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This medical policy (medical coverage guideline) is Copyright 2016, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2016 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-72

Original Effective Date: 02/15/08

Reviewed: 01/13/16

Revised: 02/15/16

Subject: Zoledronic Acid IV (Reclast®; Zometa®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Zoledronic acid, a member of bisphosphonate class, inhibits bone resorption. The anti-resorptive mechanism is not fully understood and several factors are thought to contribute to this action. Bisphosphonates have high affinity for mineralized bone, with relatively long duration of action. In the osteoclast, the main molecular target of zoledronic acid is the enzyme farnesyl pyrophosphate synthase. However, this does not exclude other inhibitory mechanisms. 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 IV injection.

Zoledronic acid appears to have the ability to suppress bone turnover for long periods of time. This long-term effect may be due to its effects on the basic multicellular units in bone. Exposure of the multicellular units to the bisphosphonate inhibits the activity of that unit for its entire life span, and defines the duration of action of the drug. The bisphosphonate may also be deposited on osteoblastic and resting bone surfaces; these deposits (or residual drug) may interfere with the future development of basic multicellular units on these bone surfaces.

POSITION STATEMENT:

I. Initiation of zoledronic acid IV (Zometa®, Reclast®) meets the definition of medical necessity when administered for the treatment of the indications listed in Table 1 and ALL of the indication specific criteria are met:

Table 1

Indications and Specific Criteria

Indication

Specific Criteria

Reclast

Approval duration

• Paget’s disease: 30 days

ALL other indications: 1 year

Treatment of osteoporosis in men and postmenopausal women

When ALL of the following are met:

1. Member meets ONE of the following:

a. Diagnosed with osteoporosis defined as a pre-treatment BMD T-score -2.5 or lower*

b. Member has a history of osteoporotic hip or vertebral fracture

2. The dose does not exceed 5 mg IV once a year

3. ONE or more of the following:

a. Member has tried and failed an oral bisphosphonate therapy

b. Member has a contraindication or intolerance to oral bisphosphonate therapy

Prevention of osteoporosis in postmenopausal women

When ALL of the following are met:

1. Member is diagnosed with osteopenia, defined as a pre-treatment BMD T-score of -1.0 to -2.5*

2. The dose does not exceed 5 mg IV every 2 years

3. ONE or more of the following are met:

a. Member has tried and failed an oral bisphosphonate therapy

b. Member has a contraindication or intolerance to oral bisphosphonate therapy

Treatment of glucocorticoid-induced osteoporosis in men and women

When ALL of the following are met:

1. Member is diagnosed with glucocorticoid-induced osteoporosis

2. Member has a history of prednisone or its equivalent at a dose of 5 mg/day or greater for 3 months or more

3. The dose (zoledronic acid) does not exceed 5 mg IV once a year

4. ONE or more of the following:

a. Member has tried and failed an oral bisphosphonate therapy

b. Member has a contraindication or intolerance to oral bisphosphonate therapy

Prevention of glucocorticoid-induced osteoporosis in men and women

Systemic glucocorticoids are initiated or continued and ALL of the following are met:

1. The dose (zoledronic acid) does not exceed 5 mg IV once a year

2. The member is prescribed prednisone or its equivalent at a dose of 5 mg/day or greater

3. The expected duration of therapy is 12 months or longer

4. ONE or more of the following:

a. Member has tried and failed an oral bisphosphonate therapy

b. Member has a contraindication or intolerance to oral bisphosphonate therapy

Paget’s disease

When ALL of the following are met:

1. Reclast will be used to induce remission or normalize serum alkaline phosphatase in a member that has ONE or more of the following:

a. Symptoms

b. Elevation in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range

c. Risk for complications

2. The dose is a single 5 mg infusion

3. ONE or more of the following:

a. Member has tried and failed an oral bisphosphonate therapy

b. Member has a contraindication or intolerance to oral bisphosphonate therapy

Zometa

Approval duration:

• Hypercalcemia of Malignancy: 30 days

ALL other indications: 180 days

Bone Metastases Secondary to Solid Tumor*

(*for bone metastases secondary to breast or prostate cancer, see below)

When ALL of the following are met:

1. Member has a solid tumor cancer diagnosis (e.g., thyroid cancer, lung cancer, kidney cancer)

2. Member has bone metastases – documentation from the medical record must be provided

3. Dose does not exceed 4 mg IV every 3 to 4 weeks

Breast Cancer

When used for ONE of the following:

