BlueCross BlueShield of Tennessee Medical Policy Manual

Zoledronic Acid

NDC CODE(S)

00078-0387-XX Zometa 4 MG/5ML CONC (NOVARTIS)

 

00078-0435-XX Reclast 5 MG/100ML SOLN (NOVARTIS)

 

00078-0590-XX Zometa 4 MG/100ML SOLN (NOVARTIS)

 

35356-0351-XX Reclast 5 MG/100ML SOLN (QUALITY CARE)

 

(Multiple Generics available from WEST-WARD, HOSPIRA, ACCORD HEALTHCARE, AKORN, HERITAGE PHARMACEUTICALS, SAGENT PHARMACEUTICAL, NOVAPLUS/DR.REDDY'S, ACTAVIS, BRECKENRIDGE, DR.REDDY'S LABORATORIES, INC., APOTEX, FRESENIUS KABI USA and MYLAN INSTITUTIONAL)

DESCRIPTION

Zoledronic acid is a bisphosphonate which inhibits osteoclast-mediated bone resorption. Although the antiresorptive mechanism is not completely understood, several factors are thought to contribute to this action.  Bisphosphonates show selective action on bone due to their high affinity for mineralized bone.  Zoledronic acid is drawn to bone in areas of high bone turnover where its main target is the osteoclast.  It binds to mineralized bone targeting the osteoclast.  Within the osteoclast it inhibits the action of the enzyme farnesyl pyrophosphate synthase, resulting in disruption of the osteoclast cytoskeleton and cell death.  This action prevents the increased osteoclastic activity and accompanying skeletal calcium release of certain tumors and other conditions.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Note: 

      • Ineffective response defined as ANY ONE of the following:

        • Decrease in T-score in comparison with baseline T-score from DXA scan

        • New fracture while on bisphosphonate therapy

      • Contraindication to oral bisphosphonate therapy defined as ANY ONE of the following:

        • Documented inability to sit or stand upright for at least 30 minutes

        • Documented pre-existing gastrointestinal disorder such as inability to swallow, Barrett’s esophagus, esophageal stricture, dysmotility, or achalasia

RENEWAL CRITERIA

AGENTS

INDICATION(S)

DOSAGE & ADMINISTRATION

Zometa®

Hypercalcemia of malignancy

4 mg IV x 1 dose, may be repeated after 7 days if serum calcium does not return to normal

Prevention of aromatase inhibitor-induced bone loss in breast cancer

4 mg IV every 6 months

Prevention of androgen deprivation-induced bone loss in prostate cancer

4 mg IV every 3 months

Multiple myeloma& bone metastases from solid tumors

4 mg IV every 3 to 4 weeks

OR

4 mg every 12 weeks

 

 

Reclast®

Active Paget’s Disease

5 mg IV x 1 dose

Prevention of osteoporosis in post-menopausal women

5 mg IV every 2 years

Prevention of glucocorticoid-induced osteoporosis

5 mg IV every year

Treatment of osteoporosis

5 mg IV every year

Prevention of androgen deprivation-induced bone loss in prostate cancer

5 mg every year

Length of Authorization

Zometa:  Coverage is provided for 12 months and may be renewed.

Reclast:

Click here to view DOSAGE LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validates the use of zoledronic acid for the treatment of other conditions or diseases.

SOURCES

Camacho, P.M., Petak, S.M., Binkley, N. et al, American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis - 2016. Endocr Pract. 2016; Sep 2; 22 (Suppl 4):1-42.

Dhesy-Thind S, Fletcher GG, Blanchette PS, et al.: Use of adjuvant bisphosphonates and other bone-modifying agents in breast cancer: a Cancer Care Ontario and American Society of Clinical Oncology clinical practice guideline. DOI: 10.1200/JCO.2016.70.7257 Journal of Clinical Oncology - published online before print March 6, 2017.

Lexi-Comp Online. (2017). AHFS DI. Zoledronic acid. Retrieved October 09, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, September). Zoledronic acid. Retrieved October 09, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Zoledronic acid. Retrieved October 09, 2017 from the National Comprehensive Cancer Network.

Qaseem A, Forciea MA, McLean RM, Denberg TD; for the Clinical Guidelines Committee of the American College of Physicians. Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians [published online May 9, 2017]. Ann Intern Med. doi:10.7326/M15-1361.

U. S. Food and Drug Administration. (2016, December). Center for Drug Evaluation and Research. Label and Approval History. Zometa® (zoledronic acid). Retrieved October 09, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021223s035lbl.pdf.

U. S. Food and Drug Administration. (2017, July). Center for Drug Evaluation and Research. Label and Approval History. Reclast® (zoledronic acid) injection. Retrieved October 09, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/9/2007

MOST RECENT REVIEW DATE:  2/16/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

AGENTS  

INDICATION(S)

BILLABLE UNITS

Zometa®

Hypercalcemia of malignancy

4 billable units every 7 days

Multiple myeloma& bone metastases from solid tumors

4 billable units every 21 days

Prevention of bone loss in breast cancer

4 billable units every 168 days (6 months)

Prevention of bone loss in prostate cancer & Prevention or treatment of osteoporosis in prostate cancer

4 billable units every 84 days (3 months)

 

 

 

Reclast®

Prevention of osteoporosis in post-menopausal women

5 billable units every 730 days (24 months)

All other indications

5 billable units every 365 days (12 months)