Medicare Advantage

Medical Policy

Title:

Atezolizumab (Tecentriq®)

Policy #:

MA08.127c

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

INDEX OF MEDICALLY NECESSARY INDICATIONS

This policy addresses numerous medically necessary indications for the use of atezolizumab (Tecentriq) listed in order of appearance within the Policy section. Please see below for the specific medical necessity criteria. (NOTE: Experimental/Investigational section below must also be reviewed).

CANCER TYPE

Alveolar Soft Part Sarcoma

Cervical Cancer

Hepatocellular Carcinoma

Melanoma: Cutaneous

Mesothelioma: Peritoneal

Non-Small Cell Lung Cancer

Small Cell Lung Cancer

Urothelial Cancer

MEDICALLY NECESSARY

ALVEOLAR SOFT PART SARCOMA

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered for the treatment of adult individuals and pediatric individuals 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) and all of the following:

ASPS has been histologically or cytologically confirmed
The individual has not received prior treatment with an anti-programmed death (PD)-1 or anti-PD-ligand (L)-1 therapeutic antibody, or pathway-targeting agents

CERVICAL CANCER

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered for adult individuals with persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) as first-line, second-line, or subsequent therapy as clinically appropriate (if not used previously as first-line) in either of the following regimens:

In combination with cisplatin and etoposide
In combination with carboplatin and etoposide

HEPATOCELLULAR CARCINOMA (HCC)

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered as a first-line systemic therapy in combination with bevacizumab (National Comprehensive Cancer Network [NCCN]-preferred regimen) for the treatment of adult individuals with HCC (Child-Pugh Class A only) with any of the following:

Unresectable disease and not a transplant candidate
Liver-confined disease, inoperable by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), or comorbidity, or with minimal or uncertain extrahepatic disease
Metastatic disease or extensive liver tumor burden

MELANOMA: CUTANEOUS
Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered in combination with cobimetinib and vemurafenib for adult individuals with cutaneous melanoma in either of the following:

Second-line or subsequent treatment of individuals with proto-oncogene B-Raf (BRAF) V600 mutation-positive unresectable or metastatic melanoma following progression or intolerance if BRAF/mitogen-activated protein kinase (MEK) and/or PD-L1 checkpoint inhibition was not previously used
As re-induction therapy if prior combination BRAF/MEK with PD-L1 checkpoint inhibition resulted in disease control (complete response, partial response, or stable disease), no residual toxicity, and disease progression/relapse greater than 3 months after treatment discontinuation

MESOTHELIOMA: PERITONEAL
Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered for adult individuals with benign multicystic, biphasic, epithelioid, sarcomatoid, or well-differentiated papillary peritoneal mesothelioma (may also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma) and all of the following:

As subsequent systemic therapy
ECOG PS 0 to 2
In combination with bevacizumab if not previously treated with immune checkpoint inhibitors

NON-SMALL CELL LUNG CANCER (NSCLC)

Initial Therapy for NSCLC

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered for the treatment of adult individuals with recurrent (excluding locoregional recurrence or symptomatic local disease with no evidence of disseminated disease; however, including mediastinal lymph node recurrence with prior radiation therapy [RT]), advanced or metastatic NSCLC in any of the following regimens:

First-line systemic therapy (NCCN preferred) when all of the following criteria are met:

PD-L1 expression positive (50 percent or greater or PD-L1 stained tumor-infiltrating immune cells [IC] covering 10 percent or greater of the tumor area [IC 10 percent or greater]) tumors (as determined by a US Food and Drug Administration [FDA]-approved test) that are epidermal growth factor receptor (EGFR), Kirsten rat sarcoma viral oncogene homolog (KRAS), erythroblastic oncogene B2 (ERBB2 [human epidermal growth factor receptor 2 (HER2)]), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), BRAF, neurotrophic tyrosine kinase receptor (NTRK) 1/2/3, mesenchymal-epithelial transition (MET) exon 14 skipping mutation, and rearranged during transfection (RET) negative*
No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Adenocarcinoma (with mixed subtypes), large cell carcinoma, or squamous cell carcinoma histology

First-line systemic therapy when all of the following criteria are met:

