1)
Erbitux (Cetuximab) is
eligible for coverage if meeting the following criteria:
a)
Head and Neck Squamous
Cell Cancer
i)
Diagnosis of HNSCC;
ii)
Prescribed by or in
consultation with an oncologist;
iii)
Age > 18 years;
iv)
Disease is advanced,
recurrent, or metastatic;
v)
Prescribed as one of the
following:
(1)
As a single agent;
(2)
In combination with
platinum-based therapy (e.g. cisplatin or carboplatin);
vi)
Dosing consistent with FDA labeling or NCCN.
b)
Non small cell lung
cancer (off label)
i)
Diagnosis of recurrent,
advanced, or metastatic NSCLC;
ii)
Prescribed by or in
consultation with an oncologist;
iii)
Age > 18 years;
iv)
Tumor is positive for a
sensitizing EGFR mutation;
v)
Prescribed in combination
with Gilotrif as subsequent therapy;
vi)
One of the following:
(1)
Disease has progressed on
or after an EGFR tyrosine kinase inhibitor (TKI) therapy (e.g. Tarceva,
Gilotrif, or Iressa);
(2)
Tumor is T790M positive
and disease has progressed on or after Tagrisso;
vii)
Dosing is consistent with FDA labeling or NCCN.
c)
Colorectal Cancer
i)
Diagnosis of CRC;
ii)
Prescribed by or in
consultation with an oncologist;
iii)
Age > 18 years;
iv)
Disease is one of the
following:
(1)
Wild-type RAS
(defined as wild-type in both KRAS and NRAS);
(2)
BRAF wild-type;
(3)
BRAF V600E mutation
positive;
v)
Member has advanced,
unresectable or metastatic CRC and one of the following:
(1)
Request is for use as a
single agent or in combination with FOLFIRI, FOLFOX, or irinotecan in the
initial or subsequent line setting;
(2)
Prescribed in combination
with Braftovi if BRAF V600E mutation positive after prior therapy;
vi)
Dosing is consistent with
FDA labeling or NCCN.
d)
Penile Cancer (off label)
i)
Diagnosis of metastatic
penile cancer;
ii)
Prescribed by or in
consultation with an oncologist;
iii)
Age > 18 years;
iv)
Requests is for use as a
single agent as subsequent-line systemic therapy;
v)
Dosing is consistent with
FDA labeling or NCCN
e)
Squamous Cell Skin Cancer
(off label)
i)
Diagnosis of squamous
cell skin cancer;
ii)
Prescribed by or in
consultation with an oncologist;
iii)
Age > 18 years;
iv)
Request is for use as a
single agent;
v)
Disease is locally
advanced, high-risk, very high-risk, metastatic, inoperable or not fully
resectable;
vi)
Dosing is consistent with
FDA labeling or NCCN.
Approval Duration: 6 months
Codes
Used In This BI:
J9055 - Cetuximab injection