CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Preferred Injectable Oncology Program “Notification” (PDF)

Defines medical necessity criteria, restricted product list (bevacizumab, trastuzumab, rituximab and biosimilars), initial and continuation approval requirements, duration, and FDA/NCCN alignment for healthcare-administered injectable oncology agents. Part 1 lists products, FDA indications/dosing/HCPCS where present, and full medical necessity criteria for approval and continuation.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyPreferred Injectable Oncology Program “Notification” (PDF)

Policy CodePolicy N/A

Change TypeRevisions and additions to restricted/non-preferred product lists; coding updates

Effective DateJan 1, 2026

Next Review Date

Key ActionPrescriber must meet all initial or continuation criteria and submit medical record documentation (including NCCN support when applicable) to obtain approval; approval duration is 365 days.

SourceLink

POLICY UPDATE CHANGES

January 2026: Changed requirement for trial and failure of preferred rituximab biosimilar products to include Riabni in addition to Ruxience and Truxima; adjusted non-preferred rituximab products to include Rituxan and Rituxan Hycela.

January 2026: Changed requirement for trial and failure of preferred trastuzumab biosimilar products to include Ogivri and Ontruzant in addition to existing preferred Trazimera; adjusted non-preferred trastuzumab biosimilar products to include Hercessi, Herzuma, and Kanjinti.

July 2025: Added Jobevne (bevacizumab-nwgd) to policy as non-preferred with same criteria as Avastin.

January 2025: Coding change: For Hercessi, added HCPCS code Q5146 to dosing reference table effective 1/1/2025; deleted C9399, J3490, J3590, and J9999 termed 12/31/2024.

September 2024: Added new-to-market Hercessi (trastuzumab-strf) to policy as non-preferred with same criteria as Herceptin.

April 2024: Changed preferred trastuzumab biosimilar requirements to include Kanjinti and Trazimera; adjusted non-preferred trastuzumab biosimilars to include Herzuma, Ogivri, and Ontruzant. Added Ogivri (Q5114) to restricted products; removed Trazimera (Q5116) from restricted products.

January 2024: Added Avzivi (bevacizumab-tnjn) to policy as non-preferred with same criteria as Avastin.

April 2023: Coding update: Added HCPCS code Q5129 for Vegzelma effective 4/1/2023; deleted miscellaneous codes for Vegzelma termed 3/31/2023.

November 2022: Added Vegzelma (bevacizumab-adcd) to policy as non-preferred with same criteria as Avastin.

October 2022: Added Herceptin Hylecta and Rituxan Hycela to policy as non-preferred products with same criteria as Herceptin and Rituxan respectively.

June 2022: Original medical policy criteria issued; added Alymsys (bevacizumab-maly) as non-preferred with same criteria as Avastin.

11Restricted products listed in part 1

365Approval duration (days)

180Stability requirement (days)

MultipleProducts mentioned/updated

2026-01-01Primary effective date

AnnualPolicy review frequency

Coverage Summary

Overview: This coverage criteria (Preferred Injectable Oncology Program) defines medical necessity for restricted oncology injectables and biosimilars. Subject: Preferred Injectable Oncology Program – restricted oncology injectables. Primary effective date: 2026-01-01. Status: CURRENT. Headline thresholds: patients must be stable on therapy for ≥ 180 days (or treated within past 180 days and at risk if changed) to meet initial stability criteria, and approved therapy duration is 365 days (1 year) for initial and continuation approvals.

Key policy facts

Restricted products count11

Approval duration365 days (1 year)

Stability requirementPatient stable on therapy >= 180 days

Primary effective date2026-01-01

Policy review frequencyReviewed annually in Q3

Scope summaryDefines medical necessity criteria, restricted product list (bevacizumab, trastuzumab, rituximab and biosimilars), initial and continuation approval requirements, duration, and FDA/NCCN alignment for healthcare-administered injectable oncology agents.

