Opdivo (Nivolumab) is
considered medically necessary for patients with:
A.
Melanoma
(must meet all):
1.
Diagnosis of
unresectable, metastatic, or lymph node positive melanoma;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 12 years;
4.
Request meets one of the
following (a, b, or c):*
a.
If prescribed as
monotherapy (unresectable or metastatic disease, or adjuvant treatment), dose
does not exceed any of the following (i or ii):
i.
Adult and pediatric
members weighing ≥ 40 kg: 240 mg every 2 weeks or 480 mg every 4 weeks;
ii.
Pediatric members
weighing < 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks (see
Appendix E for dose rounding guidelines);
b.
If prescribed in
combination with Yervoy® (unresectable or metastatic disease), dose
does not exceed any of the following (i or ii;
see Appendix E for dose rounding
guidelines):
i.
Adult and pediatric
members weighing ≥ 40 kg: 1 mg/kg every 3 weeks for 4 doses, followed by 240 mg
every 2 weeks or 480 mg every 4 weeks;
ii.
Pediatric members
weighing < 40 kg: 1 mg/kg every 3 weeks for 4 doses, followed by 3 mg/kg every 2
weeks or 6 mg/kg every 4 weeks;
c.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
B.
Non-Small Cell Lung
Cancer
(must meet all):
1.
Diagnosis of resectable,
recurrent, advanced, or
metastatic NSCLC;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
Member has not previously
progressed on a PD-1/PD-L1 inhibitor (e.g., Keytruda®, Tecentriq®,
Imfinzi®);
5.
For resectable NSCLC:
Both of the following are met (a and b):
a.
Opdivo is prescribed as
neoadjuvant treatment;
b.
Tumors ≥ 4 cm or node
positive disease;
6.
For
recurrent, advanced, or
metastatic NSCLC: Opdivo is prescribed
in one of the following ways (a, b, or c):
a.
For use as a single agent, and disease has
progressed on or after
systemic therapy;
b.
For use as a single agent or in combination with
Yervoy for tumors positive for the Tumor Mutation Burden (TMB) biomarker;
c.
For use in combination
with Yervoy, and both of the following (i and ii):
i.
Request meets one of the following (a, b, or c):
a)
Disease mutation status
is unknown or negative for EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, and RET,
and member has not received prior systemic therapy for advanced disease;
b)
Disease mutation status
is positive for EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, RET, or NTRK gene
fusion, and member has received mutation-specific treatment;
c)
Disease is positive for a
RET rearrangement;
ii.
Request meets one of the
following (a or b):
a)
Member has PD-L1 tumor
expression of ≥ 1%;
b)
Opdivo is being used in
combination with Yervoy ± a platinum-based regimen (see
Appendix B);
*Prior authorization may
be required for Yervoy
7.
Request meets one of the
following (a, b, c, d, or e):*
a.
Monotherapy: Dose does
not exceed 240 mg every 2 weeks or 480 mg every 4 weeks;
b.
In combination with
Yervoy: Dose does not exceed 3 mg/kg every 2 weeks (see
Appendix E for dose rounding guidelines);
c.
In combination with
Yervoy and platinum-doublet chemotherapy: Dose does not
exceed 360 mg every 3 weeks;
d.
In combination with
platinum-doublet chemotherapy, both of the following are met (i and ii):
i.
Dose does not exceed 360
mg every 3 weeks;
ii.
Request does not exceed 3 cycles;
e.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6 months
(9 weeks for neoadjuvant
NSCLC)
C.
Malignant Pleural
Mesothelioma
(must meet all):
1.
Diagnosis of unresectable malignant pleural
mesothelioma;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
Prescribed in one of the
following ways (a or b):
a.
As first-line therapy in
combination with Yervoy;
b.
If not administered
first-line, as subsequent therapy in combination with Yervoy or as a single
agent;
5.
Request meets one of the
following (a or b):*
a.
Dose does not exceed 360
mg every 3 weeks;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber
must submit supporting evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
D.
Renal Cell Carcinoma
(must meet all):
1.
Diagnosis of RCC;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
Request
meets one of the following (a, b, or c):*
a.
