BONIVA INJ, Ibandronate Sodium Form

Ibandronate injection (Boniva®) is a bisphosphonate. FDA Approved Indication(s) Boniva is indicated for the treatment of osteoporosis in postmenopausal women (PMO). In postmenopausal women with osteoporosis, Boniva increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. Limitation(s) of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that ibandronate injection is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Osteoporosis (must meet all):

1. Diagnosis of PMO;
   2. Age ≥ 18 years or documentation of closed epiphyses on x-ray;
   3. Failure of a 12-month trial of an oral bisphosphonate (see Appendix B; generic alendronate is preferred) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required.
2. Member must use generic ibandronate injection, unless contraindicated or clinically significant adverse effects are experienced;

3. 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 – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer
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   CLINICAL POLICY Ibandronate Injection B. Other diagnoses/indications (must meet 1 or 2):

4. 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
5. 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):
6. 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. Member must use generic ibandronate injection, unless contraindicated or clinically significant adverse effects are experienced;
7. 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):

8. 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 Page 2 of 6

   CLINICAL POLICY Ibandronate Injection 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

9. 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.
   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. Drug Name Dosing Regimen Dose Limit/ Maximum Dose Oral bisphosphonates alendronate (Fosamax®) Fosamax® Plus D (alendronate / cholecalciferol) risedronate (Actonel®, Atelvia®) 10 mg PO QD or 70 mg PO once weekly 70 mg alendronate /2800 IU vitamin D3 or 70 mg alendronate /5600 IU vitamin D3 PO once weekly
   Actonel: 5 mg PO QD or 35 mg PO once weekly or 75 mg PO QD taken on two consecutive days each month or 150 mg PO once monthly Atelvia: 35 mg PO once weekly 40 mg/day 70 mg/week 70 mg / 5600 IU/ week Actonel: 5 mg/day 35 mg/week 150 mg/month Atelvia: 35 mg/week ibandronate (Boniva®) 150 mg PO once monthly 150 mg/month 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. Page 3 of 6

   CLINICAL POLICY Ibandronate Injection Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypocalcemia, hypersensitivity
   • Boxed warning(s): none reported V. Dosage and Administration Indication PMO Dosing Regimen 3 mg IV every 3 months Maximum Dose 3 mg/3 months VI. Product Availability
   Single-use prefilled syringe: 3 mg/3 mL VII.