ModifiedPremera BluecrossPolicy N/A

Bispecific Antibodies

Defines medical necessity, coverage criteria, documentation, coding, and evidence summaries for multiple bispecific antibody drugs managed under the medical benefit for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyBispecific Antibodies

Policy CodePolicy N/A

Change TypeCoverage additions and coding updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of indication, prior therapies, and required clinical records to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Lunsumio Velo (mosunetuzumab-axgb) SC for relapsed or refractory follicular lymphoma.

Added coverage criteria for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) SC for NSCLC with EGFR exon 20 insertion mutations and for certain exon 19/21 mutations when criteria met.

Updated coverage criteria for Epkinly to include combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma.

Removed ECOG performance status 0-1 requirement for Bizengri (zenocutuzumab-zbco), Imdelltra (tarlatamab-dlle), and Ziihera (zanidatamab-hrii).

Added coverage criteria for Lynozyfic (linvoseltamab-gcpt) for relapsed or refractory multiple myeloma.

Added and updated multiple HCPCS codes including J9276 (Ziihera), J9382 (Bizengri), J9999 (unspecified), and C9307 (added then later terminated).

Updated Blincyto (blinatumomab) coverage to include treatment of standard or high-risk B-cell ALL in pediatric patients.

Multipleproducts listed

6 monthsinitial auth

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Coverage Criteria

Bizengri (zenocutuzumab-zbco) — Initial therapy

Covered when ALL of the following are met

ALL of the following

Age: Individual is aged 18 years or older18+
Diagnosis: Has been diagnosed with advanced, unresectable, or metastatic pancreatic adenocarcinoma OR advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC)
Biomarker: Is harboring a neuregulin 1 (NRG1) gene fusion
Monotherapy: Bizengri (zenocutuzumab-zbco) will be administered as monotherapy
Prior therapy: Has experienced disease progression on or after prior systemic therapy
Dose limit: Dose is limited to 750 mg every 2 weeks

Blincyto (blinatumomab) — Indications covered

Covered when ALL of the following are met

ALL of the following

Age: Individual is aged 1 month or older>=1 month
Indication: One of: CD19-positive B-cell precursor ALL in first or second complete remission with MRD ≥ 0.1% OR Relapsed or refractory CD19-positive B-cell precursor ALL OR CD19-positive Philadelphia chromosome–negative B-cell precursor ALL in the consolidation phase OR Standard or high-risk B-cell ALL in appropriate age groups

Columvi (glofitamab-gxbm) — Relapsed or refractory LBCL/DLBCL

Covered when ALL of the following are met

ALL of the following

Age: Individual is aged 18 years or older18+
Prior therapy: Has had an inadequate response to 2 or more lines of systemic therapy
Pretreatment: Documentation of pretreatment with a single 1,000 mg IV dose of obinutuzumab approximately 7 days before initiation of Columvi

Elrexfio, Lynozyfic, Lunsumio, Tecvayli, Tecvayli/Tecvayli SC and similar multiple myeloma agents

Covered when ALL of the following are met (agent-specific)

ALL of the following

Age: Individual is aged 18 years or older18+
Prior lines: Has received at least 4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Epkinly, Lynozyfic, Lunsumio, Tecvayli, Tecvayli/Tecvayli SC and similar multiple myeloma agents

Covered when ALL of the following are met

ALL of the following

Age: Individual is aged 18 years or older18+
DLBCL indication: Has relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after two or more lines of systemic therapy

FL combination: For relapsed/refractory follicular lymphoma when used in combination with lenalidomide and rituximab per EPCORE FL-1, patient meets trial-equivalent eligibility (no CNS involvement, no recent allogeneic HSCT, no active infection, adequate performance status)

Rybrevant and Rybrevant Faspro — NSCLC with EGFR mutations

Covered when ALL of the following are met (agent- and mutation-specific options)

ALL of the following

Age: Individual is aged 18 years or older18+
Diagnosis: Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations OR with EGFR exon 19 deletions or exon 21 L858R substitution mutations (criteria differ by mutation and regimen)
Therapy setting: Either: disease progressed on or after platinum-based chemotherapy and Rybrevant/Rybrevant Faspro is used as single agent OR used as first-line in combination with specified agents (e.g., carboplatin+pemetrexed or lazertinib) with maintenance dosing limits per regimen
Maintenance dosing limits described in policy (single-agent and combination schedules)

