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-120-029

Section: Injections

Effective Date: January 01, 2019

Revised Date: November 22, 2021

Revision Effective Date: January 01, 2022

Last Reviewed: November 23, 2021

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.

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.

Compendia Sources

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.

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.

J9022

J9023

J9173

J9119

J9271

J9272

J9299

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

Breast Cancer, Triple-Negative, TNBC

Used in combination with paclitaxel protein-bound for the treatment of unresectable locally advanced or metastatic TNBC with tumors which express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA approved test; or

Hepatocellular Carcinoma, HCC

Used 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

For the 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), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; or
In combination with bevacizumab, paclitaxel, and carboplatin, for the first line treatment of adult patients 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
For the 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

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

Melanoma

Used 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

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), as determined by an FDA-approved test; or
Individuals who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The use of atezolizumab (Tecentriq) is considered experimental/investigational and, therefore, non-covered for any other indication not listed above. Scientific evidence does not support the use for any other indication.

Procedure Codes

J9022

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

Bladder (Urothelial) Carcinoma, Locally Advanced or Metastatic (FDA)

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

Kidney (Renal) Cell Carcinoma (FDA)

First-line treatment, in combination with axitinib of individuals with advanced renal cell carcinoma (RCC); or

Kidney Cancer, Clear Cell (NCCN)

First-line or subsequent therapy, in combination with axitinib of individuals with relapse or stage IV disease and clear cell histology; or

Merkel Cell Carcinoma, MCC (FDA)

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

Merkel Cell Carcinoma, MCC (NCCN)

Treatment for disseminated, clinical M1 disease with or without surgery and/or radiation therapy; or

The use of avelumab (Bavencio) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication.

Procedure Codes

J9023

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

Basal Cell Carcinoma (BCC)

for the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
for the treatment of patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate

Non-Small Cell Lung Cancer (NSCLC)

for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is:
- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
- metastatic

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) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication.

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.

Dostarlimab-gxly (Jemperli) for any other indication is considered experimental and investigational. Scientific evidence does not support the use for any other indication.

Procedure Codes

C9272

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

Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Unresectable, Stage III disease which has not progressed following concurrent platinum-based chemotherapy and radiation therapy; or

Lung Cancer, Small Cell

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

The use of durvalumab (Imfinzi) is considered experimental/investigational and, therefore, non-covered for any other indication not listed above. Scientific evidence does not support the use for any other indication.

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 Squamous Cell Carcinoma

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 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
Individual 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 2 cycles of platinum-doublet chemotherapy; or
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

Unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; or
Lymph node involvement or metastatic disease in individuals 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.

Urothelial Carcinoma, Locally Advanced or Metastatic

Individuals with disease progression during or following platinum-containing chemotherapy; or
Individuals with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The use of nivolumab (Opdivo) is considered experimental/investigational and, therefore, non-covered for any other indication not listed above. Scientific evidence does not support the use for any other indication. Scientific evidence does not support the use for any other indication.

Procedure Codes

J9299

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 cisplatin-containing chemotherapy and whose tumors express PD-L1 (combined Positive Score (CPS) greater than or equal to ten (10); or
- Are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; 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

Cervical Cancer

Treatment of individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (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

Treatment of individuals with advanced endometrial carcinoma that in not MSI-H or dMMR; and
Individual has disease progression following prior systemic therapy; and
Individual is not a candidate for curative surgery or radiation; and
Pembrolizumab (Keytruda) is given in combination with lenvatinib; 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 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

Treatment in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for first-line therapy of individuals with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma; or
As a single agent for the treatment of individuals with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1], with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; or

Head and Neck Squamous Cell Cancer, HNSCC

Combination treatment with platinum and FU for first-line treatment of individuals with metastatic or unresectable, recurrent HNSCC; or
Single agent, 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 1); or
Single agent 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

Combination therapy with axitinib, for first line treatment of individuals with advanced RCC; or

Lung Cancer, NSCLC

As first-line treatment in combination with pemetrexed and platinum chemotherapy for metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; or
As first-line treatment in combination with carboplatin and either paclitaxel or nab-paclitaxel (paclitaxel protein-bound) for metastatic squamous NSCLC; or
As first-line, single agent for 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 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 relapse 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 with melanoma with involvement of lymph node(s) 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 mismatch repair deficient:
- 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.

The use of pembrolizumab (Keytruda) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication. Scientific evidence does not support the use of any other indication.

Procedure Codes

J9271

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

Z85.118

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

Z385.118

Covered Diagnosis Codes for Procedure Code J9299

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

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

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

C7A.8

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

D09.0

Z85.3

Z85.51

Z85.59

Z85.118

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

C38.4

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

C45.0

C47.0

C47.10

C47.11

C47.12

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

C56.9

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

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

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C86.0

C91.10

C91.12

D09.0

D15.0

D37.01

D37.02

D37.05

D37.09

D37.1

D37.8

D37.9

D38.0

D38.5

D38.6

D39.2

Z85.00

Z85.01

Z85.028

Z85.038

Z85.068

Z85.118

Z85.43

Z85.47

Z85.51

Z85.59

Z85.71

Z85.820

Z85.830

Z85.831

Z85.858

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

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

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

D09.0

Z85.118

Z85.51

Z85.59

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

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

D09.0

D39.2

Z85.51

Z85.59

Covered Diagnosis Codes for Procedure Code J9272

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

C24.1

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

C56.9

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

Z85.038

Z85.068

Z85.43

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

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-120-028

Section: Injections

Effective Date: January 01, 2019

Revised Date: September 21, 2021

Revision Effective Date: October 01, 2021

Last Reviewed: September 21, 2021

Archived Date:December 31, 2021

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.

