Neighborhood Health Plan RI Bone Modifying Agents Coverage | OpenPayer

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Neighborhood Health Plan RI Bone Modifying Agents Coverage | OpenPayer

Coverage Criteria for Bone Modifying Agents

Breast cancer

Covered when ANY one of the following is met

Breast cancer indications: 1) Member has non-metastatic breast cancer and bone modifying agents are being used for prevention or treatment of osteoporosis when receiving adjuvant aromatase inhibitor therapy and/or ovarian suppression/ablation; OR 2) Bone modifying agents are being used as part of the adjuvant therapy regimen in combination with adjuvant endocrine treatment for early breast cancer in a postmenopausal woman or a premenopausal woman on ovarian suppression/ablation.note: typical dosing zoledronic acid 4 mg IV every 6 months

Giant cell tumor of bone

Covered when ALL of the following are met

Giant cell tumor: Member is an adult or adolescent ≥12 years with giant cell tumor of bone and a bone modifying agent will be used as a single agent for unresectable localized disease or for metastatic disease.

Hypercalcemia of malignancy

Covered when ALL of the following are met

Hypercalcemia: Bone modifying agents are being used in conjunction with hydration for hypercalcemia defined as corrected calcium ≥ 12 mg/dL (corrected for albumin).Corrected calcium ≥ 12 mg/dL

Corrected Calcium (mg/dL) = Calcium + 0.8 x (4 - patient Albumin).

Multiple myeloma

Covered when ALL of the following are met

Myeloma: Member has multiple myeloma and a bone modifying agent is being used with or without anti-myeloma therapy.

Prostate cancer

Covered when ALL of the following are met

Prostate cancer: Member has prostate cancer and a bone modifying agent is being used for prevention or treatment of osteoporosis during androgen deprivation therapy for members aged ≥70 years or who are at high risk for fractures.age ≥70 or high fracture risk

Solid tumors with skeletal metastases

Covered when ALL of the following are met

Skeletal metastases: Member has a solid tumor with skeletal metastases documented on any imaging study.

Dose adjustments for zoledronic acid by creatinine clearance are provided; use not recommended if creatinine clearance <30 mL/min.

Requests for bone modifying agents will be excluded when use is investigational or off‑label without adequate supporting evidence, or when dosing exceeds the policy’s single‑dose limits. Specifically, coverage excludes members with creatinine clearance < 60 mL/min if an appropriate zoledronic acid dose adjustment is not provided, and any request where the ordered dose exceeds the listed single‑dose maximums: Zoledronic Acid 4 mg, Pamidronate 90 mg, Xgeva/Wyost 120 mg, or Prolia/Jubbonti 60 mg.

Use is considered not medically necessary when the indication is off‑label or experimental and lacks sufficient evidence from CMS‑recognized compendia, guideline sources, or acceptable peer‑reviewed literature. The policy defines sufficient evidence by criteria that include appropriate representation of the patient population and cancer therapy in published studies, clinically meaningful outcomes (for example ASCO‑recommended thresholds), and reliance on robust study designs and full peer‑reviewed publications rather than case reports or meeting abstracts.

Coding and Clinical Thresholds

Hypercalcemia threshold

Hypercalcemia thresholdCorrected calcium ≥ 12 mg/dL

Calculation formulaCorrected Calcium (mg/dL) = Calcium + 0.8 × (4 - patient Albumin)

Context for useUsed in conjunction with hydration for hypercalcemia of malignancy

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Approval Authority

Medication requests are processed by Evolent/Utilization Management and require utilization management review. Final approval authority rests with the Utilization Management Committee. Medications not authorized by Evolent/UM may be deemed not approvable and therefore not reimbursable. The use of the requested drug must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare standards.

Review: Utilization Management Department (Evolent/UM)
Final approval: Utilization Management Committee
Supportive evidence required: FDA labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or CMS‑standard peer‑reviewed literature

Denial Risk

Triggers for Denial

Requests will be excluded or denied when any of the following exclusion/denial triggers apply. Providers should confirm renal function, dosing limits, and adequacy of supporting evidence prior to submission.

Background

Bone modifying agents — including bisphosphonates (pamidronate, zoledronic acid) and RANK‑ligand inhibitors (denosumab products such as Xgeva/Prolia and biosimilars) — are used in oncology to prevent or treat cancer‑therapy‑related osteoporosis, reduce skeletal‑related events from bone metastases, treat hypercalcemia of malignancy, and manage conditions such as giant cell tumor of bone and multiple myeloma. Use must align with FDA labeling or accepted oncology compendia/guidelines, and certain clinical or laboratory constraints (for example renal function thresholds and single‑dose limits) factor into treatment appropriateness and coverage determinations.

Definitions and Clinical Calculations

Corrected calcium calculation and hypercalcemia definition

Corrected calcium formulaCorrected Calcium (mg/dL) = Calcium + 0.8 × (4 - patient Albumin)

Hypercalcemia definitionHypercalcemia of malignancy defined as corrected calcium ≥ 12 mg/dL (corrected for albumin)

Required concomitant therapyBone modifying agents used in conjunction with hydration for hypercalcemia management

Initial Therapy Coverage Criteria

Initial therapy coverage

Initial use covered when indication-specific criteria are met

Initial therapy: Coverage is aligned to the listed oncology indications: breast cancer adjuvant osteoporosis prevention/treatment, giant cell tumor of bone, hypercalcemia of malignancy, multiple myeloma, prostate cancer during androgen deprivation therapy for older or high-risk members, and solid tumors with skeletal metastases.

Zoledronic acid dosing adjustments by creatatinine clearance/age provided; typical adjuvant zoledronic acid dosing is 4 mg IV every 6 months.

Continuation and Renewal Criteria

Continuation requests

Conditions for exempt continuation of previously used medication

Continuation exemption: Requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; and additional medication(s) are not being added to the continuation request.

Applies to continuation requests even if the medication would otherwise be non-approvable under this policy.

Step Therapy and Exemptions

Step	Requirement	Continuation exemption
1	Members must complete required prior steps unless an exemption applies (step therapy applies as described in policy).	Covered (continuation exemption applies) — requested medication was used within the last year, member has not experienced disease progression or intolerance to the medication, and no additional medication(s) are being added to the continuation request.

Quantity Limits and Single-Dose Maximums

Zoledronic Acid — single-dose limit

DrugZoledronic Acid

Maximum single dose listed4 mg single dose (maximum listed)

Related exclusionDosing that exceeds single-dose limits is an exclusion criterion

Pamidronate — single-dose limit

DrugPamidronate

Maximum single dose listed90 mg single dose (maximum listed)

Related exclusionDosing that exceeds single-dose limits is an exclusion criterion

Site of Care and Administration

Billing Rule

Follow FDA label for site‑of‑care and administration

Refer to the FDA product label/package insert for site‑of‑care and administration details when delivering these agents in an infusion center.

Biosimilar and Interchangeable Products

Billing Rule

Denosumab products and biosimilars covered per labeling

Denosumab reference and biosimilar products (Xgeva/Prolia and Wyost/Jubbonti) are listed together and are covered interchangeably per their product labeling references.

Wyost and Jubbonti are listed alongside Xgeva/Prolia
Coverage applies per labeling references