Investigational / Not covered uses

Investigational: Use of Rybrevant for other solid tumors and hematologic malignancies not listed is investigational; all other uses of medications listed in this policy that are not specified in the coverage criteria are investigational

Epkinly – coverage conditions

Coverage supported when ALL of the following are met for Epkinly in specified indications

Epkinly for R/R LBCL: Patient has relapsed or refractory B-cell lymphoma (DLBCL per EPCORE NHL-1) and meets trial-equivalent eligibility (excludes CNS involvement, recent allogeneic HSCT, active infection, known impaired T-cell immunity); dosing follows step-up schedule with Cycle 1 step-up and continued until progression or unacceptable toxicityas per trial eligibility and labeling

ORR 61% in DLBCL; inpatient observation for 24 hours after Cycle 1 Day 15 dose; boxed warning for CRS and ICANS

Imdelltra – coverage conditions

Coverage supported when ALL of the following are met for Imdelltra

Imdelltra for ES-SCLC: Patient has extensive-stage small cell lung cancer progressed after platinum-based chemotherapy; ECOG performance status 0-1 and measurable disease per RECIST v1.1; no symptomatic brain metastases or active immunodeficiencyas per DeLLphi-304 trial eligibility

Imdelltra demonstrated median OS 13.6 vs 8.3 months; HR 0.60; boxed warning for CRS and ICANS; step-up dosing per label

Lunsumio – coverage conditions

Coverage supported when ALL of the following are met for Lunsumio

Lunsumio for relapsed/refractory FL: Patient has relapsed or refractory follicular lymphoma after ≥2 prior therapies including an anti-CD20 monoclonal antibody and an alkylating agent; no active infection, no autoimmune disease requiring systemic therapy, no prior allogeneic transplant, and no CNS lymphomatrial-equivalent eligibility

Step-up dosing: 1 mg Day 1, 2 mg Day 8, 60 mg Day 15 and Cycle 2 Day 1, then 30 mg every 3 weeks; administered for 8 cycles with continuation rules per response (complete response discontinue; partial response or stable disease may continue up to 17 cycles); ORR 80% and median DOR 22.8 months

Lynozyfic – coverage conditions

Coverage supported when ALL of the following are met for Lynozyfic

Lynozyfic for multiple myeloma: Patient has multiple myeloma with prior exposure to ≥3 prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody; no prior BCMA-directed bispecific or BCMA CAR-T; REMS program requirements metas per LINKER-MM1 trial eligibility

ORR 70% in heavily pretreated population; CRS and neurologic toxicity risks; REMS required

Rybrevant – coverage conditions

Coverage supported when ALL of the following are met for Rybrevant

Rybrevant for exon 20 insertion: Patient has locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation and disease progressed on or after platinum-based chemotherapy; mutation confirmed by tissue or plasma testingmutation confirmed (tissue or plasma)

ORR 40% in exon 20 insertion trial; single-agent maintenance dosing limits specified in policy

Rybrevant combination use: Use in combination with carboplatin/pemetrexed or with lazertinib for EGFR exon 19 deletions or exon 21 L858R mutants per trial-specific eligibility and demonstrated PFS benefittrial-based

Maintenance dosing limits differ by regimen

Ziihera – coverage conditions

Coverage supported when ALL of the following are met for Ziihera

Ziihera for HER2-positive BTC: Patient has previously treated, locally advanced unresectable or metastatic biliary tract cancer with HER2 IHC 2+ or 3+ by PATHWAY 4B5 assay; has received prior gemcitabine-based therapy; has adequate cardiac function (LVEF ≥50%); Ziihera will be administered as monotherapy and prescribed by or in consultation with an oncologistIHC 2+ or 3+ confirmed

Dose limited to 20 mg/kg every 2 weeks; ORR 52% in IHC 3+ cohort; no responses in IHC 0-1+

Notable added/revised product coverage

Product-specific coverage additions or revisions in this document portion include:

Lunsumio Velo: Added coverage for subcutaneous mosunetuzumab-axgb (Lunsumio Velo) for relapsed or refractory follicular lymphomaproduct indication

See full policy for detailed eligibility and dosing

Rybrevant Faspro: Added coverage for amivantamab + hyaluronidase SC (Rybrevant Faspro) for NSCLC with EGFR exon 20 insertion mutations and for certain exon 19/21 mutations when criteria are metmutation and prior therapy conditions

Maintenance dosing limits provided in policy

Epkinly update: Updated Epkinly to include combination with lenalidomide and rituximab for relapsed or refractory follicular lymphomacombination regimen

Use of Rybrevant (amivantamab-vmjw) to treat solid tumors or hematologic malignancies other than the specific indications listed in this policy is considered investigational. In addition, all other uses of medications listed in this policy that are not specified in the coverage criteria are considered investigational / not medically necessary. Initial authorizations for drugs in this policy may be approved for up to 6 months; re-authorizations may be approved for up to 12 months when drug-specific coverage criteria are met and chart notes document continued positive clinical response.

