CurrentMass General Brigham Health PlanPolicy N/A

Single-agent therapies for B-cell precursor acute lymphoblastic leukemia (Besponsa, Blincyto)

Policy governs prior authorization and coverage criteria for Besponsa (inotuzumab ozogamicin) and Blincyto (blinatumomab) for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicySingle-agent therapies for B-cell precursor acute lymphoblastic leukemia (Besponsa, Blincyto)

Policy CodePolicy N/A

Change TypeAge indication expandedreauthorization clarified

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required and must include documentation of B-ALL diagnosis, prescriber specialty (oncology/hematology), appropriate dosing (weight), and age eligibility for Besponsa.

SourceLink

POLICY UPDATE CHANGES

Criteria updated to reflect expanded age indication of Besponsa for pediatric patients 1 year and older.

Criteria updated to reflect expanded indication for Blincyto and to address trial of combination therapy with TKIs per NCCN.

Reauthorization duration standardized to 6 months for initial approvals and reauthorizations.

2drugs covered (Besponsa, Blincyto)

6 moinitial approval / reauthorization duration

PA requiredaccess control

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Coverage Criteria for Besponsa and Blincyto

Initial Authorization criteria

Authorization may be granted when ALL of the following are met:

Primary requirements: Member has diagnosis of B-cell precursor acute lymphoblastic leukemia (B-ALL); prescriber is an oncologist or hematologist; appropriate dosing documented (weight is required); age eligibility for Besponsa met (>= 1 year).

From policy coverage guidelines and review history.

Drug-specific or situational criteria

Blincyto pathway (remission): For Blincyto: member is in complete remission following initial treatment.
From policy coverage guidelines.
Philadelphia chromosome-positive pathway (TKI prior or combination): Philadelphia chromosome-positive disease: either (1) inadequate response or adverse reaction to, or contraindication to, ONE of the following TKIs: bosutinib, dasatinib, imatinib, ponatinib, nilotinib; OR (2) agent (Besponsa or Blincyto) will be used in combination with ONE of the following TKIs: bosutinib, dasatinib, imatinib, ponatinib, nilotinib.
Policy specifies prior TKI therapy or use in combination per NCCN trial considerations.
Philadelphia chromosome-negative pathway: Both of the following: prior therapy for the treatment of ALL with ONE prior systemic therapy; (agent selection consistent with relapsed/refractory indication).
From policy coverage guidelines.

Continuation / Reauthorization

Reauthorization/Continuation of therapy

Continuation of therapy: Reauthorization requires prescriber attestation of continued benefit or positive response to therapy; initial approvals and reauthorizations are granted for 6 months.

Prescriber attestation and 6-month authorization period per Limitations and Review History.

Authorization decisions are based on meeting the specific clinical requirements listed in this policy or, for members who are already receiving therapy and newly join the plan, on case‑by‑case review. Per policy language, authorizations "may be reviewed on a case by case basis for members who are new to the plan currently receiving treatment with requested medication" unless the product was provided only as samples or via a manufacturer's patient assistance program. When the listed criteria are met and supporting documentation is provided, authorization may be granted for treatment of B‑cell precursor acute lymphoblastic leukemia (B‑ALL) with the covered agents.

Treatment is considered not medically necessary when required documentation or the clinical criteria in this policy are not provided. Specifically, authorization may be denied if documentation does not verify the diagnosis of B‑cell precursor acute lymphoblastic leukemia (B‑ALL), the prescriber specialty (oncologist or hematologist), appropriate dosing including weight, or age eligibility where applicable (for Besponsa). Likewise, lack of evidence that one of the drug‑specific pathways is met (for example prior therapy requirements or Philadelphia chromosome‑related sequencing) may render the request not approvable.

Regimen	Indication / Clinical Conditions	Coverage Conditions / Notes
Single‑agent Besponsa (inotuzumab ozogamicin)
Relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (B‑ALL); age eligibility updated to include pediatric patients (>=1 year).
Prior authorization required; prescriber must be an oncologist or hematologist; appropriate dosing (weight) documented; meets age criteria (Besponsa ≥1 year as updated). Combination with TKIs may be considered per NCCN for Philadelphia chromosome‑positive disease (see policy for TKI trial/combination conditions).

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Besponsa (inotuzumab ozogamicin) and Blincyto (blinatumomab). Authorizations may be reviewed on a case‑by‑case basis for members new to the plan who are currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance program supply).

