Keytruda is considered
medically necessary for patients meeting the following criteria when prescribed
by or in consultation with an oncologist:
Renal Cell Carcinoma (RCC)
1)
Diagnosis of RCC; AND
2)
Prescribed by or in
consultation with an oncologist
3)
Age > 18 years;
4)
Keytruda is prescribed in
one of the following ways (a, b, or c):
a.
In combination with
Inlyta or Lenvima, and disease is advanced (i.e., relapsed or stage IV);
b.
As single-agent adjuvant
treatment, and member is at intermediate-high or high risk of recurrence
following nephrectomy, or following nephrectomy and resection metastatic
lesions;
c.
As a single agent for
relapsed or stage IV disease with non-clear cell histology (off-label); AND
5)
Request meets one of the
following (a or b):*
a.
Dose does not exceed
200mg every 3 weeks or 400mg every 6 weeks for a maximum of 24 months
(combination therapy) or 12months (monotherapy);
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber
must submit supporting evidence)
*Prescribed regiment must be FDA-approved or recommended by NCCN.
Urothelial Carcinoma
1)
Diagnosis of urothelial
carcinoma;
2)
Prescribed by or in
consultation with an oncologist or urologist;
3)
Age > 18 years;
4)
Keytruda is prescribed in
one of the following ways (a, b or c);
a.
In combination with
Padcev for locally advanced or metastatic disease, and member is not eligible
for cisplatin-containing chemotherapy;
b.
As a single agent for
locally advanced or metastatic disease and member is ineligible for or has
previously received platinum-containing chemotherapy (e.g., cisplatin,
carboplatin);
c.
As a single agent for
BCG-unresponssive, high-risk, NMIBC with CIS and member is ineligible for or has
elected not to undergo cystectomy.
Cervical Cancer
1)
Diagnosis of cervical
cancer;
2)
Prescribed by or in
consultation with an oncologist;
3)
Age ≥ 18 years;
4)
Tumor expresses PD-L1
(CPS ≥ 1);
5)
Prescribed in one of the
following ways (a or b):
a.
As a single agent, and (i
and ii):
i.
Disease is recurrent or
metastatic;
ii.
Disease has progressed on
or after ≥ 1 line of systemic therapy;
b. In
combination with chemotherapy (e.g., paclitaxel/cisplatin,
paclitaxel/carboplatin) with or without bevacizumab, and (i):
i. Disease is persistent,
recurrent, or metastatic
Cutaneous Squamous Cell Carcinoma
1)
Diagnosis of cSCC;
2)
Prescribed by or in
consultation with an oncologist;
3)
Age ≥ 18 years;
4)
Member is not a candidate
for curative surgery or radiation
5)
Prescribed as a single
agent
Endometrial Carcinoma
1)
Diagnosis of endometrial
carcinoma;
2)
Prescribed by or in
consultation with an oncologist;
3)
Age ≥ 18 years;
4)
Prescribed in combination
with Lenvima* ;
*Prior authorization may be required for Lenvima
5)
Disease is pMMR or not
MSI-H
6)
Disease has progressed
following prior systemic therapy (e.g., carboplatin/paclitaxel);
7)
Member is not a candidate
for curative surgery or radiation
Gastric Cancer, Esophageal Cancer, or Gastroesophageal Junction Adenocarcinoma
1)
Diagnosis of gastric
cancer, esophageal cancer, or gastroesophageal junction adenocarcinoma;
2)
Prescribed by or in
consultation with an oncologist;
3)
Age > 18 years;
4)
Disease is unresectable,
locally advanced, recurrent, or metastatic;
5)
Keytruda is prescribed in
one of the following ways (a or b):
a.
In combination with
trastuzumab, fluoropyrimdine- and platinum-containing or platinum- and
fluoropyrimidine-based chemotherapy;
b.
As a single agent after
one or more prior lines of systemic therapy for patients with tumors of squamous
cell histology that express PD-L1 (CPS ≥ 10);
Head and Neck Squamous Cell Carcinoma
1)
Diagnosis of HNSCC
(locations include paranasal sinuses, larynx, pharynx, lip, oral cavity,
salivary glands; may be occult primary - i.e., primary source unknown);
2)
Prescribed by or in
consultation with an oncologist;
3)
Age ≥ 18 years;
4)
Disease is unresectable,
recurrent, or metastatic;
5)
Keytruda is prescribed in one of the
following ways (a, b, or c):
a.
