BlueCross BlueShield of Tennessee
Medical Policy Manual
Bevacizumab for the Treatment of Neoplastic Disease
DESCRIPTION
Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that
binds to and inhibits the biologic activity of human vascular endothelial
growth factor (VEGF). Bevacizumab binds VEGF and prevents the interaction
of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial
cells. The interaction of VEGF with its receptors leads to endothelial
cell proliferation and new blood vessel formation in vitro models of angiogenesis.
Administration of bevacizumab results in reduction of microvascular growth
and inhibition of metastatic disease progression.
An example of a preparation of bevacizumab is AvastinŽ.
Note:
This policy does not address the use of bevacizumab for the treatment
of disorders of the eye. Preauthorization
is not needed for Avastin when used in the treatment of eye disorders.
Bevacizumab for the treatment of the following
conditions is considered
medically necessary if the medical appropriateness criteria are
met. (See Medical Appropriateness below.)
Colorectal
carcinoma
Renal
cell carcinoma
Non-small
cell lung cancer
Breast
carcinoma
Gliomas
Ovarian cancer
Bevacizumab for the treatment of other neoplastic
conditions/diseases, including, but not limited to, the following: mesothelioma,
prostate cancer, melanoma, multiple myeloma, pancreatic cancer, and hepatocellular
carcinoma is considered investigational. (See
Applicable Tennessee State Mandate Requirements
below.)
Bevacizumab
is considered medically appropriate
for the treatment of ANY ONE of
the following:
Metastatic
colorectal carcinoma with ANY ONE
of the following:
As
first line therapy in combination with oxaliplatin-containing regimens
(e.g., FOLFOX4, CapeOX, XELOX)
As
a first-or second-line treatment in combination with intravenous 5-fluorouracil-based
chemotherapy or with oral capecitabine
Metastatic
renal cell carcinoma when the agent is being used in combination with
interferon alfa
Unresectable,
locally advanced, recurrent or metastatic non-squamous, non-small cell
lung cancer with ANY ONE of the
following:
The
agent is being used as a first-line treatment in combination with a platinum
agent (e.g., carboplatin, cisplatin) and paclitaxel
The agent is being
used as a first-line treatment in combination with a platinum agent and
gemcitabine
Metastatic
HER2-negative breast carcinoma with ANY
ONE of the following:
The
agent is being used as first-line or second-line therapy in combination
with paclitaxel
The agent is being
used in combination with capecitabine (XelodaŽ)
Gliomas
with ALL of the following:
The
individual has failed radiation therapy or is not a candidate for radiation
therapy
The
agent is being used for the treatment of gliomas with progressive disease
following prior therapy
Ovarian cancer with
ANY ONE of the following:
For Stage III
or IV disease when used in combination with carboplatin (ParaplatinŽ)
and paclitaxel (TaxolŽ) followed by bevacizumab maintenance to progression
The agent is being
used in combination with carboplatin (ParaplatinŽ) and paclitaxel (TaxolŽ)
as salvage therapy for recurrent disease in a platinum sensitive individual
who has not previously been treated with bevacizumab and it has been more
than 6 months since prior platinum therapy
APPLICABLE
TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee
State law requires coverage of off-label indications of Food and Drug
Administration (FDA) approved drugs when the off-label use is relative
to life-threatening illnesses, such as cancer, AIDS, and coronary heart
disease and recognized in one of the standard reference compendia (As
defined in the statute: The
United States Pharmacopoeia Drug Information, The American Medical Association
Drug Evaluations, & The American Hospital Formulary Service Drug Information)
or in the medical literature. This law is applicable to all fully insured
members. The law is not applicable to self-funded
accounts, but coverage for off-label uses may be provided based on the
contractual agreement.
The NCCN Drugs & Biologics
Compendium recognizes the use of bevacizumab for additional uses beyond
the FDA-approved labeling in the treatment of the following conditions
(Refer to the NCCN Drugs & Biologics Compendium or NCCN Clinical Practice
Guidelines for detailed recommendations):
Breast cancer
Central nervous system
cancers
Adult intracranial
ependymoma (excludes subependymoma and myxopapillary)
Anaplastic gliomas/glioblastoma
Colon cancer / Rectal
cancer
Kidney cancer
Non-small cell lung
cancer (NSCLC)
Ovarian cancer
Epithelial Ovarian
Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
Ovarian stromal
tumors
Soft tissue sarcoma
Angiosarcoma
Solitary fibrous
tumor/Hemangiopericytoma
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers.
This Medical Policy relates only to the services or supplies described
in it. The existence of a Medical Policy is not an authorization,
certification, explanation of benefits or a contract for the service (or
supply) that is referenced in the Medical Policy. For a determination
of the benefits that a Member is entitled to receive under his or
her health plan, the Member's health plan must be reviewed. If
there is a conflict between the Medical Policy and a health plan, the
express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions,
warnings, and monitoring information, please refer to one of the standard
reference compendia (e.g., The American Hospital Formulary Service Drug
Information).
