Programmed Death Receptor (PD-1) / Programmed Death-Ligand (PD-L1) Blocking Antibodies

Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies

Policy ID: I-120-031

Section: Injections

Effective Date: January 01, 2019

Revised Date: September 16, 2022

Revision Effective Date: October 01, 2022

Last Reviewed: September 28, 2022

Applies To: Commercial and Medicaid Expansion

Description

Atezolizumab (Tecentriq®) is a monoclonal antibody which binds to programmed death-ligand 1 (PD-L1) expressed on tumor cells or tumor-infiltrating immune cells and blocks its interaction with Programmed Death Receptor 1 (PD-1) and B7.1 receptors present on T cells and antigen-presenting cells, which releases the inhibition of the immune response and activates the antitumor response.

Avelumab (Bavencio®) binds PD-L1, blocking interaction with receptors PD-1 and B7.1. This blockade results in a release of the inhibitory effects of PD-L1 on the immune response and the restoration of antitumor immune responses.

Cemiplimab-rwlc (Libtayo®) binds PD-1 blocking interaction with PD-L1 and PD-L2 releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Dostarlimab-gxly (Jemperli®) is a programmed death receptor-1 (PD-1)–blocking antibody.

Durvalumab (Imfinzi™) binds PD-L1, blocking interaction with PD-1 and CD80 (B7.1). This blockade reduces cytotoxic T-cell activity, proliferation, and cytokine production and allows for immune responses without inducing antibody dependent cell-mediated cytotoxicity.

Nivolumab (Opdivo®) is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Nivolumab and relatlimab-rmbw (Opdualag™) is immune checkpoint inhibitor combination treatment comprised of PD-1 inhibitor nivolumab and lymphocyte activation gene -3 (LAG-3)-blocking antibody relatilimab. This combination improves anti-tumor response by targeting two different immune checkpoints-LAG-3 and PD-1.

Pembrolizumab (Keytruda®) is a monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Atezolizumab (Tecentriq) may be considered medically necessary for adult individuals 18 years of age and older for ANY of the following conditions:

Hepatocellular Carcinoma, HCC

In combination with bevacizumab for the treatment of individuals with unresectable or metastatic HCC who have not received prior systemic therapy; or

Lung Cancer, Metastatic, Non-Small Cell Lung Cancer, NSCLC

As adjuvant treatment following resection and platinum-based chemotherapy for individuals with Stage II to IIIA NSCLC whose tumors have PD-L1 expression greater than or equal to 1% of tumor cells; or
First-line treatment of individuals with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 10% of the tumor area), with no EGFR or ALK genomic tumor aberrations; or
In combination with bevacizumab, paclitaxel, and carboplatin, for the first line treatment of individuals with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; or
In combination with paclitaxel protein-bound and carboplatin for the first-line treatment of individuals with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; or
Treatment of individuals with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. (Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving atezolizumab (Tecentriq); or

Lung Cancer, Small Cell Carcinoma

In combination with carboplatin and etoposide, for the first-line treatment of individuals with extensive-stage small cell lung cancer (ES-SCLC); or

Melanoma

In combination with cobimetinib and vemurafenib for the treatment of individuals with BRAF V600 mutation-positive unresectable or metastatic melanoma; or

Urothelial Cancer, Locally Advanced or Metastatic

Treatment of individuals who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area); or
Treatment of individuals who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The use of atezolizumab (Tecentriq) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9022

Avelumab (Bavencio) may be considered medically necessary for ANY of the following conditions:

Bladder (Urothelial) Carcinoma, Locally Advanced or Metastatic

Maintenance treatment of individuals who have not progressed with first-line platinum-containing chemotherapy; or
Treatment of individuals with disease progression during or following platinum-containing chemotherapy; or
Treatment of individuals with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; or

Kidney (Renal) Cell Carcinoma

In combination with axitinib for the first-line treatment of individuals with advanced renal cell carcinoma (RCC); or

Merkel Cell Carcinoma, MCC

Treatment of adult and pediatric individuals 12 years of age or older with metastatic MCC.

The use of avelumab (Bavencio) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9023

Cemiplimab (Libtayo) may be considered medically necessary for ANY of the following conditions:

Basal Cell Carcinoma (BCC)

Treatment of individuals with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; or
Treatment of individuals with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; or

Non-Small Cell Lung Cancer (NSCLC)

First-line treatment of individuals with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%], with no EGFR, ALK or ROS1 aberrations, and is:
- locally advanced where individuals are not candidates for surgical resection or definitive chemoradiation; or
- metastatic; or

Squamous Cell Carcinoma, Cutaneous, Locally Advanced or Metastatic

Treatment of individuals who are not candidates for curative surgery or curative radiation.

The use of cemiplimab (Libtayo) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9119

Dostarlimab-gxly (Jemperli) may be considered medically necessary for ANY of the following conditions:

Mismatch Repair Deficient (dMMR)

Treatment of individuals 18 years of age or older with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen; or
Treatment of individuals 18 years of age or older with dMMR solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

The use of dostarlimab-gxly (Jemperli) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9272

Durvalumab (Imfinzi) may be considered medically necessary for ANY of the following conditions:

Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Treatment of individuals 18 years of age or older with unresectable, Stage III disease who have not progressed following concurrent platinum-based chemotherapy and radiation therapy; or

Lung Cancer, Small Cell

In combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of individuals 18 years of age or older with extensive-stage small cell lung cancer; or

Biliary Tract Cancer

In combination with gemcitabine and cisplatin, as treatment of individuals 18 years of age and older with locally advanced or metastatic biliary tract cancer.

