CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Blincyto (blinatumomab)

Defines coverage, utilization management, and authorization requirements for Blincyto (blinatumomab) for treatment of B-cell acute lymphoblastic leukemia for Neighborhood Health Plan of Rhode Island members and managing UM processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Blincyto (blinatumomab)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

28 mcgsingle dose maximum

4 cyclesmax duration (ind/consol)

J9039billing code

2025-01-08committee approval

2025-01-31effective

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Covered Indications

Covered when ANY of the following are met:

ALL Indications: 1) Consolidation for MRD-positive disease at the end of induction for BCR-ABL negative and BCR-ABL positive B-cell ALL.

from policy chunk 5

MRD-negative consolidation: 2) Consolidation for MRD-negative disease at the end of induction for BCR-ABL negative B-cell ALL after standard induction chemotherapy.

from policy chunk 5

Relapsed/Refractory single agent: 3) Single-agent use for relapsed/refractory CD19-positive B-cell ALL.

from policy chunk 5

Use of Blincyto (blinatumomab) for indications that are not supported by the FDA label, CMS‑recognized compendia, or acceptable peer‑reviewed literature is considered investigational and is excluded from coverage. The policy defines insufficient evidence when the published literature does not adequately represent the patient or disease characteristics, the therapeutic regimen used, or clinically meaningful outcomes (for example, ASCO‑recommended thresholds such as a hazard ratio < 0.80 or survival benefit ≥ 3 months). Case reports and meeting abstracts without full peer‑reviewed articles are specifically noted as inadequate evidence sources.

Requests for off‑label use must be supported by CMS‑recognized compendia or peer‑reviewed literature that meet the policy's evidentiary standards; absent such support, the use is treated as investigational and not covered.

Disease progression on or after prior treatment with blinatumomab is an explicit exclusion in this policy. If a member has demonstrated disease progression while receiving Blincyto, subsequent requests for blinatumomab are not eligible for coverage under this policy.

Coverage is excluded when dosing exceeds the policy limits. The policy sets a single dose limit of 28 mcg for blinatumomab and a maximum duration of 4 cycles when used for induction and/or consolidation therapy; requests exceeding these thresholds are not covered.

The policy’s definition of not medically necessary for investigational or off‑label use requires that supporting evidence meet seven specified criteria. Uses lacking adequate evidence are considered not medically necessary; examples of inadequate evidence include insufficient representation of patient or regimen characteristics in published studies, reliance on case reports, or abstracts without full peer‑reviewed publication. Providers must supply adequate, peer‑reviewed or compendia‑recognized evidence to establish medical necessity for off‑label indications.

Coding and Quantity Limits

Covered HCPCS CodesHCPCSCovered

J9039

Injection, blinatumomab, 1 microgram

inv-07: Single dose limit — 28 mcg

Single dose limit28 mcg per single dose

ApplicabilityApplies to Blincyto (blinatumomab) dosing in this policy

Denial triggerRequests exceeding this single dose may be denied per exclusion criteria

inv-08: Maximum duration (induction/consolidation) — 4 cycles

Maximum duration (induction/consolidation)4 cycles

ScopeLimit applies when blinatumomab is used for induction and/or consolidation therapy

Denial triggerTreatment exceeding 4 cycles may be excluded from coverage

inv-19: blinatumomab — billing per J9039 = 1 microgram units; single dose 28 mcg

HCPCS billing unitJ9039 = Injection, blinatumomab, 1 microgram

Single dose amountSingle dose of blinatumomab = 28 mcg

Billing noteBill appropriate number of J9039 units to equal total micrograms administered

Provider Actions, Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests for Blincyto (blinatumomab). Use must be supported by one of the following: FDA-approved product labeling, CMS-approved compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

All initial and continuation requests require prior authorization.
Supporting references must be provided with the request (see documentation callout).