In combination with either of the following regimens:

Bevacizumab, carboplatin, and paclitaxel (if no history of recent hemoptysis)
Carboplatin and albumin-bound paclitaxel

PD-L1 expression positive (1 percent or greater) tumors that are EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET, and RET negative*
No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Non-squamous cell history (i.e., adenocarcinoma [with mixed subtypes], large cell carcinoma)

Single-agent as subsequent therapy (NCCN preferred) when all of the following criteria are met:

PS 0-2
No prior progression on a PD-1 or PD-L1 inhibitor
Adenocarcinoma (with mixed subtypes), large cell carcinoma, or squamous cell carcinoma histology

Combination systemic therapy with carboplatin, paclitaxel, and bevacizumab (if no history of recent hemoptysis), or in combination with carboplatin and albumin-bound paclitaxel, for the treatment of individuals with PS 0-1, no contraindications** to PD-1 or PD-L1 inhibitors, and tumors of non-squamous cell histology (i.e., adenocarcinoma [with mixed subtypes], large cell carcinoma histology) in any of the following regimens:

Initial systemic therapy for EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET, and RET negative* and PD-L1 expression positive (<1 percent) tumors
First-line therapy for EGFR exon 20 mutation positive* tumors
First-line therapy for KRAS G12C mutation positive* tumors
First-line or subsequent therapy for BRAF V600E-mutation positive* tumors
First-line or subsequent therapy for NTRK 1/2/3 gene fusion positive* tumors
First-line or subsequent therapy for MET exon 14 skipping mutation positive* tumors
First-line or subsequent therapy for RET rearrangement positive* tumors
First-line therapy for ERBB2 (HER2) mutation positive* tumors
Subsequent therapy for EGFR exon 19 deletion or exon 21 L858R tumors* and prior erlotinib with or without (ramucirumab or bevacizumab), afatinib, gefitinib, osimertinib, or dacomitinib therapy
Subsequent therapy for EGFR S768I, L861Q, and/or G719X mutation positive tumors* and prior afatinib, osimertinib, erlotinib, gefitinib, or dacomitinib therapy
Subsequent therapy for ALK rearrangement positive tumors* and prior crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib therapy
Subsequent systemic therapy for ROS1 rearrangement-positive* tumors and prior crizotinib, entrectinib, or ceritinib therapy

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 an FDA-approved therapy for NSCLC harboring these aberrations prior to receiving atezolizumab (Tecentriq)
As single-agent treatment for individuals with completely resected stage IIB to IIIA, high-risk stage IIA, or stage IIIB (T3, N2) whose tumors have PD-L1 expression on 1 percent or greater of tumor cells, as determined by an FDA-approved test and negative for EGFR exon 19 deletion or exon 21 L858R mutations, or ALK rearrangements who received previous adjuvant chemotherapy and have adenocarcinoma (with mixed subtypes), large cell carcinoma, or squamous cell carcinoma histology

**Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, or presence of some oncogenic drivers (i.e., EGFR exon 19 deletions or exon 21 L858R, ALK rearrangements), which have been shown to be associated with less benefit from PD-1/PD-L1 inhibitors.

Continuation Maintenance Therapy for NSCLC

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered for continuation maintenance therapy for the treatment of individuals with NSCLC, recurrent (excluding locoregional recurrence or symptomatic local disease with no evidence of disseminated disease; however, including mediastinal lymph node recurrence with prior RT), advanced, or metastatic disease in any of the following:

For PD-L1 expression positive (<1 percent) tumors that are EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET exon 14 skipping mutation, and RET* negative for tumor response or stable disease following first-line systemic combination therapy with atezolizumab (Tecentriq), carboplatin, and albumin-bound paclitaxel with all of the following:

No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Non-squamous cell histology (i.e., adenocarcinoma [with mixed subtypes], large cell carcinoma histology)

In combination with bevacizumab for PD-L1 expression positive (<1 percent) tumors that are EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET exon 14 skipping mutation, and RET* negative for tumor response or stable disease following first-line systemic combination therapy with atezolizumab (Tecentriq), carboplatin, paclitaxel, and bevacizumab with all of the following:

