ModifiedCentenePolicy CP.PHAR.312

Blinatumomab (Blincyto) clinical policy — coverage criteria

Defines medical necessity and prior authorization criteria for blinatumomab (Blincyto) for treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) across Centene lines of business.

Policy Summary

PayerCentene

PolicyBlinatumomab (Blincyto) clinical policy — coverage criteria

Policy CodePolicy CP.PHAR.312

Change TypeUpdated coverage pathways and indications (material changes)

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added FDA-approved indication for Ph- B-ALL as consolidation therapy and age restriction of at least 1 month.

Specified that infant ALL must have KMT2A status and later removed that requirement.

Clarified that 'Ph' refers to adult disease and added the term BCR::ABL1 for pediatric disease.

Added pathways for use in Ph+ B-ALL in combination with TKI and for use in infant ALL per NCCN.

Updated FDA approved indication(s) to reflect conversion from accelerated to full approval for MRD-positive ALL.

Added new FDA approved indication for Ph- B-ALL as consolidation therapy and added age restriction of at least 1 month.

Clarified that Ph refers to adult disease and added the term BCR::ABL1 for pediatric disease (NCCN-aligned updates).

≥ 1 monthMinimum age

28 mcg/day

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Coverage Criteria for Blinatumomab (Blincyto)

Initial Therapy — Covered when ALL of the following are met for B-Cell Acute Lymphoblastic Leukemia (B-ALL).

Covered when ALL of the following are met for B-Cell Acute Lymphoblastic Leukemia (B-ALL):

B-ALL initial therapy criteria: 1. Diagnosis of B-ALL; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 1 month; 4. Requested as treatment for ONE of the following: a) B-ALL in remission but MRD-positive (≥ 0.1%); b) Philadelphia chromosome–positive (Ph) disease in adults or BCR::ABL1-positive disease in pediatrics, prescribed either i) in combination with a tyrosine kinase inhibitor (TKI) for induction (adults only), consolidation, or relapsed/refractory disease, or ii) as single-agent for relapsed/refractory disease or consolidation (adult consolidation must be MRD-positive); c) Ph-negative (adults) or BCR::ABL1-negative (pediatrics) disease, prescribed as i) consolidation as a single agent, alternating with multiagent therapy (adults only), or combination therapy (pediatrics), ii) for relapsed or refractory disease as a single agent, or iii) as maintenance therapy for adult disease alternating with POMP; d) BCR::ABL1-like pediatric ALL as consolidation (single agent or combination); e) Infant ALL in combination with an Interfant regimen; 5. Dose does not exceed 28 mcg/day OR dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence); 6. Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months. See dosing guidance for weight/BSA-based schedules (fixed dosing for ≥45 kg up to 28 mcg/day).

Continuation Therapy — Covered when ALL of the following are met for continuation therapy.

Covered when ALL of the following are met for continuation therapy:

Continuation criteria: 1. Member is currently receiving Blincyto via the Centene benefit, or documentation supports member has received Blincyto for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. If the request is for a dose increase, the new dose does not exceed 28 mcg/day OR the new dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); 4. Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months. See dosing schedules for continued therapy cycles and weight/BSA-based dosing.

Updated coverage pathways and indications — Policy updated to add and reorganize clinical pathways according to FDA approvals and NCCN guidance.

Policy updated to add and reorganize clinical pathways according to FDA approvals and NCCN guidance.

MRD-positive ALL indication: FDA accelerated approval for MRD-positive ALL was converted to full approval; MRD-positive remission (≥ 0.1%) is an FDA-recognized indication for Blincyto in adult and pediatric patients ≥ 1 month.

See dosing and cycle guidance for MRD-positive indications.

Ph+ B-ALL: Added pathway for use in Ph-positive disease (adults termed Ph; pediatrics termed BCR::ABL1) including use in combination with TKIs for induction (adults), consolidation, or relapsed/refractory disease, and added induction pathway for Ph+ disease; removed prior requirement that relapsed/refractory Ph+ disease be refractory to TKIs.

Pediatric and adult distinctions clarified (Ph vs BCR::ABL1).

Ph- B-ALL: Added FDA-approved consolidation indication for Ph-negative (Ph-) B-ALL with age restriction of at least 1 month; added pathways for consolidation, maintenance, and frontline consolidation per NCCN.>= 1 month

Non-FDA approved indications that are not specifically addressed in this clinical policy are not authorized for coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the Health Plan's applicable off-label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage and benefit determinations are governed by the member's contractual documents and Health Plan administrative policies. Authorization and payment decisions are subject to all terms, conditions, exclusions, and limitations of the evidence of coverage, certificate of coverage, policy, contract of insurance, and applicable state and federal requirements; when state Medicaid provisions conflict with this clinical policy, the state Medicaid requirements supersede.