1. Bone metastases and ALL of the following are met:

a. Member is diagnosed with breast cancer

b. Member has bone metastases – documentation from the medical record must be provided

c. Member has a life expectancy of 3 or more months

d. Zoledronic acid will be used in conjunction with standard antineoplastic therapy (i.e., chemotherapy or endocrine therapy)

e. Dose does not exceed 4 mg IV every 3 to 4 weeks

2. Prevention of drug-induced osteoporosis when ALL of the following are met:

a. Member is receiving hormonal therapy (e.g., anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin], tamoxifen [Nolvadex])

b. Dose does not exceed 4 mg IV every 6 months

c. ONE of the following:

i. Member has tried and failed† an oral bisphosphonate therapy

ii. Member has a contraindication or intolerance to oral bisphosphonate therapy

Hypercalcemia of Malignancy

When BOTH of the following are met:

1. Member has a cancer diagnosis with tumor related hypercalcemia (albumin corrected calcium± of 12 mg/dL or greater)

2. Dose does not exceed 4 mg IV (dose may be repeated if serum calcium does not return to normal [i.e., albumin corrected calcium less than 12 mg/dL] after 7 days)

Multiple Myeloma

When ALL of the following are met:

1. Member is diagnosed with active (symptomatic) multiple myeloma [i.e., NOT smoldering (asymptomatic) myeloma]

2. Zoledronic acid will be used in combination with primary myeloma therapy

3. Dose does not exceed 4 mg IV every 3 to 4 weeks

Prostate Cancer

When used for ONE of the following:

1. Bone metastases and ALL of the following are met:

a. Zometa is for prevention of skeletal related events

b. Member has castration-recurrent prostate cancer that has progressed after 1 or more hormonal therapies

c. Member has bone metastases – documentation from the medical record must be provided

d. Dose does not exceed 4 mg IV every 3 to 4 weeks

2. Prevention or treatment of drug-induced osteoporosis and ALL of the following:

a. Male member is beginning or continuing long-term androgen deprivation therapy (e.g., surgical castration, medical castration, gonadotropin-releasing hormone agonist)

b. Member meets ONE of the following:

i. Pre-treatment BMD T-score of -1 or lower

ii. Member has a history of osteoporotic hip or vertebral fracture

c. Dose does not exceed 4 mg IV every three months

d. ONE of the following:

i. Member has tried and failed† an oral bisphosphonate therapy

ii. Member has a contraindication or intolerance to oral bisphosphonate therapy

*Measured at the femoral neck, total hip, or lumbar spine

Failure is defined as a new fracture in a compliant member or significant loss of bone mineral density on follow-up scans

Failure is defined as continued elevation of serum alkaline phosphatase of two times or higher than the upper limit of age-specific normal range or member is symptomatic

± Albumin corrected calcium: [(4-albumin g/dL) x 0.8] plus observed calcium (mg/dL)

II. Zoledronic acid meets the definition of medical necessity when used for the following designated Orphan Drug indication (http://www.fda.gov/orphan/designat/list.htm) when the dose does not exceed the maximum FDA-approved dose:

1. Treatment of complex regional pain syndrome (CRPS).

Duration of approval: 1 year

III. Continuation of zoledronic acid meets the definition of medical necessity when ALL of the following are met

1. Member has a history of beneficial response to therapy

2. Authorization/reauthorization for zoledronic acid has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of any indication in Table 1. OR the member previously met all indication-specific initiation criteria.

3. The dose does not exceed the following:

a. Reclast (based on indication):

i. Prevention of osteoporosis in postmenopausal women: 5 mg every 2 years

ii. All other indications: 5 mg every 365 days

b. Zometa (based on indication)

i. Prevention of drug-induced osteoporosis in members with breast cancer: 4 mg every 180 days

ii. Prevention or treatment of drug-induced osteoporosis in members with prostate cancer: 4 mg every 90 days

iii. Hypercalcemia of Malignancy: 4 mg IV (dose may be repeated if serum calcium does not return to normal [i.e., albumin corrected calcium less than 12 mg/dL] after 7 days)

iv. All others: 4 mg every 3 to 4 weeks.

Approval duration: 30 days (hypercalcemia of malignancy) or 1 year (all others)

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Table 2

FDA-Approved Indications and Recommended Dosages

Indication

Usual Dosage

Comments

Reclast

Treatment of postmenopausal osteoporosis

5 mg IV administered once a year

• Co-administer with at least 1200 mg elemental calcium and 800-1000 IU Vitamin D daily

• Member should be appropriately hydrated prior to administration

• The IV infusion should be followed by a 10 mL normal saline flush

Prevention of postmenopausal osteoporosis

5 mg IV administer every 2 years

Treatment to increase bone mass in men with osteoporosis

5 mg IV administered once a year

Treatment and prevention of glucocorticoid-induced osteoporosis

5 mg administered once a year

Treatment of Paget’s disease of the bone in men and women

A single 5 mg IV infusion

Co-administer with 1500 mg elemental calcium and 800 IU Vitamin D daily

Zometa

Hypercalcemia of Malignancy

4 mg IV administered as a single use

Retreatment may be required after a minimum of 7 days

Multiple Myeloma

4 mg IV administered every 3-4 weeks

• Co-administer with 500 mg elemental calcium and 400 IU vitamin D daily

• Reduce dose for CrCl less than 60 ml/min

Bone Metastases Secondary to Solid Tumor

Dosage Adjustments:

Reclast

Renal Impairment: Reclast should not be used in members with a creatinine clearance (CrCl) less than 35 ml/min and in those with evidence of acute renal impairment. There are no safety data or efficacy data to support the adjustment of the Reclast dose based on baseline renal function. As such, no dose adjustment is required in members with a CrCl of 35 ml/min or greater.