No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Non-squamous cell histology (i.e., adenocarcinoma [with mixed subtypes], large cell carcinoma histology)
No history of recent hemoptysis

In combination with bevacizumab for PD-L1 expression positive (1 percent or greater) tumors that are EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET exon 14 skipping mutation, and RET* negative with all of the following:

Tumor response or stable disease following first-line systemic combination therapy with atezolizumab (Tecentriq), carboplatin, paclitaxel, and bevacizumab
No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Non-squamous cell histology (i.e., adenocarcinoma [with mixed subtypes], large cell carcinoma histology)
No history of recent hemoptysis

For PD-L1 expression positive (1 percent or greater) tumors that are EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET exon 14 skipping mutation, and RET* negative with all of the following:

Tumor response or stable disease following first-line systemic combination therapy with atezolizumab (Tecentriq), carboplatin, and albumin-bound paclitaxel
No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Non-squamous cell history (i.e., adenocarcinoma [with mixed subtypes], large cell carcinoma histology)

For PD-L1 expression positive (50 percent or greater) tumors that are EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET exon 14 skipping mutation, and RET* negative with all of the following:

Tumor response or stable disease following first-line therapy with single-agent atezolizumab (Tecentriq)
No contraindications** to PD-1 or PD-L1 inhibitors
PS 0-2
Adenocarcinoma (with mixed subtypes), large cell carcinoma, or squamous cell carcinoma histology

*If there is insufficient tissue to allow testing for all of EGFR, KRAS, ERBB2 (HER2), ALK, ROS1, BRAF, NTRK 1/2/3, MET, and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these individuals are treated as though they do not have driver oncogenes.

**Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, or presence of some oncogenic drivers (i.e., EGFR exon 19 deletions or exon 21 L858R, ALK rearrangements), which have been shown to be associated with less benefit from PD-1/PD-L1 inhibitors.

SMALL CELL LUNG CANCER (SCLC)

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered for first-line systemic combination therapy with etoposide and carboplatin (followed by single-agent maintenance) for the treatment of adult individuals with extensive-stage* small cell lung cancer (NCCN-preferred regimen) and any of the following criteria:

Without localized symptomatic sites or brain metastases and good PS (0-2)
Without localized symptomatic sites or brain metastases and poor PS (3-4) due to SCLC
Localized symptomatic sites
Brain metastases

*Extensive stage: Stage IV (T any, N any, M 1a/b/c), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan (American Joint Committee on Cancer, 8th edition).

UROTHELIAL CARCINOMA

Atezolizumab (Tecentriq) is considered medically necessary and, therefore, covered as single-agent therapy for the treatment of adult individuals with primary carcinoma of the urethra, as first-line systemic therapy (NCCN-preferred regimen) for recurrent or metastatic disease (except recurrent T3-4 disease or palpable inguinal lymph nodes) and either of the following:

Cisplatin-ineligible individuals whose tumors express PD-L1
Individuals who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 expression*

*Chemotherapy regimen based on histology.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for atezolizumab (Tecentriq) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

There is no Medicare coverage determination addressing atezolizumab (Tecentriq); therefore, the Company policy is applicable.

Certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when atezolizumab (Tecentriq) is covered under a member's medical benefit (Part B benefit). It does not address instances when atezolizumab (Tecentriq) is covered under a member's pharmacy benefit (Part D benefit).

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, atezolizumab (Tecentriq) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
Grade	ECOG
0	Fully active, able to carry on all pre-disease performance without restriction
1	Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work)
2	Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3	Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4	Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5	Dead

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

THE CHILD-PUGH SCORE

Note: The Child-Pugh score is calculated by adding the scores of the five factors and can range from 5 to 15. Child-Pugh class is A (a score of 5-6), B (7-9), or C (10 or above). Decompensation indicates cirrhosis with a Child-Pugh score of 7 or more (class B). This level has been the accepted criterion for listing for liver transplantation.

