CurrentBlue Cross Blue Shield - MassachusettsPolicy 105

Supportive Care Treatments for Patients with Cancer.pdf

BCBSMA medical-benefit policy governing prior authorization, formulary status, and medical necessity criteria for colony stimulating factor agents (filgrastim, pegfilgrastim, tbo-filgrastim, sargramostim and biosimilars) for Commercial and Medicare Advantage medical benefits. Delegates Medical Utilization Management for CSFs to Carelon MBM and specifies covered indications, prophylaxis/treatment criteria, formulary tiers, and prior authorization submission instructions.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicySupportive Care Treatments for Patients with Cancer.pdf

Policy CodePolicy 105

Change TypeFormulary & coverage updates (additions, tier changes, NFNC designations)

Effective DateJul 1, 2021

Next Review Date

Key ActionPrior authorization required for listed CSF agents administered under the medical benefit; submit requests to Carelon MBM (provider portal or phone) and include documentation of trial/failure of two preferred formulary alternatives for non-formulary requests.

SourceLink

POLICY UPDATE CHANGES

9/30/2025 - Added Ryzneuta.

8/2025 - Added Udenyca Onbody listing.

2/2025 - Added Nypozi to the policy.

1/2025 - Moved Fulphila and Udenyca to preferred and moved Ziextenzo and Neulasta to Non-Formulary, Non-Covered.

7/2024 - Updated to make Nivestym, Releuko, Fulphila, Fylnetra, Nyvepria, Rolvedon, Stimufend, & Udenyca Non-Formulary, Non-Covered.

2/2024 - Clarified formulary status within the policy.

1/2024 - Moved Fulphila to non-preferred.

10/2023 - Reformatted Policy and updated IC to align with 118E MGL § 51A.

MultipleGrowth factor products

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Coverage Summary & Scope

BCBSMA delegates medical utilization management for colony stimulating factors to Carelon Medical Benefits Management (Carelon MBM) and requires prior authorization under the National Cancer Quality Program (NCQP). The policy aligns with Carelon MBM clinical appropriateness guidelines that are informed by ASCO and NCCN recommendations. It covers G-CSF and GM-CSF agents with specific indications for prophylaxis, treatment, and hematopoietic support. The policy applies to Commercial and Medicare Advantage medical benefits when medications are administered under the medical benefit and is effective 2021-07-01 with last review on 2025-09-30.

Key thresholds and scope

High FN risk threshold≥ 20% (per Carelon MBM Febrile Neutropenia Risk Guideline)

Intermediate FN risk threshold≥ 10% but < 20% (per Carelon MBM Febrile Neutropenia Risk Guideline)

ANC (febrile neutropenia definition)ANC < 500 cells/µL or <1000 cells/µL and expected to fall <500 within 48 hours

Fever thresholdOral temp > 38.3°C or two readings ≥ 38.0°C for 1 hour

Liver thresholdBilirubin ≥ 1.0 or liver enzymes ≥ 2x ULN

Renal thresholdCreatinine clearance < 50 mL/min

Nutritional thresholdBaseline albumin ≤ 3.5 g/dL or BMI < 20

Medical-benefit settingsPrior authorization required when administered under the medical benefit (office, home health, outpatient hospital, dialysis, surgical day care)

DelegationMedical utilization management delegated to Carelon Medical Benefits Management (Carelon MBM)

Initial Therapy Criteria (Primary Prophylaxis)

Continuation / Secondary Prophylaxis Criteria

Other Covered Indications by Growth Factor Type

Exclusions, Limits, and General Use Rules

QCD: Quality Care Dosing (quantity limits policy #621B).

PA: Prior Authorization required for listed medical-benefit CSF agents.

NFNC: Non-Formulary, Non-Covered — non-covered agents generally require prior documentation of trial and failure of at least two covered formulary alternatives.

