Mountain State Medical Policy Bulletin
Section: Injections
Number: I-23
Topic: Pamidronate (Aredia®)
Effective Date: August 1, 2005
Issued Date: September 10, 2007
Date Last Reviewed: 06/2005

General Policy Guidelines

Indications and Limitations of Coverage

Pamidronate (Aredia®) is FDA approved for the following indications:

  1. The treatment of moderate to severe hypercalcemia associated with malignancy (275.42), with or without bone metastases.

  2. The treatment of moderate to severe Paget's disease of bone (731.0)(osteitis deformans) characterized by abnormal and accelerated bone metabolism.

  3. The treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma (174.0-174.9, 175.0-175.9, 198.5, 198.81, 203.00, 203.01) in conjunction with standard antineoplastic therapy.

The recommended dose for the treatment of moderate hypercalcemia is 60-90 mg given as a single dose intravenous infusion over 2 to 24 hours. The recommended dose for the treatment of severe hypercalcemia is 90 mg as a single dose intravenous infusion over 2 to 24 hours.

The recommended dose for the treatment of moderate to severe Paget's disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.

The recommended dose for the treatment of osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis. The recommended dose for the treatment of osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3-4 weeks.

The use of pamidronate 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 pamidronate is determined according to individual or group customer benefits. Pamidronate is not reimbursable under the prescription drug benefit.

Description

The principal pharmacologic action of Aredia is inhibition of bone resorption. Although the mechanism of antiresorptive action is not completely understood, several factors are thought to contribute to this action. Aredia adsorbs to calcium phosphate (hydroxyapatite) crystals in bone and may directly block dissolution of this mineral component of bone. In vitro studies also suggest that inhibition of osteoclast activity contributes to inhibition of bone resorption. Of relevance to the treatment of hypercalcemia of malignancy is the finding that Aredia inhibits the accelerated bone resorption that results from osteoclast hyperactivity induced by various tumors in animal 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

J2430     

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.

Also refer to General Policy Guidelines

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

Aredia® (Pamidronate) package insert; Novartis Pharmaceutical Corporation, East Hanover, NJ, 04/2005

Pamidronate, USPDI - Vol. I, Edition 24, 2004, Micromedex, INc.

View Previous Versions

[Version 001 of I-23]

Table Attachment

Text Attachment

Procedure Code Attachment


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.