Medicare Advantage

Medical Policy

Notification

Efbemalenograstim alfa-vuxw (Ryzneuta®), Eflapegrastim-xnst (Rolvedon™), Pegfilgrastim (Neulasta®) and Related Biosimilars

Notification Issued Date: N/A

This version of the policy will become effective 12/19/2022.

This policy has been updated to communicate continuing coverage for pegfilgrastim (Neulasta®), and to add the following products and associated coverage criteria per recent approvals from the US Food and Drug Administration (FDA) for Pegfilgrastim-pbbk (Fylnetra®), pegfilgrastim-fpgk (Stimufend®) and eflapegrastim-xnst (Rolvedon™).

The following HCPCS codes have been added to this policy:

THE FOLLOWING CODES ARE USED TO REPRESENT eflapegrastim-xnst (Rolvedon™), Pegfilgrastim-pbbk (Fylnetra®) , pegfilgrastim-fpgk (Stimufend®):

C9399 Unclassified drugs or biologicals
J3590 Unclassified biologics

The following ICD-10 CM codes have been added to this policy:

D61.81 Pancytopenia
D61.810 Antineoplastic chemotherapy induced pancytopenia
D61.811 Other drug-induced pancytopenia
D61.818 Other pancytopenia
T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z51.12 Encounter for antineoplastic immunotherapy

The following ICD-10 CM codes have been removed from this policy:

D75.9 Disease of blood and blood-forming organs, unspecified
Z48.298 Encounter for aftercare following other organ transplant
Z52.011 Autologous donor, stem cells

Policy Attachment

Attachment to Policy #

MA08.082m

Attachment:

Policy #:

MA08.082m

Description:

EXAMPLES OF DISEASE SETTINGS AND CHEMOTHERAPY REGIMENS WITH A HIGH (>20%) OR INTERMEDIATE (10-20%) RISK FOR FEBRILE NEUTROPENIA

Title:

Efbemalenograstim alfa-vuxw (Ryzneuta®), Eflapegrastim-xnst (Rolvedon™), Pegfilgrastim (Neulasta®) and Related Biosimilars

EXAMPLES OF DISEASE SETTINGS AND CHEMOTHERAPY REGIMENS WITH A HIGH (>20%) OR INTERMEDIATE (10-20%) RISK FOR FEBRILE NEUTROPENIA

Chemotherapy regimens and associated incidence of febrile neutropenia (FN) are based on the clinical trial(s) according to the grade based on The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria. Note: These are not all-inclusive lists. For those regimens not included in this list, assess febrile neutropenia risk based on published peer-reviewed clinical trials.

Per The National Comprehensive Cancer Network (NCCN) Guidelines, the decision for use of Efbemalenograstim alfa-vuxw (Ryzneuta),Eflapegrastim-xnst (Rolvedon), Pegfilgrastim (Neulasta), and related biosimilars during the first chemotherapy cycle is based on the disease, type of chemotherapy regimen (i.e., high-dose, dose-dense, or standard-dose therapy), patient risk factors, and treatment intent (i.e., curative or palliative).

The decision for use of Efbemalenograstim alfa-vuxw (Ryzneuta), Eflapegrastim-xnst (Rolvedon), Pegfilgrastim (Neulasta), and related biosimilars during the second and subsequent chemotherapy cycles is based on whether there was prior febrile neutropenia or a dose-limiting neutropenic event (e.g., a nadir count or day of treatment count that could otherwise impact the planned chemotherapy dose). If there was prior use of a granulocyte-colony stimulating factor (G-CSF), NCCN Guidelines recommend a dose reduction in chemotherapy or a change in the treatment regimen. If there was no prior use of a G-CSF, The NCCN Guidelines indicate to consider using a G-CSF.

EXAMPLES OF DISEASE SETTINGS AND CHEMOTHERAPY REGIMENS WITH A HIGH RISK FOR FEBRILE NEUTROPENIA (>20%)

Note: This is not an all-inclusive list.