Factor	Units	1	2	3
Serum bilirubin	mmol/L mg/dL	< 34 < 2.0	34-51 2.0-3.0	>51 >3.0
Serum albumin	g/L g/dL	>35 >3.5	30-35 3.0-3.5	< 30 < 3.0
Prothrombin time	Seconds prolonged INR	0-4 < 1.7	4-6 1.7-2.3	>6 >2.3
Ascites		None	Easily controlled	Poorly controlled
Hepatic encephalopathy		None	Minimal	Advanced

Note: Table 154-1: Child-Pugh Classification of Cirrhosis: In Harrison's Manual of Medicine 19th ed.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Atezolizumab (Tecentriq) was approved by the FDA on May 18, 2016 for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who either 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. The manufacturer has subsequently voluntarily removed this indication from the FDA labeling. Supplemental approvals for atezolizumab (Tecentriq) have since been issued by the FDA.

Refer to the atezolizumab (Tecentriq) prescribing information for further information on FDA-approved tests for determining Programmed Death-1 (PD-1), Programmed Death-Ligand 1 (PD-L1), epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), proto-oncogene B-Raf (BRAF), neurotrophic tyrosine kinase receptor (NTRK) 1/2/3, mesenchymal-epithelial transition (MET) exon 14 skipping mutation, and rearranged during transfection (RET) expression.

PEDIATRIC USE
The safety and effectiveness of atezolizumab (Tecentriq) for unresectable or metastatic alveolar soft part sarcoma have been established for pediatric individuals age 2 years and older. The safety and effectiveness of atezolizumab (Tecentriq) have not been established in pediatric individuals for any other indication.

Description

In a normal immune response, the body can recognize the presence of tumors and mount a response to eradicate them. The process of eradicating a tumor begins with antigen-presenting cells that gather and process the antigens released by tumors. This activates the T cells, which proliferate and attack the tumor.

Tumors have learned to evade the normal immune response by exploiting the immune checkpoint pathway. The Programmed Death Receptor-1 (PD-1) is a checkpoint protein expressed on the membrane of activated T cells. The Programmed Death-Ligand 1 (PD-L1) and the Programmed Death-Ligand 2 (PD-L2) are checkpoint proteins expressed on tumor cells and tumor-infiltrating immune cells. When PD-L1 and PD-L2 attach to PD-1 receptors on the T cells, the T cells become inhibited and will not attack the tumor; thus, the tumor can continue to proliferate.

Atezolizumab (Tecentriq) is a human monoclonal antibody and immune checkpoint inhibitor that binds to PD-L1 on tumor cells and tumor-infiltrating immune cells and blocks the interaction with PD-1 and B7.1 receptors on T cells and antigen-presenting cells. Consequently, the tumor is no longer able to inactivate the T cells, and the antitumor response continues.

ATEZOLIZUMAB (TECENTRIQ) INDICATIONS

ALVEOLAR SOFT PART SARCOMA
A soft tissue sarcoma is a type of cancer that starts in tissues like fat, muscle, nerves, or blood vessels. They are rare and slow growing, and often start in the arms or legs, but can spread to other parts of the body such as, frequently, the lungs. Alveolar soft part sarcomas (ASPS) are caused by a translocation of two chromosomes within the tumor cells themselves, so cannot be passed on through the genes. These sarcomas tend to occur more frequently in adolescents and young adults. Treatment may involve surgical resection of the primary site either with or without adjunctive radiation therapy. If the tumor has spread, local treatment may not be adequate, and systemic therapy may be needed. Traditional chemotherapies are generally ineffective, however.

The efficacy of atezolizumab (Tecentriq) to treat untreated, advanced, or metastatic ASPS that is unresectable is being evaluated in an ongoing phase II, nonrandomized, parallel assignment clinical trial where one cohort receives only atezolizumab (Tecentriq) and a second cohort receives atezolizumab (Tecentriq) along with bevacizumab (Avastin®; NCT03141684). The primary endpoint is objective response rate (ORR). The secondary endpoints are duration of response (DOR), progression-free survival (PFS), Response Evaluation Criteria in Solid Tumors (RECIST) response, immune biomarkers found in paired biopsies, and pediatric pharmacokinetics and anti-drug antibodies. At the time of the US Food and Drug Administration (FDA) approval, 49 adults and pediatric individuals aged 2 years and older were enrolled in the study. The ORR was 24 percent with no complete responses and 12 partial responses. The median DOR has not been reached, but at that time, ranged from 1 to 41 months. The clinical trial is continuing to recruit additional individuals and is expected to be complete late in 2023.