Febrile neutropenia (as used in the criteria): oral temp > 38.3°C or 2 readings ≥ 38.0°C for 1 hour with ANC < 500 cells/µL or <1000 cells/µL expected to fall <500 within 48 hours.

Applicable Drugs & Formulary Status

Policy-listed drugs (formulary status summarized)mixed

Granix	tbo-filgrastim - Preferred; Covered, PA, QCD
Zarxio	filgrastim-sndz - Preferred; Covered, PA, QCD
Fulphila	pegfilgrastim-jmdb - Preferred; Covered, PA, QCD
Udenyca	pegfilgrastim-cbqv/Udenyca Onbody - Preferred; Covered, PA, QCD
Neupogen	filgrastim - Non-Formulary, Non-Covered (NFNC); PA, QCD; requires prior use of TWO Preferred agents
Nivestym	filgrastim-aafi - NFNC; PA, QCD; requires prior use of TWO Preferred agents
Nypozi	filgrastim-txid - NFNC; PA, QCD; requires prior use of TWO Preferred agents
Releuko	filgrastim-ayow - NFNC; PA, QCD; requires prior use of TWO Preferred agents
Fylnetra	pegfilgrastim-pbbk - NFNC; PA, QCD; requires prior use of TWO Preferred agents
Neulasta / OnPro	pegfilgrastim - NFNC; PA, QCD; requires prior use of TWO Preferred agents

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Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior Authorization required for medical-benefit administration

Prior authorization is required for listed colony stimulating factor (CSF) agents when administered under the medical benefit in clinician office, home health, outpatient hospital, dialysis settings, and surgical day care. Prior authorization requests are delegated to Carelon Medical Benefits Management and may be submitted via the Carelon provider portal or by phone (see Carelon MBM provider portal/call instructions).

Documentation Required

Documentation of prior use of formulary alternatives

When requesting a non-formulary agent or documenting prior use of formulary alternatives, provide the name and strength of the alternatives tried, dates if available, and specifics regarding the treatment failure or clinical reason preventing use of the formulary alternative. Prescription claims records may be used to verify prior use; additional provider documentation may be requested if claims data are unavailable or insufficient.

Clinical Evidence & Guidelines

Evidence sources informing the policy include guideline sources such as ASCO, NCCN, and the Carelon MBM febrile neutropenia risk guideline. Key references cited in the policy include multiple peer-reviewed studies and product labels (examples listed in the references: J Clin Oncol, NEJM, Cochrane reviews, and product information for agents like Granix, Zarxio, Fulphila, Neulasta, Leukine and others).

Background & Definitions

BCBSMA has delegated medical utilization management for colony stimulating factors to Carelon MBM and requires prior authorization per NCQP/Carelon MBM clinical guidelines. The policy lists covered agents (including filgrastim and biosimilars, pegfilgrastim products, tbo-filgrastim, and sargramostim [Leukine]) and summarizes formulary tiers and requirements. Typical indications covered include primary and secondary prophylaxis of febrile neutropenia, adjunctive treatment of febrile neutropenia, hematopoietic stem cell transplant support, treatment of severe neutropenia in hematologic conditions, radiation exposure, and support for dose-dense or dose-intensive chemotherapy. Prior authorization requests for medical-benefit administration are handled via Carelon MBM (provider portal or phone) and Medicare Part D retail pharmacy claims are excluded from this medical-benefit program.

Definitions (policy terms)

QCDQuality Care Dosing (quantity limits policy #621B)

PAPrior Authorization required

NFNCNon‑Formulary, Non‑Covered (requests generally require prior failure of at least two covered formulary alternatives)

Febrile neutropenia (definition)Oral temp > 38.3°C or 2 readings ≥ 38.0°C for 1 hour plus ANC < 500 cells/µL or <1000 cells/µL expected to fall <500 within 48 hours

Revision History

7/2023reformatted

Reformatted Policy.

10/2023administrative

Reformatted Policy and updated IC to align with 118E MGL § 51A.

1/2024revised

Moved Fulphila to non-preferred.