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.

J9022

J9023

J9173

J9119

J9271

J9299

C9082

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

Breast Cancer, Triple-Negative, TNBC

Used in combination with paclitaxel protein-bound for the treatment of unresectable locally advanced or metastatic TNBC with tumors which express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA approved test; or

Hepatocellular Carcinoma, HCC

Used 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

For the 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), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; or
In combination with bevacizumab, paclitaxel, and carboplatin, for the first line treatment of adult patients 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
For the 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

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

Melanoma

Used 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

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), as determined by an FDA-approved test; or
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 (FDA)

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

Kidney (Renal) Cell Carcinoma (FDA)

First-line treatment, in combination with axitinib of individuals with advanced renal cell carcinoma (RCC); or

Kidney Cancer, Clear Cell (NCCN)

First-line or subsequent therapy, in combination with axitinib of individuals with relapse or stage IV disease and clear cell histology; or

Merkel Cell Carcinoma, MCC (FDA)

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

Merkel Cell Carcinoma, MCC (NCCN)

Treatment for disseminated, clinical M1 disease with or without surgery and/or radiation therapy; or

The use of avelumab (Bavencio) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication.

Procedure Codes

J9023

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

Basal Cell Carcinoma (BCC)

for the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
for the treatment of patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate

Non-Small Cell Lung Cancer (NSCLC)

for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is:
- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
- metastatic

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) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication.

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.

Dostarlimab-gxly (Jemperli) for any other indication is considered experimental and investigational. Scientific evidence does not support the use for any other indication.

Procedure Codes

C9082

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

Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Unresectable, Stage III disease which has not progressed following concurrent platinum-based chemotherapy and radiation therapy; or

Lung Cancer, Small Cell

First line treatment in combination with etoposide and either carboplatin or cisplatin, for 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 Squamous Cell Carcinoma

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 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
Individual 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 2 cycles of platinum-doublet chemotherapy; or
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

Unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; or
Lymph node involvement or metastatic disease in individuals 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.

Urothelial Carcinoma, Locally Advanced or Metastatic

Individuals with disease progression during or following platinum-containing chemotherapy; or
Individuals with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Procedure Codes

J9299

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 cisplatin-containing chemotherapy and whose tumors express PD-L1 (combined Positive Score (CPS) greater than or equal to ten (10); or
- Are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; 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

Cervical Cancer

Treatment of individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (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

Treatment of individuals with advanced endometrial carcinoma that in not MSI-H or dMMR; and
Individual has disease progression following prior systemic therapy; and
Individual is not a candidate for curative surgery or radiation; and
Pembrolizumab (Keytruda) is given in combination with lenvatinib; 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 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

Treatment in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for first-line therapy of individuals with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma; or
As a single agent for the treatment of individuals with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1], with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; or

Head and Neck Squamous Cell Cancer, HNSCC

Combination treatment with platinum and FU for first-line treatment of individuals with metastatic or unresectable, recurrent HNSCC; or
Single agent, 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 1); or
Single agent 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

Combination therapy with axitinib, for first line treatment of individuals with advanced RCC; or

Lung Cancer, NSCLC

As first-line treatment in combination with pemetrexed and platinum chemotherapy for metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; or
As first-line treatment in combination with carboplatin and either paclitaxel or nab-paclitaxel (paclitaxel protein-bound) for metastatic squamous NSCLC; or
As first-line, single agent for 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 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 relapse 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 with melanoma with involvement of lymph node(s) 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 mismatch repair deficient:
- 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.

Procedure Codes

J9271

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

Z85.118

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

Z385.118

Covered Diagnosis Codes for Procedure Code J9299

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

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

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

C7A.8

C78.00

C78.01

C78.02

C79.31

C79.51

C79.52

D09.0

Z85.3

Z85.51

Z85.59

Z85.118

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

C38.4

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

C45.0

C47.0

C47.10

C47.11

C47.12

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

C56.9

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

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

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C86.0

C91.10

C91.12

D09.0

D15.0

D37.01

D37.02

D37.05

D37.09

D37.1

D37.8

D37.9

D38.0

D38.5

D38.6

D39.2

Z85.00

Z85.01

Z85.028

Z85.038

Z85.068

Z85.118

Z85.43

Z85.47

Z85.51

Z85.59

Z85.71

Z85.820

Z85.830

Z85.831

Z85.858

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

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

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

D09.0

Z85.118

Z85.51

Z85.59

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

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

D09.0

D39.2

Z85.51

Z85.59

Covered Diagnosis Codes for Procedure Code C9082

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

C24.1

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

C56.9

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

Z85.038

Z85.068

Z85.43

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Coding update

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References (PDF)

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