HEPATOCELLULAR CARCINOMA (HCC)

Hepatocellular carcinoma (HCC), the most common type of cancer in the liver, gallbladder, and bile ducts, is usually diagnosed at an advanced stage and is the third leading cause of cancer-related deaths worldwide.

In May 2020, the FDA approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin®) for individuals with unresectable or metastatic HCC who had not received prior systemic therapy. Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in individuals with locally advanced unresectable or metastatic HCC who had not received prior systemic therapy. A total of 501 individuals were randomly assigned (2:1) to receive either atezolizumab (Tecentriq) 1200 mg as an intravenous intravenous (IV) infusion followed by bevacizumab 15 mg/kg IV on the same day, every 3 weeks, or sorafenib orally twice daily. The main efficacy outcome measures were overall survival (OS) and independent review facility (IRF)-assessed PFS per RECIST volume (v)1.1. Additional efficacy outcome measures were IRF-assessed ORR per RECIST v1.1 and modified RECIST (mRECIST). Median OS was not reached in the individuals who received atezolizumab (Tecentriq) plus bevacizumab and was 13.2 months (95 percent confidence interval [CI], 10.4 to not estimable [NE]) in the individuals who received sorafenib (hazard ratio [HR] 0.58; 95 percent CI, 0.42 to 0.79; P=0.0006). Median PFS was 6.8 months (95 percent CI, 5.7 to 8.3) versus 4.3 months (95 percent CI, 4.0 to 5.6), respectively (HR 0.59; 95 percent CI, 0.47 to 0.76; P<0.0001). The ORR per RECIST v1.1 was 27.3 percent (95 percent CI, 22.5 to 32.5) in the atezolizumab (Tecentriq) plus bevacizumab group compared with 11.9 percent (95 percent CI, 7.4 to 18.0) in the sorafenib group (P<0.0001). The ORR per mRECIST was 33.2 percent (95 percent CI, 28.1 to 38.6) versus 13.3 percent (95 percent CI, 8.4 to 19.6), respectively (P<0.0001). The most common adverse reactions (reported in 20 percent or greater of individuals) with atezolizumab (Tecentriq) plus bevacizumab in individuals with HCC were hypertension, fatigue, and proteinuria.

MELANOMA
Melanoma tumors are composed of abnormal melanocytes that have become cancer cells. Melanoma is much less common than some other types of skin cancers. But melanoma is more dangerous because it is much more likely to spread to other parts of the body if not caught and treated early.

In July 2020, the FDA approved atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib for individuals with proto-oncogene B-Raf (BRAF) V600 mutation-positive unresectable or metastatic melanoma. The efficacy of atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib was evaluated in a phase III, double-blind, randomized (1:1), placebo-controlled, multicenter trial (IMspire150; NCT02908672) conducted in 514 individuals. Eligible individuals were required to have previously untreated unresectable or metastatic BRAF V600 mutation-positive melanoma. Individuals were enrolled and randomly assigned to the atezolizumab (Tecentriq) group (n=256) or control group (n=258). At a median follow-up of 18.9 months (interquartile range [IQR] 10.4 to 23.8), PFS as assessed by the study investigator was significantly prolonged with atezolizumab (Tecentriq) versus control (15.1 versus 10.6 months; [HR] 0.78; 95 percent CI 0.63 to 0.97; P=0.025). The addition of atezolizumab (Tecentriq) to targeted therapy with vemurafenib and cobimetinib was safe and tolerable and significantly increased PFS in individuals with BRAF V600 mutation-positive advanced melanoma.

NON-SMALL CELL LUNG CANCER (NSCLC)
Lung cancer is the leading cause of cancer-related mortality in both men and women, not only in the United States but also throughout the world. In the United States, lung cancer is the second most common cancer. NSCLC accounts for approximately 85 percent of all lung cancers, and its subtype, squamous cell lung cancer, accounts for 25 to 30 percent of all lung cancers.

