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Besponsa (inotuzumab ozogamicin) Medication Precertification Request - Coverage Criteria
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Precertification form and requirements for Aetna coverage of Besponsa (inotuzumab ozogamicin) for patients with acute lymphoblastic leukemia; applies to providers submitting prior authorization requests to Aetna.
No material clinical or coverage changes in this revision.
Coverage Criteria for Besponsa (inotuzumab ozogamicin)
Clinical information required for medical necessity determination
Coverage assessment requires completion of clinical criteria and documentation; the form captures the following items to determine medical necessity.
All items requested on the form must be completed for precertification review.
Required for evaluation of continuation approval.
Form captures these regimen choices; provider must indicate which applies.
The precertification form does not include an explicit list of exclusionary conditions. There are no stated exclusion criteria on the document; reviewers must rely on the completed clinical fields and submitted documentation to determine whether a request meets coverage requirements.
All fields on the form are required and must be completed and legible for precertification review. Failure to provide the required clinical information or to submit a complete, legible form may prevent review and can result in denial or a request for additional information.
| Regimen option | Notes |
|---|---|
| Single agent | |
| Besponsa in combination with cyclophosphamide, dexamethasone, vincristine, methotrexate, and cytarabine (with or without blinatumomab) | |
| Besponsa in combination with a tyrosine kinase inhibitor (e.g., imatinib, dasatinib, nilotinib, bosutinib, ponatinib) for Philadelphia chromosome–positive (Ph+) disease | |
| Other (provider to specify) |
Coding and Billing Information
| Administration code(s) (CPT) | Place on form for provider to list relevant CPT administration codes |
| Primary ICD Code | Provider to supply primary diagnosis ICD code |
| Secondary ICD Code | Provider to supply secondary diagnosis ICD code |
| Other ICD Code | Provider to supply additional ICD codes as applicable |
| NDC or drug identification not listed | Form requests product, dose, frequency but does not list NDC |
Provider Actions and Submission Requirements
Precertification required — submit via Aetna phone/fax
Precertification (prior authorization) is required for Besponsa; providers must submit the completed precertification request to Aetna via the phone or fax numbers listed on the form.
- Phone: 1-866-752-7021 (TTY: 711)
- Fax: 1-888-267-3277
- All fields must be completed and legible for precertification review.
Capture regimen and treatment setting on the form
The form requires the provider to indicate the treatment setting (relapsed, refractory, frontline/induction, or other) and to specify the requested regimen as single agent, one of the listed combination regimens, or Other.
- Select treatment setting: Relapsed; Refractory; As frontline (induction) therapy; Other
- Select regimen: Single agent; Combination with cyclophosphamide, dexamethasone, vincristine, methotrexate, and cytarabine ± blinatumomab; Combination with a tyrosine kinase inhibitor for Ph+ disease; Other
- Indicate whether patient will receive >6 treatment cycles
Include required clinical documentation (diagnosis, CD22, Ph status, regimen, dosing)
Provide required clinical documentation with the request: diagnosis of ALL (and for initiation, documentation of B‑cell precursor ALL), CD22 testing result, Philadelphia chromosome status, the requested regimen and setting, and product/dosing information.
- Documented diagnosis of acute lymphoblastic leukemia (ALL); for initiation, documentation that the patient has B‑cell precursor ALL
- CD22 testing result (positive/negative/unknown) and Philadelphia chromosome status (Ph+/Ph-/Unknown)
- Requested product (Besponsa), dose, frequency, and whether >6 cycles are planned
- For continuation requests: evidence of disease progression or unacceptable toxicity and number of cycles already received
Risk of denial for incomplete or illegible submissions
Incomplete or illegible fields or missing required clinical information may prevent precertification review and can lead to denial or a request for additional information.
- The form states: "All fields must be completed and legible for precertification review."
- Missing continuation details (e.g., progression/toxicity, number of cycles) or initiation details (e.g., B‑ALL documentation, CD22 status) may delay or deny review
Biomarker and Test Results
Line of Therapy
first-line | second-line | salvage
Provider must indicate the treatment setting on the form.
Key Definitions
Background
Besponsa (inotuzumab ozogamicin) is presented on the form as the requested product for patients with acute lymphoblastic leukemia. The form collects diagnosis subtype (including B‑cell precursor ALL), biomarker data (CD22 status), Philadelphia chromosome status, treatment setting (relapsed, refractory, frontline, or other), the specific regimen requested (single agent or several combination options), and whether the patient will receive more than 6 cycles—information used to support medical necessity determinations.
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