CurrentViva HealthPolicy IC-0225

Blincyto (blinatumomab) — Coverage Criteria

Policy governing prior authorization, coverage criteria, dosing, and billing for intravenous blinatumomab (Blincyto) for pediatric and adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) under Viva Health.

Policy Summary

PayerViva Health

PolicyBlincyto (blinatumomab) — Coverage Criteria

Policy CodePolicy IC-0225

Change TypeRoutine review — no material changes

Effective Date

Next Review DateAug 5, 2025

Key ActionObtain prior authorization; validity periods vary by indication (examples: initial 30 weeks for relapsed/refractory, 24 weeks for MRD+).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9039HCPCS

980Max units/42d

≥0.1%MRD threshold

Up to 9Max cycles (R/R)

>=13Covered ICD-10 codes

Coverage Criteria for Blinatumomab (Blincyto)

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Initial Approval Criteria

Covered when ALL of the following are met (universal plus indication-specific criteria):

Universal: Patient has not received a live vaccine within 2 weeks prior to initiating therapy and will not receive concurrent treatment with live vaccines while on therapy.

From Universal Criteria

Adult ALL Indications: Patient is at least 18 years of age AND has B-cell precursor acute lymphoblastic leukemia (ALL) AND meets one of the following indication-specific paths: MRD-positive (>= 0.1%) used as single agent in first or second complete remission; frontline induction in combination with a tyrosine kinase inhibitor (TKI) for Philadelphia chromosome–positive (Ph+) disease; consolidation therapy for Ph- disease or Ph+ disease (including as single agent within mini-hyperCVD + inotuzumab ozogamicin if refractory to TKIs, or in combination with a TKI); maintenance therapy as single agent alternating with POMP for Ph+ (refractory to TKIs) or Ph- disease; or relapsed/refractory disease.MRD >= 0.1% where specified

See Adult ALL branch

Pediatric ALL Indications: Patient is at least 1 month of age AND has either infant ALL (used in combination with an Interfant regimen as consolidation) OR B-cell precursor ALL meeting one of: MRD-positive (>= 0.1%) single-agent use in first or second CR; consolidation (for Ph+, Ph-, or Ph-like disease with options for single-agent or combination with chemotherapy, a TKI, or ruxolitinib); relapsed/refractory disease as a single agent (Ph- or Ph+ intolerant/refractory to TKI); or as a component of COG AALL1331 per specified dosing/uses.MRD >= 0.1% where specified

See Pediatric ALL branch

MRD+ (single agent)

MRD+ single-agent dosing eligibility:

MRD+ single agent: Weight-based dosing applies: For patients >= 45 kg — Cycle 1: 28 mcg daily x 28 days in a 42-day cycle; Cycles 2–4: 28 mcg daily x 28 days in a 42-day cycle. For patients < 45 kg — Cycle 1: 15 mcg/m2/day (not to exceed 28 mcg/day) x 28 days in a 42-day cycle; Cycles 2–4: 15 mcg/m2/day (not to exceed 28 mcg/day) x 28 days in a 42-day cycle. Up to 4 total cycles of therapy.Up to 4 total cycles

See Dosage/Administration for weight-based details

Some initial authorizations for blinatumomab are issued as non‑renewable depending on the indication. Examples in this policy include the pediatric COG AALL1331 regimen, frontline induction in adults (when given with a TKI), consolidation regimens in certain settings, MRD+ initial authorizations, and infant ALL used with an Interfant regimen. Where non‑renewable initial authorizations apply, the initial prior authorization validity period is specified (for example, up to 24 weeks for COG AALL1331 and MRD+, 4 weeks for frontline induction in adults, and 28 days for infant ALL with Interfant); renewal is explicitly disallowed for those pathways.

This section does not list any Medicare Part B covered diagnosis codes. The policy indicates Medicare Part B Covered Diagnosis Codes: N/A for the applicable NCD/LCD/LCA listings; Medicare coverage determinations and applicable contractor jurisdictions are referenced separately in Appendices.

Renewal will be considered not medically necessary if any of the following apply: the authorization duration specified for the indication has been exceeded (see Section I for the initial validity periods and renewal limits); the member has experienced unacceptable toxicity

Coding and Billing

HCPCS CodeHCPCSCovered

J9039

Injection, blinatumomab, 1 microgram; 1 billable unit = 1 microgram

NDCNDC

55513-0160-xx

Blincyto 35 mcg single-dose powder for injection (NDC)

