Besponsa (inotuzumab ozogamicin) Medical Drug Clinical Criteria
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Clinical criteria governing prior authorization and medical necessity determinations for Besponsa (inotuzumab ozogamicin) use for CD22+ B-cell acute lymphoblastic leukemia (ALL), including frontline induction and relapsed/refractory settings; applies to Anthem members subject to medical benefit review.
Updated combination with TKI to specify Philadelphia chromosome-positive disease and clarified frontline therapy may be used with or without blinatumomab.
Removed ICD-10-CM D46.A and added C83.50-C83.59 to the coding list.
Coverage Criteria for Besponsa (inotuzumab ozogamicin)
Covered Indications (Initial and Frontline)
Requests for Besponsa (inotuzumab ozogamicin) may be approved if the following criteria are met:
Pediatric use allowed per NCCN; FDA approval is for adults but policy permits under-19 approval.
Relapsed/refractory requirement applies to this pathway.
Combination regimens and consolidation/induction per label and NCCN are accepted.
Frontline induction use is limited to Ph-negative disease when given with mini-hyper CVD (blinatumomab optional).
second-line | first-line
Policy allows both relapsed/refractory and specified frontline induction uses per NCCN.
Requests for Besponsa (inotuzumab ozogamicin) for indications other than those explicitly listed in this policy are not approved. Coverage is limited to the specific diagnosis, age pathways, and regimen scenarios described in the criteria set.
Requests that do not meet the required clinical criteria — including the specified diagnosis of CD22+ B-cell ALL, the applicable age pathway (pediatric pathway under 19 years when applicable versus relapsed/refractory pathway for adults), documented relapsed or refractory disease when required, or use of a permitted regimen (single-agent Besponsa; Besponsa + an approved TKI for Ph+ disease; or Besponsa + mini-hyper CVD with or without blinatumomab for the indicated frontline/consolidation uses) — may not be approved and can be denied as not medically necessary.
| Regimen | Details / Notes |
|---|---|
| Single‑agent Besponsa (inotuzumab ozogamicin) | Use as monotherapy per label and NCCN (relapsed/refractory CD22+ B‑cell ALL). |
| Besponsa + tyrosine kinase inhibitor (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) | Permitted for Philadelphia chromosome–positive (Ph+) B‑ALL per NCCN guidance (combination with a TKI). |
| Besponsa + mini‑hyper CVD (cyclophosphamide, dexamethasone, vincristine, methotrexate, cytarabine) | Permitted in combination with or without blinatumomab for consolidation or as induction for Philadelphia chromosome–negative (Ph‑) disease per NCCN; includes mini‑hyper CVD backbone details. |
Coding (HCPCS and ICD-10)
| J9229 | Injection, inotuzumab ozogamicin, 0.1 mg [Besponsa] |
| C83.50-C83.59 | Lymphoblastic (diffuse) lymphoma |
| C91.00-C91.02 | Acute lymphoblastic leukemia (ALL) |
Provider Actions, Documentation & Authorization
Prior authorization required — approval contingent on meeting clinical criteria
Prior authorization is required for Besponsa (inotuzumab ozogamicin); approval is contingent on meeting the policy's clinical criteria for age or CD22+ B-cell ALL diagnosis, relapsed/refractory status or permitted frontline regimen, and the specified permitted regimens.
- Submit PA for HCPCS J9229 (Injection, inotuzumab ozogamicin, 0.1 mg).
No explicit step therapy — NCCN regimens permitted
No explicit step therapy sequence is required by this policy; allowed regimens follow NCCN recommendations and include single-agent Besponsa or specified combination regimens without requiring prior alternatives.
- Permitted regimens: single-agent Besponsa; Besponsa + a TKI (bosutinib, dasatinib, imatinib, nilotinib, ponatinib) for Ph+ disease; Besponsa + mini‑hyper CVD with or without blinatumomab.
Required documentation to support diagnosis and planned regimen
Provide documentation that establishes a CD22+ B-cell ALL diagnosis and the clinical rationale for Besponsa use consistent with policy pathways (pediatric under‑19 pathway, relapsed/refractory pathway, or frontline induction pathway with mini‑hyper CVD).
- Relevant ICD-10 diagnosis codes (e.g., C91.00-C91.02 for ALL; C83.50-C83.59 as applicable).
- Clinical notes documenting CD22 positivity and whether the disease is relapsed or refractory, or documentation supporting frontline induction use with mini‑hyper CVD (with/without blinatumomab) for Ph‑negative disease.
- Planned regimen details (single-agent vs. specified combination and TKI selection if Ph‑positive).
Denial triggers — criteria not met or unsupported indication
Requests may be denied if the clinical criteria in the policy are not met or if the indication is not one of those listed (including failure to document CD22+ B-cell ALL, relapsed/refractory status when required, or permitted regimen).
- Missing evidence of CD22‑positive B‑cell ALL.
- No documentation of relapsed or refractory disease when not eligible via the pediatric (<19) pathway.
- Use as frontline induction for Ph‑negative disease without combination with mini‑hyper CVD (with or without blinatumomab) as specified.
Biomarker Requirements
Background
Besponsa (inotuzumab ozogamicin) is an anti-CD22 antibody–drug conjugate that delivers a cytotoxic payload to CD22-expressing B-cell precursor leukemias. Its use in this policy is limited to CD22-positive B-cell acute lymphoblastic leukemia (ALL) in the relapsed/refractory setting for adults and in specified frontline induction or consolidation regimens per NCCN recommendations.
Definitions and Safety Terms
Revision History
Document history notes removal of ICD-10-CM D46.A and addition of C83.50–C83.59 to the coding list.
Clinical wording clarified to specify that combination with a tyrosine kinase inhibitor applies to Philadelphia chromosome–positive disease and that frontline induction may be used with or without blinatumomab per NCCN guidance.
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