Hepatic Impairment: Reclast is not metabolized in the liver. No clinical data are available for the use of Reclast in members with hepatic impairment.

Zometa

Renal Impairment: The recommended dose of Zometa in multiple myeloma and metastatic bone lesions from solid tumors should be adjusted in members with a CrCl less than 60 ml/min.

Table 3

Table 3: Dosage adjustments for members with baseline CrCl 60 ml/min or less

Baseline CrCl (ml/min)

Recommended Dose

Greater than 60

4 mg

50-60

3.5 mg

40-49

3.3 mg

30-39

3 mg

• Renal Function Deterioration: if during treatment a member’s renal function deteriorates (e.g., increase of 0.5 mg/dL for members with normal baseline creatinine or increase of 1 mg/dL for members with abnormal baseline creatinine), Zometa should be withheld. In clinical studies, Zometa treatment was resumed only when the creatinine returned to within 10% of the baseline value. Zometa should be reinitiated at the same dose as that prior to treatment interruption.

• Hepatic Impairment: Only limited clinical data are available for use of Zometa to treat hypercalcemia of malignancy in individuals with hepatic insufficiency, and these data are not adequate to provide guidance of dosage selection or how to save use Zometa in members with hepatic impairment.

Drug Availability:

• Reclast: 5 mg in a 100 mL ready-to-infuse solution

• Zometa: 4 mg/100 mL single-use ready-to-use bottle and 4 mg/5 mL single-sue vial of concentrate

PRECAUTIONS:

CONTRAINDICATIONS

Both agents are contraindicated in members with a hypersensitivity to any component in the formulation or in members with bisphosphonate hypersensitivity.

Reclast is also contraindicated in the following situations:

• Hypocalcemia

• Creatinine clearance (CrCl) less than 35 ml/min or acute renal impairment.

Precautions/Warnings

Zometa

• Adequately rehydrate members with hypercalcemia of malignancy prior to administration of Zometa and monitor electrolytes during treatment.

Both formulations

Members receiving Zometa should not receive Reclast and vice versa.

• Hypocalcemia may occur or worsen during treatment: Members must be adequately supplemented with calcium and vitamin D

• Renal toxicity may be greater in members with renal impairment. Treatment in members with severe renal impairment is not recommended. Monitor serum creatinine before each dose.

• Osteonecrosis of the jaw has been reported. Preventive dental exams should be performed before starting zoledronic acid. Avoid invasive dental procedures.

• Severe incapacitating bone, joint, muscle pain may occur. Discontinue zoledronic acid if severe symptoms occur.

• Atypical subtrochanteric and diaphyseal femoral fractures have been reported in individuals receiving bisphosphonate therapy. These fractures may occur after minimal or no trauma. Evaluate members with thigh or groin pain to rule out a femoral fracture. Consider drug discontinuation in patients suspected to have an atypical femur fracture.

• Pregnancy and Lactation: zoledronic acid is classified as pregnancy category D and may cause fetal harm if administered to a pregnant woman. Although no adequate well-controlled studies in humans, animal studies have demonstrated harm. It is unknown if zoledronic acid is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from zoledronic acid, a decision should be made to discontinue nursing or to discontinue the dug.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J3489

Injection, zoledronic acid, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

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.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

M80.0
69A – 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 – M80.8
62S
M80.869A – M80.869S

M80.871A – M80.871S

M80.872A – M80.872S

M80.879A – M80.879S

M80.88XA – M80.88XS

Other osteoporosis with current pathological fracture

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

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications, (L33270) located at fcso.com.

DEFINITIONS:

Albumin corrected calcium: [(4-albumin g/dL) x 0.8] plus observed calcium (mg/dL)

Androgen deprivation: loss or absence of androgen.

Androgen: any substance that promotes masculinization.

Hypercalcemia: an excess of calcium in the blood that causes fatigability, muscle weakness, depression, anorexia, nausea and constipation.

Multiple myeloma: a disseminated type of plasma cell dyscrasia characterized by multiple bone marrow tumor foci.

Myeloma: a tumor composed of cells of the type normally found in the bone marrow.

