CurrentCentenePolicy CP.PHAR.359

Inotuzumab Ozogamicin (Besponsa) (PDF)

Defines medical necessity criteria, approval durations, dosing limits, covered indications, and billing code for Besponsa for commercial, HIM and Medicaid lines of business within Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyInotuzumab Ozogamicin (Besponsa) (PDF)

Policy CodePolicy CP.PHAR.359

Change TypeCriteria additions and dosing/approval revisions

Effective DateSep 26, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Pediatric expansion to include age ≥ 1 year added to criteria.

Removed monotherapy requirement and updated dosing per FDA label and NCCN; added limit of no more than 6 cycles total.

Added frontline therapy age criterion allowing frontline use only for age ≥ 18 years (when used as frontline per NCCN compendium).

Continuation criteria clarified to require positive response and <6 prior cycles.

1FDA-approved indication (B-cell precursor ALL)

6Maximum cycles allowed

≥1Minimum age for coverage (years)

1HCPCS code provided

Coverage Summary

Coverage stance: Besponsa (inotuzumab ozogamicin) is covered with criteria for treatment of relapsed or refractory CD22‑positive B‑cell precursor acute lymphoblastic leukemia (ALL) per the FDA‑approved label and NCCN compendia. The policy incorporates boxed warnings for hepatotoxicity (including hepatic veno‑occlusive disease) and increased risk of post‑HSCT non‑relapse mortality.

Approval limits and durations: treatment is limited to a maximum of 6 cycles total. Approval duration is Commercial: 6 months or to the member's renewal date, whichever is longer (up to 6 cycles total); HIM/Medicaid: 6 months (up to 6 cycles total). Dosing limits follow the label (maximum 1.8 mg/m2 per cycle, administered as 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15).

Maximum dose per cycle1.8 mg/m2 per cycle (0.8 mg/m2 Day 1; 0.5 mg/m2 Days 8 and 15)

Maximum total cycles6 cycles total

Age for initial approval≥ 1 year

Frontline therapy age exception≥ 18 years if prescribed as frontline therapy

Continuation minimum exposureMember has received medication for at least 30 days

Initial Therapy Criteria — B‑Cell Precursor ALL

Continuation (Reauthorization) Criteria

Exclusions / Other Indications

Other diagnoses/indications / Diagnoses/Indications Not Authorized

If initial or continuation criteria not met, one of the following must apply:

ref

Applicable Codes

Covered HCPCSHCPCSCovered

J9229

Injection, inotuzumab ozogamicin, 0.1 mg

Provider Actions / Prior Authorization

Prior Authorization

Documentation submission required for approval

Provider must submit documentation (office chart notes, lab results, or other clinical information) that supports the member meets all approval criteria for Besponsa. This documentation is required for prior authorization approval.

J9229

Prior Authorization

Prescriber specialty requirement

Prescriptions must be written by an oncologist or hematologist, or by another prescriber in consultation with an oncologist or hematologist, as a requirement for approval.

Clinical Evidence & Guidelines

Primary sources and guidelines: Besponsa Prescribing Information (Wyeth/Pfizer; March 2024) and the NCCN Acute Lymphoblastic Leukemia and Pediatric ALL compendia are cited as the primary references for indications, dosing, and recommendations.

The policy is aligned with the FDA label and NCCN compendia and explicitly incorporates the drug's boxed warnings for hepatotoxicity and increased post‑HSCT non‑relapse mortality as safety considerations.

Background

Besponsa is a CD22‑directed antibody‑drug conjugate indicated for relapsed or refractory CD22‑positive B‑cell precursor acute lymphoblastic leukemia in adult and pediatric patients aged ≥ 1 year.

Boxed warnings include hepatotoxicity (including hepatic veno‑occlusive disease) and increased risk of post‑HSCT non‑relapse mortality.

This policy aligns coverage with the FDA label and NCCN recommendations, including limits on total cycles, dosing thresholds (maximum 1.8 mg/m2 per cycle with the Day 1/8/15 split), and approval durations consistent with commercial and HIM/Medicaid lines of business.

QUICK DEFINITIONS

ALLacute lymphoblastic leukemia

CRcomplete remission

CRicomplete remission with incomplete hematologic recovery

HSCThematopoietic stem cell transplant

Revision History

05.13.24RT4 update (material)

RT4 update added pediatric expansion to include age ≥ 1 year and adjusted age criteria for certain non-relapsed/non-refractory Philadelphia chromosome-negative disease to >15 years per NCCN compendium.

4Q2021 (06.28.21 / P&T 11.21.21)Annual review (material)

Added pathway for use as induction therapy; revised single-agent requirement to only apply to pediatric ALL per NCCN and clarified dosing per FDA label.

4Q2022 (08.02.22 / P&T 11.22.22)Annual review (material)

Removed requirement for Philadelphia chromosome-positive disease to be intolerant or refractory to TKI per NCCN; added cap that Besponsa is prescribed for no more than 6 cycles total; approval duration revised to 6 months (up to 6 cycles total).

Policy Summary

PayerCentene

PolicyInotuzumab Ozogamicin (Besponsa) (PDF)

Policy CodePolicy CP.PHAR.359

Change TypeCriteria additions and dosing/approval revisions

Effective DateSep 26, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Documentation Required

Support dose justification for off-label dosing

If the requested dose exceeds the label-specified maximum or the use is off-label, the prescriber must submit supporting evidence such as a relevant practice guideline or peer-reviewed literature to justify the dosing.

Prescriber must attach supporting practice guideline or peer-reviewed literature evidence

Billing Rule

Cycle and quantity limits

Approval is limited to a maximum of 6 cycles total. Commercial approvals are for 6 months or to the member's renewal date (whichever is longer) up to 6 cycles total; HIM/Medicaid approvals are 6 months up to 6 cycles total. The policy also specifies a maximum dose threshold per cycle.

J9229
Maximum dose per cycle: 1.8 mg/m2 per cycle (0.8 mg/m2 Day 1; 0.5 mg/m2 Days 8 and 15)

4Q2023 (08.06.23 / P&T 11.23.23)Annual review (material)

Removed monotherapy requirement since Besponsa is also indicated as combination therapy for age ≤ 18 years per NCCN Compendium; corrected criteria logic regarding relapsed/refractory and Philadelphia chromosome scenarios.

4Q2024 (07.11.24 / P&T 11.24.24)Annual review (material)

Removed criterion that Besponsa is prescribed as induction therapy for Philadelphia chromosome-negative disease per NCCN; revised Commercial approval durations to '6 months or to the member's renewal date, whichever is longer.'

4Q2025 (07.15.25 / P&T 11.25.25)Annual review (material)Latest

Removed criteria option for age ≥ 15 years for Philadelphia chromosome-negative per NCCN Compendium; added criteria option allowing frontline therapy only when prescribed as frontline and patient is age ≥ 18 years per NCCN Compendium; references updated.

Continuation criteria (policy text)Clarification (material)Latest

Continuation (reauthorization) criteria clarified to require member has received medication for at least 30 days, is responding positively to therapy, and has received fewer than 6 prior cycles (<6); dose limits and maximum total cycles (6) reiterated per FDA label.