The use of durvalumab (Imfinzi) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9173

Nivolumab (Opdivo) may be considered medically necessary for ANY of the following conditions:

Colorectal Cancer

Treatment of individuals 12 years of age or older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic disease that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab; or

Esophageal Cancer

Treatment of individuals with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy; or
Treatment of individuals with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy; or
Treatment of individuals with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy; or
Treatment of individuals with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab; or

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma

Treatment of individuals with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy; or

Head and Neck Cancer

Treatment of individuals with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy; or

Hepatocellular Carcinoma, HCC

Treatment of individuals with HCC who have been previously treated with sorafenib, in combination with ipilimumab; or

Kidney (Renal) Cell Carcinoma

Treatment of individuals with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab; or
Treatment of individuals with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib; or
Treatment of individuals with advanced renal cell carcinoma who have received prior anti-angiogenic therapy; or

Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Treatment of individuals 18 years of age or older with resectable (tumors greater than or equal to four (4) cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy; or
Treatment of individuals 18 years of age or older with metastatic non-small cell lung cancer expressing PD-L1(greater than or equal to 1%), with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab; or
Treatment of individuals 18 years of age or older with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and two (2) cycles of platinum-doublet chemotherapy; or
Treatment of individuals with metastatic NSCLC and progression on or after platinum-based chemotherapy. Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab (Opdivo); or

Lymphoma, Hodgkin Classic

Treatment of individuals 18 years of age or older with classical Hodgkin lymphoma that has relapsed or progressed after:
- Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or
- Three (3) or more lines of systemic therapy that includes autologous HSCT; or

Melanoma

Treatment of individuals with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; or
Treatment of individuals with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting; or

Mesothelioma, Malignant Pleural

Treatment of individuals 18 years of age or older with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab; or

Urothelial Carcinoma

Adjuvant treatment of individuals with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC; or
Individuals with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy; or
Individuals with locally advanced or metastatic UC who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The use of nivolumab (Opdivo) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9299

Nivolumab and relatlimab-rmbw (Opdualag) may be considered medically necessary for ANY of the following conditions:

Melanoma

Treatment of individuals 12 years of age or older with unresectable or metastatic melanoma.

The use of nivolumab and relatlimab-rmbw (Opdualag) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9999

Pembrolizumab (Keytruda) may be considered medically necessary for ANY of the following conditions:

Bladder (Urothelial) Carcinoma

Treatment of individuals with locally advance or metastatic Urothelial Carcinoma who:
- Are not eligible for any platinum-containing chemotherapy; or
- Have disease progression during or following platinum-containing chemotherapy; or
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; or
Treatment of individuals with Bacillus Calmette-Guerin (BCG) unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy; or

Breast Cancer, Triple-Negative (TNBC)

Treatment of individuals with high-risk early stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; or
In combination with chemotherapy, for the treatment of individuals with locally recurrent unresectable or metastatic TNBC whose tumor express PD-L1 (CPS greater than or equal to 10); or

Cervical Cancer

In combination with chemotherapy, with or without bevacizumab, for the treatment of individuals with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to one (1)]; or
As a single agent for the treatment of individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [CPS greater than or equal to one (1)]; or

Cutaneous Squamous Cell Carcinoma (cSCC)

Treatment of individuals with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation; or

Endometrial Carcinoma

In combination with lenvatinib, for the treatment of individuals with advanced endometrial carcinoma and who:
- Are not MSI-H or dMMR; and
- Have disease progression following prior systemic therapy in any setting; and
- Are not candidates for curative surgery or radiation; or
As a single agent, for the treatment of individuals with advanced endometrial carcinoma and who:
- Are MSI-H or dMMR; and
- Have disease progression following prior systemic therapy in any setting; and
- Are not candidates for curative surgery or radiation; or

Esophageal Cancer

Treatment of individuals with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- In combination with platinum- and fluoropyrimidine-based chemotherapy; or
- As a single agent after one (1) or more prior lines of systemic therapy for individuals with tumors of squamous cell histology that express PD-L1 (CPS greater than or equal to 10); or

Gastric Cancer

In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of individuals with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma; or

Head and Neck Squamous Cell Cancer, HNSCC

In combination with platinum and FU for first-line treatment of individuals with metastatic or unresectable, recurrent HNSCC; or
As a single agent for the first line treatment of individuals with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1 (Combined Positive Score (CPS) greater than or equal to one (1); or
As a single agent for the treatment of individuals with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy; or

Hepatocellular Carcinoma, HCC

Treatment of individuals with HCC who have been previously treated with sorafenib; or

Kidney (Renal) Cell Carcinoma, RCC

In combination with axitinib, for first-line treatment of adult individuals with advanced RCC; or
In combination with lenvatinib, for first-line treatment of adult individuals with advanced RCC; or
Adjuvant treatment of individuals with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions; or

