CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization and coverage criteria, dosing, and conditions for medical-benefit coverage of Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) across pediatric and adult populations, including relapsed/refractory, consolidation, induction, and maintenance settings.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeRevised indications and criteria (annual revisions)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approve for 1 year if the patient meets the listed criteria and dosing, with approvals provided for the noted duration.

SourceLink

POLICY UPDATE CHANGES

For Philadelphia chromosome positive disease, 'has relapsed or refractory disease' and 'medication is used for maintenance therapy' were added as additional options for approval.

For Philadelphia chromosome negative and Philadelphia chromosome-like disease, prior MRD-positive requirements were removed and induction/consolidation therapy options were added.

1Year approval duration for FDA indication

4Max cycles (MRD-positive B-cell precursor ALL)

9Max cycles (relapsed/refractory B-cell precursor ALL)

2024-09-04

Coverage Summary & Scope

Scope: Defines prior authorization and coverage criteria, dosing, and conditions for medical-benefit coverage of Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) across pediatric and adult populations, including relapsed/refractory, consolidation, induction, and maintenance settings. Coverage is limited to patients meeting the listed authorization criteria and dosing requirements and requires prescribing by or in consultation with an oncologist.

Coverage stance: Covered with criteria — Blincyto is approved for specified B-cell precursor ALL indications (relapsed/refractory disease and consolidation; induction and maintenance options per Philadelphia status) when the patient meets all listed criteria. The policy notes a boxed warning for cytokine release syndrome and states approvals are provided for 1 year for the FDA-approved ALL indication.

Key thresholds & status

Year approval duration (FDA ALL indication)1 year

Max cycles (MRD-positive B-cell precursor ALL)Maximum of 4 cycles

Max cycles (relapsed/refractory B-cell precursor ALL)Maximum of 9 cycles

Last review date2024-09-04

Dosing summary (>=45 kg)Cycle 1: 9 mcg/day Days 1–7 then 28 mcg/day Days 8–28; subsequent cycles 28 mcg/day Days 1–28 (28-day continuous IV infusion per cycle)

Dosing summary (<45 kg)Cycle 1: 5 mcg/m2/day (not to exceed 9 mcg/day) Days 1–7 then 15 mcg/m2/day (not to exceed 28 mcg/day) Days 8–28; subsequent cycles 15 mcg/m2/day (not to exceed 28 mcg/day) Days 1–28

Cycle scheduling28-day continuous IV infusion followed by a minimum 14-day treatment-free interval (some courses specify 14- or 56-day intervals depending on induction/consolidation/continued therapy)

FDA-Approved Indication — Acute Lymphoblastic Leukemia (Initial Authorization)

FDA-Approved Indication — Acute Lymphoblastic Leukemia

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

Patient has B-cell precursor disease.
Philadelphia chromosome status
- Philadelphia chromosome negative
  - One of:
    Patient has relapsed or refractory disease.
    Medication is used for consolidation therapy.

Continuation / Duration / Dosing Limits

Continuation/authorization approach: Prior authorization is recommended and approvals are provided for the duration noted in the policy — 1 year for the FDA-approved ALL indication — provided the patient continues to meet the listed Criteria and Dosing. Extended approvals are allowed if criteria and dosing continue to be met.

Dosing exceptions and denials: Requests for doses outside the established dosing in the policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist). Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria, and claims may be denied if the criteria are not met.

Numeric thresholds

Maximum cycles for MRD-positiveMaximum of 4 cycles

Maximum cycles for relapsed/refractoryMaximum of 9 cycles

Cycle scheduling28-day continuous IV infusion + minimum 14-day treatment-free interval (14- or 56-day variants for specific courses)

Dosing for patients >=45 kgCycle 1: 9 mcg/day Days 1–7 then 28 mcg/day Days 8–28; subsequent cycles 28 mcg/day Days 1–28

Provider Actions & Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage; approve if patient meets listed criteria and dosing; approvals are provided for the duration noted (1 year for FDA-approved ALL indication).

Approvals provided for 1 year for the FDA-approved ALL indication

Documentation Required

Specialist prescribing requirement

Blincyto must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

oncologist

Applicable Codes

DrugNDC

No codes listed

J-code / HCPCS (implied injectable billing)HCPCS

No codes listed

Evidence & Guideline Sources

Evidence cited: NCCN guideline versions — NCCN ALL v2.2024 (July 19, 2024) and Pediatric ALL v1.2025 (Aug 28, 2024) — recommend Blincyto for relapsed/refractory B-cell ALL and for use in induction, consolidation, and maintenance settings.

Safety and prescribing information: Amgen Blincyto prescribing information, June 2024 is cited as the prescribing information reference. The prescribing information and policy background include a boxed warning for cytokine release syndrome as a significant safety concern.

Background & Definitions

Background: Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager. It is indicated for relapsed or refractory CD19-positive B-cell precursor ALL and for consolidation in certain CD19-positive B-cell precursor ALL patients. Dosing and cycle limits vary by weight/BSA and indication: for patients ≥45 kg fixed dosing is used and for patients <45 kg dosing is based on BSA; maximum cycles differ by indication (up to 4 cycles for MRD-positive disease and up to 9 cycles for relapsed/refractory disease). The agent carries a boxed warning for cytokine release syndrome.

MRD = Minimal residual disease.

BSA = Body surface area.

Revision History

09/06/2023annual_review

For Philadelphia chromosome positive disease, 'has relapsed or refractory disease' and 'medication is used for maintenance therapy' were added as additional options for approval.

09/04/2024annual_revisionLatest

For Philadelphia chromosome negative and Philadelphia chromosome-like disease, prior MRD-positive requirements were removed and induction/consolidation therapy options were added; additionally, for Philadelphia chromosome positive disease induction and maintenance options were clarified per authorization criteria.