CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Blincyto (blinatumomab) — Coverage Criteria

Defines coverage, medical necessity, and authorization requirements for Blincyto (blinatumomab) for treatment of B‑cell acute lymphoblastic leukemia and related indications for members of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBlincyto (blinatumomab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJan 31, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing indication matches FDA labeling or recognized compendia/guidelines and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

28 mcgsingle dose limit

4 cyclesmax induction duration

J9039billing code

FDA+NCCN/ASCOevidence required

Coverage Criteria for Blincyto (blinatumomab)

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Indication: Member has one of the following: (1) MRD positive B‑cell ALL at the end of induction therapy (BCR‑ABL positive or negative) for consolidation; (2) MRD negative B‑cell ALL at the end of induction therapy for consolidation after standard induction chemotherapy (BCR‑ABL negative); or (3) relapsed/refractory CD19 positive B‑cell ALL to be treated with single‑agent blinatumomab.

Evidence: Use is supported by FDA‑approved product labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS requirements.

Providers must supply supporting documentation showing the member clinical characteristics and regimen align with cited evidence.

Dosing and duration: Requested dosing must not exceed a single dose of 28 mcg and total treatment must not exceed 4 cycles when used as induction or consolidation therapy.single dose ≤ 28 mcg; max 4 cycles for induction/consolidation

Exceeding these limits is an exclusion trigger.

Use of Blincyto (blinatumomab) must conform to the dosing and duration limits set by this policy. Specifically, requested dosing must not exceed a single dose of 28 mcg, and when used for induction or consolidation the total course must not exceed 4 cycles. Prior authorization is required and approvals are contingent on documentation that the indication and regimen align with FDA labeling or accepted compendia/guidelines.

Investigational or off‑label uses are only considered when there is sufficient supportive evidence as defined in this policy (see exclusion criteria). Sufficient evidence includes representation of the patient and cancer characteristics in published studies, appropriate representation of the administered regimen, clinically meaningful outcomes (for example ASCO‑recommended thresholds), and acceptable study design or alternative supportive non‑randomized data. Case reports and abstracts without full peer‑reviewed articles do not constitute sufficient evidence.

Use of Blincyto (blinatumomab) is considered not medically necessary for off‑label indications that lack adequate supporting evidence as defined by this policy. Examples of insufficient evidence include reliance solely on case reports, meeting abstracts without a full peer‑reviewed publication, or studies that do not adequately represent the patient population, the specific chemotherapy/biologic regimen, or clinically meaningful outcomes.

Requests will also be excluded/denied when there is documented disease progression on or after prior blinatumomab therapy, when dosing exceeds the single dose limit of 28 mcg, or when treatment duration for induction/consolidation exceeds 4 cycles.

Coding and Billing

Covered HCPCS CodeHCPCSCovered

J9039

Injection, blinatumomab, microgram

Single dose limit

Single-dose maximum28 mcg

Applies toAny single administration of blinatumomab (Blincyto)

Denial triggerRequests exceeding 28 mcg for a single dose will be excluded/denied

Maximum duration for induction/consolidation

Maximum cycles for induction/consolidation4 cycles

Applies whenBlinatumomab is used as induction or consolidation therapy

Denial triggerTreatment beyond 4 cycles for induction/consolidation will be excluded/denied

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Blincyto (blinatumomab). Approvals will be based on supporting evidence consistent with FDA-approved labeling, CMS-recognized compendia, or widely accepted oncology guidelines (e.g., NCCN, ASCO) and peer-reviewed literature that meet CMS standards.

Prior authorization required before initiation
Approval basis: FDA label / CMS-recognized compendia / NCCN or ASCO guidelines / acceptable peer-reviewed literature

Note

Provider Documentation and Impact

Providers must submit clinical information demonstrating the indication for use (e.g., MRD-positive consolidation, relapsed/refractory CD19+ B-cell ALL), prior therapies, and relevant dosing/treatment duration to support authorization decisions.