Lung Cancer, NSCLC

In combination with pemetrexed and platinum chemotherapy, as first-line treatment of individuals with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; or
In combination with carboplatin and either paclitaxel or nab-paclitaxel (paclitaxel protein-bound), as first-line treatment of individuals with metastatic squamous NSCLC; or
As a single agent for the first-line treatment of individuals with NSCLC expressing PD-L1 (Tumor Proportion Score (TPS) greater than or equal to 1%), with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III in individuals who are not candidates for surgical resection or definitive chemoradiation; or
- Metastatic; or
As a single agent for the treatment of individuals with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1%) with disease progression on or after platinum-containing chemotherapy. Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab (Keytruda); or

Lymphoma, Hodgkin, Classic, cHL

Treatment of individuals 18 years of age or older with relapsed or refractory cHL; or
Treatment of pediatric individuals with refractory cHL, or cHL that has relapsed after two (2) or more prior lines of therapy; or

Lymphoma, Primary Mediastinal Large B-Cell (PMBCL)

Treatment of adult and pediatric individuals with:
- Refractory PMBCL; or
- Relapse after two (2) or more prior lines of therapy; or

Limitation of Use: pembrolizumab (Keytruda) is not recommended for treatment of individuals with PMBCL who require urgent cytoreductive therapy.

Melanoma

Treatment of individuals with unresectable or metastatic disease; or
Adjuvant treatment of individuals 12 years of age or older with Stage IIB, IIC, or III melanoma following complete resection; or

Merkel Cell Carcinoma, MCC

Treatment of adult and pediatric individuals with recurrent locally advanced or metastatic MCC; or

Microsatellite Instability-High, MSI-H or Mismatch Repair Deficient Cancer

Treatment of adult and pediatric individuals with unresectable or metastatic, MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options; or
Treatment of individuals with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC); or

Limitation of use: The safety and effectiveness of pembrolizumab (Keytruda) in pediatric individuals with MSI-H central nervous system cancers have not been established.

Tumor Mutational Burden-High (TMB-H) Cancer

Treatment of adult and pediatric individuals with unresectable or metastatic TMB-H [greater than or equal to 10 mutations/megabase (mut/Mb)] solid tumors, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Limitation of use: The safety and effectiveness of pembrolizumab (Keytruda) in pediatric individuals with TMB-H central nervous system cancers have not been established.

The use of pembrolizumab (Keytruda) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9271

Compendia Sources

Atezolizumab (Tecentriq), avelumab (Bavencio), cemiplimab-rwlc (Libtayo), dostarlimab-gxly (Jemperli), durvalumab (Imfinzi), nivolumab (Opdivo), nivolumab and relatlimab-rmbw (Opdualag), or pembrolizumab (Keytruda) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

PD-1/PD-L1 blocking antibodies for any other indication not listed within this policy is considered experimental and investigational because scientific evidence does not support its use.