There is insufficient evidence supporting the use of bevacizumab for
the treatment of other conditions/diseases.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2010).
Bevacizumab in advanced adenocarcinoma
of the pancreas (5.01.18). Retrieved May 20, 2011 from BlueWeb.
Chemotherapy for esophageal, gastric and colorectal cancers. (2006,
August). Treatment Guidelines from The
Medical Letter, 4 (Issue 48), 55-60.
Genentech, Incorporated. AvastinŽ
(bevacizumab). Full Prescribing Information. Retrieved May 20,
2011 from http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf.
Lexi-Comp Online. (2011). AHFS DI. Bevacizumab.
Retrieved May 20, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011). Bevacizumab. Retrieved May 20, 2011
from MICRODEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics
Compendium. Bevacizumab. Retrieved
May 20, 2011 from the National Comprehensive Cancer Network.
ORIGINAL EFFECTIVE DATE: 2/1/2005
MOST RECENT
REVIEW DATE: 10/8/2011
ID_BT
Policies included in the Medical
Policy Manual are not intended to certify coverage availability. They
are medical determinations about a particular technology, service, drug,
etc. While a policy or technology may be medically necessary, it could
be excluded in a member's benefit plan. Please check with the appropriate
claims department to determine if the service in question is a covered
service under a particular benefit plan. Use of the Medical Policy Manual
is not intended to replace independent medical judgment for treatment
of individuals. The content on this Web site is not intended to be a substitute
for professional medical advice in any way. Always seek the advice of
your physician or other qualified health care provider if you have questions
regarding a medical condition or treatment.
Pharmaceutical
Decision Support Tree
Bevacizumab (AvastinŽ)
Note: This policy
does not address the use of bevacizumab for the treatment of disorders
of the eye. Preauthorization is not needed for Avastin when used
in the treatment of eye disorders.
Is the requested medication being used to treat
mesothelioma, prostate cancer, melanoma, multiple myeloma, pancreatic
cancer or hepatocellular carcinoma?
If yes, this does not meet medical necessity
and/or medical appropriateness criteria
If no, go to question #2
Is bevacizumab being used for the treatment of
metastatic colorectal carcinoma for ANY
ONE of the following?
As
first line therapy in combination with oxaliplatin-containing regimens
(e.g., FOLFOX4, CapeOX, XELOX)
As
a first-or second-line treatment in combination with intravenous 5-fluorouracil-based
chemotherapy or with oral capecitabine
If yes, this satisfies medical necessity
and medical appropriateness criteria
If no, go to question #3
Is bevacizumab being used in combination with
interferon alfa for the treatment of metastatic renal cell carcinoma?
If yes, this satisfies medical necessity
and medical appropriateness criteria
If no, go to question #4
Is bevacizumab being used for the treatment of
unresectable, locally advanced, recurrent or metastatic non-squamous,
non-small cell lung cancer with ANY ONE
of the following?
The
agent is being used as a first-line treatment in combination with a platinum
agent (e.g., carboplatin, cisplatin) and paclitaxel
The agent is being
used as a first-line treatment in combination with a platinum agent and
gemcitabine
If yes, this satisfies medical necessity
and medical appropriateness criteria
If no, go to question #5
Is bevacizumab being used for the treatment of
metastatic, HER2-negative, breast carcinoma with ANY
ONE of the following?
The
agent is being used as first-line or second-line therapy in combination
with paclitaxel
The agent is being
used in combination with capecitabine (XelodaŽ)
If yes, this satisfies medical necessity
and medical appropriateness criteria
If no, go to question #6
Is bevacizumab being used to treat gliomas when
ALL of the following criteria
are met?
The
individual has failed radiation therapy or is not a candidate for radiation
therapy
The
agent is being used for the treatment of gliomas with progressive disease
following prior therapy
If yes, this meets medical necessity and/or
medical appropriateness criteria
If no, go to question #7
Is bevacizumab being used
to treat ovarian cancer with ANY ONE
of the following:
For Stage III or IV
disease when used in combination with carboplatin (ParaplatinŽ) and paclitaxel
(TaxolŽ) followed by bevacizumab maintenance to progression
The agent is being
used in combination with carboplatin (ParaplatinŽ) and paclitaxel (TaxolŽ)
as salvage therapy for recurrent disease in a platinum sensitive individual
who has not previously been treated with bevacizumab and it has been more
than 6 months since prior platinum therapy
If yes, this meets medical
necessity and/or medical appropriateness criteria
If no, this does not meet
medical necessity and/or medical appropriateness criteria
This document
has been classified as public information.