Several pivotal trials informing coverage decisions (for example, the EPCORE NHL-1 program for Epkinly) excluded individuals with central nervous system (CNS) involvement. Requests for coverage where CNS disease is present should include supporting clinical evidence; absent such documentation, CNS involvement may be a basis for exclusion from coverage consistent with the trial eligibility analogs used to define covered populations.

Trial-based monitoring and eligibility constructs for agents such as Epkinly also excluded individuals with recent allogeneic hematopoietic stem cell transplant, ongoing active infection, or known impaired T-cell immunity — factors that should be documented when applicable to support medical necessity determinations.

This medical policy is a guide for evaluating medical necessity and does not apply to Medicare Advantage. Providers and members should consult the member benefit booklet or contact customer service to determine coverage limits and benefit applicability for a specific member.

When a requested use is not specifically listed in the drug-specific coverage criteria, it will be treated as investigational and is not eligible for coverage under this policy. Prior authorization requests for such uses are subject to denial unless robust clinical evidence justifying coverage is provided and meets medical necessity requirements.

Ziihera (zanidatamab-hrii) demonstrated clinically meaningful activity in HER2-positive biliary tract cancer cohorts (IHC 2+ or 3+) but produced no responses in the cohort with HER2 IHC 0 or 1+. Use of Ziihera in biliary tract cancers with HER2 IHC 0 or 1+ is therefore considered not medically necessary.

Coding

HCPCS / J-codesHCPCS

C9307	Injection, linvoseltamab-gcpt, 1 mg (code termed 04/01/26)
J1323	Injection, elranatamab-bcmm (Elrexfio), 1 mg
J3055	Injection, talquetamab-tgvs (Talvey), 0.25 mg
J9026	Injection, tarlatamab-dlle (Imdelltra), 1 mg
J9039	Injection, blinatumomab (Blincyto), 1 mcg
J9061	Injection, amivantamab-vmjw, (Rybrevant) 2 mg
J9276	Injection, zanidatamab-hrii (Ziihera), 2 mg (new code effective 07/01/25)
J9286	Injection, glofitamab-gxbm (Columvi), 2.5 mg
J9321	Injection, epcoritamab-bysp (Epkinly), 0.16 mg
J9350	Injection, mosunetuzumab-axgb (Lunsumio, Lunsumio Velo), 1 mg

1–10 of 14

1/2

Policy-related HCPCS additions and updatesHCPCS

J9276	HCPCS code added (Zihera)
J9382	HCPCS code added (Bizengri)
J9999	Unspecified HCPCS code (used for Lynozyfic previously)
C9307	HCPCS code added effective Jan 1, 2026

HCPCS codes referencedHCPCS

J9276	Ziihera (zanidatamab-hrii) HCPCS
J9382	Bizengri (zenocutuzumab-zbco) HCPCS
J9601	New HCPCS code added (not further described in this excerpt)
J9999	Unspecified HCPCS code (used for Lynozyfic)
C9307	HCPCS code added (later terminated effective April 1, 2026)
J1323	Previously added HCPCS code (listed in history)
J3055	Previously added HCPCS code (listed in history)
J9026	Previously added HCPCS code (listed in history)
J9039	Previously added HCPCS code (listed in history)
J9061	Previously added HCPCS code (listed in history)

1–10 of 14

1/2

Referenced product prescribing informationmixed

N/A	Prescribing information references for individual products (see list)

Dose limits examples

Bizengri dosingDose is limited to 750 mg every 2 weeks

Ziihera dosingDose is limited to 20 mg/kg every 2 weeks

Rybrevant maintenance examplesMaintenance dosing varies by formulation: examples include 1,400 mg every 2 weeks or 2,100 mg every 3 weeks for Rybrevant; Rybrevant Faspro maintenance examples include 2,240 mg every 2 weeks or 3,360 mg every 3 weeks

Post-dose observation

Epkinly post-dose observationIndividuals should be hospitalized for 24 hours following the Cycle 1 Day 15 48 mg dose to monitor for CRS/ICANS

Qualified administration setting

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Approval Lengths

Prior authorization is required for all drugs listed in this policy. Initial approvals may be granted for up to 6 months; re-authorization may be granted for up to 12 months when drug‑specific coverage criteria are met and chart notes document continued clinical benefit.