Uses of blinatumomab that are non–FDA-approved and that are not supported by the Health Plan's listed off-label policies or the member's evidence of coverage are considered not authorized under this policy. Providers seeking coverage for off-label uses must follow the specified off-label review processes and submit supporting clinical evidence per the referenced off-label policies.

This policy does not enumerate every possible non‑medically necessary (NMN) scenario. When a requested service does not meet the clinical criteria in this policy or is inconsistent with the member's coverage documents, the request may be denied. Lack of documentation showing that the member meets all approval criteria or requests for non‑FDA uses not supported by off‑label policies are common reasons for denial.

Coding and Dose Limits

HCPCS CodesHCPCS

J9039

Injection, blinatumomab, 1 microgram

Coding implications (unspecified)mixed

affected codes

Document references coding implications and template changes; specific CPT/HCPCS/NDC codes are not listed in these chunks.

Coding guidance notemixed

informational only

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; providers should reference current professional coding guidance prior to claim submission.

inv-10: Maximum adult dose — 28 mcg/day

Maximum adult dose28 mcg/day

Dose limit conditionDose must not exceed 28 mcg/day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence)

Fixed dosing for ≥45 kgPatients ≥45 kg receive fixed dose up to 28 mcg/day (consolidation: Days 1–28: 28 mcg/day)

BSA‑based dosing for <45 kgPatients <45 kg: BSA‑based dosing (consolidation: Days 1–28: 15 mcg/m2/day)

inv-11: Minimum age for Ph- B-ALL consolidation — >= 1 month

Minimum age (Ph‑ B-ALL consolidation)>= 1 month

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required. Authorization decisions follow the Health Plan’s administrative policies and the member’s coverage documents; providers must obtain approval before initiation of therapy when required by the plan.

Prior authorization must document that the member meets all applicable policy criteria: diagnosis, prescriber specialty, age, and indication-specific requirements.
Authorization decisions are made per the member’s evidence of coverage, certificate of coverage, policy or contract and applicable Health Plan procedures.

Documentation Required

Documentation Requirements

Required Clinical Documentation: Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Include documentation of diagnosis, prescriber specialty (oncologist/hematologist when applicable), member age, prior therapies, response to therapy, and any guideline or literature support for off‑label dosing.

Background on Blinatumomab

Blinatumomab (Blincyto) is a bispecific CD19-directed CD3 T‑cell engager indicated for treatment of CD19‑positive B‑cell precursor acute lymphoblastic leukemia (B‑ALL) in adult and pediatric patients. Indications addressed in the policy include use for MRD‑positive disease, relapsed or refractory disease, and consolidation/maintenance scenarios as specified by FDA labeling and NCCN guidance.

Definitions and Abbreviations

inv-21: B-ALL — B-cell precursor acute lymphoblastic leukemia.

DefinitionB-ALL: B-cell precursor acute lymphoblastic leukemia

ContextUsed throughout policy to denote CD19‑positive B‑cell precursor ALL indications

Abbreviation sourceDefined in Appendix A: Abbreviation/Acronym Key

inv-22: Abbreviations — MRD: minimal residual disease; CRS: cytokine release syndrome; TKI: tyrosine kinase inhibitor.

MRDminimal residual disease

CRScytokine release syndrome

TKI

Line of Therapy Pathways

first-line | consolidation | relapsed/refractory — line-of-therapy pathways

Line-of-therapy pathways (single top-level node):

Line of therapy: Includes use for MRD-positive remission (consolidation), relapsed or refractory disease (induction/consolidation/continued therapy), consolidation phase of multiphase chemotherapy, and specified pediatric consolidation/combination regimens.

Refer to indication-specific criteria for Ph+ vs Ph- and pediatric distinctions.

first-line | consolidation | maintenance — updated line-of-therapy distinctions

Updated line-of-therapy distinctions (three top-level nodes):

Induction: Added pathway for induction use in Ph+ disease (combination with a TKI for adults) and induction regimens per NCCN where applicable.

See dosing schedules for induction cycles (weight/BSA adjustments).

Biomarker and Genetic Requirements

inv-27: BCR::ABL1 / Philadelphia chromosome (Ph) — biomarker references across adult and pediatric disease.

BCR::ABL1 / Philadelphia chromosome (Ph)Biomarker references used to differentiate adult (Ph) versus pediatric (BCR::ABL1) pathways; guides use with or without TKI

Policy clarification3Q2025 review clarified that 'Ph' refers to adult disease and BCR::ABL1 is the pediatric term

Clinical implicationDetermines whether blinatumomab is used alone or in combination with a TKI per pathway

inv-28: KMT2A (11q23 rearranged) — biomarker reference (previously required for infant ALL).