Monotherapy or in combination with cabozantinib: Dose
does not exceed
240 mg every 2 weeks or 480 mg every 4 weeks;
b.
In combination with Yervoy: Dose does not exceed 3
mg/kg every 3 weeks for 4 doses, followed by 240 mg every 2 weeks or 480 mg
every 4 weeks (see
Appendix E for dose rounding guidelines);
c.
Dose is supported by practice guidelines or
peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
E.
Classical Hodgkin
Lymphoma
(must meet all):
1.
Diagnosis of relapsed, refractory or progressive cHL;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
Prescribed as subsequent
therapy;
5.
Request meets one of the
following (a or b):*
a.
Dose does not exceed
240 mg every 2 weeks or 480 mg every 4 weeks;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
F.
Squamous Cell Carcinoma
of the Head and Neck
(must meet all):
1.
Diagnosis of SCCHN;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
Prescribed as a single agent;
5.
Disease has progressed on
or after a platinum-containing regimen (e.g., cisplatin, carboplatin);
6.
Request meets one of the
following (a or b):*
a.
Dose does not exceed
240 mg every 2 weeks or 480 mg every 4 weeks;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
G.
Urothelial Carcinoma
(must meet all):
1.
Diagnosis of UC;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
One of the following (a,
b, or c):
a.
Failure of a
platinum-containing regimen (e.g., cisplatin, carboplatin), unless clinically
significant adverse effects are experienced or all are contraindicated;
b.
Prescribed as adjuvant
treatment and member is at high risk of recurrence after undergoing resection of
UC;
c.
Member is at high risk of
recurrence and did not previously receive a platinum-containing regimen;
5.
Request meets one of the
following (a or b):*
a.
Dose does not exceed
240 mg every 2 weeks or 480 mg every 4 weeks;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
H.
Colorectal Cancer
(must meet all):
1.
Diagnosis of
unresectable or
metastatic CRC;
2.
Tumor is characterized as MSI-H or dMMR;
3.
Prescribed by or in
consultation with an oncologist;
4.
Age ≥ 12 years;
5.
Dose does not exceed one of the following (a, b, or
c):*
a.
Monotherapy: 240 mg every
2 weeks;
b.
In combination with
Yervoy: 3 mg/kg every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg
every 4 weeks (see Appendix E for dose
rounding guidelines);
c.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
I.
Hepatocellular Carcinoma
(must meet
all):
1.
Diagnosis of HCC;
2.
Prescribed by or in
consultation with an oncologist;
3.
Age ≥ 18 years;
4.
Member has had disease
progression following treatment with Nexavar®, Lenvima®,
Tecentriq® + bevacizumab (Mvasi® and Zirabev™
are preferred), or Imfinzi®;
*Prior authorization may be required for
Nexavar, Lenvima, Tecentriq, bevacizumab, and Imfinzi.
5.
Prescribed in combination
with Yervoy;
6.
Documentation of
Child-Pugh Class A status;
7.
Dose does not exceed one
of the following (a or b):*
a.
In combination with
Yervoy: 1 mg/kg every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg
every 4 weeks (see Appendix E for dose
rounding guidelines);
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
J.
Esophageal Cancer
(must meet all):
1.
Diagnosis of one of the following (a or b):
a.
Completely resected esophageal cancer or
gastroesophageal junction
(esophagogastric
junction; EGJ) cancer;
b.
Unresectable advanced, recurrent, or metastatic ESCC;
2.
Prescribed by or in consultation with an oncologist;
3.
Age ≥ 18 years;
4.
For completely resected esophageal cancer or EGJ
cancer, member meets both of the following (a and b):
a.
Member has residual pathologic disease;
b.
Member has previously received CRT;
5.
For ESCC, one of the following (a or b):
a.
For unresectable advanced or metastatic disease:
Prescribed in combination with Yervoy or
with fluoropyrimidine-
and platinum-containing chemotherapy;
b.
For unresectable advanced, recurrent, or metastatic
disease: Member has had previous treatment with a fluoropyrimidine-based (e.g.,
5-fluorouracil, capecitabine) and platinum-based (e.g., carboplatin, cisplatin,
oxaliplatin) chemotherapy;
6.
Request meets one of the
following (a, b, or c):*
a.