Step Therapy

No step therapy sequencing is defined for Blincyto (blinatumomab). Coverage is specified for consolidation in MRD-positive and MRD-negative settings and for relapsed/refractory disease per the clinical criteria in this policy.

Step therapy: None required/defined.
Covered clinical settings: MRD-positive consolidation, MRD-negative consolidation (BCR-ABL negative B-Cell ALL after standard induction), and relapsed/refractory CD19 positive B-cell ALL.

Documentation Required

Required Supporting Documentation

Requests must include documentation demonstrating the indication and supporting evidence per the prior authorization requirements. Acceptable supporting documentation includes FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Clinical notes indicating diagnosis, disease status (e.g., MRD-positive or MRD-negative), prior therapies and response, and intent of therapy (consolidation, induction, relapsed/refractory).
Relevant pathology, molecular testing (e.g., CD19 status, BCR-ABL status), and prior treatment history including dates and outcomes.
Copies or citations of supporting guideline or peer-reviewed literature when the request relies on non-FDA labeled or compendia-supported indications.

Denial Risk

Denial Triggers / Exclusion Risks

Denial may be triggered when exclusion criteria are met or when dosing/duration limits are exceeded.

Disease progression on or after prior treatment with Blincyto (blinatumomab) is not eligible for coverage.
Any request where the dosing exceeds a single-dose limit of 28 mcg will be denied.
Treatment beyond the maximum duration limit of 4 cycles for induction and/or consolidation therapy will be denied.
Investigational or off-label uses lacking sufficient evidence (not supported by CMS compendia, NCCN/ASCO, or acceptable peer-reviewed literature meeting CMS standards) will be denied.

Key Definitions

inv-14: MRD — measurable residual disease positive/negative status used to guide consolidation therapy decisions

DefinitionMRD (measurable residual disease) status (positive or negative) used to guide consolidation therapy decisions

Clinical useMRD-positive at end of induction supports consolidation with blinatumomab for BCR-ABL negative and positive B-cell ALL

MRD-negative useMRD-negative consolidation after standard induction chemotherapy supported for BCR-ABL negative B-cell ALL

inv-15: Relapsed/Refractory CD19+ B-cell ALL — indication for single-agent blinatumomab

IndicationSingle-agent use for relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL)

DrugBlincyto (blinatumomab) used as single agent

PopulationMembers with relapsed or refractory CD19+ B-cell ALL

Prior step(s) required?	Clinical situations where blinatumomab is covered
No—this policy does not define any required prior step therapy sequences.
1) Consolidation for MRD-positive disease at the end of induction for both BCR-ABL–negative and BCR-ABL–positive B‑cell ALL; 2) Consolidation for MRD‑negative disease at the end of induction for BCR‑ABL–negative B‑cell ALL after standard induction chemotherapy; 3) Single‑agent use for relapsed/refractory CD19‑positive B‑cell ALL.

Background

Blinatumomab (Blincyto) is a bispecific T‑cell engager indicated for treatment of B‑cell precursor acute lymphoblastic leukemia (ALL), including use for measurable residual disease (MRD) consolidation and for relapsed/refractory CD19‑positive B‑cell ALL. This policy contextualizes blinatumomab coverage within FDA labeling and recognized compendia and directs clinicians to follow the FDA label/package insert for administration and monitoring details.

Coverage decisions are tied to specific clinical situations (e.g., MRD‑positive or MRD‑negative consolidation and relapsed/refractory single‑agent use) and must be supported by the documentation sources required by the policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Blincyto (blinatumomab)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 31, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

On This Page

OpenPayer

Drug Policy: Blincyto (blinatumomab)

Coverage Criteria for Blincyto (blinatumomab)

Initial / Consolidation Therapy Criteria

Continuation Therapy Criteria

Coding and Quantity Limits

Provider Actions, Authorization and Documentation

Key Definitions

Step Therapy and Prior Steps

Quantity and Dosing Limits

Site of Care and Administration

Background