In October 2016, the FDA granted supplemental approval of atezolizumab (Tecentriq) for the treatment of individuals with metastatic NSCLC whose disease progressed during or following platinum-containing chemotherapy. Individuals with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on an FDA-approved therapy for these aberrations prior to receiving atezolizumab (Tecentriq).

The safety and efficacy of atezolizumab (Tecentriq) for this indication was evaluated in two clinical trials. The first (NCT01903993; POPLAR) was a phase II, multicenter, international, randomized, open-label trial in individuals with advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression. The study enrolled 287 individuals who were randomly assigned to receive either atezolizumab (Tecentriq) or docetaxel. The study showed that atezolizumab (Tecentriq) doubled the likelihood of survival in individuals whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in individuals who had medium and high or any level of PD-L1 expression.

The second study (NCT02008227; OAK) was a phase III multicenter, international, randomized, open-label trial that enrolled 1225 individuals in the same population comparing the same treatments as the phase II trial. The median OS was 13.8 months in the atezolizumab (Tecentriq) cohort versus 9.6 months in the docetaxel cohort (HR 0.74 [0.63 to 0.87]; P=0.0004).

In December 2018, atezolizumab (Tecentriq) also received the FDA-approved indication of NSCLC, in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult individuals with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. The safety and efficacy of atezolizumab (Tecentriq) with bevacizumab, paclitaxel, and carboplatin was evaluated in IMpower150 (NCT02366143), a multicenter, international, randomized, open-label trial in 1202 individuals with metastatic nonsquamous NSCLC. Three hundred ninety-three chemotherapy-naïve individuals with metastatic nonsquamous NSCLC received atezolizumab (Tecentriq) 1200 mg with bevacizumab 15 mg/kg, paclitaxel 175 mg/m² or 200 mg/m², and carboplatin area under the curve (AUC) 6 mg/mL/min every 3 weeks for a maximum of four or six cycles, followed by atezolizumab (Tecentriq) 1200 mg with bevacizumab 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity. The median OS for individuals receiving atezolizumab (Tecentriq) with bevacizumab, paclitaxel, and carboplatin was 19.2 months versus 14.7 months in individuals not receiving atezolizumab (Tecentriq) along with the other infusions (HR 0.78; 95 percent CI, 0.64 to 0.96; P=0.016). The median PFS for individuals receiving atezolizumab (Tecentriq) with bevacizumab, paclitaxel, and carboplatin was 80.5 months versus 7.0 months in individuals not receiving atezolizumab (Tecentriq) along with other infusions (HR 0.71; 95 percent CI, 0.59 to 0.85; P=0.002). The ORR for individuals receiving atezolizumab (Tecentriq) with bevacizumab, paclitaxel, and carboplatin was 55 percent (4 percent complete responses, 51 percent partial responses) versus 42 percent (1 percent complete responses, 41 percent partial responses) in individuals not receiving atezolizumab (Tecentriq) along with the other infusions. The median DOR for individuals receiving atezolizumab (Tecentriq) with bevacizumab, paclitaxel, and carboplatin was 10.8 months versus 6.5 months in individuals not receiving atezolizumab (Tecentriq) along with the other infusions.

In December 2019, the FDA approved atezolizumab (Tecentriq) for the first-line treatment of adult individuals with metastatic nonsquamous NSCLC with no EFGR or ALK genomic tumor aberrations, in combination with albumin-bound paclitaxel and carboplatin. This was based on a multicenter, randomized, open-label trial (NCT02367781; IMpower130) in individuals with stage IV nonsquamous NSCLC. Individuals were randomly assigned to one of the following treatment regimens: atezolizumab (Tecentriq), albumin-bound paclitaxel, and carboplatin for a maximum of four or six cycles followed by atezolizumab (Tecentriq) until disease progression or unacceptable toxicity, or albumin-bound paclitaxel and carboplatin for a maximum of four or six cycles followed by best supportive care or pemetrexed. Major efficacy outcome measures were PFS by RECIST v1.1 and OS in the subpopulation of individuals evaluated for and documented to have no EGFR or ALK genomic tumor aberrations intention to treat–wild type (ITT-WT). A total of 724 individuals were enrolled; of these, 681 (94 percent) were in the ITT-WT population. Fifty percent of individuals treated with atezolizumab (Tecentriq) died compared to 57 percent treated with placebo (HR, 0.80; 95 percent CI 0.64 to 0.99; P=0.0384). The duration of response was 10.8 months in the atezolizumab (Tecentriq) group compared to 7.8 months in the placebo group.