Document disease subtype (BCR-ABL positive or negative) and MRD status when applicable
List prior lines of therapy and response
Specify intended dosing schedule and planned number of cycles

Documentation Required

Required Supporting Documentation

Required supporting documentation must include one or more of the following sources: FDA product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

FDA-approved product labeling for blinatumomab
CMS-recognized compendia (as applicable)
NCCN or ASCO clinical practice guidelines
Peer-reviewed literature meeting CMS evidence standards (full articles preferred; abstracts alone are insufficient)

Denial Risk

Key Denial Triggers

Requests will be denied when exclusion criteria are met, including prior disease progression on blinatumomab, dosing or duration limits exceeded, or investigational/off-label use lacking sufficient evidence.

Prior progression on or after treatment with blinatumomab — denial
Single dose exceeds 28 mcg — denial
Treatment duration exceeds 4 cycles for induction/consolidation — denial
Off-label or investigational uses without supporting CMS compendia or acceptable peer-reviewed evidence — denial
Insufficient evidence examples: reliance on abstracts only, case reports without broader supportive data, or patient/therapy characteristics not represented in the evidence

Background

Blinatumomab is a bispecific T‑cell engager used in B‑cell precursor acute lymphoblastic leukemia (ALL) for consolidation after induction in patients with measurable residual disease (MRD) and as single‑agent therapy in relapsed or refractory CD19‑positive B‑cell ALL. Its use requires alignment with FDA labeling or accepted compendia/guidelines and appropriate documentation supporting the clinical scenario.

Clinical evidence supporting investigational or off‑label use must meaningfully represent the treated population and regimen, and demonstrate clinically meaningful outcomes; lower‑quality evidence such as case reports or abstracts without full publications are not sufficient.

Definitions

MRD consolidation

DefinitionMRD consolidation = use of blinatumomab after induction when measurable residual disease is present (MRD positive) or in specified MRD negative settings after standard induction chemotherapy

Indications includedMRD positive at end of induction for BCR-ABL positive and negative B-cell ALL; select MRD negative consolidation for BCR-ABL negative B-cell ALL after standard induction

ContextUsed to consolidate response following induction therapy in B-cell precursor ALL

Initial Therapy

Initial authorization for listed indications requires documentation consistent with FDA labeling or recognized guidelines/compendia.

Initial authorization: Indication must be one of the covered uses (MRD consolidation [positive or select negative after standard induction] or relapsed/refractory CD19+ B‑cell ALL) as specified in the policy.

Evidence requirement: Request must be supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS criteria.

Provider should document citations and demonstrate the member’s clinical characteristics and regimen match published evidence.

Dosing limits for initial therapy: Planned dosing must not exceed a single dose of 28 mcg; for induction/consolidation, planned total duration must not exceed 4 cycles.single dose ≤ 28 mcg; max 4 cycles

Requests exceeding these limits should be denied per exclusion criteria.

Continuation Therapy

Continuation requests may be approved if all the following are met:

Continuation criteria: (1) The medication was used within the last year; AND (2) the member has not experienced disease progression while on blinatumomab and has not had intolerance to the medication; AND (3) no additional medications are being added to the continuation request.

Continuation exemptions apply only when the original use aligns with policy indications and evidence.

Ongoing dosing and duration: Continued use must remain within the single‑dose and cycle limits established by policy (single dose ≤ 28 mcg; induction/consolidation ≤ 4 cycles).single dose ≤ 28 mcg; max 4 cycles

Disease progression or exceeding dosing/duration limits are exclusion triggers for continuation.

Step Therapy

Step	Requirement / sequencing	Coverage status
1
No specific step therapy sequence is required. Coverage is contingent on meeting the policy's evidence and clinical criteria (alignment with FDA‑approved labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature) and other authorization requirements.
Covered with criteria

Quantity Limits

blinatumomab — key limits

Single-dose limit28 mcg

Maximum induction/consolidation durationUp to 4 cycles

IndicationsUsed for MRD positive consolidation and select MRD negative consolidation after induction, and for relapsed/refractory CD19+ B-cell ALL

Denial conditionsRequests exceeding single dose 28 mcg or beyond 4 cycles for induction/consolidation will be excluded/denied

Site of Care