Download Investigational (Non-Recommended) Uses of G-CSFs

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Transcript
What is neutropenia?
Is Neulasta safe?
Neutrophils are the most common type of white
blood cell in your body and its main defense against
infection. Any below-normal level of these cells is
called neutropenia, which can range from mild to
moderate to severe.
Pegfilgrastim (Neulasta) has been widely prescribed
for over 10 years and its earlier form, filgrastim, has
been in use since 1991. Both are known as safe, welltolerated medications. Common side effects include
bone or muscle aches, and can be relieved with a
nonaspirin pain reliever such as acetaminophen.
Some chemotherapy treatments cause seriously low
neutrophil levels and, with other health factors, can
increase the risk of febrile neutropenia—a fever of
100.9°F or higher from infection. Patients with this
condition usually must be hospitalized.
How much does Neulasta cost?
Depending on your coverage and choice of health care
setting, where you get pegfilgrastim (Neulasta) can
affect its cost—and convenience. Prices charged for a
single dose (6 mg) vary by location type:
What is pegfilgrastim?
Pegfilgrastim is a long-acting version of the drug
filgrastim. Both are synthetic forms of granulocytecolony stimulating factor (G-CSF), a protein your
body uses to “switch on” production of white blood
cells. Like naturally occurring G-CSF, pegfilgrastim
works to raise levels of neutrophils and other white
blood cells you need to fight infection.
Health Care Setting
The brand name for pegfilgrastim is Neulasta; it was
approved by the US Food and Drug Administration
in 2002. There is no generic version at this time.
Average
Charge

Hospital outpatient infusion center:
Up to $15,000

Professional office/clinic:
Under $5,000

Home health services:
Under $5,000

Outpatient pharmacy:
Under $5,000
Does my doctor have to administer Neulasta?
Do G-CSFs prevent neutropenia?
Granulocyte-colony stimulating factor medications are
proven to help prevent neutropenia with certain types
of cancer treatments. Research, clinical experience, and
evidence-based guidelines show that using
pegfilgrastim (Neulasta) following chemotherapy
decreases rates of infection in high-risk patient groups.
No. Although it is given by injection, pegfilgrastim
(Neulasta) is designed for use by nonprofessional
caregivers and patients themselves. The medication
comes in a prefilled, single-use syringe with needle
guard/cover, and easy, step-by-step instructions.
Instructions for injecting Neulasta can be downloaded
from the Web site listed in “More Information” at the
bottom of the following page.
Continued
Investigational (Non-Recommended) Uses of G-CSFs
Several
conditions
have not
shown
evidence of
benefit with
G-CSFs.
Revised Sept. 2014
Acute Myeloid Leukemia (AML)
No additional benefit compared to patients receiving chemotherapy alone
Agranulocytosis
No evidence supporting use of pegfilgrastim
Aplastic Anemia
No controlled studies evaluating treatment with G-CSFs
Crohn’s Disease
Hepatitis C Treatment-Induced
Neutropenia
HIV-Associated Neutropenia
No evidence supporting use of pegfilgrastim
Myelodysplastic Syndrome
No controlled studies evaluating treatment with pegfilgrastim
No evidence supporting use of pegfilgrastim
No evidence supporting use of pegfilgrastim
© 2014 OmedaRx
NCCN-Advised Therapy for Pegfilgrastim (Neulasta) b
Who should use Neulasta?
Patients receiving myelosuppressive chemotherapy
to treat solid tumors and cancer not involving bone
marrow may benefit from Neulasta.
Disease Setting
The National Comprehensive Cancer Network
(NCCN) recommends using pegfilgrastim (Neulasta)
with specific cancer treatments, and when...
Bladder Cancer



High risk for febrile neutropenia is linked
to the chemotherapy regimen
Acute Lymphoblastic
Leukemia
Breast Cancer
Chemotherapy Regimen
ALL induction regimens
MVAC (methotrexate, vinblastine, doxorubicin,
cisplatin)
Docetaxel + trastuzumab
Dose-dense AC followed by T (doxorubicin,
cyclophosphamide, paclitaxel)
TAC (docetaxel, doxorubicin, cyclophosphamide)
TC (cyclophosphamide, docetaxel)
Health factors increase patient risk for
developing febrile neutropenia
Neutropenia or related complications were
experienced with previous chemotherapy
Esophageal, Gastric
Cancers
Docetaxel/cisplatin/fluorouracil
Hodgkin Lymphoma
BEACOPP (bleomycin, etoposide, doxorubicin,
cyclophosphamide, vincristine, procarbazine,
prednisone)
Kidney Cancer
Doxorubicin/gemcitabine
CFAR (cyclophosphamide, fludarabine,
alemtuzumab, rituximab)
Getting Neulasta in a clinic
or at home may save patients
up to $500 per treatment
Non-Hodgkin’s
Lymphomas
ICE (ifosfamide, carboplatin, etoposide)
RICE (rituximab, ifosfamide, carboplatin, etoposide)
CHOP-14 (cyclophosphamide, doxorubicin,
vincristine, prednisone) ± rituximab
MINE (mesna, ifosfamide, Novantrone, etoposide)
DHAP (dexamethasone, cisplatin, cytarabine)
The Bottom Line



Patients at high risk for febrile neutropenia
(determined by treatment program and/or
health factors) can lower their risk of infection
by using pegfilgrastim (Neulasta) after
chemotherapy.
Melanoma
Myelodysplastic
Syndromes
ESHAP (etoposide, methylprednisolone, cisplatin,
cytarabine)
HyperCVAD + rituximab (cyclophosphamide,
vincristine, doxorubicin, dexamethasone +
rituximab)
Dacarbazine-based combination (dacarbazine,
cisplatin, vinblastine)
Dacarbazine-based combination with IL-2,
interferon alfa (dacarbazine, cisplatin, vinblastine,
IL-2, interferon alfa)
Antithymocyte globulin, rabbit/cyclosporine
Decitabine
Topotecan
Paclitaxel
Docetaxel
MAID (mesna, doxorubicin, ifosfamide,
dacarbazine)
Doxorubicin
For many health plan members, receiving
pegfilgrastim (Neulasta) in an outpatient or
home setting can provide a substantial cost
savings.
Ovarian Cancer
To see if changing treatment settings can save
you money, please call the Customer Service
number on the back of your membership card.
Small Cell Lung Cancer
Topotecan
Testicular Cancer
VeIP (vinblastine, ifosfamide, cisplatin)
VIP (etoposide, ifosfamide, cisplatin)
BEP (bleomycin, etoposide, cisplatin)
TIP (paclitaxel, ifosfamide, cisplatin)
Soft Tissue Sarcoma
Ifosfamide/doxorubicin
For More Information on Pegfilgrastim (Neulasta)
Organization
Subject
Web Link
US Food and Drug
Administration (FDA)
Pegfilgrastim product
approval information
http://www.fda.gov/Biologics
Neulasta® product Web site
Medication information,
injection instructions
http://pi.amgen.com/united_states/neulasta
a
Pricing based on average cost-per-prescription from claims data as listed for a single injection, or estimated for a single injection using Red Book™ Average
Wholesale Price (AWP). b Additional agents/regimens with high risk for febrile neutropenia may be covered if listed in more current NCCN guidelines.
Note: Since many medication options are available, our physicians and pharmacists developed this ConsumerRx to provide you with
information about the available alternatives, as well as potential advantages and lack of advantages of the various products. This
medication summary was developed based upon an evaluation of information from the US Food and Drug Administration (FDA),
scientific studies, and input from practicing doctors and specialists.
Revised Sept. 2014
© 2014 OmedaRx