Print

Date Printed: October 20, 2017: 08:39 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, 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 2017 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-J0000-71

Original Effective Date: 12/15/07

Reviewed: 01/11/17

Revised: 02/15/17

Subject: Ibandronate (Boniva®) Injection

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.

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

Previous Version

           

DESCRIPTION:

Ibandronate sodium (Boniva) is a third generation bisphosphonate. According to evidence based guidelines (e.g., American Academy of Clinical Endocrinologists/American College of Endocrinology guidelines for treatment of postmenopausal women with osteoporosis) oral bisphosphonate therapy is considered appropriate for most patients at high risk of fracture due to the broad spectrum antifracture efficacy. Similar to other bisphosphonates, ibandronate has been shown to decrease the risk for vertebral fractures, increase bone mineral density of the lumbar spine and total hip, and reduce biochemical markers of bone turnover when compared to placebo.

The injectable form of ibandronate was approved by the US Food and Drug Administration in January 2006 for the treatment of osteoporosis in postmenopausal women. Standard reference compendia also support the use of ibandronate for off-label use in the prevention of osteoporosis in postmenopausal women, treatment of glucocorticoid-induced osteoporosis, Paget’s disease, and hypercalcemia of malignancy.

POSITION STATEMENT:

1. Initiation of ibandronate sodium (Boniva®) intravenous (IV) injection meets the definition of medical necessity when administered for 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

Postmenopausal Osteoporosis prevention

When ALL of the following are met:

1. Member is at risk of developing osteoporosis

2. The dose does not exceed 2 mg IV every 3 months

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

Postmenopausal Osteoporosis treatment

When ALL of the following are met:

1. Member is diagnosed with osteoporosis

2. The dose does not exceed 3 mg IV every 3 months

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

Glucocorticoid-induced osteoporosis treatment

When ALL of the following are met:

1. Member is diagnosed with glucocorticoid-induced osteoporosis

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

3. The dose does not exceed 2 mg every 3 months

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. Ibandronate 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 2 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

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 6 mg IV every 4 weeks

Bone Metastases Secondary to Breast Cancer

When ALL of the following are met:

1. Member is diagnosed with breast cancer

2. Member has bone metastases

3. Dose does not exceed 6 mg IV every 3 to 4 weeks

Bone Metastases Secondary to Prostate Cancer

When ALL of the following are met:

1. Member is diagnosed with prostate cancer

2. Member has bone metastases

3. Dose does not exceed 6 mg IV every 4 weeks

†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 symptoms or continued elevation of serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range

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

Approval duration

• Treatment and Prevention of osteoporosis: 180 days

• Bone metastases secondary to breast or prostate cancer: 180 days

• Treatment of Paget’s disease or hypercalcemia of malignancy: 30 days

2. Continuation of ibandronate meets the definition of medical necessity when ALL of the following are met

a. Member has a history of beneficial response to therapy

b. The member has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

c. The dose does not exceed the following based on indication:

• Osteoporosis treatment: 3 mg IV every 3 months

• Osteoporosis prevention, glucocorticoid-induced osteoporosis: 2 mg IV every 3 months

Bone metastases secondary to breast cancer: 6 mg IV every 3 to 4 weeks

Bone metastases secondary to prostate cancer: 6 mg IV every 4 weeks

Approval duration: 1 year

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.

FDA-approved: ibandronate injection is indicated for treatment of osteoporosis in postmenopausal women. The optimal duration of use has not been determined and drug discontinuation after 3 to 5 years of use should be considered for patients at low-risk for fracture. The recommended dose is 3 mg every 3 months. Ibandronate injection should be administered intravenously over 15-30 seconds. Ibandronate should only be administered intravenously by a health care professional. It should not be mixed with calcium-containing solutions or other IV medications. Ibandronate should not be administered more than every 3 months. Patients should take supplemental calcium and vitamin D if dietary intake is inadequate.

Drug Availability: ibandronate injection is supplied as a kit containing

• 3 mg/3 mL single-use prefilled syringe.

• 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment

PRECAUTIONS:

CONTRAINDICATIONS:

• Known hypersensitivity to ibandronate Injection or to any of its excipients

• Uncorrected hypocalcemia.

WARNINGS AND PRECAUTIONS

• Hypocalcemia can worsen. Correct hypocalcemia prior to use.

• Adequately supplement members with calcium and vitamin D

• Anaphylaxis, including fatal events, has been reported.

• Renal Toxicity may be greater in persons with underlying renal impairment. Do not administer ibandronate injection to individuals with severe renal impairment (creatinine clearance less than 30 mL/min). Monitor serum creatinine prior to each dose.

• Tissue Damage with Inappropriate Drug Administration can occur. Do not administer ibandronate injection intra-arterially or paravenously.