Medical-Necessity Criteria

Duration of Approval (Initial)

Duration of Approval: 365 days (1 year)365 days

Continuation Criteria for Approval

Criteria required for renewal/continuation of therapy:

ALL of the following

The patient was approved through Blue Cross NC initial criteria for approval OR the patient would have met initial criteria for approval at the time they started therapy
The patient has continued clinical benefit while receiving the requested agent as demonstrated by tumor response or lack of disease progression, and an acceptable toxicity profile

Coding

Bevacizumab HCPCS / J-codes listedHCPCSCovered

J9035	Avastin (bevacizumab) intravenous infusion
Q5126	Alymsys (bevacizumab-maly) HCPCS listed
C9399	Avzivi (bevacizumab-tnjn) miscellaneous
J3490	Avzivi (bevacizumab-tnjn) misc
J3590	Avzivi (bevacizumab-tnjn) misc
J9999	Avzivi (bevacizumab-tnjn) misc

Trastuzumab HCPCS / Q-codes listedHCPCSCovered

J9355	Herceptin (trastuzumab) intravenous infusion
J9356	Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection
Q5146	Hercessi (trastuzumab-strf) intravenous infusion
Q5113	Herzuma (trastuzumab-pkrb) intravenous infusion

Rituximab HCPCS listedHCPCSCovered

J9312

Rituxan (rituximab)

Jobevne (bevacizumab-nwgd)HCPCS|misc

C9399	Jobevne listed with miscellaneous HCPCS/J-codes
J3490	Jobevne misc
J3590	Jobevne misc
J9999	Jobevne misc

Vegzelma (bevacizumab-adcd)HCPCS

Q5129

Vegzelma HCPCS code added to dosing reference

Alymsys (bevacizumab-maly)HCPCS

Q5126	Alymsys HCPCS code (added 1/1/2023)
C9142	Alymsys HCPCS code (added 10/1/2022)

Hercessi (trastuzumab-strf)HCPCS

Q5146

Hercessi HCPCS code added to dosing reference effective 1/1/2025

Kanjinti (trastuzumab-anns)HCPCS

Q5117

Kanjinti HCPCS code as listed in dosing reference table

Herzuma (trastuzumab-pkrb)HCPCS

Q5113

Herzuma HCPCS code as listed in dosing reference table

Rituxan Hycela (rituximab and hyaluronidase)HCPCS

J9311

Rituxan Hycela HCPCS code

Maximum units notedmixed

MAX	Maximum Units = 9999 (multiple products list maximum units = 9999)

Ogivri / Ontruzant / Riabni (historical/restricted changes)HCPCS

Q5114	Ogivri HCPCS code (referenced in revisions/removals)
Q5112	Ontruzant HCPCS code (referenced in revisions/removals)
Q5123	Riabni HCPCS code (removed from restricted products; noted in revisions)

Alymsys / Q5126 historical deletionsHCPCS|mixed

Q5126	Added for Alymsys effective 1/1/2023 (coding update)
C9399	Multiple C9399 instances were deleted/termed on various dates per revision history

Trastuzumab miscellaneous HCPCSHCPCS

J9355	Herceptin HCPCS (trastuzumab) - dosing reference
J9356	Herceptin Hylecta HCPCS (trastuzumab and hyaluronidase) - dosing reference

Rituximab miscellaneous HCPCSHCPCS

J9312	Rituxan (rituximab) HCPCS - dosing reference
J9311	Rituxan Hycela (rituximab and hyaluronidase) HCPCS - dosing reference

Vegzelma / coding updateHCPCS

Q5129

Vegzelma HCPCS code added to dosing reference effective 4/1/2023

Avzivi / Avzivi historical misc codesHCPCS|misc

C9399	Avzivi misc HCPCS previously listed
J3490	Avzivi misc
J3590	Avzivi misc
J9999	Avzivi misc

Jobevne historical codingHCPCS|misc

C9399	Jobevne misc HCPCS codes (legacy)
J3490	Jobevne misc
J3590	Jobevne misc
J9999	Jobevne misc

Coding effective dates noted in provider actions and change history include: Q5146 for Hercessi effective 1/1/2025, Q5129 for Vegzelma effective 4/1/2023, Q5126 for Alymsys effective 1/1/2023, and C9142 for Alymsys effective 10/1/2022. The changes_list also documents multiple coding deletions and term dates (miscellaneous C/J codes termed on specific dates) in the revision history.