Acute Lymphoblastic Leukemia (ALL)

Select ALL regimens as directed by treatment protocol (see NCCN guidelines for ALL)

Bladder Cancer

Dose-dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)

Bone Cancer

VAIA (vincristine, doxorubicin or dactinomycin, and ifosfamide)

VDC-IE (vincristine, doxorubicin or dactinomycin, and cyclophosphamide alternating with ifosfamide and etoposide)

Cisplatin/doxorubicin

VDC (cyclophosphamide, vincristine, doxorubicin or dactinomycin)

VIDE (vincristine, ifosfamide, doxorubicin or dactinomycin, etoposide)

Breast Cancer

Dose-dense AC followed by dose-dense paclitaxel (doxorubicin, cyclophosphamide, paclitaxel)

TAC (docetaxel, doxorubicin, cyclophosphamide)

TC* (docetaxel, cyclophosphamide)

TCH* (docetaxel, carboplatin, trastuzumab)

Head and Neck Squamous Cell Carcinoma

TPF (docetaxel, cisplatin, 5- fluorouracil)

Hodgkin Lymphoma

Brentuximab vedotin + AVD (doxorubicin, vinblastine, dacarbazine)

Escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone)

Kidney Cancer

Doxorubicin/gemcitabine

Non-Hodgkin Lymphomas

CHP (cyclophosphamide, doxorubicin, prednisone) + brentuximab vedotin

Dose-adjusted EPOCH* (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin)

ICE* (ifosfamide, carboplatin, etoposide)

Dose-dense CHOP-14* (cyclophosphamide, doxorubicin, vincristine, prednisone)

MINE* (mesna, ifosfamide, mitoxantrone, etoposide)

DHAP* (dexamethasone, cisplatin, cytarabine)

ESHAP* (etoposide, methylprednisolone, cisplatin, cytarabine)

HyperCVAD* (cyclophosphamide, vincristine, doxorubicin, dexamethasone)

Pola-R-CHP (polatuzumab vedotin-piiq, rituximab, cyclophosphamide, doxorubicin, prednisone)

Melanoma

Dacarbazine-based combination with IL-2, interferon alpha (dacarbazine, cisplatin, vinblastine, IL-2, interferon alpha)

Multiple Myeloma

DT-PACE (dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide) with or without bortezomib (VTD-PACE)

Ovarian Cancer

Topotecan*

Docetaxel

Soft Tissue Sarcoma

MAID (mesna, doxorubicin, ifosfammide, dacarbazine)

Doxorubicin*

Ifosfamide/doxorubicin

Small Cell Lung Cancer

Topotecan

Testicular Cancer

VelP (vinblastine, ifosfamide, cisplatin)

VIP (etoposide, ifosfamide, cisplatin)

TIP (paclitaxel, ifosfamide, cisplatin)

EXAMPLES OF DISEASE SETTINGS AND CHEMOTHERAPY REGIMENS WITH AN INTERMEDIATE RISK FOR FEBRILE NEUTROPENIA (10-20%)

Note: This is not an all-inclusive list.

Occult Primary – Adenocarcinoma

Gemcitabine/docetaxel

Breast Cancer

Docetaxel*

AC* (doxorubicin, cyclophosphamide) + sequential docetaxel (during taxane portion only)

Paclitaxel* every 21 days

Cervical Cancer

Cisplatin/topotecan

Paclitaxel/cisplatin*

Topotecan

Irinotecan

Colorectal Cancer

FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin)

Esophageal and Gastric Cancers

Irinotecan/cisplatin*

Non-Hodgkin Lymphomas

GDP* (gemcitabine, dexamethasone, cisplatin/carboplatin)

CHOP* (cyclophosphamide, doxorubicin, vincristine, prednisone) including regimens with pegylated liposomal doxorubicin

Bendamustine*

Non-Small Cell Lung Cancer

Cisplatin/paclitaxel

Cisplatin/vinorelbine

Cisplatin/docetaxel

Cisplatin/etoposide

Carboplatin/paclitaxel*

Docetaxel

Ovarian Cancer

Carboplatin/docetaxel

Prostate Cancer

Cabazitaxel

Small Cell Lung Cancer

Etoposide/carboplatin

Testicular Cancer

BEP (bleomycin, etoposide, cisplatin)

Etoposide/cisplatin

Uterine Sarcoma

Docetaxel

* Guidelines apply to chemotherapy regimens with or without monoclonal antibodies (e.g., trastuzumab, rituximab). There is the potential for increased neutropenia risk with the addition of monoclonal antibodies. See NCCN Guidelines for Treatment of Cancer by Site.

Reference:

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Hematopoietic growth factors. V3.2024. 01/30/2024 [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx#growthfactors [via free subscription]. Accessed February 15, 2024.

Version Effective Date:

07/01/2024

Version Issued Date:

07/01/2024

Version Reissued Date:

N/A