Osteopenia: reduced bone mass due to the decrease in the rate of osteoid synthesis to a level insufficient to compensate normal bone lysis. The World Health Organization (WHO) defines osteopenia as a T-score at the femoral neck of between –1.0 SD and –2.5 SD below the young female adult mean.

Osteoporosis: reduction in the amount of bone mass, leading to fractures after minimal trauma. According to the WHO criteria, osteoporosis is defined as a BMD that lies 2.5 standard deviations or more below the average value for young healthy women (a T-score of < –2.5 SD).

Paget’s disease: a disease of bone marked by repeated episodes of increased bone reabsorption followed by excessive attempts at repair, resulting in weakened deformed bones of increased mass, also called osteitis deformans.

RELATED GUIDELINES:

Bone Mineral Density Studies, 04-70000-21
Denosumab (Prolia™, Xgeva™) Injection, 09-J1000-25

Ibandronate IV (Boniva®), 09-J0000-71

Teriparatide (Forteo®), 09-J0000-47

OTHER:

None applicable.

REFERENCES:

  1. ACOG Practice Bulletin on Osteoporosis. American Family Physician. 2013; 88(4): 273 – 275.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2015. URL: www.clinicalpharmacology-ip.com. Accessed 12/16/15.
  3. Cosman F, de Beur SJ, LeBoff MS, et al. National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014; 25 (10): 2359-81.
  4. Kyle RA, Yee GC, Somerfield MR, et al. American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma. J Clin Oncol 2007;25:2464-74.
  5. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed12/16/15.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 12/18/15.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016. Breast Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf Accessed 12/21/15.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Kidney cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf Accessed 12/23/16.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2015. Multiple Myeloma. Available at http://www.nccn.org/professionals/physician_gls/PDF/myeloma.pdf Accessed 12/21/15.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 3.2016. Non-small cell lung cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf Accessed 12/23/16.
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016. Prostate Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf Accessed 12/21/15.
  12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2015. Thyroid Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/thyroid.pdf Accessed 12/21/15.
  13. North American Menopause Society (NAMS) Position Statement. Management of osteoporosis in postmenopausal women: 2010 position statement of the NAMS. Menopause. 2010; 17(1): 25-54.
  14. Reclast (zoledronic acid injection) [package insert]. Novartis Pharmaceuticals. East Hanover (NJ): January 2015.
  15. Watts NB, Adler RA, Bilezikan JP, Drake MT, et al. Osteoporosis in men: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2012;97(6):1802-22.
  16. Watts NB, Bilezkian JP, Camacho PM et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocrine Practice. 2010; 16 (Suppl 3): 1-37.
  17. Zoledronic acid. In: McEvoy GK, editor. AHFS drug information 2013 [monograph on the Internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2015 [cited 2015 Dec 16]. Available from: http://online.statref.com. Subscription required to view.
  18. Zometa (zoledronic acid injection) [package insert]. Novartis Pharmaceuticals. East Hanover (NJ): January 2015.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/13/16.

GUIDELINE UPDATE INFORMATION:

02/15/08

New Medical Coverage Guideline.

01/01/09

Annual HCPCS coding update: deleted code 90779; and added code 96379.

05/15/09

Review and revision; consisting of adding new indication of osteoporosis for men, added maximum dosing and updating references.

09/15/09

Revision; consisting of adding indication of prevention of osteoporosis in postmenopausal women with osteopenia.

10/15/09

Revision; consisting of updating coding.

01/15/10

Revision; consisting of updating coding.

08/01/10

Revision; consisting of updating coding.

11/15/10

Review and revision; consisting of reformatting and coding update.

02/01/11

Revision; consisting of updating position statement and dosage section.

12/15/11

Review and revision to guideline; consisting of reformatting position state and updating precautions, coding and references.

05/15/12

Review and revision to guideline; consisting of modifying position statement to include all solid tumors and updating related guidelines.

12/15/12

Review and revision to guideline; consisting of revising, reformatting, updating position statement; reformatting and revising description, dosage/administration, and precautions sections; updating coding and references.

02/15/13

Review of guideline with no changes.

05/15/13

Revision; Program Exceptions section updated.

07/01/13

Revision to guideline; consisting of updating coding and Program Exceptions section.

01/01/14

Revision to guideline; consisting of code update.

02/15/14

Review and revision to guideline consisting of revising position statement, updating dosage/administration, coding, and references.

09/15/14

Revision to guideline; consisting of updating criteria for treatment of multiple myeloma.

02/15/15

Review and revision to guideline; consisting of position statement.

08/15/15

Revision to guideline; consisting of clarifying multiple myeloma requirements in the position statement and updating continuation criteria language.

10/01/15

Revision consisting of update to Program Exceptions section.

12/15/15

Revision; consisting of updates to coding

02/15/16

Review and revision to guideline consisting of revising position statement, updating dosage/administration, precautions, coding, and references.

Date Printed: May 5, 2016: 03:53 PM