In combination with
platinum-containing chemotherapy and either FU, docetaxel, or gemcitabine;
b.
As a first-line single
agent and the tumor expresses PD-L1 with a CPS of ≥ 1;
c.
As a single agent for
disease that has progressed on or after platinum-containing chemotherapy (e.g.,
cisplatin, carboplatin)
6)
Request meets one of the
following (a or b):*
a.
Dose does not exceed
200mg every 3 weeks or 400mg every 6 weeks for a maximum of 24 months;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber
must submit supporting evidence)
*Prescribed regiment must be FDA-approved or recommended by NCCN.
Hepatocellular Carcinoma
1)
Diagnosis of
hepatocellular carcinoma (HCC);
2)
Prescribed by or in
consultation with an oncologist;
3)
Age > 18 years;
4)
Disease is classified as
Child-Pugh Class A and has progressed on or after therapy with Nexavar® or
Lenvima®;
*Prior authorization may be required for Nexavar and Lenvima
5)
Member has not previously
been treated with immune checkpoint inhibitor therapy (PD-L1/PD-1, e.g.,
Tecentriq (atezolizumab), Opdivo (nivolumab))
6)
Prescribed as a single
agent.
Classical Hodgkin’s Lymphoma
1)
Diagnosis of cHL;
2)
Prescribed by or in
consultation with an oncologist or hematologist;
3)
Age ≥ 2 years;
4)
Keytruda is prescribed as
single-agent therapy (adults or pediatrics) or in combination with GVD
(gemcitabine, vinorelbine, liposomal doxorubicin) (adults only) in one of the
following ways (a, b, c, or d):
a.
After hematopoietic stem
cell transplant;
b.
For disease that is
refractory to ≥ 1 line of systemic therapy
c.
Age ≥ 18 years: for
disease that has relapsed after ≥ 1 line of systemic therapy;
d.
Age ≥ 2 years to < 18
years: for disease that has relapsed after ≥ 2 lines of systemic therapy;
Melanoma
1)
Diagnosis of melanoma AND
2)
Prescribed by or in
consultation with an oncologist;
3)
Age ≥ 12 years;
4)
Disease is Stage IIB,
IIC, III, recurrent, unresectable, or metastatic.
5)
Prescribed as a single
agent or in combination with Lenvima or Yervoy.
Merkel Cell Carcinoma
1)
Diagnosis of MCC;
2)
Prescribed by or in
consultation with an oncologist;
3)
Age >2 years
4)
Disease is recurrent,
locally advanced, or metastatic.
Microsatellite Instability-High/Mismatch Repair Deficient Cancer
1)
Diagnosis of a solid
tumor classified as MSI-H or dMMR (indicative of MMR gene mutation or loss of
expression);
2)
Prescribed by or in
consultation with an oncologist;
3)
Member meets one of the
following (a or b):
a.
Age > 2 years to <
18 years and request is not for first-line therapy;
b.
Age > 18 years;
4)
Keytruda is prescribed in one of the
following ways (a or b):
a.
As first-line or
subsequent therapy for ampullary adenocarcinoma, colorectal cancer, gallbladder
cancer, intrahepatic/extrahepatic cholangiocarcinoma, non-nasopharyngeal head
and neck cancer, occult primary tumor, pancreatic adenocarcinoma, or small bowel
adenocarcinoma;;
b.
As subsequent therapy for
other solid tumors;
5) Prescribed as a single
agent
Non-Small Cell Lung Cancer (NSCLC)
1)
Diagnosis of NSCLC;
2)
Prescribed by or in
consultation with an oncologist;
3)
Age > 18 years;
4)
Disease is recurrent,
advanced, or metastatic; AND
5)
Request meets one of the
following:
a.
Disease mutation status
is negative for actionable biomarkers (EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET,
RET, and ERBB2 [HER2]);
b.
Disease mutation status
is positive for EGFR S768I, L861Q, and/or G719X, and member has received prior
afatinib, osimertinib, erlotinib, gefitinib, or decomitinib;
c.