ESCC in combination with
Yervoy: Dose does not exceed 3 mg/kg every 2 weeks or 360 mg every 3 weeks;
b.
Other indications: Dose
does not exceed 240 mg every 2 weeks or 480 mg every 4 weeks;
c.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
K.
Gastric and Esophageal
Adenocarcinomas (must meet all):
1.
Diagnosis of gastric cancer, EGJ
cancer, or esophageal adenocarcinoma;
2.
Member meets one of the following (a or b):
a.
Disease is advanced, recurrent, or metastatic;
b.
For EGJ cancer or esophageal adenocarcinoma: member
meets one of the following (i or ii):
i.
Member is post-operative following chemoradiation;
ii.
Disease is advanced, recurrent, or metastatic;
3.
Prescribed by or in consultation with an oncologist;
4.
Age ≥ 18 years;
5.
For advanced, recurrent, or metastatic disease: both
of the following are met (a and b):
a.
Prescribed in combination with a fluoropyrimidine-
(e.g., 5-fluorouracil, capecitabine) and platinum-containing (e.g., carboplatin,
cisplatin, oxaliplatin) chemotherapy;
b.
Disease is HER2-negative;
6.
Request meets one of the
following (a or b):*
a.
Dose does not exceed 240
mg every 2 weeks or 360 mg every 3 weeks;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting
evidence).
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6 months
A.
Off-label NCCN Compendium
Recommended Indications
(must meet all):
7.
Diagnosis of one of the following (a-o):
a.
Squamous cell anal carcinoma that is metastatic;
b.
Merkel cell carcinoma;
c.
Gestational trophoblastic neoplasia;
d.
Uveal melanoma that is metastatic;
e.
Small bowel adenocarcinoma
that is advanced or metastatic;
f.
Extranodal NK/T-cell lymphoma, nasal type,
that is relapsed or refractory;
g.
Pediatric Hodgkin lymphoma, as subsequent therapy;
h.
Vulvar cancer - HPV-related advanced, recurrent, or
metastatic disease, as second-line treatment;
i.
Cervical cancer;
j.
Endometrial carcinoma that is recurrent or
metastatic;
k.
Small cell lung cancer, as subsequent therapy;
l.
Bone cancer (e.g., Ewing Sarcoma, chordoma,
osteosarcoma, chondrosarcoma);
m.
Central nervous system (CNS) cancer (e.g., brain
metastases);
n.
Pediatric primary mediastinal large B-cell lymphoma;
o.
Pediatric diffuse high-grade gliomas;
8.
Prescribed by or in
consultation with an oncologist;
9.
For anal carcinoma:
prescribed as second line or subsequent therapy (examples of prior therapy
include 5-FU/cisplatin, carboplatin/paclitaxel, FOLFOX, FOLFCIS);
10.
For gestational
trophoblastic neoplasia: prescribed as a single agent for
multi-agent chemotherapy-resistant disease (see Appendix B) in one of
the following settings (a or b):
a.
Recurrent or progressive
intermediate trophoblastic tumor following treatment with a platinum-containing
regimen (e.g., cisplatin, carboplatin);
b.
High-risk
disease (see Appendix D);
11.
For pediatric primary
mediastinal large B-cell lymphoma: prescribed as one of the following (a or b):
a.
As a single agent as
second line therapy after failure of induction therapy/initial treatment (see
appendix B);
b.
Combination with
brentuximab vedotin as consolidation/additional therapy;
12.
For pediatric diffuse
high-grade gliomas: prescribed as a single agent for adjuvant therapy or for
recurrent/progressive disease;
13.
For uveal melanoma, bone
cancer, CNS cancer: prescribed as a single agent or in combination with Yervoy;
*Prior authorization may
be required for Yervoy.
14.
For cervical cancer:
prescribed as second line or subsequent therapy for PD-L1 tumor expression of ≥
1%;
15.
Dose is within FDA
maximum limit for any FDA-approved indication or is supported by practice
guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting evidence).*
*Prescribed regimen must
be FDA-approved or recommended by NCCN
Approval duration: 6
months
Codes
Used in this BI:
J9299 –
Injection, Nivolumab, 1mg (Opdivo) effective 1/01/2016