Health Net zoledronic acid Coverage & Prior Auth | OpenPayer

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Health Net zoledronic acid Coverage & Prior Auth | OpenPayer

Initial Approval — Osteoporosis

Covered when ALL of the following are met:

Osteoporosis initial criteria: 1) Prescribed for treatment or prevention of postmenopausal osteoporosis (PMO), glucocorticoid-induced osteoporosis (GIO), or male osteoporosis; 2) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 3) Failure of a 12‑month trial of an oral bisphosphonate (generic alendronate preferred) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 4) Dose does not exceed 5 mg; 5) If request is for brand Reclast, member must use zoledronic acid 5 mg/100 mL (generic Reclast) unless contraindicated or clinically significant adverse effects are experienced.

Prior authorization may be required for oral bisphosphonates.

Initial Approval — Paget Disease of Bone

Covered when ALL of the following are met:

Paget disease criteria: 1) Diagnosis of Paget disease of bone; 2) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 3) Dose does not exceed 5 mg; 4) If request is for brand Reclast, member must use zoledronic acid 5 mg/100 mL (generic Reclast) unless contraindicated or clinically significant adverse effects are experienced.

Initial Approval — Hypercalcemia of Malignancy

Covered when ALL of the following are met:

Hypercalcemia of malignancy criteria: 1) Request is for zoledronic acid 4 mg/5 mL or 4 mg/100 mL (formerly Zometa); 2) Diagnosis of hypercalcemia of malignancy; 3) Prescribed by or in consultation with an oncologist; 4) Albumin‑corrected calcium ≥ 12 mg/dL; 5) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 6) Dose does not exceed 4 mg.Albumin-corrected calcium >= 12 mg/dL

Initial Approval — Multiple Myeloma or Solid Tumor with Bone Metastases

Covered when ALL of the following are met:

Multiple myeloma or solid tumor criteria: 1) Request is for zoledronic acid 4 mg/5 mL or 4 mg/100 mL; 2) Diagnosis of multiple myeloma with member receiving or initiating therapy for symptomatic disease OR diagnosis of a solid tumor with bone metastases; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 5) Dose does not exceed 4 mg.

Initial Approval — Off-label Indications (Prostate/Breast Cancer Fracture Prevention; Systemic Mastocytosis; Langerhans Cell Histiocytosis)

Covered when ALL of the following are met:

Prostate/Breast cancer fracture prevention: 1) Diagnosis of prostate cancer receiving androgen deprivation therapy OR breast cancer receiving adjuvant endocrine therapy; 2) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 3) Prescribed by or in consultation with an oncologist; 4) Dose does not exceed 4 mg; 5) Request meets one of: a) dose/regimen is FDA‑approved or recommended by NCCN; or b) dose is supported by practice guidelines or peer‑reviewed literature with supporting evidence submitted by the prescriber.

Medicaid/HIM approval durations differ by cancer type (see policy).

Systemic mastocytosis: 1) Diagnosis of systemic mastocytosis; 2) Request is for zoledronic acid 4 mg formulations; 3) Member has osteopenia or osteoporosis with bone pain; 4) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 5) Prescribed by or in consultation with an oncologist; 6) Request meets one of: a) dose ≤ 4 mg; or b) dose is supported by practice guidelines or peer‑reviewed literature with prescriber submitting supporting evidence.

Langerhans cell histiocytosis: 1) Diagnosis of Langerhans cell histiocytosis; 2) Request is for zoledronic acid 4 mg formulations; 3) Member has multifocal bone disease or unifocal LCH with isolated bone disease; 4) Prescribed by or in consultation with an oncologist; 5) Age ≥ 18 years or documentation of closed epiphyses on X‑ray; 6) Request meets one of: a) dose ≤ 4 mg; or b) dose is supported by practice guidelines or peer‑reviewed literature with prescriber submitting supporting evidence.

