Clinical Policy: Ibandronate Injection (formerly Boniva)

Reference Number: CP.PHAR.189
Effective Date: 11.15.17
Last Review Date: 02.26
Line of Business: Commercial, HIM, Medicaid

[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Ibandronate injection (formerly Boniva®) is a bisphosphonate.

FDA Approved Indication(s)

Ibandronate injection is indicated for the treatment of osteoporosis in postmenopausal women (PMO). In postmenopausal women with osteoporosis, ibandronate injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Limitation(s) of use: The safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Policy/Criteria

Approval duration:
Medicaid/HIM – 12 months
Commercial – 6 months or to the member’s renewal date, whichever is longer

CLINICAL POLICY

Ibandronate Injection

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

II. Continued Therapy

A. Osteoporosis (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy;
3. If request is for a dose increase, new dose does not exceed both of the following (a and b):
   a. 3 mg every 3 months;
   b. 1 syringe every 3 months.

Approval duration:
Medicaid/HIM – 12 months
Commercial – 6 months or to the member’s renewal date, whichever is longer

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

CLINICAL POLICY

Ibandronate Injection

III.Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.

IV.Appendices/General Information

Appendix A: Abbreviation/Acronym Key

BMD: bone mineral density
FDA: Food and Drug Administration
PMO: postmenopausal osteoporosis

Appendix B: Therapeutic Alternatives

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization.

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.

CLINICAL POLICY

Ibandronate Injection

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): hypocalcemia, hypersensitivity
• Boxed warning(s): none reported

V. Dosage and Administration

VI.Product Availability

Single-dose prefilled syringe: 3 mg/3 mL

CLINICAL POLICY

Ibandronate Injection

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

1Q 2022 annual review: no significant changes; references reviewed and updated.
Template changes applied to other diagnoses/indications and continued therapy section.
1Q 2023 annual review: no significant changes; references reviewed and updated.
1Q 2024 annual review: added criteria that member must use generic ibandronate injection; clarified failure of “generic” alendronate is preferred; clarified dosage regimens in Appendix B per PI; references reviewed and updated.
1Q 2025 annual review: no significant changes; references reviewed and updated.
Revised initial approval duration to 12 months for Medicaid/HIM. Added step therapy bypass for IL HIM per IL HB 5395.
1Q 2026 annual review: no significant changes; removed redirection to generic ibandronate as branded Boniva has been discontinued; references reviewed and updated.

Important Reminder