In May 2020, the FDA approved atezolizumab (Tecentriq) for the first-line treatment of adult individuals with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained 50 percent or greater of tumor cells [TC] [TC 50 percent or greater] or PD-L1 stained tumor-infiltrating immune cells [IC] covering 10 percent or greater of the tumor area [IC 10 percent or greater), with no EGFR or ALK genomic tumor aberrations. Efficacy was evaluated in IMpower110 (NCT02409342), a multicenter, international, randomized, open-label trial in individuals with stage IV NSCLC whose tumors express PD-L1 (TC 1 percent or greater or IC 1 percent or greater), who had received no prior chemotherapy for metastatic disease. Individuals were randomly assigned (1:1) to receive atezolizumab (Tecentriq) 1200 mg every 3 weeks until disease progression or unacceptable toxicity or platinum-based chemotherapy. The main efficacy outcome measure was OS. The trial demonstrated a statistically significant improvement in OS for individuals with high PD-L1 tumor expression receiving atezolizumab (Tecentriq) compared to those treated with platinum-based chemotherapy. Median OS was 20.2 months (95 percent CI, 16.5 to NE) for individuals in the atezolizumab (Tecentriq) arm compared with 13.1 months (95 percent CI, 7.4 to 16.5) in the chemotherapy arm (HR, 0.59; 95 percent CI, 0.40 to 0.89; P=0.0106). There was no statistically significant difference in OS for the other two PD-L1 subgroups (TC 5 percent or greater or IC 5 percent or greater; and TC 1 percent or greater or IC 1 percent or greater) at the interim or final analyses. Median PFS per investigator was 8.1 months (95 percent CI, 6.8 to 11.0) in the atezolizumab (Tecentriq) arm and 5.0 months (95 percent CI, 4.2 to 5.7) in the platinum-based chemotherapy arm (HR, 0.63; 95 percent CI, 0.45 to 0.88). Confirmed ORR per investigator was 38 percent (95 percent CI, 29 to 48) and 29 percent (95 percent CI, 20 to 39), respectively.

In October 2021, the FDA approved atezolizumab (Tecentriq) as adjuvant treatment following resection and platinum-based chemotherapy for adult individuals with Stage II to IIIA NSCLC whose tumors have PD-L1 expressions on 1 percent or greater of tumor cells. This was based on interim data from an ongoing Phase III, multicenter, international, randomized, open-label trial (NCT02486718; Impower010) that is evaluating the efficacy and safety of atezolizumab (Tecentriq) versus best supportive care (BSC) in individuals with Stage IB to Stage IIIA NSCLC following resection and adjuvant chemotherapy. The primary endpoint is disease-free survival (DFS). Some secondary endpoints include OS, percentage of individuals who are disease free at year 3, percentage of individuals who are disease free at year 5, percentage of individuals with adverse events, and percentage of individuals who develop anti-therapeutic antibodies to atezolizumab (Tecentriq). At the time of the interim analysis, the study demonstrated a statistically significant improvement in median DFS in the atezolizumab (Tecentriq) cohort versus the BSC cohort: not reached (NR) versus 35.3 months, respectively (HR, 0.66 [0.50 to 0.88]; P=0.004).

SMALL CELL LUNG CANCER (SCLC)
Small cell lung cancer (SCLC), previously known as oat cell carcinoma, is considered distinct from other lung cancers, which are called NSCLCs because of their clinical and biologic characteristics. SCLC is a neuroendocrine carcinoma that exhibits aggressive behavior, rapid growth, early spread to distant sites, sensitivity to chemotherapy and radiation, and frequent association with distinct paraneoplastic syndromes.