Procedure Codes

J9022

J9023

J9119

J9173

J9271

J9272

J9299

J9999

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J9119

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C3491

C34.92

C44.01

C44.02

C44.111

C44.1121

C44.1122

C44.1191

C44.1192

C44.121

C44.1221

C44.1222

C44.1291

C44.1292

C44.211

C44.212

C44.219

C44.221

C44.222

C44.229

C44.310

C44.311

C44.319

C44.320

C44.321

C44.329

C44.41

C44.42

C44.510

C44.511

C44.519

C44.520

C44.521

C44.529

C44.611

C44.612

C44.619

C44.621

C44.622

C44.629

C44.711

C44.712

C44.719

C44.721

C44.722

C44.729

C44.81

C44.82

C44.91

C44.92

Q87.89

Covered Diagnosis Codes for Procedure Code J9173

C22.0

C22.1

C22.8

C22.9

C23

C24.0

C24.8

C24.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

C7A.1

Covered Diagnosis Codes for Procedure Code J9299

C59.8

C61

C63.2

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C69.30

C69.31

C69.32

C69.40

C69.41

C69.42

C69.60

C69.61

C69.62

C76.0

C77.0

C7A.1

C7A.8

C7.B1

C7.B8

C78.00

C78.01

C78.02

C78.6

C78.7

C79.31

C79.51

C79.52

C81.10

C81.11

C81.12

C81.13

C81.14

C81.15

C81.16

C81.17

C81.18

C81.19

C81.20

C81.21

C81.22

C81.23

C81.24

C81.25

C81.26

C81.27

C81.28

C81.29

C81.30

C81.31

C81.32

C81.33

C81.34

C81.35

C81.36

C81.37

C81.38

C81.39

C81.40

C81.41

C81.42

C81.43

C81.44

C81.45

C81.46

C81.47

C81.48

C81.49

C81.70

C81.71

C81.72

C81.73

C81.74

C81.75

C81.76

C81.77

C81.78

C81.79

C81.90

C81.91

C81.92

C81.93

C81.94

C81.95

C81.96

C81.97

C81.98

C81.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C86.0

C91.10

C91.12

Covered Diagnosis Codes for Procedure Code J9298

C43.0

C43.10

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

Covered Diagnosis Codes for Procedure Code J9271

C00.0

C00.1

C00.2

C00.3

C00.4

C00.5

C00.6

C00.8

C00.9

C01

C02.0

C02.1

C02.2

C02.3

C02.4

C02.8

C02.9

C03.0

C03.1

C03.9

C04.0

C04.1

C04.8

C04.9

C05.0

C05.1

C05.8

C05.9

C06.0

C06.2

C06.80

C06.89

C06.9

C07

C08.0

C08.1

C08.9

C09.0

C09.1

C09.8

C09.9

C10.0

C10.1

C10.2

C10.3

C10.4

C10.8

C10.9

C11.0

C11.1

C11.2

C11.3

C11.8

C11.9

C12

C13.0

C13.1

C13.2

C13.8

C13.9

C14.0

C14.2

C14.8

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C17.0

C17.1

C17.2

C17.3

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.0

C21.1

C21.2

C21.8

C22.0

C22.1

C22.3

C22.8

C22.9

C23

C24.0

C24.1

C24.8

C24.9

C25.0

C25.1

C25.2

C25.3

C25.7

C25.8

C25.9

C30.0

C31.0

C31.1

C32.0

C32.1

C32.2

C32.3

C32.8

C32.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C37

C40.00

C40.01

C40.02

C40.10

C40.11

C40.12

C40.20

C40.21

C40.22

C40.30

C40.31

C40.32

C40.80

C40.81

C40.82

C40.90

C40.91

C40.92

C41.0

C41.1

C41.2

C41.3

C41.4

C41.9

C43.0

C43.10

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

C44.00

C44.02

C44.09

C44.121

C44.1221

C44.1222

C44.1291

C44.1292

C44.221

C44.222

C44.229

C44.320

C44.321

C44.329

C44.42

C44.520

C44.521

C44.529

C44.621

C44.622

C44.629

C44.721

C44.722

C44.729

C44.82

C44.92

C47.0

C47.10

C47.11

C47.12

C47.20

C47.21

C47.22

C47.3

C47.4

C47.5

C47.6

C47.8

C47.9

C48.0

C48.1

C48.2

C48.8

C49.0

C49.10

C49.11

C49.12

C49.20

C49.21

C49.22

C49.3

C49.4

C49.5

C49.6

C49.8

C49.9

C4A.0

C4A.10

C4A.111

C4A.112

C4A.121

C4A.122

C4A.20

C4A.21

C4A.22

C4A.30

C4A.31

C4A.39

C4A.4

C4A.51

C4A.52

C4A.59

C4A.60

C4A.61

C4A.62

C4A.70

C4A.71

C4A.72

C4A.8

C4A.9

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C51.0

C51.1

C51.2

C51.8

C51.9

C53.0

C53.1

C53.8

C53.9

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

C56.1

C56.2

C56.3

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

C58

C60.0

C60.1

C60.2

C60.8

C60.9

C61

C62.00

C62.01

C62.02

C62.10

C62.11

C62.12

C62.90

C62.91

C62.92

C63.2

C63.7

C63.8

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C69.30

C69.31

C69.32

C69.40

C69.41

C69.42

C69.60

C69.61

C69.62

C72.0

C72.1

C73

C74.00

C74.01

C74.02

C74.90

C74.91

C74.92

C76.0

C77.0

C78.00

C78.01

C78.02

C78.6

C78.7

C79.31

C79.51

C79.52

C79.70

C79.71

C79.72

C7A.1

C7A.8

C7B.00

C7B.01

C7B.02

C7B.03

C7B.04

C7B.1

C7B.8

C80.0

C80.1

C81.10

C81.11

C81.12

C81.13

C81.14

C81.15

C81.16

C81.17

C81.18

C81.19

C81.20

C81.21

C81.22

C81.23

C81.24

C81.25

C81.26

C81.27

C81.28

C81.29

C81.30

C81.31

C81.32

C81.33

C81.34

C81.35

C81.36

C81.37

C81.38

C81.39

C81.40

C81.41

C81.42

C81.43

C81.44

C81.45

C81.46

C81.47

C81.48

C81.49

C81.70

C81.71

C81.72

C81.73

C81.74

C81.75

C81.76

C81.77

C81.78

C81.79

C81.90

C81.91

C81.92

C81.93

C81.94

C81.95

C81.96

C81.97

C81.98

C81.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C86.0

C86.6

C91.10

C91.12

Covered Diagnosis Codes for Procedure Code J9022

C22.0

C22.8

C22.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C43.0

C43.10

C43.11

C43.12

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

C45.1

C61

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C7A.1

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

Covered Diagnosis Codes for Procedure Code J9023

C21.0

C4A.0

C4A.10

C4A.111

C4A.112

C4A.121

C4A.122

C4A.20

C4A.21

C4A.22

C4A.30

C4A.31

C4A.39

C4A.4

C4A.51

C4A.52

C4A.59

C4A.60

C4A.61

C4A.62

C4A.70

C4A.71

C4A.72

C4A.8

C4A.9

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

C58

C61

C63.2

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C7B.1

Covered Diagnosis Codes for Procedure Code J9272

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C17.0

C17.1

C17.2

C17.3

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C22.0

C22.1

C22.8

C22.9

C23

C24.0

C24.1

C24.8

C24.9

C48.1

C48.2

C48.8

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

C56.1

C56.2

C56.3

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

C78.00

C78.01

C78.02

C78.6

C78.7

C80.0

C80.1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Coding update

Internal Medical Policy Committee 1-22-2020

Atezolizumab (Tecentriq®), Avelumab (Bavencio®), Cemiplimab-rwlc (Libtayo®), Durvalumab (Imfinzi™), Nivolumab (Opdivo®), Pembrolizumab (Keytruda®) - will require pre-certification as of 2/1/2020

