Mountain State Medical Policy Bulletin
Section: Injections
Number: I-42
Topic: Zoledronic Acid (Reclast®, Zometa®)
Effective Date: January 1, 2008
Issued Date: December 31, 2007
Date Last Reviewed: 11/2007

General Policy Guidelines

Indications and Limitations of Coverage

Zoledronic acid (Zometa®)(J3487) is indicated for the following indications:

  1. The treatment of hypercalcemia of malignancy (275.42).
  2. The treatment of multiple myeloma (203.00-203.01).
  3. The treatment of bone metastases from solid tumors in conjunction with standard anti-neoplastic therapy, including bone metastases from multiple myeloma, breast carcinoma, prostate carcinoma, and other solid tumors (162.0-162.9, 170.0-170.9, 174.0-174.9, 175.0-175.9, 185, 189.0-189.9, 193, 195.0, 197.0, 198.0, 198.5, 198.81, 198.82).
NOTE:
Prostate cancer should have progressed after treatment with at least one hormonal therapy.

The recommended dose for the treatment of hypercalcemia is 4 mg in 100 ml solution, given as a single dose over no less than 15 minutes.

The recommended dose for the treatment of bone metastases from solid tumors or multiple myeloma is 4 mg in 100 ml solution, infused over no less than 15 minutes every three to four weeks.

Date Last Reviewed: 06/2007

Zoledronic acid (Reclast®)(J3488) is indicated for the following indications:

  1. The treatment of Paget's disease of bone (731.0) in men and women.

    Treatment is indicated in patients with Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease, to induce remission (normalization of serum alkaline phosphatase).

  2. The treatment of postmenopausal women (733.01) who have documented failure of oral bisphosphonate therapy.

    Osteoporosis may be confirmed by the presence or history of osteoporotic fracture or by a finding of low bone mass (BMD more than 2.5 standard deviations below the normal adult reference population [i.e., T-score]).

    A 6-12 month trial of oral bisphosphonates will be considered adequate to determine a treatment failure. Failure will be defined as:

    • a new fracture despite bisphosphonate therapy of six months or more, or
    • a T-score ≤ -3.0 despite bisphosphonate therapy of 12 months or more.

    Individual consideration may be given in documented cases for patients who have difficulty with oral bisphosphonate dosing requirements, which include an inability to sit upright for 30 to 60 minutes and/or swallow a pill. Individual consideration may also be given in women who have esophagitis, gastritis, or esophageal or gastric ulcers prohibiting the use of oral bisphosphonates.

    A single dose of Reclast® (zoledronic acid) injection should not exceed 5 mg and the duration of infusion should be no less than 15 minutes.

    Reclast® (zoledronic acid) injection contains the same active ingredient found in Zometa®, used for oncology indications, and a patient already being treated with Zometa® should not be treated with Reclast®.

    Safety and effectiveness in pediatric patients has not been established.

Date Last Reviewed: 07/2007

The use of zoledronic acid for any other diagnosis not listed in the coverage criteria above is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service.

Coverage for zoledronic acid is determined according to individual or group customer benefits. Zoledronic acid is not reimbursable under the prescription drug benefit.

Description

Zoledronic acid inhibits bone resorption.  The antiresorptive mechanism is not fully understood and several factors are thought to contribute to this action. In vitro, zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Osteoclastic resorption of mineralized bone and cartilage through its binding to bone is blocked by zoledronic acid. Increased osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors are inhibited by zoledronic acid.

See Medical Policy Bulletin X-24 for guidelines on Bone Mineral Density Studies.


NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

J3487J3488    

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious life-threatening condition and when medically necessary and appropriate for the patient’s condition.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

Reclast® (Zoledronic Acid) package insert; Novartis Pharmaceutical Corporation, East Hanover, NJ, 04/2007

Zometa® (Zoledronic Acid) package insert; Novartis Pharmaceutical Corporation, East Hanover, NJ, 04/2005

Zoledronic Acid, USPDI, Vol. I, Edition 26, 2006 Micromedex, Inc.

Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis, The New England Journal of Medicine, Vol. 356, No. 18, 05/2007

The Research on Adverse Drug Events and Reports (RADAR) Project, Journal of the American Medical Association, Vol. 293, No. 17, 05/2005

A single zoledronic acid infusion reduces bone resorption markers more rapidly than weekly oral alendronate in postmenopausal women with low bone mineral density, BONE, Vol. 40, No. 5, 05/2007

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Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.