Continued therapy — Osteoporosis/Paget

Continued therapy — Osteoporosis and Paget Disease of Bone (must meet ALL):

Osteoporosis/Paget continued therapy criteria: Member is currently receiving medication via Centene benefit or has previously met initial approval criteria; member is responding positively to therapy; if enrolled in a state/product with continuity of care regulations, continuity applies; if request is for a dose increase, new dose does not exceed 5 mg.

Continued therapy — Oncology

Continued therapy — Oncology-Related Indications (must meet ALL):

Oncology continuation criteria: Member is currently receiving medication via Centene benefit or documentation shows current zoledronic acid use for a covered indication with at least 30 days of prior therapy; member is responding positively to therapy; new dose does not exceed 4 mg unless supported by FDA/NCCN or peer‑reviewed literature for off‑label use.

Off‑label — Langerhans cell histiocytosis

Off‑label Langerhans Cell Histiocytosis (must meet ALL):

Langerhans cell histiocytosis criteria: Diagnosis of Langerhans cell histiocytosis; request is for zoledronic acid 4 mg formulation; member has multifocal bone disease or unifocal LCH with isolated bone disease; prescribed by or in consultation with an oncologist; age ≥ 18 years or documentation of closed epiphyses on X‑ray; dose does not exceed 4 mg; prescribed regimen must be FDA‑approved or recommended by NCCN or dose supported by practice guidelines or peer‑reviewed literature with prescriber submitting supporting evidence.

Prescriber must submit supporting evidence for off‑label use.

Other indications/follow related policies

Other diagnoses/indications:

Other/Unlisted indications routing: If drug is on formulary/PDL, follow no coverage criteria policy for the line of business; if not on formulary/PDL, follow the non‑formulary policy; if requested use is not listed and prior items don't apply, refer to the applicable off‑label use policy for the line of business (commercial, HIM, or Medicaid).

References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Policy updates / criteria modifications

Policy update notes and scope changes

Annual review updates: 2021–2025 updates include removal of MM/solid tumor common criteria for solid tumors and replacement for MM to align with symptomatic disease per pivotal trials/NCCN; revised approval durations and frequency for prostate and breast cancer fracture prevention; added off‑label histiocytic neoplasms indication per NCCN; removed distinction between Zometa and Reclast; clarified failure of generic alendronate is preferred for osteoporosis; removed requirement for failure of oral bisphosphonate for Paget disease initial criteria; redirected brand Reclast requests to generic; clarified oncology dosing as zoledronic acid 4 mg/5 mL or 4 mg/100 mL for oncology indications other than prostate/breast.

Summary of template changes from annual reviews.

The safety and efficacy of zoledronic acid for certain non‑malignancy hypercalcemia causes have not been established. Specifically, use of zoledronic acid for hypercalcemia associated with primary hyperparathyroidism or other non‑tumor‑related conditions is limited by insufficient evidence and is not considered an established indication.

Non‑FDA‑approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient supporting documentation demonstrating safety and efficacy in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or unless the member’s evidence of coverage explicitly allows the use.

For Medicaid members, state Medicaid coverage provisions take precedence where they conflict with this clinical policy. Providers should follow applicable state Medicaid rules and the state Medicaid manual when there is any inconsistency between this policy and Medicaid requirements.

Requests for off‑label uses that are not supported by sufficient documentation per the referenced off‑label use policies will be considered not medically necessary. Providers must submit practice guidelines, peer‑reviewed literature, or other evidence per the applicable off‑label policy to justify coverage for non‑FDA indications.

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization and Oral Bisphosphonate Trial

Prior authorization is required for zoledronic acid and for many oral bisphosphonate therapies; providers must document a 12‑month trial of an oral bisphosphonate (generic alendronate preferred) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects occurred. If requesting brand Reclast, redirect to generic zoledronic acid 5 mg/100 mL unless contraindicated.