Covered ICD-10 Diagnosis CodesICD-10Covered

C83.50	Lymphoblastic (diffuse) lymphoma unspecified site
C83.51	Lymphoblastic (diffuse) lymphoma lymph nodes of head, face, and neck
C83.52	Lymphoblastic (diffuse) lymphoma intrathoracic lymph nodes
C83.53	Lymphoblastic (diffuse) lymphoma intra-abdominal lymph nodes
C83.54	Lymphoblastic (diffuse) lymphoma lymph nodes of axilla and upper limb
C83.55	Lymphoblastic (diffuse) lymphoma lymph nodes of inguinal region and lower limb
C83.56	Lymphoblastic (diffuse) lymphoma intrapelvic lymph nodes
C83.57	Lymphoblastic (diffuse) lymphoma spleen
C83.58	Lymphoblastic (diffuse) lymphoma lymph nodes of multiple sites
C83.59	Lymphoblastic (diffuse) lymphoma extranodal and solid organ sites

1–10 of 12
1/2

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Maximum HCPCS units per 42 days

Maximum billable HCPCS units980 billable units per 42 days (ALL, adult and pediatric)

HCPCS unit definitionPolicy uses HCPCS billing units for blinatumomab (see HCPCS code J9039 for unit = 1 microgram)

Time windowLimit applies across a 42-day period

MRD positivity threshold

MRD positivity threshold>= 0.1% minimal residual disease for MRD-directed eligibility

Applies to adult MRD indicationsAdult patients with B-cell precursor ALL require MRD >= 0.1% when used as single agent in first or second CR

Applies to pediatric MRD indicationsPediatric B-cell precursor ALL requires MRD >= 0.1% when used as single agent in first or second CR

Provider Actions, Prior Authorization, and Documentation

Prior Authorization
Prior Authorization Required
Prior authorization is required. Validity periods vary by indication (e.g., initial and renewal windows differ for relapsed/refractory disease, frontline induction, consolidation, MRD+, maintenance, pediatric COG regimens, and infant ALL). Refer to Section I (Length of Authorization) for the specific initial and renewal timeframes that apply to the member's indication.
Prior authorization validity varies by indication — confirm the appropriate initial and renewal period before authorizing therapy.
Medicare Part B: this policy is for non‑Medicare coverage determinations; where Medicare applies, follow CMS NCDs/LCDs/LCAs (see Appendix 2).

Denial Risk
Renewal Denial Risks: Unacceptable Toxicity or Exceeded Duration
Renewal may be denied if the member has experienced unacceptable toxicity or if duration limits have been exceeded. Examples of unacceptable toxicity include cytokine release syndrome (CRS), neurological toxicities including ICANS, serious infections, pancreatitis, tumor lysis syndrome (TLS), neutropenia/febrile neutropenia, elevated liver enzymes, and leukoencephalopathy.
Do not renew if toxicity is unacceptable even if other criteria are met.
Confirm duration of prior authorization has not been exceeded (see Section I).

Note
Medicare Coverage Compliance
Follow applicable Medicare coverage rules when the member is covered under Medicare. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) take precedence where they apply; use the CMS Medicare Coverage Database to verify current Medicare guidance.
Medicare Part B outpatient drug coverage follows Pub. 100-02, Chapter 15, §50 and any applicable NCDs/LCDs/LCAs.
This policy provides non‑Medicare guidance; apply Medicare rules for Medicare enrollees.

Documentation Required
Evidence Required for Renewal
For authorization renewal, documentation must demonstrate treatment response or disease stabilization. Acceptable evidence includes recent laboratory and disease assessments such as complete blood counts (CBC), bone marrow cytogenetic analysis, quantitative PCR (QPCR) for BCR::ABL1 or other markers, or FISH results.
Provide CBCs and relevant marrow or molecular testing results showing response or stable disease.
Include dates and numeric results (e.g., MRD percent, QPCR BCR::ABL1 levels) to support continued benefit.

Note
Vaccine Precaution: Live Vaccines
Do not administer live vaccines within 2 weeks prior to initiating therapy and avoid concurrent live vaccines while on therapy.
Confirm vaccination history and defer live vaccines as specified.
Document vaccine timing in the medical record prior to therapy start.

Billing Rule
Diagnosis Codes Required on Claims
Use the covered diagnosis codes listed in Appendix 1 on claims. Ensure the appropriate ICD‑10 code(s) that correspond to the patient's diagnosis are included on all claims to support coverage.
Examples include C91.00 (Acute lymphoblastic leukemia not having achieved remission) and C91.01 (Acute lymphoblastic leukemia, in remission).
Include the most specific applicable ICD‑10 code from Appendix 1 on the claim.

Note
Concomitant TKI Use for Ph+ Disease
Blinatumomab may be used concomitantly with tyrosine kinase inhibitors (TKIs) for Philadelphia chromosome‑positive (Ph+) disease. Permitted TKIs include, but are not limited to, bosutinib, dasatinib, imatinib, nilotinib, or ponatinib in adults and dasatinib or imatinib in pediatrics. Use single‑agent blinatumomab when specified (e.g., certain consolidation or COG regimens) or in combination with a TKI where indicated.
Document the specific TKI used and rationale when blinatumomab is administered with a TKI.
Refer to NCCN guidance for TKI selection and mutation‑specific contraindications.