Prior authorization required for all covered bispecific antibodies managed under the medical benefit.
Initial approval length: up to 6 months.
Re-authorization length: up to 12 months with documentation of ongoing benefit.

Documentation Required

Required Clinical Documentation

Submit clinical records sufficient to demonstrate that the individual meets the medical necessity criteria for the requested agent. Records should include office visit notes with diagnosis, relevant history, physical exam, prior treatment history, and medication history. Include pathology, molecular testing (e.g., EGFR exon20 insertion or other mutation reports when relevant), transplant history, CNS involvement assessment, and documentation of prior lines of therapy and responses.

Initial Therapy Criteria

INITIAL THERAPY CRITERIA — initial coverage criteria examples

Initial coverage criteria examples

ALL of the following

Agent-specific minimum ages (commonly 18+ unless otherwise specified)
Specified diagnosis: Agent-specific cancer diagnosis as listed in policy (see individual product sections)
Prior therapy/biomarker: Agent-specific prior therapy or biomarker requirements (e.g., NRG1 fusion for Bizengri; ≥4 prior lines for many MM agents; pretreatment with obinutuzumab for Columvi)

Epkinly initial therapy — dosing and monitoring per labeling

Epkinly initial dosing and monitoring per labeling

Continuation and Re-authorization Criteria

CONTINUATION CRITERIA — continuation/re-authorization rules

Continuation/re-authorization rules

ALL of the following

Response documentation: Chart notes must demonstrate continued positive clinical response to therapy for re-authorization (re-authorization up to 12 months)
Interval adjustment (example): After initial response at 24 weeks for Elrexfio, dosing interval may change from weekly to biweekly for responders per trial protocol

Lunsumio continuation rules — continuation per label and response criteria

Lunsumio continuation rules — per label and response criteria

Step Therapy and Prior Treatment Requirements

Requirement	Details
Prior systemic therapy documentation
Policy requires documentation of prior systemic therapy consistent with agent-specific coverage criteria (examples in policy: Columvi — inadequate response to ≥2 lines; multiple myeloma agents — at least 4 prior lines including specified classes)

Coverage-label	Required prior exposures
Lynozyfic (linvoseltamab-gcpt)
Patient must have prior exposure to at least 3 prior therapies (trial enrolled individuals with ≥3 prior therapies) and efficacy population included those with ≥4 prior lines; required classes include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (e.g., daratumumab)

Agent / Context	Sequencing or mutation-specific requirement
Rybrevant (amivantamab-vmjw) — EGFR exon 20 insertion
Indicated after progression on or after platinum-based chemotherapy for EGFR exon 20 insertion NSCLC when given as single agent; maintenance dosing limits specified (e.g., 1,400 mg q2w single agent)
Rybrevant Faspro (amivantamab + hyaluronidase) — EGFR exon 19/21 or exon 20
May be used in combination regimens or as first-line with specified TKIs per mutation context; sequencing requires prior EGFR TKI for exon 19/21 when used after progression, or specific combination regimens per policy; maintenance dosing limits specified (e.g., 2,240 mg q2w)

Quantity Limits and Dosing Constraints

Bizengri, Ziihera, Rybrevant — product-specific dosing/schedule examples

Bizengri example dose/scheduleBizengri (zenocutuzumab-zbco) — IV, dose limited to 750 mg every 2 weeks

Ziihera example dose/scheduleZiihera (zanidatamab-hrii) — IV, dose limited to 20 mg/kg every 2 weeks

Rybrevant examplesRybrevant (amivantamab-vmjw) — single-agent and combination regimens with maintenance dosing examples (e.g., 1,400 mg q2w or 2,100 mg q3w); Rybrevant Faspro SC maintenance examples include 2,240 mg q2w or 3,360 mg q3w

Various bispecifics — quantity limit notes

HCPCS-related quantity limitsVarious bispecifics are subject to product-specific dose and schedule limits reflected in HCPCS coding and policy quantity limits

Coding examples

Site of Care and Administration

Note

Administer under the medical benefit in infusion center, office, or hospital outpatient

These bispecific antibody drugs are administered under the medical benefit and may be given in infusion centers, physician offices, or hospital outpatient settings as appropriate for the product and patient.

