Durvalumab (Imfinzi) is considered medically necessary and, therefore, covered when the individual meets ALL of the requirements in the following sections: - Duration of Treatment requirements listed in Attachment A
- Indications and all the criteria are met
AMPULLARY
ADENOCARCINOMA
Durvalumab
(Imfinzi), in combination with gemcitabine and cisplatin, is considered
medically necessary and, therefore, covered as a first-line therapy for
ampullary adenocarcinoma (pancreatobiliary and mixed
type metastatic disease) when the individual meets EITHER of
the following:
- Individual with good Eastern
Cooperative Oncology Group (ECOG) performance status (PS) (PS 0-1) and BOTH of the following:
- Good biliary
drainage
- Adequate
nutritional intake
- Individual with intermediate ECOG PS 2
BILIARY
TRACT CANCERS
Gallbladder
Cancer
Durvalumab (Imfinzi), in combination with gemcitabine and
cisplatin (or carboplatin if ineligible for
cisplatin), is considered medically necessary and, therefore,
covered for the treatment of gallbladder cancer for ANY of
the following:
- As primary systemic
treatment for unresectable or gross
residual (R2) disease, or metastatic disease
- As systemic therapy for individuals
who developed recurrent disease more than 6 months after
surgery with curative intent and more than 6 months after
completion of adjuvant therapy
- Subsequent
treatment for progression on or after systemic treatment for
unresectable or gross residual (R2) disease, or metastatic disease in those who have not
been previously treated with a checkpoint inhibitor
- As neoadjuvant systemic therapy for resectable
locally advanced disease that presents as ONE of
the following:
- Incidental
finding of suspicious mass during surgery where hepatobiliary surgery
expertise unavailable
- Incidental
finding on pathologic review (cystic duct node
positive)
- Mass on
imaging
Intrahepatic and
Extrahepatic Cholangiocarcinoma
Durvalumab (Imfinzi), in combination with gemcitabine and cisplatin
(or carboplatin if ineligible for cisplatin),
is considered medically necessary and, therefore, covered for the treatment
of intrahepatic and extrahepatic cholangiocarcinoma for ANY of
the following:
- As primary systemic
treatment for unresectable or gross
residual (R2) disease, or metastatic disease
- As systemic therapy for individuals
who developed recurrent disease more than 6 months after surgery with
curative intent and more than 6 months after completion of adjuvant
therapy
- Subsequent
treatment for progression on or after systemic treatment for
unresectable or gross residual (R2) disease, or metastatic disease in those who have not
been previously treated with a checkpoint inhibitor
BLADDER
CANCER
Durvalumab
(Imfinzi), in combination with neoadjuvant gemcitabine and cisplatin (National
Comprehensive Cancer Network [NCCN] preferred), or
other cisplatin-based combination chemotherapy, is
considered medically necessary and, therefore, covered as
perioperative/sandwich immunotherapy for muscle-invasive bladder cancer prior to cystectomy, followed by
postoperative durvalumab (Imfinzi) for ANY of the following:
- Stage II (cT2, N0) disease followed
by radical cystectomy
- Stage II (cT2, N0) disease followed
by partial cystectomy for highly selected individuals with solitary lesion in
a suitable location; no carcinoma in situ (CIS)
- Stage IIIA (cT3, N0; cT4a, N0;
cT1-4a, N1) disease followed by radical cystectomy
CERVICAL
CANCER
Durvalumab
(Imfinzi) is considered medically necessary and, therefore, covered for
persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of
the cervix (NECC) when the individual meets BOTH of
the following:
- ONE of the
following lines of therapy:
- First-line
- Second-line
- Subsequent
therapy (if not used previously as first line)
- In combination with ONE of the
following regimens, and durvalumab (Imfinzi) continued as
single agent for maintenance:
- Cisplatin and
etoposide
- Carboplatin and
etoposide
ENDOMETRIAL
CARCINOMA
Durvalumab
(Imfinzi), in combination with carboplatin and paclitaxel^, and durvalumab
(Imfinzi) continued as single agent for maintenance therapy (NCCN preferred),
is considered medically necessary and, therefore, covered for individuals
with stage III-IV deficient mismatch repair (dMMR) endometrioid
adenocarcinoma histology in ONE of the following:
- As primary treatment in ONE of the following:
- Preoperatively for individuals
presenting with abdominal/pelvic-confined disease that is suitable for
primary surgery