Internal Medical Policy Committee 1-19-2021

FDA indications and/or NCCN recommendations updated for atezolizumab (Tecentriq), avelumab (Bavencio), cemiplimab (Libtayo), durvalumab (Imfinzi), nivolumab (Opdivo) and pembrolizumab (Keytruda)

Internal Medical Policy Committee 9-21-2021

Added dostarlimab-gxly (Jemperli) to policy,
Removed NCCN recommendations and
Added this statement "Atezolizumab (Tecentriq), avelumab (Bavencio), cemiplimab-rwlc (Libtayo), dostarlimab-gxly (Jemperli), durvalumab (Imfinzi), nivolumab (Opdivo), or pembrolizumab (Keytruda) may be considered medically necessary for treatment of any of the current category 1, or 2A NCCN recommendations.",
Updated FDA criteria found in policy,
Updated diagnosis codes

Internal Medical Policy Committee 11-23-2021- Effective January 01, 2022

Added new code J9272 to policy and removed C9082

Internal Medical Policy Committee 5-24-2022 - Effective June 01, 2022

Added relatlimab-rmbw (Opdualag) to the policy,
Updated all criteria and diagnosis codes for all drugs within the policy

Internal Medical Policy Committee 9-28-2022 - Effective October 01, 2022

Added new code, J9298, to the policy, and
Added additional indications for durvalumab (Imfinzi) and nivolumab (Opdivo)

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-120-030

Section: Injections

Effective Date: January 01, 2019

Revised Date: May 12, 2022

Revision Effective Date: June 01, 2022

Last Reviewed: May 24, 2022

Archived Date: September 30, 2022

Applies To: Commercial and Medicaid Expansion

Description

Cemiplimab-rwlc (Libtayo®) binds PD-1 blocking interaction with PD-L1 and PD-L2 releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Dostarlimab-gxly (Jemperli®) is a programmed death receptor-1 (PD-1)–blocking antibody.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Atezolizumab (Tecentriq) may be considered medically necessary for adult individuals 18 years of age and older for ANY of the following conditions:

Hepatocellular Carcinoma, HCC

In combination with bevacizumab for the treatment of individuals with unresectable or metastatic HCC who have not received prior systemic therapy; or

Lung Cancer, Metastatic, Non-Small Cell Lung Cancer, NSCLC

As adjuvant treatment following resection and platinum-based chemotherapy for individuals with Stage II to IIIA NSCLC whose tumors have PD-L1 expression greater than or equal to 1% of tumor cells; or
First-line treatment of individuals with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 10% of the tumor area), with no EGFR or ALK genomic tumor aberrations; or
In combination with bevacizumab, paclitaxel, and carboplatin, for the first line treatment of individuals with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; or
In combination with paclitaxel protein-bound and carboplatin for the first-line treatment of individuals with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; or
Treatment of individuals with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. (Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving atezolizumab (Tecentriq); or

Lung Cancer, Small Cell Carcinoma

In combination with carboplatin and etoposide, for the first-line treatment of individuals with extensive-stage small cell lung cancer (ES-SCLC); or

Melanoma

In combination with cobimetinib and vemurafenib for the treatment of individuals with BRAF V600 mutation-positive unresectable or metastatic melanoma; or

Urothelial Cancer, Locally Advanced or Metastatic

Treatment of individuals who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area); or
Treatment of individuals who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

Procedure Codes

J9022

Avelumab (Bavencio) may be considered medically necessary for ANY of the following conditions:

Bladder (Urothelial) Carcinoma, Locally Advanced or Metastatic

Maintenance treatment of individuals who have not progressed with first-line platinum-containing chemotherapy; or
Treatment of individuals with disease progression during or following platinum-containing chemotherapy; or
Treatment of individuals with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; or

Kidney (Renal) Cell Carcinoma

In combination with axitinib for the first-line treatment of individuals with advanced renal cell carcinoma (RCC); or

Merkel Cell Carcinoma, MCC

Treatment of adult and pediatric individuals 12 years of age or older with metastatic MCC.

Procedure Codes

J9023

Cemiplimab (Libtayo) may be considered medically necessary for ANY of the following conditions:

Basal Cell Carcinoma (BCC)

Treatment of individuals with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; or
Treatment of individuals with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; or

Non-Small Cell Lung Cancer (NSCLC)

First-line treatment of individuals with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%], with no EGFR, ALK or ROS1 aberrations, and is:
- locally advanced where individuals are not candidates for surgical resection or definitive chemoradiation; or
- metastatic; or

Squamous Cell Carcinoma, Cutaneous, Locally Advanced or Metastatic

Treatment of individuals who are not candidates for curative surgery or curative radiation.

Procedure Codes

J9119

Dostarlimab-gxly (Jemperli) may be considered medically necessary for ANY of the following conditions:

Mismatch Repair Deficient (dMMR)

Treatment of individuals 18 years of age or older with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen; or
Treatment of individuals 18 years of age or older with dMMR solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

Procedure Codes

J9272

Durvalumab (Imfinzi) may be considered medically necessary for ANY of the following conditions:

Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Treatment of individuals 18 years of age or older with unresectable, Stage III disease who have not progressed following concurrent platinum-based chemotherapy and radiation therapy; or

Lung Cancer, Small Cell

In combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of individuals 18 years of age or older with extensive-stage small cell lung cancer.

