CAM 204

ZOMETA (zoledronic acid)

Category:Prescription Drug   Last Reviewed:July 2019
Department(s):Medical Affairs   Next Review:July 2020
Original Date:July 2018    

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 
The indications below, including FDA-approved indications and compendial uses, are considered MEDICALLY NECESSARY.

FDA-Approved Indications

  1. Treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greaterthan or equal to 12mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 (4.0 g/dL –patient albumin [g/dL])
  2. Treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy
    • Prostate cancer should have progressed after treatment with at least one hormonal therapy 

Compendial Uses

  1. Treatment or prevention of osteoporosis during androgen-deprivation therapy (ADT) in prostate cancer patients with high fracture risk
  2. Treatment in postmenopausal patients with breast cancer who are receiving adjuvant therapy to maintain or improve bone mineral density and reduce risk of fractures
  3. Treatment for osteopenia or osteoporosis in patients with systemic mastocytosis

All other indications are considered NOT MEDICALLY NECESSARY.

References 

  1. 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.
  2. 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.
  3. Lexi-Comp Online. (2017). AHFS DI. Zoledronic acid. Retrieved October 09, 2017 from Lexi-Comp Online with AHFS.
  4. MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, September). Zoledronic acid. Retrieved October 09, 2017 from MICROMEDEX Healthcare Series.
  5. National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Zoledronic acid. Retrieved October 09, 2017 from the National Comprehensive Cancer Network.
  6. 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.
  7. 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.
  8. 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. 
  9. Zometa (package insert). East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2016.
  10. Micromedex Solutions (database online). Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com (available with subscription). Accessed October 18, 2017.
  11. American Society of Health System Pharmacists. AHFS Drug Information (electronic version). Bethesda, MD. Available at: http://online.lexi.com. Accessed October 18, 2017.
  12. The NCCN Drugs & Biologics Compendium™ © 2015 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 20, 2016.
  13. Gralow JR, Biermann S, Farooki A, et al. NCCN Task Force Report: Bone Health in Cancer Care. JNCCN. 2013; 11(Suppl 3):S1-50.
  14. World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield. FRAX WHO fracture risk assessment tool. Available at http://www.shef.ac.uk/FRAX/tool.jsp. Accessed October 18, 2017.

Dosage  
Hypercalcemia of malignancy

  • 4 mg as a single-use intravenous infusion over no less than 15 minutes. 
  • 4 mg as retreatment after a minimum of 7 days.

Multiple myeloma and bone metastasis from solid tumors.

  • 4 mg as a single-use intravenous infusion over no less than 15 minutes every 3-4 weeks for patients with creatinine clearance of greater than 60 mL/min. 
  • Reduce the dose for patients with renal impairment. 
  • Co-administer oral calcium supplements of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily. 

Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions.

 Coding Section

HCPCS 

J3489 

Injection, zoledronic acid, 1 mg

 ICD-10 Diagnosis Codes

C33.00

Malignant neoplasm of trachea

 

C34.00 – C34.02

Malignant neoplasm of unspecified main bronchus

 

C34.10 – C34.12

Malignant neoplasm of upper lobe, unspecified bronchus or lung

 

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

 

C34.30 – C34.32

Malignant neoplasm of lower lobe, unspecified bronchus or lung

 

C34.80 – C34.82

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

 

C34.90 – C34.92

Malignant neoplasm of unspecified part of unspecified bronchus or lung

 

C50.011 – C50.929

Malignant neoplasm of breast

 

C61

Malignant neoplasm of prostate

 

C64.1 – C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

 

C65.1 – C65.9

Malignant neoplasm of unspecified renal pelvis

 

C73

Malignant neoplasm of thyroid gland

 

C79.51 – C79.52

Secondary malignant neoplasm of bone and bone marrow

 

C90.00 – C90.32

Multiple myeloma and malignant plasma cell neoplasms

 

D47.2

Monoclonal gammopathy

 

D47.Z9

Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue                                                                                                                  

 

E83.52

Hypercalcemia

 

G90.50 – G90.59

Complex regional pain syndrome I

 

M80.00XA – M80.00XS M80.011A – M80.011S M80.012A – M80.012S M80.019A – M80.019S M80.021A – M80.021S M80.022A – M80.022S M80.029A – M80.029S M80.031A – M80.031S M80.032A – M80.032S M80.039A – M80.039S M80.041A – M80.041S M80.042A – M80.042S M80.049A – M80.049S M80.051A – M80.051S M80.052A – M80.052S M80.059A – M80.059S M80.061A – M80.061S M80.062A – M80.062S M80.069A – M80.069S M80.071A – M80.071S M80.072A – M80.072S M80.079A – M80.079S M80.08XA – M80.08XS

Age-related osteoporosis with current pathological fracture

 

M80.80XA – M80.80XS M80.811A – M80.811S M80.812A – M80.812S M80.819A – M80.819S M80.821A – M80.821S M80.822A – M80.822S M80.829A – M80.829S M80.831A – M80.831S M80.832A – M80.832S M80.839A – M80.839S M80.841A – M80.841S M80.842A – M80.842S M80.849A – M80.849S M80.851A – M80.851S M80.852A – M80.852S M80.859A – M80.859S M80.861A – M80.861S M80.862A – M80.862S M80.869A – M80.869S M80.871A – M80.871S M80.872A – M80.872S M80.879A - M80.879S M80.88XA - M80.88

Other osteoporosis with current pathological                                                                                                      

 

M81.0

Age-related osteoporosis without current pathological fracture                                                                                                                       

 

M81.6

Localized osteoporosis (Lequesne)

 

M81.8

Other osteoporosis without current pathological fracture

 

M85.80 – M85.89

Other specified disorders of bone density and structure

 

M88.0 – 88.9

Osteitis deformans of unspecified bone

 

M89.9

Disorder of bone, unspecified

 

M94.9

Disorder of cartilage, unspecified

 

N95.1

Menopausal and female climacteric states

 

T38.0X5A

Adverse effect of glucocorticoids and synthetic analogues, initial encounter

 

T38.0X5D

Adverse effect of glucocorticoids and synthetic analogues, subsequent encounter

 

T38.0X5S

Adverse effect of glucocorticoids and synthetic analogues, sequela

 

T38.6X5A – T38.6X5S

Adverse effect of antigonadotrophins, antiestrogens, antiandrogens, not elsewhere classified

 

T38.7X5A – T38.7X5S

Adverse effect of androgens and anabolic congeners

 

Z78.0

Asymptomatic menopausal state

 

Z79.810

Long term (current) use of selective estrogen receptors modulators

 

Z79.811

Long term (current) use of aromatase inhibitors

 

Z79.818

Long term (current) use of other agents affecting estrogen receptors and estrogen levels

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2018 Forward     

07/01/2019 

Annual review, adding a third compendial use and rephrasing existing compendial uses for specificity.

07/30/2018

New Policy


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