- With or without external beam
radiation therapy (EBRT), stereotactic body radiation therapy (SBRT), and/or total
hysterectomy/bilateral salpingo-oophorectomy (TH/BSO) for distant metastases
that are suitable for primary surgery
- With sequential EBRT and with or
without brachytherapy for locoregional extrauterine disease that is not
suitable for primary surgery
- For locoregional extrauterine
disease or distant metastases that are not suitable for primary surgery
- As adjuvant treatment with or
without EBRT and with or without vaginal brachytherapy
Durvalumab
(Imfinzi), in combination with carboplatin and paclitaxel^^, and durvalumab
(Imfinzi) continued as single agent for maintenance therapy (NCCN preferred),
is considered medically necessary and, therefore, covered for recurrent dMMR
endometrial carcinoma as first-line therapy (or
second-line or subsequent therapy as clinically
appropriate if not used previously) when BOTH of the following
are met:
- Tumor
histology is ONE of the following:
- Serous carcinoma
- Clear cell carcinoma
- Carcinosarcoma
- Endometrioid adenocarcinoma
- Undifferentiated/dedifferentiated carcinoma
- In ONE of the
following scenarios:
- For isolated metastases
- For disseminated metastases with or without
sequential palliative EBRT
- After surgical exploration, with sequential EBRT
for locoregional recurrence in individuals with disease (not confined to the
vagina or paravaginal soft tissue) in pelvic or para-aortic lymph nodes
- After surgical exploration, with or without
sequential EBRT for locoregional recurrence (not confined to vagina or paravaginal soft tissue) in individuals with microscopic residual upper abdominal or peritoneal disease
- With or without sequential palliative EBRT or
brachytherapy for locoregional recurrence in individuals who have received
prior EBRT to site of recurrence
Durvalumab (Imfinzi), in
combination with carboplatin and paclitaxel^, and durvalumab (Imfinzi)
continued as single agent for maintenance therapy (NCCN preferred), is
considered medically necessary and, therefore, covered for individuals with
stage III-IV dMMR endometrial carcinoma when BOTH of
the following are met:
- Tumor
histology can include ONE of the following:
- Serous carcinoma
- Clear cell carcinoma
- Carcinosarcoma
- Undifferentiated/dedifferentiated carcinoma
- As ONE of the following:
- Disease is suitable for primary surgery as
additional treatment with or without sequential EBRT and with or without
vaginal brachytherapy after TH/BSO
- Disease is not suitable for primary surgery as
primary treatment with or without sequential EBRT and with or without
brachytherapy
^For stage III with measurable disease
post-surgery and stage IV with or without measurable disease.
^^For adult individuals with recurrent endometrial
carcinoma with or without measurable disease.
ESOPHAGEAL
AND ESOPHAGOGASTRIC JUNCTION CANCERS
Durvalumab (Imfinzi), in combination with tremelimumab-actl (Imjudo), is
considered medically necessary and, therefore, covered as primary neoadjuvant
immunotherapy for esophageal or esophagogastric junction adenocarcinoma with ALL
of the following:
- Tumor is microsatellite instability-high (MSI-H) or dMMR
- Individual is medically fit for surgery
- Individual has ONE of the following disease types:
- cT2,
N0 (high-risk lesions: lymphovascular invasion, 3 cm or greater, poorly
differentiated)
- cT1b-cT2,
N+
- cT3-cT4a,
any N
Durvalumab
(Imfinzi), (NCCN preferred), in combination with fluorouracil, leucovorin,
oxaliplatin, docetaxel (FLOT), is considered medically necessary and, therefore,
covered for individuals with esophageal (including clinical node-negative tumor) or
esophagogastric junction adenocarcinoma, as induction
systemic therapy for relieving dysphagia in individuals with BOTH of the
following:
- Are medically fit and planned for esophagectomy with ONE of
the following:
- Programmed
death-ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater
- Tumor area
positivity (TAP) 1 percent or greater
- Individual has ONE of the following disease types:
- cT2, N0
(high-risk lesions: lymphovascular invasion, 3cm or greater, poorly
differentiated)
- cT1b-cT2,
N+
- cT3-cT4a,
any N
Durvalumab (Imfinzi), in combination with FLOT, is
considered medically necessary and, therefore covered for individuals with
esophageal (including clinical node
negative tumor) or esophagogastric junction adenocarcinoma as perioperative
systemic therapy, in EITHER of the following:
- As primary treatment in individuals with BOTH of the
following:
- Are
medically fit for surgery with ONE of the following:
- PD-L1 CPS of 1 or greater
- TAP 1 percent or greater
- Individual
has ONE of the following disease types:
- cT2, N0 (high-risk lesions: lymphovascular invasion, 3cm or
greater, poorly differentiated)
- cT1b-cT2, N+
- cT3-cT4a, any N
- As postoperative management following R0 resection in
individuals who have received preoperative therapy with the same regimen for ONE of the following:
- PD-L1 CPS of 1 or greater
- TAP 1 percent or greater
GASTRIC CANCER
Durvalumab (Imfinzi), in combination with tremelimumab-actl (Imjudo), is
considered medically necessary and, therefore, covered as primary neoadjuvant
immunotherapy prior to surgery for gastric adenocarcinoma if the tumor is MSI-H or
dMMR for potentially resectable locoregional disease (cT2 or higher, any
N) if medically fit for surgery
Durvalumab (Imfinzi), in combination with FLOT, is
considered medically necessary and, therefore, covered for individuals with
gastric adenocarcinoma (including clinical node
negative tumor) as perioperative systemic
therapy, in EITHER of the following:
- As primary treatment prior to surgery for potentially
resectable locoregional disease (cT2 or higher, any N) in individuals who are
medically fit for surgery with ONE of the following:
- PD-L1 CPS of 1 or greater
- TAP 1 percent or greater
- As postoperative management following R0 resection in
individuals who have received systemic therapy for ONE of the following:
- PD-L1 CPS of 1 or greater
- TAP 1 percent or greater
HEPATOCELLULAR CARCINOMA
Durvalumab (Imfinzi), in combination with
tremelimumab-actl (Imjudo) (NCCN preferred), or as a single agent, is considered medically necessary
and, therefore, covered for the treatment of hepatocellular carcinoma (HCC) as first-line systemic
treatment for individuals with ANY of
the following:
- Unresectable liver-confined
disease and are not a transplant candidate
- Extrahepatic/metastatic
disease and are deemed ineligible for resection, transplant, or
locoregional therapy
Durvalumab
(Imfinzi), in combination with tremelimumab-actl (Imjudo)+ or as a
single agent++, is considered medically necessary and, therefore,
covered for the treatment of HCC as subsequent-line systemic therapy (consider if not previously used)
if progression on or after systemic therapy.
+For
those who have not been previously treated with anti-cytotoxic T
lymphocyte–associated antigen (CTLA)4-based combinations.
++For
those who have not been previously treated with a checkpoint inhibitor.
MALIGNANT
MESOTHELIOMA OF PLEURA
Durvalumab (Imfinzi), in combination with pemetrexed and a platinum
agent, is considered medically necessary and, therefore, covered
as first-line treatment of individuals with unresectable malignant
mesothelioma of the pleura.
NON-SMALL CELL LUNG CANCER
Durvalumab (Imfinzi), as a single agent, is considered medically
necessary and, therefore, covered for the treatment of individuals
with unresectable stage II-III non-small cell lung cancer
(NSCLC) as consolidation
immunotherapy when ALL of the following are met:
- PS 0-1
- No disease
progression after definitive concurrent chemoradiation (for individuals
who have received sequential chemoradiation, durvalumab [Imfinzi] can be
considered as consolidation immunotherapy)
- Histology
demonstrates squamous cell carcinoma, adenocarcinoma (with mixed
subtypes), or large cell carcinoma
- No epidermal growth
factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutations
present*
Durvalumab
(Imfinzi), as neoadjuvant systemic therapy, is considered medically necessary
and, therefore, covered for the treatment of individuals with NSCLC with
adenocarcinoma (with mixed subtypes), large cell carcinoma, or squamous cell
carcinoma histology when ALL of the following are met:- Stage IB-IIIA, IIIB (T2-T3, N2b; T4, N2) disease (tumors node positive or 4 cm or greater)
- Deemed resectable after surgical evaluation
- Candidate for immune checkpoint inhibitors**
- No known EGFR mutations or anaplastic lymphoma kinase (ALK) gene fusions*
- In ONE of the following combinations (continue durvalumab [Imfinzi] as single agent adjuvant after surgery):
- Carboplatin and paclitaxel (squamous cell histology)
- Cisplatin and gemcitabine (squamous cell histology)
- Cisplatin and pemetrexed (nonsquamous cell histology)
- Carboplatin and pemetrexed (nonsquamous cell histology)
- Carboplatin and gemcitabine (squamous cell histology)
Durvalumab
(Imfinzi), as a
single-agent adjuvant systemic therapy, is considered
medically necessary and, therefore, covered for the treatment of individuals
with resected NSCLC with adenocarcinoma
(with mixed subtypes), large cell carcinoma, or squamous cell carcinoma
histology when ALL of the following are met:
- Received
previous neoadjuvant durvalumab (Imfinzi) plus chemotherapy
- No contraindications to immune checkpoint inhibitors**
- No
known EGFR mutations or ALK gene fusions*
Durvalumab
(Imfinzi), as a single agent, is considered medically necessary and, therefore,
covered as systemic therapy, after completion of adjuvant chemoradiation, for
the treatment of individuals with NSCLC with adenocarcinoma (with mixed
subtypes), large cell carcinoma, or squamous cell carcinoma histology when ALL
of the following are met:
- Margin-positive (R1 or R2) residual disease
- Received previous neoadjuvant chemotherapy plus durvalumab
(Imfinzi)
- No known EGFR mutations or ALK gene fusions*
- No contraindications** to immune checkpoint inhibitors
Durvalumab
(Imfinzi), in combination with tremelimumab-actl (Imjudo), is considered
medically necessary and, therefore, covered for the treatment of individuals
with NSCLC with adenocarcinoma (with mixed subtypes), large
cell carcinoma, or squamous cell carcinoma histology in ONE of
the following scenarios:
- As treatment for
recurrent, advanced, or
metastatic disease as
first-line therapy for programmed death ligand 1 (PD-L1)
expression-positive (1-49 percent) tumors that are negative for
actionable molecular biomarkers* (may be Kirsten rat sarcoma [KRAS]
G12C mutation positive) and no contraindications** to programmed death 1
(PD-1) or PD-L1 inhibitors and PS 0-2 in ONE of the
following regimens:
- With
albumin-bound paclitaxel and carboplatin
- With pemetrexed
and either carboplatin or cisplatin for nonsquamous cell histology
- With gemcitabine
and either carboplatin or cisplatin for squamous cell histology
- As treatment for
recurrent, advanced, or
metastatic disease when ALL of the
following are met:
- ALL
the following are met:
- PS 0-2
- No contraindications**
to immune checkpoint inhibitors
- No EGFR exon 19 deletion or
L858R, ALK, receptor for tyrosine-protein kinase (RET), or reactive
oxygen species (ROS)1 gene fusions*
- In ONE of
the following regimens:
- With
albumin-bound paclitaxel and carboplatin
- With pemetrexed
and either carboplatin or cisplatin for nonsquamous cell histology
- With
gemcitabine and either carboplatin or cisplatin for squamous cell histology
- In ONE of
the following lines of therapy:
- Initial
systemic therapy for PD-L1 less than 1 percent and negative for
actionable molecular biomarkers* (may be KRAS G12C mutation positive)
- First-line
therapy for EGFR exon 20 insertion mutation positive tumors
- First-line or
subsequent therapy for b-rapidly
accelerated fibrosarcoma (BRAF) V600E mutation positive tumors
- First-line or
subsequent therapy for neurotrophic
tropomyosin receptor kinase (NTRK)1/2/3 gene
fusion positive tumors
- First-line or
subsequent therapy for mesenchymal-epithelial
transition factor (MET) exon 14 skipping mutation positive tumors
- First-line
therapy for erythroblastic oncogene B (ERBB2) (human
epidermal growth factor receptor [HER]-2) mutation
positive tumors
- First-line therapy
for neuregulin (NRG)1 gene fusion positive tumors
- Subsequent
therapy for EGFR S768I, L861Q, and/or G719X mutation–positive tumors
and prior afatinib, osimertinib, erlotinib, gefitinib, or dacomitinib
therapy
Durvalumab
(Imfinzi), as a single agent, as continuation maintenance therapy for
recurrent,
advanced, or metastatic disease, is considered medically necessary and,
therefore, covered for the treatment of individuals with NSCLC with
adenocarcinoma (with mixed subtypes), large cell carcinoma, or squamous cell
carcinoma histology in ONE of the following scenarios:
- As treatment for individuals
with ALL of the following:
- PD-L1 expression 1-49 percent
tumors that are negative for actionable molecular biomarkers* (may be
KRAS G12C mutation positive)
- No contraindications** to immune checkpoint inhibitors
- PS 0-2
- Have achieved a response or
stable disease following first-line therapy with durvalumab (Imfinzi)
and tremelimumab-actl (Imjudo) plus chemotherapy
- As treatment for individuals
with ALL of the following:
- PD-L1 expression less than 1
percent tumors that are negative for actionable molecular biomarkers*
(may be KRAS G12C mutation positive)