In March 2019, the FDA approved atezolizumab (Tecentriq) for the first-line treatment of adult individuals with extensive-stage SCLC, with carboplatin and etoposide. This was based on a randomized, multicenter, double-blind, placebo-controlled trial (NCT02763579) in 403 individuals with extensive-stage SCLC. Individuals were randomly assigned to atezolizumab (Tecentriq) in combination with carboplatin and etoposide or placebo in combination with carboplatin and etoposide. The major efficacy outcome measures were OS and PFS as assessed by investigators in the ITT population. Fifty-two percent of individuals treated with atezolizumab (Tecentriq) died compared to 66 percent of those treated with placebo (HR, 0.70; 95 percent CI, 0.54 to 0.91; P=0.0069). The duration of response was 4.2 months in the atezolizumab (Tecentriq) group compared to 3.9 months in placebo group.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

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Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

See Attachment A.

HCPCS Level II Code Number(s)

J9022

Injection, atezolizumab, 10 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA08.127c:

04/03/2023

This version of the policy will become effective 04/03/2023.

The following policy criteria have been added to this policy in accordance with the US Food and Drug Administration (FDA) label (12/09/2022) and the National Comprehensive Cancer Network (NCCN) compendium (accessed 01/30/2023) and guidelines:

Cervical cancer (V1.2023; 12/23/2022)
Mesothelioma: Peritoneal (V1.2023; 12/15/2022)
Soft tissue sarcoma

The following policy criteria have been revised in accordance with the NCCN compendium and guidelines:

Melanoma: Cutaneous
Non-small cell lung cancer
Urothelial carcinoma

The following ICD-10 codes have been added to this policy:

C45.1, C45.2, C45.7, C45.9, C49.0, C49.11, C49.12, C49.21, C49.22, C49.3, C49.4, C49.5, C49.6, C49.8, C49.9, C53.0, C53.1, C53.8, C53.9, C78.01, C78.02, C79.31, C79.51, C79.52, D19.1

The following ICD-10 codes have been removed from this policy:

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, C68.1

Revisions From MA08.127b:

03/14/2022

This version of the policy will become effective 03/14/2022.

The following policy criteria have been deleted from this policy:

Medically necessary criteria for Breast Cancer in accordance with the US Food and Drug Administration (FDA) label (10/15/2021) and the National Comprehensive Cancer Network (NCCN) compendium (accessed 12/27/2021)

The following ICD-10 codes have been removed from this policy:

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, C50.019, C50.921, C50.922, C50.929

The following policy criteria have been revised in accordance with the NCCN compendium and guidelines:

Hepatocellular Carcinoma (V05.2021; 09/21/2021)

Melanoma (V01.2022; 12/03/2021)

Non-Small Cell Lung Cancer (V01.2022; 12/07/2021)
Urothelial Cancer (V06.2021; 12/06/2021)

Revisions From MA08.127a:

08/30/2021

This version of the policy will become effective 08/30/2021.

The criteria section has been updated to address recommendations from the National Comprehensive Cancer Network (NCCN) Compendium accessed 06/17/2021:

Breast cancer
Urothelial cancer

The following policy criteria have been revised to address recommendations from the NCCN Compendium accessed 06/17/2021:

Breast cancer
Hepatocellular cancer
Melanoma
Non-small cell lung cancer
Urothelial cancer

The following criteria has been deleted from this policy in accordance with US Food and Drug Administration labeling (04/13/2021):

The use of atezolizumab (Tecentriq) for subsequent-line systemic therapy for disease progression following platinum-containing chemotherapy

The following ICD-10 code has been added to this policy:
C7A.1 Malignant poorly differentiated neuroendocrine tumors

The explanation of the TNM Staging System was deleted from the policy

Revisions From MA08.127:

09/28/2020

This version of the policy will become effective 09/28/2020.

New policy number MA08.127 supersedes MA08.010j for atezolizumab (Tecentriq®).

The following criteria have been revised in this policy for non-small cell lung cancer, and urotherlial cancer

In accordance with National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium® 2020 and/or FDA labeling through 07/30/2020

The following criteria have been added to this policy for triple negative breast cancer, hepatocellular cancer, small cell lung cancer and melanoma

In accordance with FDA labeling through 07/30/2020 and/or NCCN Drugs and Biologics Compendium® 2020.

The following ICD-10 CM codes have been added to this policy:

C22.0, C22.8, C22.9, 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, 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

Version Effective Date:

4/3/2023

Version Issued Date: