember must be 18 years of age or older

Source context (Reclast)Reclast criteria explicitly state 'Patient is 18 years of age or older'

Source context (Zometa)Zometa criteria explicitly state 'Patient is 18 years of age or older'

inv-07: DXA T-score for osteoporosis treatment — <= -2.5 (femoral neck or spine) or radiographic vertebral fracture

DXA T-score thresholdT-score ≤ -2.5 at the femoral neck or spine

Alternative radiographic findingOsteoporotic vertebral fracture confirmed by radiographic imaging qualifies

Indication contextApplies to treatment of osteoporosis in postmenopausal women for Reclast

inv-08: FRAX hip fracture probability — >= 3% (10-year)

FRAX hip threshold10-year probability of hip fracture ≥ 3% per the WHO FRAX tool

Clinical useUsed for prevention of osteoporosis in postmenopausal women to meet Reclast prevention criteria

Tool identifiedFRAX referenced as the WHO Fracture Risk Assessment Tool in policy definitions

inv-09: FRAX major osteoporotic fracture probability — >= 20% (10-year)

FRAX major osteoporotic fracture threshold10-year probability of a major osteoporosis-related fracture ≥ 20% per FRAX

Clinical useUsed for prevention of osteoporosis in postmenopausal women to meet Reclast prevention criteria

Tool identifiedFRAX referenced as the WHO Fracture Risk Assessment Tool in policy definitions

inv-10: Glucocorticoid dose threshold — >= 7.5 mg prednisone equivalent daily for expected >= 12 months

Glucocorticoid dose thresholdSystemic glucocorticoid dose equivalent to ≥ 7.5 mg prednisone daily and expected to continue ≥ 12 months

Indication contextCriteria apply to treatment or prevention of glucocorticoid-induced osteoporosis for Reclast

Duration requirementExpectation that glucocorticoid therapy will remain for at least 12 months

inv-11: Paget's disease alkaline phosphatase threshold — >= 2 times the upper limit of age-specific normal

Alkaline phosphatase threshold for Paget'sSerum alkaline phosphatase elevated ≥ 2 times the upper limit of the age-specific normal reference range

Indication contextApplies to treatment of Paget's disease of bone when symptomatic, at risk for complications, or meets this lab threshold

Measurement noteThreshold references age-specific normal reference range

inv-12: Hypercalcemia threshold — albumin-corrected calcium >= 12 mg/dL

Hypercalcemia thresholdAlbumin-corrected calcium ≥ 12 mg/dL defines hypercalcemia of malignancy for Zometa

Indication contextThis threshold is a qualifying indication for Zometa therapy

Laboratory parameter specifiedPolicy requires albumin-corrected calcium value for assessment

Prior Authorization, Step Requirements, and Denial Triggers

Prior Authorization

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

Step Therapy

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.

Documentation Required

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 Risk

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.

Definitions

inv-18: zoledronic acid — definition and mechanism

DefinitionZoledronic acid is a bisphosphonate that inhibits osteoclastic bone resorption by binding to bone matrix

Mechanism of actionDecreases osteoclastic activity, prevents bone resorption and skeletal calcium release

Brand namesMarketed as Reclast® and Zometa®

inv-19: FRAX — World Health Organization Fracture Risk Assessment Tool definition

FRAX definitionWorld Health Organization Fracture Risk Assessment Tool to estimate 10-year probability of hip or major osteoporotic fracture

Use in policyFRAX hip (≥3%) or major osteoporotic fracture (≥20%) probabilities are used to determine Reclast prevention eligibility

Metric timeframeEstimates are 10-year fracture probabilities

Reclast®, Zometa® (zoledronic acid) prior authorization

Sign up for all Alaska Medicaid policy alerts

Coverage Criteria for Reclast® and Zometa® (Zoledronic acid)

Reclast®, Zometa® (zoledronic acid) prior authorization

Sign up for all Alaska Medicaid policy alerts

Coverage Criteria for Reclast® and Zometa® (Zoledronic acid)

Coding, Age & Clinical Thresholds

Prior Authorization, Step Requirements, and Denial Triggers

Background

Definitions