Prior authorization required for initial and continuation requests
Document 12‑month oral bisphosphonate trial or provide contraindication/clinical adverse effect evidence
Generic alendronate preferred when documenting oral bisphosphonate failure

Prior Authorization

Prior Authorization Requirements for Continuation and Dose Changes

For continuation therapy and dose changes, prior authorization requires evidence that the member previously met the initial approval criteria and is responding positively to therapy. For members currently receiving zoledronic acid via the plan benefit, provide documentation of current therapy (e.g., infusion records) or prior approval and evidence of clinical benefit. Requests for dose increases must not exceed policy maximums (osteoporosis: 5 mg; oncology‑related typical limit: 4 mg where specified).

Continuation requests: documentation that initial criteria were met and positive clinical response
Dose increase requests: submit rationale and ensure new dose does not exceed policy limits (<=5 mg for osteoporosis; <=4 mg for certain oncology uses)
If member is enrolled in a continuity of care program, follow state/product specific addendums

Prior Authorization

Prior Authorization Required for Zoledronic Acid

Prior authorization is required for zoledronic acid (Reclast/generic) and for zoledronic acid 4 mg formulations when requested for oncology indications other than prostate and breast cancer; approvals will be based on meeting the specific policy criteria for the requested indication (e.g., osteoporosis, oncology-related uses, Langerhans cell histiocytosis).

Initial requests must meet indication‑specific criteria in the policy
Brand Reclast requests should be redirected to generic zoledronic acid 5 mg/100 mL when appropriate
Oncology initial requests: provide indication, dosing (4 mg vs 5 mg as applicable), and supporting documentation

Documentation Required

Documentation Requirement

Provider must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, infusion records, laboratory results, imaging (e.g., x‑ray demonstrating closed epiphyses when applicable), treatment history showing oral bisphosphonate use and duration, and any relevant specialty consultation notes.

Lack of submitted documentation may result in denial
Include dosing history, dates of therapy, and evidence of clinical response or adverse effects
For off‑label uses (e.g., Langerhans cell histiocytosis), include supporting evidence such as relevant guidelines or peer‑reviewed literature

Note

Coding and Coverage Disclaimer

Inclusion or exclusion of any codes in this policy is informational only and does not guarantee coverage. Providers should reference the most up‑to‑date professional coding guidance when submitting claims.

Coding referenced in the policy is for informational purposes only (e.g., HCPCS J3489 for zoledronic acid)
Coverage is determined by the member's benefit documents and applicable laws

Documentation Required

Documentation for Off‑Label LCH Use

For off‑label requests such as Langerhans cell histiocytosis, prescribers must submit evidence supporting the requested regimen: relevant practice guidelines (e.g., NCCN where applicable) or peer‑reviewed literature that documents the dose and efficacy for the off‑label indication. The request must also meet the policy’s off‑label criteria (diagnosis, dosing limits, specialist involvement, and disease extent).

Off‑label requests require supporting practice guideline or peer‑reviewed literature
Include documentation of diagnosis, extent of disease, prescriber specialty/consultation, and dosing rationale

Step Therapy and Therapeutic Alternatives

Step	Requirement	Details / Notes
1
Trial of oral bisphosphonate therapy (12 months); generic alendronate preferred
Allowed if oral bisphosphonates are contraindicated or clinically significant adverse effects occur; prior authorization may be required for oral bisphosphonates

Step	Therapeutic alternative	Notes / Appendix reference
1
Alendronate (Fosamax, Fosamax Plus D), Risedronate (Actonel, Atelvia), Ibandronate (Boniva) — see Appendix B for full list
Consider listed therapeutic alternatives per Appendix B prior to or instead of zoledronic acid when clinically appropriate; agents may require separate authorization and may not be on formulary

Jurisdiction / Program	Step therapy bypass	Citation / Notes
Added step therapy bypass for Illinois Health Insurance Marketplace (HIM) per Illinois HB 5395
Policy update: step therapy bypass added as noted in annual review entries