Procedure Codes

J9173

Nivolumab (Opdivo) may be considered medically necessary for ANY of the following conditions:

Colorectal Cancer

Treatment of individuals 12 years of age or older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic disease that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab; or

Esophageal Cancer

Treatment of individuals with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy; or
Treatment of individuals with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy; or

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma

Treatment of individuals with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy; or

Head and Neck Cancer

Treatment of individuals with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy; or

Hepatocellular Carcinoma, HCC

Treatment of individuals with HCC who have been previously treated with sorafenib, in combination with ipilimumab; or

Kidney (Renal) Cell Carcinoma

Treatment of individuals with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab; or
Treatment of individuals with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib; or
Treatment of individuals with advanced renal cell carcinoma who have received prior anti-angiogenic therapy; or

Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Treatment of individuals 18 years of age or older with resectable (tumors greater than or equal to four (4) cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy; or
Treatment of individuals 18 years of age or older with metastatic non-small cell lung cancer expressing PD-L1(greater than or equal to 1%), with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab; or
Treatment of individuals 18 years of age or older with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and two (2) cycles of platinum-doublet chemotherapy; or
Treatment of individuals with metastatic NSCLC and progression on or after platinum-based chemotherapy. Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab (Opdivo); or

Lymphoma, Hodgkin Classic

Treatment of individuals 18 years of age or older with classical Hodgkin lymphoma that has relapsed or progressed after:
- Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or
- Three (3) or more lines of systemic therapy that includes autologous HSCT; or

Melanoma

Treatment of individuals with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; or
Treatment of individuals with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting; or

Mesothelioma, Malignant Pleural

Treatment of individuals 18 years of age or older with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab; or

Urothelial Carcinoma

Adjuvant treatment of individuals with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC; or
Individuals with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy; or
Individuals with locally advanced or metastatic UC who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Procedure Codes

J9299

Nivolumab and relatlimab-rmbw (Opdualag) may be considered medically necessary for ANY of the following conditions:

Melanoma

Treatment of individuals 12 years of age or older with unresectable or metastatic melanoma.

Procedure Codes

J9999

Pembrolizumab (Keytruda) may be considered medically necessary for ANY of the following conditions:

Bladder (Urothelial) Carcinoma

Treatment of individuals with locally advance or metastatic Urothelial Carcinoma who:
- Are not eligible for any platinum-containing chemotherapy; or
- Have disease progression during or following platinum-containing chemotherapy; or
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; or
Treatment of individuals with Bacillus Calmette-Guerin (BCG) unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy; or

Breast Cancer, Triple-Negative (TNBC)

Treatment of individuals with high-risk early stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; or
In combination with chemotherapy, for the treatment of individuals with locally recurrent unresectable or metastatic TNBC whose tumor express PD-L1 (CPS greater than or equal to 10); or

Cervical Cancer

In combination with chemotherapy, with or without bevacizumab, for the treatment of individuals with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to one (1)]; or
As a single agent for the treatment of individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [CPS greater than or equal to one (1)]; or

Cutaneous Squamous Cell Carcinoma (cSCC)

Treatment of individuals with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation; or

Endometrial Carcinoma

In combination with lenvatinib, for the treatment of individuals with advanced endometrial carcinoma and who:
- Are not MSI-H or dMMR; and
- Have disease progression following prior systemic therapy in any setting; and
- Are not candidates for curative surgery or radiation; or
As a single agent, for the treatment of individuals with advanced endometrial carcinoma and who:
- Are MSI-H or dMMR; and
- Have disease progression following prior systemic therapy in any setting; and
- Are not candidates for curative surgery or radiation; or

Esophageal Cancer

Treatment of individuals with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- In combination with platinum- and fluoropyrimidine-based chemotherapy; or
- As a single agent after one (1) or more prior lines of systemic therapy for individuals with tumors of squamous cell histology that express PD-L1 (CPS greater than or equal to 10); or

Gastric Cancer

In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of individuals with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma; or

Head and Neck Squamous Cell Cancer, HNSCC

In combination with platinum and FU for first-line treatment of individuals with metastatic or unresectable, recurrent HNSCC; or
As a single agent for the first line treatment of individuals with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1 (Combined Positive Score (CPS) greater than or equal to one (1); or
As a single agent for the treatment of individuals with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy; or

Hepatocellular Carcinoma, HCC

Treatment of individuals with HCC who have been previously treated with sorafenib; or

Kidney (Renal) Cell Carcinoma, RCC

In combination with axitinib, for first-line treatment of adult individuals with advanced RCC; or
In combination with lenvatinib, for first-line treatment of adult individuals with advanced RCC; or
Adjuvant treatment of individuals with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions; or

Lung Cancer, NSCLC

In combination with pemetrexed and platinum chemotherapy, as first-line treatment of individuals with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; or
In combination with carboplatin and either paclitaxel or nab-paclitaxel (paclitaxel protein-bound), as first-line treatment of individuals with metastatic squamous NSCLC; or
As a single agent for the first-line treatment of individuals with NSCLC expressing PD-L1 (Tumor Proportion Score (TPS) greater than or equal to 1%), with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III in individuals who are not candidates for surgical resection or definitive chemoradiation; or
- Metastatic; or
As a single agent for the treatment of individuals with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1%) with disease progression on or after platinum-containing chemotherapy. Individuals with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab (Keytruda); or

Lymphoma, Hodgkin, Classic, cHL

Treatment of individuals 18 years of age or older with relapsed or refractory cHL; or
Treatment of pediatric individuals with refractory cHL, or cHL that has relapsed after two (2) or more prior lines of therapy; or

Lymphoma, Primary Mediastinal Large B-Cell (PMBCL)

Treatment of adult and pediatric individuals with:
- Refractory PMBCL; or
- Relapse after two (2) or more prior lines of therapy; or

Limitation of Use: pembrolizumab (Keytruda) is not recommended for treatment of individuals with PMBCL who require urgent cytoreductive therapy.