• Osteonecrosis of the jaw (ONJ) has been reported

• Severe Bone, Joint, and/or Muscle Pain may occur, consider discontinuing use if symptoms occur.

• Atypical Femur Fractures have been reported. Individuals with new thigh or groin pain should be evaluated to rule out a femoral fracture.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J1740

Injection, ibandronate sodium, 1mg

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

C50.011 – C50.929

Malignant neoplasm of breast

C61

Malignant neoplasm of prostate

C79.51 – C79.52

Secondary malignant neoplasm of bone and bone marrow

E83.52

Hypercalcemia

M80.00XA – M80.00XS
M80.0
11A – 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

M
80.052A – 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 – M80.0
79S
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 – M
80.851S
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
M80.879
A – 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 – M88.9

Osteitis deformans of unspecified bone

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

Z78.0

Asymptomatic menopausal state

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:

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:

Achalasia: an esophageal motility disorder involving the smooth muscle layer of the esophagus and the lower esophageal sphincter (LES). It is characterized by incomplete LES relaxation, increased LES tone, and lack of peristalsis of the esophagus (i.e., inability of smooth muscle to move food down the esophagus) in the absence of other explanations like cancer or fibrosis

Osteoporosis: reduction in the amount of bone mass, leading to fractures after minimal trauma. Osteoporosis is defined by the World Health Organization (WHO) as a bone mineral density (BMD) value for the hip, spine, or wrist of 2.5 standard deviations (SD) or more below the mean for healthy young white women, or a T-score of less than or equal to – 2.5. The disease is characterized by an increased risk of fractures, which can result in pain, diminished quality of life, decreased physical mobility and independence, inability to work, and increased burden on caregivers.

Postmenopausal osteoporosis: that occurring in women within 3 to 20 years after menopause, affecting trabecular bone more than cortical bone, and manifested mainly by vertebral fractures of the painful crush type, hip fracture, Colles’ fracture, and increased tooth loss.

RELATED GUIDELINES:

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

Teriparatide (Forteo®), 09-J0000-47

Zoledronic Acid IV (Reclast®, Zometa®), 09-J0000-72

OTHER:

None applicable.

REFERENCES:

  1. ACOG Practice Bulletin on Osteoporosis. American Family Physician. 2013; 88(4): 273 – 275.
  2. American College of Obstetricians and Gynecologists, News Release; statement of hormone therapy for the prevention and treatment of postmenopausal osteoporosis, 10/07/03.
  3. American Society of Clinical Oncology, 2003 Update on the Role of Bisphosphonates and Bone Health Issues in Women with Breast Cancer.
  4. Boniva® (ibandronate sodium injection) Prescribing Information. Genentech Inc. South San Francisco, CA. December 2016.
  5. Camacho PM, Petak SM, 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. Endocr Pract. 2016; 22: Suppl 4;1-42.
  6. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2016. URL www.clinicalpharmacilogy-ip.com Accessed 12/16/16.
  7. 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.
  8. Ibandronate. In: McEvoy GK, editor. AHFS drug information 2016 [monograph on the Internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 Dec 16]. Available from: http://online.statref.com. Subscription required to view.
  9. Ingenix HCPCS Level II, Expert 2013.
  10. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2. Expert 2013
  11. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 12/16/16.
  12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Breast Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf Accessed12/27/16.
  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. Pavlakis N, Schmidt RL, Stockler M. Bisphosphonates for breast cancer. Cochrane Database of Systematic Reviews 2002, Issue 1. Art. No.: CD003474. DOI: 10.1002/14651858.CD003474.pub2.
  15. 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.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/11/17.

GUIDELINE UPDATE INFORMATION:

12/15/07

New Medical Coverage Guideline.

01/01/09

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

02/15/09

Reviewed with no changes made.

01/15/11

Review and revision; consisting of updating precautions, coding, related guidelines and references.

01/15/12

Review and revision to guideline; consisting of updating dosing and administration, precautions and references.

01/15/13

Review and revision to guideline; consisting of reformatting the position statement, updating the precautions section, program exceptions, definitions and references.

02/15/13

Review of guideline; no changes.

02/15/14

Review and revision to guideline; consisting of revising position statement to include compendia supported indications, revising dosage/administration, precautions, references, coding and program exceptions.

02/15/15

Review and revision to guideline; consisting of reformatting position statement; updating references.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

02/15/16

Review and revision to guideline; consisting of reformatting position statement; updating administration, coding and references.

12/15/16

Review and revision to guideline; consisting of updating position statement, description and references.

02/15/17

Review and revision to guideline; consisting of updating position statement and references.

Date Printed: October 20, 2017: 08:39 AM