Prior authorization required for Besponsa and Blincyto
Case‑by‑case review allowed for members new to the plan who are currently receiving treatment (excluding samples or manufacturer assistance)

Step Therapy

Step / Sequence Considerations

Step/sequence requirements vary by disease subtype and agent: for Philadelphia chromosome‑negative disease, prior therapy with ONE prior systemic therapy is required; for Philadelphia chromosome‑positive disease, there must be inadequate response or intolerance to ONE or contraindication to ALL listed TKIs (bosutinib, dasatinib, imatinib, ponatinib, nilotinib). For combination use, the agent may be used with ONE of the listed TKIs per NCCN guidance. Ensure step‑therapy/trial of prior agents is documented.

Approved Regimens and Indications

Agent	Approved Indication / Age Range	Combination Exceptions / NCCN Notes
Blincyto (blinatumomab)
Treatment of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (B‑ALL); indicated for adults and pediatric patients per updated policy language and NCCN alignment (policy updated to reflect expanded Blincyto indication).
Prescriber must be an oncologist or hematologist; members in complete remission following initial treatment may meet criteria for Blincyto per policy. For Philadelphia chromosome‑positive disease, trial or combination with TKIs per NCCN may apply; prior authorization required.

Line of Therapy Specifications

Second-line

Line of therapy notes: Policy describes use in relapsed or refractory B-ALL; some subgroups reference prior systemic therapy (e.g., ONE prior systemic therapy required for specified Philadelphia chromosome-negative pathway).

Line of therapy per coverage guidelines.

Biomarker and Test Requirements

Philadelphia chromosome (BCR-ABL) — Ph-positive disease considerations

RelevancePhiladelphia chromosome (BCR-ABL) positive disease alters the treatment pathway: patients require either inadequate response/adverse reaction to or contraindication to TKIs, or use of Blincyto/Besponsa in combination with a TKI per NCCN guidance.

Required testing/documentationDocumented Philadelphia chromosome (BCR-ABL) positive status is required to trigger the Ph-positive treatment pathway (per coverage criteria referencing TKIs and combination use).

Prior TKI requirementAuthorization for Ph-positive patients requires inadequate response or adverse reaction to ONE or contraindication to ALL listed TKIs (bosutinib, dasatinib, imatinib, ponatinib, nilotinib) unless combination TKI use is planned per NCCN.

Combination usePolicy allows use of Blincyto or Besponsa in combination with ONE listed TKI (bosutinib, dasatinib, imatinib, ponatinib, nilotinib) when indicated per NCCN or trial considerations.

ReferencesPolicy cites NCCN guidelines and product prescribing information supporting Ph-positive management and TKI agents (see referenced NCCN and package inserts).

Definitions and Abbreviations

B-ALL — definition required for coverage

DefinitionB-cell precursor acute lymphoblastic leukemia (B-ALL): the diagnosis required for coverage under this policy.

Age eligibility (agent-specific)Besponsa: expanded pediatric indication noted (policy requires age criteria for Besponsa as specified in coverage guidelines).

Prescriber requirementPrescriber must be an oncologist or hematologist as part of required documentation for coverage of B-ALL therapies.

Diagnostic documentationClinical documentation must support diagnosis of B-ALL (as the covered indication for Blincyto and Besponsa).

Background on Therapies

Besponsa (inotuzumab ozogamicin) is a CD22‑directed antibody‑drug conjugate indicated for relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (B‑ALL). Blincyto (blinatumomab) is a bispecific T‑cell engager (CD19xCD3) indicated for relapsed or refractory B‑ALL and has pediatric indications in updated guidance. Both agents are single‑agent therapies addressed by this policy and are subject to the coverage pathways outlined here, including specific requirements for Philadelphia chromosome (BCR‑ABL)‑positive disease where tyrosine kinase inhibitor (TKI) sequencing or combination use is referenced per NCCN considerations.

Policy Revision History

2025-10-01criteria_revisionLatest

Criteria updated to reflect expanded indication for Blincyto and to address trial of combination therapy with TKIs per NCCN; reauthorization duration standardized to 6 months.

2025-09-01operational_update

Formatting updates and removal of appendix during annual UM review (information accessible via NCCN); administrative review for P&T.

2024-10-01