Trastuzumab preferred biosimilar products (Kanjinti, Ogrivi, and Trazimera)
are covered without PA. They are subject to retrospective review to
ensure they are used in compliance with the Medical Policy Statement below.
Herceptin, Herceptin Hylecta,
Ontruzant, and Herzuma require prior authorization (PA). For new patients, a
preferred biosimilar product must be tried first before these products would be
approved.
Trastuzumab is considered medically necessary for patients meeting the following
criteria and subject to the step therapy noted immediately above.
Breast Cancer
1)
Diagnosis of
HER2-positive breast cancer AND
2)
Age >18 years old
AND
Gastric, Esophageal and
Esophagogastric Junction Cancer
1)
Diagnosis of
HER2-positive metastatic gastric, esophageal, or EGJ adenocarcinoma AND
2)
Age >18 years old
AND
3)
Prescribed in combination
with a platinum agent (cisplatin or oxaliplatin) and either capecitabine or
5-fluorouracil
Endometrial Carcinoma
1)
Diagnosis of
HER2-positive endometrial carcinoma with serous histology AND
2)
Age >18 years old
AND
3)
Disease is advanced (i.e.
stage III/IV) or recurrent AND
4)
Prescribed in combination
with carboplatin and paclitaxel
Colorectal Cancer
(off-label)
1.
Diagnosis of advanced or
metastatic colorectal cancer and all of the following (a, b, and c):
a.
Disease is HER2
positive;\
b.
Disease is wild-type
RAS (defined as wild-type in both KRAS
and NRAS as determined by an FDA-approved test for this use);
c.
Wild-type
BRAF;
2.
Age > 18 years
Salivary Gland Tumor
(off-label)
1.
Diagnosis of
HER2-positive slivary gland tumore:
Age > 18 years;
2.
Prescribed in one of the
following manners (a, b, or c):
a.
Single agent;
b.
Combination with
docetaxel;
c.
Combination with Perjeta
Initial Approval
Duration: 6 months
Reauthorization is allowed if patient is responding to therapy and above
prescribing guidelines are met for the specific diagnosis.
Reauthorization Approval Duration: 12
months
Codes
Used In This BI:
Q5112 – Injection, trastuzumab-dttb, biosimilar (Ontruzant), 10mg
Q5113 – Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10mg
Q5114 – Injection, trastuzumab-dkst, biosimilar, (Ogivri), 10mg
Q5116 – Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10mg
Q5117 – Injection, trastuzumab-anns, biosimilar, (kanjinti), 10mg
J9355 – Injection, trastuzumab, excludes biosimilar, 10mg
J9356 – Injection, trastuzumab, 10mg and Hyaluronidase-oysk