- No contraindications** to immune checkpoint inhibitors
- PS 0-2
- Have achieved a tumor response
or stable disease following initial systemic therapy with durvalumab
(Imfinzi) and tremelimumab-actl (Imjudo) plus chemotherapy
Durvalumab
(Imfinzi), in combination with pemetrexed, as continuation maintenance
therapy for recurrent, advanced, or metastatic disease, is considered
medically necessary and, therefore, covered for the treatment of individuals
with NSCLC with adenocarcinoma (with mixed subtypes) or large cell
carcinoma histology in ONE of the following scenarios:
- As
treatment for individuals with ALL of the following:
- PD-L1 expression 1-49 percent
tumors that are negative for actionable molecular biomarkers* (may be
KRAS G12C–mutation positive)
- No contraindications** immune checkpoint inhibitors
- PS 0-2
- Have achieved a response or
stable disease following first-line therapy with durvalumab (Imfinzi),
tremelimumab-actl (Imjudo), and pemetrexed plus either carboplatin or
cisplatin for nonsquamous cell histology
- As treatment for individuals
with ALL of the following:
- PD-L1 expression less
than 1 percent tumors that are negative for actionable molecular
biomarkers* (may be KRAS G12C–mutation positive)
- No contraindications** to immune checkpoint inhibitors
- PS 0-2
- Have achieved a tumor response
or stable disease following initial systemic therapy with durvalumab
(Imfinzi), tremelimumab-actl (Imjudo), and pemetrexed plus either
carboplatin or cisplatin for nonsquamous cell histology
*Complete
genotyping for EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2) via biopsy and/or plasma
testing. Treatment is guided by available
results and, if unknown, these individuals are treated as though they do not
have driver oncogenes. For those who require an
urgent start to therapy, but biomarker testing is pending, consider holding
immunotherapy for one cycle, unless confirmed that no driver mutations are
present.
**Contraindications for treatment with PD-1/PD-L1 inhibitors may include
active or previously documented autoimmune disease and/or current use of
immunosuppressive agents, and some oncogenic drivers (i.e., EGFR exon 19
deletion or exon 21 L858R, ALK, RET, or ROS1 gene fusions), have been shown to be associated with less benefit from
PD-1/PD-L1 inhibitors.
SMALL
BOWEL ADENOCARCINOMA
Durvalumab
(Imfinzi), as a single agent, is considered medically necessary and, therefore,
covered as neoadjuvant therapy for resectable small bowel adenocarcinoma for ANY
of the following:
- T4 disease
- Has a bulky primary (dMMR/MSI-H)
- POLE/POLD1 mutation with ultrahypermutated phenotype (e.g.,
TMB >50 mut/Mb)
Durvalumab
(Imfinzi), as a single agent, is considered medically necessary and, therefore,
covered as primary treatment for small bowel adenocarcinoma for ANY of the
following:
- Locally unresectable
- Medically inoperable disease (dMMR/MSI-H)
- POLE/POLD1 mutation with ultrahypermutated phenotype (e.g.,
TMB >50 mut/Mb)
Durvalumab
(Imfinzi), as a single agent, is considered medically necessary and, therefore,
covered as treatment for small bowel adenocarcinoma, in any line of therapy, if
no previous treatment with a checkpoint inhibitor, for EITHER of the following:
- Advanced or metastatic disease (dMMR/MSI-H)
- POLE/POLD1 mutation with ultrahypermutated phenotype (e.g.,
TMB >50 mut/Mb)
SMALL CELL LUNG CANCER
Durvalumab (Imfinzi), in combination with etoposide and either carboplatin or
cisplatin followed by single-agent maintenance with
durvalumab (Imfinzi), is considered medically necessary and,
therefore, covered for primary treatment (NCCN preferred) of
extensive-stage small cell lung cancer (ES-SCLC) in individuals
with ANY of the following:
- Without localized
symptomatic sites or brain metastases and good
PS (0-2)
- Without localized symptomatic
sites or brain metastases and poor PS (3-4) due to small
cell lung cancer (SCLC)
- With localized symptomatic
sites (used with RT [typically
sequential] if spinal cord compression)
- With brain metastases
|
Durvalumab
(Imfinzi), as a single agent (NCCN preferred), is considered medically
necessary and, therefore, covered for limited-stage SCLC (LS-SCLC) with ALL of
the following:
- As adjuvant consolidation therapy
- No disease progression following systemic therapy with concurrent
RT
- Good PS (0-2)
- Individual is medically inoperable or decision was made not
to pursue surgical resection
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