Billing and benefit application: drugs in this policy are managed through the medical benefit.
Suitable settings include infusion center, office, or hospital outpatient depending on product labeling and patient needs.

Documentation Required

Administer only in settings with qualified staff and support; inpatient observation when specified

Administer products only in settings staffed by qualified healthcare professionals with appropriate medical support to manage CRS/ICANS; where labeling indicates, inpatient observation (for example, 24‑hour hospitalization after Epkinly Cycle 1 Day 15) is recommended.

Ensure staff and emergency support are available to manage severe cytokine release syndrome and neurotoxicity.
Follow specific inpatient observation recommendations from product labeling (e.g., Epkinly post‑dose hospitalization).

Background

Bispecific antibodies are engineered immunotherapy agents that simultaneously engage a tumor-associated antigen and an effector immune cell (for example, a T cell) to direct immune-mediated tumor cell killing. The products addressed in this policy include multiple mechanisms and targets (for example, BCMA-directed agents for multiple myeloma, CD3-engaging T-cell redirectors, HER2-targeting and EGFR/MET-targeting agents).

Coverage determinations are product-specific and align with FDA-labeled indications and pivotal trial eligibility analogs, including biomarker requirements (e.g., NRG1 fusion for Bizengri or HER2 IHC 2+/3+ for Ziihera), prior-line therapy prerequisites (examples include requirements for ≥4 prior lines for some multiple myeloma agents or prior platinum-based chemotherapy for certain Rybrevant indications), and dosing/administration constraints (including step-up dosing and site-of-care considerations to manage cytokine release syndrome and neurotoxicity).

Because these agents can be associated with serious toxicities (for example, cytokine release syndrome, immune effector cell–associated neurotoxicity, and serious infections), the policy specifies monitoring, administration in settings with qualified personnel, and documentation requirements to support authorization and safe use.

Definitions

Medical necessity definition

Definition (medical necessity)Use of a listed bispecific antibody in the specific patient population and setting described in the drug-specific criteria constitutes medical necessity

ScopeMedical necessity applies when all agent-specific coverage criteria (age, diagnosis, biomarkers, prior therapy, dosing limits) are met

Benefit applicationDrugs in this policy are managed under the medical benefit; prior authorization is required per policy

NRG1 fusion definition (Bizengri requirement)

NRG1 fusion requirementAn NRG1 (neuregulin 1) gene fusion is required for Bizengri (zenocutuzumab-zbco) coverage in specified advanced pancreatic adenocarcinoma or NSCLC

Testing implicationDocumentation of NRG1 fusion status must be provided to meet Bizengri coverage criteria

Revision History

2026-04-01annual_reviewLatest

Added coverage criteria for Lunsumio Velo (mosunetuzumab-axgb) SC and for Rybrevant Faspro (amivantamab + hyaluronidase) SC for specified NSCLC mutations; removed ECOG 0-1 requirement for Imdelltra and Ziihera; added HCPCS J9601 and noted termination of C9307 effective April 1, 2026.

2026-02-01interim_review

Updated Epkinly coverage to include combination with lenalidomide and rituximab for relapsed/refractory follicular lymphoma; removed ECOG 0-1 requirement for Bizengri; updated Ziihera criteria for BTC HER2-positive disease.

Policy Summary

PayerPremera Bluecross

PolicyBispecific Antibodies

Policy CodePolicy N/A

Change TypeCoverage additions and coding updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of indication, prior therapies, and required clinical records to support medical necessity.

SourceLink

On This Page

Note

Member Benefit Verification

Verify member eligibility and benefit limitations prior to submission. Benefit determination should confirm medical benefit coverage, any plan-specific prior authorization requirements, quantity limits, site-of-care restrictions, and member cost-share. Contact customer service if plan language is unclear.

Confirm member medical benefit covers the requested bispecific antibody.
Check for site-of-care or infusion setting restrictions and plan-specific prior authorization requirements.
Confirm member cost-share, prior authorization number format, and any pre-certification phone/fax requirements.

