Last Review Date: 10/22/2021

Date of Origin: 09/19/2017

Dates Reviewed: 09/2017, 11/2018, 11/2019, 11/2020, 11/2021

I. Length of Authorization

Coverage will be provided for 6 months (for up to a maximum of 6 cycles) and may not be renewed.

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Besponsa 0.9 mg powder for injection: 7 vials per 21 days

2. Max Units (per dose and over time) [HCPCS Unit]:

Cycle 1

• 27 billable units (2.7 mg) on Day 1, 18 billable units (1.8 mg) on Days 8 and 15 of a 21 to 28-day cycle

Subsequent Cycles (maximum of 5 cycles)

• 27 billable units (2.7 mg) on Day 1, 18 billable units (1.8 mg) on Days 8 and 15 of a 28-day cycle for up to 2 cycles
• 18 billable units (1.8 mg) on Day 1, Day 8, and Day 15 of a 28-day cycle for up to 3 cycles

III. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Baseline electrocardiogram (ECG) is within normal limits; AND
• Patient has not previously received inotuzumab ozogamicin; AND

Universal Criteria ^1-3

• Patient has CD22-positive disease; AND

Adult B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) † Ф ^1-3

• Patient is at least 18 years of age; AND
  • Patient has relapsed or refractory disease; AND
    • Used as single agent therapy or in combination with mini-hyper CVD (cyclophosphamide, dexamethasone, vincristine, methotrexate, cytarabine); AND
      • Patient is Philadelphia chromosome (Ph)-negative; OR
      • Patient is Philadelphia chromosome (Ph)-positive and is intolerant or refractory to prior tyrosine kinase inhibitor therapy (e.g., imatinib, dasatinib, ponatinib, nilotinib, bosutinib, etc.); OR
    • Used in combination with bosutinib; AND
      • Patient is Philadelphia chromosome (Ph)-positive; OR
  • Used as induction therapy in patients ≥65 years of age or with substantial comorbidities; AND
    • Used in combination with mini-hyper CVD; AND
    • Patient is Philadelphia chromosome (Ph)-negative

Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) ‡ ^3,4

• Patient is at least 2 years of age; AND
• Patient has relapsed or refractory disease; AND
• Used as single agent therapy; AND
  • Patient is Philadelphia chromosome (Ph)-negative; OR
  • Patient is Philadelphia chromosome (Ph)-positive and is intolerant or refractory to prior tyrosine kinase inhibitor therapy (e.g., imatinib, dasatinib, etc.)

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria

Coverage cannot be renewed.

V. Dosage/Administration

VI. Billing Code/Availability Information

HCPCS Code:

• J9229 - Injection, inotuzumab ozogamicin, 0.1 mg: 1 billable units = 0.1 mg

NDC:

• Besponsa 0.9 mg lyophilized powder in single-dose vial: 00008-0100-xx

VII. References

1. Besponsa [package insert]. Philadelphia, PA; Pfizer Inc., March 2018. Accessed October 2021.
2. Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) inotuzumab ozogamicin. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2021.
4. Bhojwani D, Sposto R, Shah NN, et al. Inotuzumab ozogamicin in pediatric patients with relapsed/refractory acute lymphoblastic leukemia [published correction appears in Leukemia. 2019 Mar 7;:]. Leukemia. 2019;33(4):884–892. doi:10.1038/s41375-018-0265-z.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Articles (LCAs), and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/Aw