KMT2A (11q23 rearranged)Previously required biomarker for infant ALL pathway per 3Q2024 update

Subsequent change

Dosing Regimens and Combination Therapies

Regimen / Indication	Patient weight or BSA	Dosing schedule	Maximum dose / Notes
Induction — B-ALL (in remission, MRD-positive)
Patients ≥ 45 kg
Cycle 1: Days 1–28: 28 mcg/day; Days 29–42: 14-day treatment-free interval
Maximum: 28 mcg/day
Induction — B-ALL (in remission, MRD-positive)
Patients < 45 kg (BSA-based)
Cycle 1: Days 1–28: 15 mcg/m2/day; Days 29–42: 14-day treatment-free interval
Dose expressed per m2; maximum 28 mcg/day for larger patients
Consolidation — B-ALL (in remission, MRD-positive), Cycles 2–4
Patients ≥ 45 kg
Each cycle Days 1–28: 28 mcg/day; Days 29–42: 14-day treatment-free interval
Maximum: 28 mcg/day
Consolidation — B-ALL (in remission, MRD-positive), Cycles 2–4
Patients < 45 kg (BSA-based)
Each cycle Days 1–28: 15 mcg/m2/day; Days 29–42: 14-day treatment-free interval
Dose per m2; observe m2-based dosing guidance
Relapsed or refractory B-ALL — Treatment course: induction (2 cycles) then consolidation (3 cycles) and continued therapy (up to cycles 6–9)
Patients ≥ 45 kg
Induction cycle 1: Days 1–7: 9 mcg/day; Days 8–28: 28 mcg/day; Days 29–42: 14-day interval. Induction cycle 2: Days 1–28: 28 mcg/day; Consolidation cycles 3–5: Days 1–28: 28 mcg/day; Continued cycles 6–9: Days 1–28: 28 mcg/day (longer off-treatment intervals per continued therapy)
Maximum dose: 28 mcg/day
Relapsed or refractory B-ALL — Treatment course: induction (2 cycles) then consolidation (3 cycles) and continued therapy (up to cycles 6–9)
Patients < 45 kg (BSA-based)
Induction cycle 1: Days 1–7: 5 mcg/m2/day; Days 8–28: 15 mcg/m2/day; Days 29–42: 14-day interval. Induction cycle 2 and subsequent consolidation/continued cycles: 15 mcg/m2/day on Days 1–28 with specified off-treatment intervals
BSA-based dosing (5→15 mcg/m2/day titration for induction); maximum referenced as 28 mcg/day for larger patients

Regimen / Indication	Combination	Coverage stance	Notes / Source
Ph-positive (Ph+) B-ALL — defined adult pathway
Blinatumomab administered in combination with a tyrosine kinase inhibitor (TKI)
covered
NCCN-supported pathway added to policy (3Q2023 updates); used in Ph+ disease per NCCN recommendations

Regimen / Indication	Patient age	Dosing	Coverage stance / Notes
Blinatumomab monotherapy — Consolidation therapy for Ph-negative (Ph-) B-ALL
≥ 1 month
Patients ≥ 45 kg: Days 1–28: 28 mcg/day; Patients < 45 kg: Days 1–28: 15 mcg/m2/day; Days 29–42: 14-day treatment-free interval (1 cycle), as per prescribing information for consolidation
covered

Policy Summary

PayerCentene

PolicyBlinatumomab (Blincyto) clinical policy — coverage criteria

Policy CodePolicy CP.PHAR.312

Change TypeUpdated coverage pathways and indications (material changes)

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria when requesting prior authorization.

SourceLink

On This Page

Denial Risk

Noncompliance Risk

Documentation and Indication Noncompliance: Lack of required documentation that the member meets all approval criteria or requests for non‑FDA–approved indications not addressed in this policy without sufficient off‑label evidence may result in denial of the request.

Non‑FDA indications require sufficient documentation of efficacy and safety per the Health Plan’s off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) and evidence of coverage documents.
Incomplete clinical records, missing proof of prescriber specialty, age, dose rationale, or absence of response documentation for continuation requests increase denial risk.

Note

Coverage Decision Caveat

Coverage Decision Caveat and Provider Responsibilities: Coverage determinations and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents and to state and federal requirements. Providers must follow Health Plan‑level administrative policies and procedures.

This clinical policy is effective per the Health Plan and may be changed, amended, or withdrawn; legal and regulatory requirements supersede the policy where applicable.
Providers are expected to exercise professional judgment; the policy does not dictate medical care and providers remain responsible for treatment decisions.