Step Therapy

Prior Therapy Requirements and Examples

Prior therapy requirements and sequencing vary by product and indication. Requests must document prior classes and specific agents when required by the drug coverage criteria. Examples: Columvi requires prior systemic therapy lines and a pretreatment obinutuzumab dose; Lynozyfic requires prior exposure to a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody; Elrexfio requires ≥4 prior lines including PI, IMiD, and anti‑CD38.

Document specific prior agents and number of prior lines as listed in product criteria (e.g., Lynozyfic: prior PI, IMiD, anti‑CD38).
For Columvi, document a single 1000 mg obinutuzumab IV dose given ~7 days before Columvi initiation when required.
For multiple myeloma bispecifics, document prior BCMA-directed or CAR‑T therapy status if listed as exclusion.

Step Therapy

Therapy Sequencing

Therapy sequencing requirements must be met per indication. Document whether the requested agent is being used in the labeled line of therapy or in sequence with other indicated treatments (for example, Rybrevant specified uses for EGFR exon 20 insertion after progression on platinum chemotherapy or as first‑line in specified combinations; Epkinly documented settings for monotherapy vs combination with lenalidomide/rituximab).

Indicate prior platinum‑based chemotherapy and progression status when Rybrevant is requested for EGFR exon 20 insertion.
Specify whether Epkinly is requested as monotherapy for R/R DLBCL after ≥2 lines or in combination with lenalidomide/rituximab for FL per updated criteria.
If sequencing deviates from product‑specific criteria, include rationale and supporting clinical evidence.

Billing Rule

Authorization and HCPCS Coding

Authorization coding and billing: include the appropriate HCPCS/J‑code(s) and diagnosis code(s) with the prior authorization request. Use the HCPCS codes listed in the policy and verify quarterly coding updates. Providers should use the newest HCPCS codes added in policy history and may include unspecified J‑code J9999 only when a specific code is not yet available and per payer guidance.

Include HCPCS/CPT/NDC codes and corresponding diagnosis ICD‑10 with the authorization request.
Use newly added HCPCS codes as listed in policy history and check for coding updates effective dates (e.g., J9601 added, C9307 terminated 04/01/26).
When necessary and allowed, use J9999 as an unspecified code per payer instructions.

Denial Risk

Denial Triggers

Denial triggers — requests that do not meet the drug‑specific coverage criteria, requests for investigational or non‑listed indications, incomplete documentation of prior therapies or diagnostic testing, missing required pre‑treatment steps (e.g., required obinutuzumab for Columvi), or failure to demonstrate appropriate site/monitoring plans for agents with CRS/ICANS risk may be denied.

Requests for uses not listed in the policy are considered investigational and may be denied.
Incomplete prior therapy documentation or absence of required pretreatment (e.g., Columvi obinutuzumab) can trigger denial.
Lack of documentation of appropriate monitoring, hospitalization plan, or REMS requirements for agents with CRS/ICANS risk (e.g., Epkinly, Lynozyfic) may result in denial.

Lunsumio initial therapy — step-up dosing

Lunsumio step-up dosing

Lunsumio initial dosing: Step-up dosing: 1 mg on Cycle 1 Day 1, 2 mg on Cycle 1 Day 8, 60 mg on Cycle 1 Day 15 and Cycle 2 Day 1, then 30 mg every 3 weeks thereafter; treatment administered for up to 8 cycles with continuation rules per responseas per label

Administered for 8 cycles unless progression or unacceptable toxicity; responders may continue per label

Initial therapy notes — product-specific initial therapy contexts updated

Policy updates specify product-specific initial therapy contexts.

Rybrevant exon 20 note: Rybrevant single-agent use indicated after progression on platinum-based chemotherapy for EGFR exon 20 insertion mutations; Rybrevant Faspro SC added with specified maintenance dosing limitsprior platinum therapy for exon 20 insertion use

See product sections for combination regimen options and maintenance dose limits

Note

SC formulations require administration sites per labeling (clinic/infusion center)

Newly covered subcutaneous formulations (for example, Lunsumio Velo and Rybrevant Faspro) imply administration in appropriate clinic or infusion settings per product labeling; site‑of‑care selection and billing should follow the SC formulation prescribing information.

Lunsumio Velo (mosunetuzumab‑axgb SC) and Rybrevant Faspro (amivantamab + hyaluronidase SC) are covered per policy updates and should be administered per SC labeling.
Select an administration site consistent with SC product labeling (clinic, infusion center) and bill under the medical benefit as appropriate.