Note
Regimen Sequencing and Combination Regimens
Coverage criteria reference sequencing and combination regimens (for example, use of blinatumomab with TKIs for Ph+ disease, sequencing with hyper‑CVAD, or use as a component of mini‑hyper‑CVD/inotuzumab regimens). Ensure the planned regimen and sequence align with the indication‑specific criteria and the authorization length limits in Section I.
If blinatumomab is part of a sequential regimen (e.g., hyper‑CVAD then blinatumomab), document prior and planned treatment dates and responses.
For combinations (e.g., inotuzumab ozogamicin + mini‑hyperCVD ± blinatumomab), document rationale and refractory status to prior therapies as required.

Regimen	Indication	Coverage status
Blinatumomab + TKI (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib)
Frontline induction for Philadelphia chromosome–positive (Ph+) B-cell precursor acute lymphoblastic leukemia (used in combination with a TKI)
Covered

Regimen	Indication	Coverage status
Blinatumomab in combination with an Interfant regimen (e.g., Interfant-06, Interfant-99)
Infant acute lymphoblastic leukemia (used as consolidation therapy in infant ALL in combination with an Interfant regimen)
Covered

Regimen	Dosing (per policy)	Coverage status
Blinatumomab as specified in COG AALL1331
15 mcg/m2/day × 28 days in a 56‑day cycle for cycles 1–3 (used as a component of the AALL1331 regimen)
Covered with criteria

Regimen / Study	Context / Population	Coverage status
Ponatinib plus blinatumomab (Jabbour et al.)
Phase 2 single‑arm trial in Philadelphia chromosome–positive ALL evaluating combination therapy
Informational

Line of Therapy Indications

first-line | second-line | salvage

Line-of-therapy distinctions used to determine indication and authorization length:

Lines of therapy specified: Indications include frontline induction (e.g., in combination with a TKI for Ph+ disease), consolidation, maintenance, MRD-directed therapy in first or second complete remission, and relapsed/refractory settings. Dosing, combination requirements (TKI or chemotherapy), and authorization duration vary by line of therapy.

See respective Adult and Pediatric branches for eligibility details

mixed

Mixed/combination regimen considerations (single top-level node):

Mixed/Combination regimens: Blinatumomab may be used in combination with other systemic therapies per indication: examples include blinatumomab plus a TKI for Ph+ disease (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib in adults; dasatinib or imatinib referenced in pediatrics), blinatumomab as a component of mini‑hyper‑CVD with inotuzumab ozogamicin (with or without blinatumomab), hyper‑CVAD with sequential blinatumomab, and blinatumomab combined with Interfant regimens for infant ALL. Referenced clinical trials support these combinations.

TKI options and trial references cited in policy

Definitions and Appendix References

MRD+

Policy MRD+ definitionMRD+ defined as greater than or equal to 0.1% minimal residual disease

Use caseMRD+ (>=0.1%) is required for single-agent MRD-directed therapy in first or second CR

Applies to age groupsDefinition used for both adult and pediatric MRD-directed eligibility pathways

Ph+ / Ph-

Ph+ (definition)Philadelphia chromosome–positive disease = BCR::ABL1-positive

Ph- (definition)Philadelphia chromosome–negative disease = BCR::ABL1-negative

Therapeutic implicationPh+ status guides addition of a TKI and specific regimen pathways; Ph- status permits other consolidation/maintenance options

Appendix 1 ICD-10 codes

C83.50Lymphoblastic (diffuse) lymphoma unspecified site

C83.51Lymphoblastic (diffuse) lymphoma lymph nodes of head, face, and neck

C83.52Lymphoblastic (diffuse) lymphoma intrathoracic lymph nodes

C83.53Lymphoblastic (diffuse) lymphoma intra-abdominal lymph nodes

C83.54Lymphoblastic (diffuse) lymphoma lymph nodes of axilla and upper limb

C83.55Lymphoblastic (diffuse) lymphoma lymph nodes of inguinal region and lower limb

C83.56Lymphoblastic (diffuse) lymphoma intrapelvic lymph nodes

C83.57

OpenPayer

Blincyto (blinatumomab) — Coverage Criteria

Coverage Criteria for Blinatumomab (Blincyto)

Coding and Billing

Provider Actions, Prior Authorization, and Documentation

Authorized Regimens and Combinations

Line of Therapy Indications

Biomarker and Diagnostic Requirements

Definitions and Appendix References

Background

Revision History and References