Provider Actions & Billing Notes

Prior Authorization

Prior authorization required per criteria

Prior authorization is required. The prescriber must meet all initial or continuation criteria in the policy (including FDA-labeled indication, diagnostic testing and prior therapy requirements, NCCN support when applicable, and stability requirements) and submit medical record documentation to obtain approval. Approval duration is 365 days (1 year).

Documentation Required

Genetic/specific diagnostic testing documentation

When the FDA labeling for the requested indication requires a genetic or specific diagnostic test (for example, ALK, EGFR, HER2, KRAS or an FDA‑approved companion diagnostic), the test must have been performed and the results documented in the medical record demonstrating the requested therapy is appropriate per FDA labeling.

Background & Definitions

Background: The Preferred Injectable Oncology Program identifies preferred versus non-preferred healthcare-administered oncology injectables and biosimilars—specifically bevacizumab, trastuzumab, and rituximab products—and applies medical necessity criteria aligned to FDA labeling and NCCN compendia (Level 1/2A). Part 1 of the document lists restricted products, their FDA indications and dosing, and includes HCPCS/Q/J codes where present.

Evidence: Source of drug information: FDA package insert (referenced throughout dosing and indication entries). Additional references are policy change history and P&T committee review noted in the document.

Definitions / Preferred biosimilars

Preferred biosimilars (examples)Bevacizumab: bevacizumab-awwb (Mvasi), bevacizumab-bvzr (Zirabev); Trastuzumab: trastuzumab-dkst (Ogivri), trastuzumab-dttb (Ontruzant), trastuzumab-qyyp (Trazimera); Rituximab: rituximab-arrx (Riabni), rituximab-pvvr (Ruxience), rituximab-abbs (Truxima)

Definition: 'restricted products'Products subject to additional policy restrictions requiring trial/failure of preferred biosimilars or other specified criteria per policy (listed in restricted product section)

Revision History

January 2026revisedLatest

Material: Revised rituximab and trastuzumab requirements — added Riabni to required trial/failure list for preferred rituximab biosimilars (alongside Ruxience and Truxima) and adjusted non-preferred rituxuximab products to Rituxan and Rituxan Hycela; removed Riabni (Q5123) from restricted products (now unrestricted for oncologic indications). Also changed trastuzumab requirements to include Ogivri and Ontruzant with Trazimera as preferred and adjusted non-preferred trastuzumab biosimilars to include Hercessi, Herzuma, and Kanjinti; added Kanjinti (Q5117) to restricted products and removed Ogivri (Q5114) and Ontruzant (Q5112) from restricted products.

July 2025added

Material: Added Jobevne (bevacizumab-nwgd) as a non-preferred product with the same criteria as Avastin.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyPreferred Injectable Oncology Program “Notification” (PDF)

Policy CodePolicy N/A

Change TypeRevisions and additions to restricted/non-preferred product lists; coding updates

Effective DateJan 1, 2026

Next Review Date

Key ActionPrescriber must meet all initial or continuation criteria and submit medical record documentation (including NCCN support when applicable) to obtain approval; approval duration is 365 days.