Disease mutation is
positive for EGFR exon 19 deletion or L858R, and member has received prior
erlotinib + (ramucirumab or bevacizumab), afatinib, gefitinib,
osimertinib, or dacomitinib;
d.
Disease mutation status
is positive for ROS1 rearrangement, and member has received prior crizotinib,
entrectinib, or ceritinib;
e.
Disease mutation status
is positive for ALK rearrangement, and member has received prior crizotinib,
ceritnib, alectinib, brigatinib, or lorlatinib;
f.
Disease mutation status
is positive for EGFR exon 20, KRAS G12C, NRTK1/2/3, BRAF V600E, MET exon 14
skipping, or RET rearrangement;
6)
Keytruda is prescribed in
one of the following ways (a, b, c, or d)):
a.
For PD-L1 positive
disease (TPS>1%);
b.
In combination with a
chemotherapy regimen;
c.
As single-agent
continuation maintenance therapy if previously given first line as part of a
chemotherapy regimen;
d.
As single-agent adjuvant
treatment following resection and platinum-based chemotherapy (e.g., cisplatin,
carboplatin) for adult patients with stage IB (T2a > 4cm), II, or IIIA
disease;
7)
Member does not have contraindications to PD-1/PD-L1 inhibitor therapy (e.g.
Opdivo, Yervoy, Tecentriq, Imfinzi);
Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
1)
Diagnosis of PMBCL;
2)
Prescribed by or in
consultation with an oncologist or hematologist;
3)
Age > 2 years;
4)
Disease is refractory to
or has relapsed after > 1 line of systemic therapy;
5)
Prescribed as a single
agent;
Triple Negative Breast Cancer (TNBC)
1)
Diagnosis of TNBC (i.e.,
estrogen receptor/progesterone receptor [ER/PR] negative and human epidermal
growth factor receptor 2 [HER2]-negative);
2)
Prescribed by or in
consultation with an oncologist;
3)
Age > 18 years;
4)
One of the following (a
or b):
a.
Disease is high-risk
early-stage , and:
i.
Prescribed in combination
with chemotherapy (e.g., carboplatin, paclitaxel, doxorubicin, cyclophosphamide)
as neoadjuvant treatment, and then continued as a single agent as adjuvant
treatment after surgery;
b.
Disease is locally
recurrent unresectable or metastatic, and both of the following (i and ii):
i.
Tumor expresses PD-L1
(CPS ≥ 10);
ii.
Prescribed in combination
with chemotherapy (e.g., paclitaxel, paclitaxel protein-bound, gemcitabine and
carboplatin)
Tumor
Mutational Burden-High Cancer
1)
Diagnosis of a solid
tumor classified as TMB-H (i.e., ≥ 10 mutations/megabase [mut/Mb]);
2)
Prescribed by or in
consultation with an oncologist;
3)
Age ≥ 2 years;
4)
Disease is unresectable
or metastatic;
5)
One of the following (a
or b):
a.
Disease has progressed
following prior treatment;
b.
Prescribed as first-line
therapy for ampullary adenocarcinoma or pancreatic adenocarcinoma
6)
Prescribed as a single agent;
NCCN Recommended Uses (off-label) (must meet all)
1)
Diagnosis of one of the
following (a or b):
a.
Keytruda is prescribed as
first-line or subsequent therapy:
i.
Stage IIIb or III mycosis
fungoides;
ii.
Stage IV Sezary sundrome;
iii.
Unresectable or
metastatic adrenocortical carcinoma;
iv.
Alveolar soft part
sarcoma;
v.
Metastatic or
unresectable thymic carcinoma, and prescribed as a single agent.
b.
Keytruda is prescribed as
single-agent subsequent therapy:
i.
Metastatic anal carcinoma
and member has not previously received Keytruda or Opdivo;
ii.
Gestational trophoblastic
neoplasia;
iii.
Extranodal NK/T-cell
lymphoma;
iv.
Advanced, recurrent, or
metastatic PD-L1-positive (CPS> 1) vulvar carcinoma;
v.
Relapsed or refractory
cutaneous anaplastic large cell lymphoma;
vi.
Relapsed or primary
progressive small cell lung cancer
2)
Prescribed by or in
consultation with an oncologist;
3)
Age > 18 years;
4)
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.
Codes
Used In This BI:
J9271 Injection, Pembrolizumab, 1mg
(Keytruda)