Melanoma

Treatment of individuals with unresectable or metastatic disease; or
Adjuvant treatment of individuals 12 years of age or older with Stage IIB, IIC, or III melanoma following complete resection; or

Merkel Cell Carcinoma, MCC

Treatment of adult and pediatric individuals with recurrent locally advanced or metastatic MCC; or

Microsatellite Instability-High, MSI-H or Mismatch Repair Deficient Cancer

Treatment of adult and pediatric individuals with unresectable or metastatic, MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options; or
Treatment of individuals with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC); or

Limitation of use: The safety and effectiveness of pembrolizumab (Keytruda) in pediatric individuals with MSI-H central nervous system cancers have not been established.

Tumor Mutational Burden-High (TMB-H) Cancer

Treatment of adult and pediatric individuals with unresectable or metastatic TMB-H [greater than or equal to 10 mutations/megabase (mut/Mb)] solid tumors, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Limitation of use: The safety and effectiveness of pembrolizumab (Keytruda) in pediatric individuals with TMB-H central nervous system cancers have not been established.

Procedure Codes

J9271

Compendia Sources

PD-1/PD-L1 blocking antibodies for any other indication not listed within this policy is considered experimental and investigational because scientific evidence does not support its use.

Procedure Codes

J9022

J9023

J9119

J9173

J9271

J9272

J9299

J9999

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J9119

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C3491

C34.92

C44.01

C44.02

C44.111

C44.1121

C44.1122

C44.1191

C44.1192

C44.121

C44.1221

C44.1222

C44.1291

C44.1292

C44.211

C44.212

C44.219

C44.221

C44.222

C44.229

C44.310

C44.311

C44.319

C44.320

C44.321

C44.329

C44.41

C44.42

C44.510

C44.511

C44.519

C44.520

C44.521

C44.529

C44.611

C44.612

C44.619

C44.621

C44.622

C44.629

C44.711

C44.712

C44.719

C44.721

C44.722

C44.729

C44.81

C44.82

C44.91

C44.92

Q87.89

Covered Diagnosis Codes for Procedure Code J9173

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

C7A.1

Covered Diagnosis Codes for Procedure Code J9299

C59.8

C61

C63.2

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C69.30

C69.31

C69.32

C69.40

C69.41

C69.42

C69.60

C69.61

C69.62

C76.0

C77.0

C7A.1

C7A.8

C7.B1

C7.B8

C78.00

C78.01

C78.02

C78.6

C78.7

C79.31

C79.51

C79.52

C81.10

C81.11

C81.12

C81.13

C81.14

C81.15

C81.16

C81.17

C81.18

C81.19

C81.20

C81.21

C81.22

C81.23

C81.24

C81.25

C81.26

C81.27

C81.28

C81.29

C81.30

C81.31

C81.32

C81.33

C81.34

C81.35

C81.36

C81.37

C81.38

C81.39

C81.40

C81.41

C81.42

C81.43

C81.44

C81.45

C81.46

C81.47

C81.48

C81.49

C81.70

C81.71

C81.72

C81.73

C81.74

C81.75

C81.76

C81.77

C81.78

C81.79

C81.90

C81.91

C81.92

C81.93

C81.94

C81.95

C81.96

C81.97

C81.98

C81.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C86.0

C91.10

C91.12

Covered Diagnosis Codes for Procedure Code J9271

C00.0

C00.1

C00.2

C00.3

C00.4

C00.5

C00.6

C00.8

C00.9

C01

C02.0

C02.1

C02.2

C02.3

C02.4

C02.8

C02.9

C03.0

C03.1

C03.9

C04.0

C04.1

C04.8

C04.9

C05.0

C05.1

C05.8

C05.9

C06.0

C06.2

C06.80

C06.89

C06.9

C07

C08.0

C08.1

C08.9

C09.0

C09.1

C09.8

C09.9

C10.0

C10.1

C10.2

C10.3

C10.4

C10.8

C10.9

C11.0

C11.1

C11.2

C11.3

C11.8

C11.9

C12

C13.0

C13.1

C13.2

C13.8

C13.9

C14.0

C14.2

C14.8

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C17.0

C17.1

C17.2

C17.3

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.0

C21.1

C21.2

C21.8

C22.0

C22.1

C22.3

C22.8

C22.9

C23

C24.0

C24.1

C24.8

C24.9

C25.0

C25.1

C25.2

C25.3

C25.7

C25.8

C25.9

C30.0

C31.0

C31.1

C32.0

C32.1

C32.2

C32.3

C32.8

C32.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C37

C40.00

C40.01

C40.02

C40.10

C40.11

C40.12

C40.20

C40.21

C40.22

C40.30

C40.31

C40.32

C40.80

C40.81

C40.82

C40.90

C40.91

C40.92

C41.0

C41.1

C41.2

C41.3

C41.4

C41.9

C43.0

C43.10

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

C44.00

C44.02

C44.09

C44.121

C44.1221

C44.1222

C44.1291

C44.1292

C44.221

C44.222

C44.229

C44.320

C44.321

C44.329

C44.42

C44.520

C44.521