SourceLink

On This Page

The requested quantity (dose) and treatment duration (and maximum units) is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication

Bevacizumab-specific continuation requirements (if request is for bevacizumab or non-preferred bevacizumab biosimilar)

The patient has a documented serious adverse event that required medical intervention to both preferred bevacizumab biosimilar products (bevacizumab-awwb [Mvasi], bevacizumab-bvzr [Zirabev]) that is not anticipated with the requested product
medical record documentation required
The prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form
medical record documentation required

Rituximab-specific continuation requirements (if request is for rituximab, Rituxan Hycela, or non-preferred rituximab biosimilar)

The patient has a documented serious adverse event that required medical intervention to ALL preferred rituximab biosimilar products (rituximab-arrx [Riabni], rituximab-pvvr [Ruxience], rituximab-abbs [Truxima]) that is not anticipated with the requested product
medical record documentation required
The prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form
medical record documentation required

Trastuzumab-specific continuation requirements (if request is for trastuzumab, Herceptin Hylecta, or non-preferred trastuzumab biosimilar)

The patient has a documented serious adverse event that required medical intervention to ALL preferred trastuzumab biosimilar products (trastuzumab-dkst [Ogivri], trastuzumab-dttb [Ontruzant], trastuzumab-qyyp [Trazimera]) that is not anticipated with the requested product
medical record documentation required
The prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form
medical record documentation required

Duration of Approval (Continuation)

Duration of Approval: 365 days (1 year)365 days

Documentation Required

MedWatch adverse event report required for biosimilar exceptions

For requests to use non-preferred bevacizumab, rituximab, or trastuzumab products after a serious adverse event to preferred biosimilars, the prescriber must complete and submit an FDA MedWatch Adverse Event Reporting Form and document the serious adverse event in the medical record as required by the policy.

Documentation Required

NCCN-supported indication required when applicable

For off‑label or compendia‑based uses, the indication must be supported by ALL requirements in the NCCN 1 or 2A 'Recommended Use' box (for example, performance status, disease severity, prior failures, and whether monotherapy or combination therapy is required). Document these NCCN requirements in the medical record when applicable.

Note

Policy notifications and effective dates

Providers should note policy notification and effective dates and follow coding effective dates when submitting claims. The policy was implemented effective January 1, 2026 (notification given 10/1/2025), and prior coding effective dates are listed in the revision history and must be followed for claim submission.

Billing Rule

Use updated HCPCS codes per coding updates

Bill using the HCPCS codes added or updated in the dosing reference on the effective dates provided.

Q5146 — Hercessi (effective 1/1/2025)
Q5129 — Vegzelma (effective 4/1/2023)
Q5126 — Alymsys (effective 1/1/2023)
C9142 — Alymsys (effective 10/1/2022)

January 2025revised

Non-material: Coding update — added HCPCS Q5146 for Hercessi to dosing reference effective 1/1/2025 and deleted miscellaneous codes C9399, J3490, J3590, and J9999 termed 12/31/2024.

September 2024added

Material: Added Hercessi (trastuzumab-strf) as a non-preferred product with the same criteria as Herceptin (policy notification given 1/8/2024 for effective date 4/1/2024).

April 2024revised

Material: Changed preferred trastuzumab biosimilar requirements to include Kanjinti and Trazimera; adjusted non-preferred trastuzumab biosimilars to include Herzuma, Ogivri, and Ontruzant; added Ogivri (Q5114) to restricted products and removed Trazimera (Q5116) from restricted products (policy notification given 1/8/2024 for effective date 4/1/2024).

January 2024added

Material: Added Avzivi (bevacizumab-tnjn) to policy as non-preferred with same criteria as Avastin.

April 2023revised

Non-material: Coding update — added HCPCS Q5129 for Vegzelma effective 4/1/2023 and deleted miscellaneous codes for Vegzelma termed 3/31/2023.

November 2022added

Material: Added Vegzelma (bevacizumab-adcd) to policy as non-preferred with same criteria as Avastin.

October 2022added

Material: Added Herceptin Hylecta and Rituxan Hycela as non-preferred products with the same criteria as Herceptin and Rituxan respectively (policy notification 8/4/2022 for effective date 10/1/2022).

June 2022added

Material: Original medical policy criteria issued; added Alymsys (bevacizumab-maly) as non-preferred with same criteria as Avastin (formatting adjustments only).