C44.529

C44.621

C44.622

C44.629

C44.721

C44.722

C44.729

C44.82

C44.92

C47.0

C47.10

C47.11

C47.12

C47.20

C47.21

C47.22

C47.3

C47.4

C47.5

C47.6

C47.8

C47.9

C48.0

C48.1

C48.2

C48.8

C49.0

C49.10

C49.11

C49.12

C49.20

C49.21

C49.22

C49.3

C49.4

C49.5

C49.6

C49.8

C49.9

C4A.0

C4A.10

C4A.111

C4A.112

C4A.121

C4A.122

C4A.20

C4A.21

C4A.22

C4A.30

C4A.31

C4A.39

C4A.4

C4A.51

C4A.52

C4A.59

C4A.60

C4A.61

C4A.62

C4A.70

C4A.71

C4A.72

C4A.8

C4A.9

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C51.0

C51.1

C51.2

C51.8

C51.9

C53.0

C53.1

C53.8

C53.9

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

C56.1

C56.2

C56.3

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

C58

C60.0

C60.1

C60.2

C60.8

C60.9

C61

C62.00

C62.01

C62.02

C62.10

C62.11

C62.12

C62.90

C62.91

C62.92

C63.2

C63.7

C63.8

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C69.30

C69.31

C69.32

C69.40

C69.41

C69.42

C69.60

C69.61

C69.62

C72.0

C72.1

C73

C74.00

C74.01

C74.02

C74.90

C74.91

C74.92

C76.0

C77.0

C78.00

C78.01

C78.02

C78.6

C78.7

C79.31

C79.51

C79.52

C79.70

C79.71

C79.72

C7A.1

C7A.8

C7B.00

C7B.01

C7B.02

C7B.03

C7B.04

C7B.1

C7B.8

C80.0

C80.1

C81.10

C81.11

C81.12

C81.13

C81.14

C81.15

C81.16

C81.17

C81.18

C81.19

C81.20

C81.21

C81.22

C81.23

C81.24

C81.25

C81.26

C81.27

C81.28

C81.29

C81.30

C81.31

C81.32

C81.33

C81.34

C81.35

C81.36

C81.37

C81.38

C81.39

C81.40

C81.41

C81.42

C81.43

C81.44

C81.45

C81.46

C81.47

C81.48

C81.49

C81.70

C81.71

C81.72

C81.73

C81.74

C81.75

C81.76

C81.77

C81.78

C81.79

C81.90

C81.91

C81.92

C81.93

C81.94

C81.95

C81.96

C81.97

C81.98

C81.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C86.0

C86.6

C91.10

C91.12

Covered Diagnosis Codes for Procedure Code J9022

C22.0

C22.8

C22.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C43.0

C43.10

C43.11

C43.12

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

C45.1

C61

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C7A.1

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

Covered Diagnosis Codes for Procedure Code J9023

C21.0

C4A.0

C4A.10

C4A.111

C4A.112

C4A.121

C4A.122

C4A.20

C4A.21

C4A.22

C4A.30

C4A.31

C4A.39

C4A.4

C4A.51

C4A.52

C4A.59

C4A.60

C4A.61

C4A.62

C4A.70

C4A.71

C4A.72

C4A.8

C4A.9

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

C58

C61

C63.2

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C7B.1

Covered Diagnosis Codes for Procedure Code J9272

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C17.0

C17.1

C17.2

C17.3

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C22.0

C22.1

C22.8

C22.9

C23

C24.0

C24.1

C24.8

C24.9

C48.1

C48.2

C48.8

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

C56.1

C56.2

C56.3

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

C78.00

C78.01

C78.02

C78.6

C78.7

C80.0

C80.1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Coding update

Internal Medical Policy Committee 1-22-2020 Atezolizumab (Tecentriq®), Avelumab (Bavencio®), Cemiplimab-rwlc (Libtayo®), Durvalumab (Imfinzi™), Nivolumab (Opdivo®), Pembrolizumab (Keytruda®) - will require pre-certification as of 2/1/2020

Internal Medical Policy Committee 1-19-2021 FDA indications and/or NCCN recommendations updated for atezolizumab (Tecentriq), avelumab (Bavencio), cemiplimab (Libtayo), durvalumab (Imfinzi), nivolumab (Opdivo) and pembrolizumab (Keytruda)

Internal Medical Policy Committee 9-21-2021 Added dostarlimab-gxly (Jemperli) to policy, removed NCCN recommendations and added this statement "Atezolizumab (Tecentriq), avelumab (Bavencio), cemiplimab-rwlc (Libtayo), dostarlimab-gxly (Jemperli), durvalumab (Imfinzi), nivolumab (Opdivo), or pembrolizumab (Keytruda) may be considered medically necessary for treatment of any of the current category 1, or 2A NCCN recommendations.", updated FDA criteria found in policy, updated diagnosis codes

Internal Medical Policy Committee 11-23-2021 Added new code J9272 to policy and removed C9082 effective 1-1-2022

Internal Medical Policy Committee 5-24-2022 Added relatlimab-rmbw (Opdualag) to the policy effective 6-1-2022, updated all criteria and diagnosis codes for all drugs within the policy

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