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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:140
Effective Date: 09/11/2020
Original Policy Date:06/28/2016
Last Review Date:09/08/2020
Date Published to Web: 06/28/2016
Subject:
Atezolizumab (Tecentriq)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who (1) have disease progression during or following platinum-containing chemotherapy or (2) have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Tecentriq (atezolizumab) is the first PD-L1 inhibitor approved by the FDA.

The safety and efficacy of Tecentriq (atezolizumab)were studied in a single-arm clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. This trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors. The study also looked at the difference in effect based on “positive” versus “negative” expression of the PD-L1 protein on patients’ tumor-infiltrating immune cells. In all patients, 14.8 percent of participants experienced at least a partial shrinkage of their tumors, an effect that lasted from more than 2.1 to more than 13.8 months at the time of the response analysis. In patients who were classified as “positive” for PD-L1 expression, 26 percent of participants experienced a tumor response (compared to 9.5 percent of participants who were classified as “negative” for PD-L1 expression).

While patients who received Tecentriq (atezolizumab) experienced a tumor response across the study, the greater effect in those who were classified as “positive” for PD-L1 expression suggests that the level of PD-L1 expression in tumor-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq (atezolizumab). Therefore, the FDA also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells and help physicians determine which patients may benefit most from treatment with Tecentriq (atezolizumab).

Tecentriq (atezolizumab) is also indicated for patients with metastatic non-small cell lung cancer with disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Tecentriq (atezolizumab).

The safety of Tecentriq (atezolizumab) was evaluated in a multi-center, international, randomized, open-label trial in patients with metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression. The FDA approval of Tecentriq (atezolizumab) for metastatic non-small cell lung cancer was based on results from Phase III and Phase II studies. The Phase III study enrolled 1,225 patients who were randomized 1:1 ratio to receive either docetaxel (75mg/m2) or Tecentriq (atezolizumab)1200 mg intravenous infusion) every 3 weeks. Results from the Phase III indicates that Tecentriq (atezolizumab) helped subjects in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy. The Phase II study enrolled 287 subjects and the study showed that Tecentriq (atezolizumab) doubled the likelihood of survival in subjects whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in subjects who had medium and high or any level of PD-L1 expression.

Tecentriq (atezolizumab) received FDA approval for use in locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing therapy. The FDA approval was based on a multicenter, open-label, single-arm trial that included 119 patients with locally advanced or metastic urothelial carcinoma who were ineligible for cisplatin. Patient were ineligible for cisplatin therapy for the following reasons, impaired renal function, Eastern Cooperative Oncology Group (ECOG) score of 2 or higher, hearing loss of > 25 dB at two contiguous frequencies, or greater than grade 2 peripheral neuropathy. The overall response rate was 23.5% with 6.7% of patients experiencing a complete response. The median duration of response has not been yet been reached. This additional indication was approved under an accelerated approval that was based on tumor response rate and durability of response in this population. Continued approval of this indication will be contingent upon verification and description of clinical benefit in a confirmatory trial.

In December 2018, Tecentriq also received the FDA approved indication of non-small cell lung cancer (NSCLC), 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. The safety and efficacy of Tecentriq with bevacizumab, paclitaxel and carboplatin was evaluated in IMpower150 (NCT02366143), a multicenter, international, randomized, open-label trial in 1202 patients with metastatic non-squamous NSCLC. Three hundred ninety-three chemotherapy-naïve patients with metastatic non-squamous NSCLC received TECENTRIQ 1200 mg with bevacizumab 15 mg/kg, paclitaxel 175 mg/m2 or 200 mg/m2 , and carboplatin AUC 6 mg/mL/min every 3 weeks for a maximum of 4 or 6 cycles, followed by Tecentriq 1200 mg with bevacizumab 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity. The median duration of exposure to Tecentriq was 8.3 months in patients receiving Tecentriq with bevacizumab, paclitaxel, and carboplatin.

In March 2019, Tecentriq (atezolizumab) received FDA approval for locally advanced or metastatic triple negative breast cancer (TNBC) in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1. The approval was based on a multicenter, international, double-blinded, placebo-controlled, randomized trial that included 902 unresectable locally advanced or metastatic triple-negative breast cancer patients that had not received prior chemotherapy for metastatic disease. Patients were randomized 1:1 to Tecentriq 840mg or placebo IV on days 1 and 15 of 28-day cycle, plus paclitaxel protein-bound 100mg/m2. Treatment continued till disease progression or unacceptable toxicity. The major efficacy outcomes were investigator-assessed progression free survival in the ITT and PD-L1 expression patient population and overall survival in the ITT population. Overall survival data were immature with 43% deaths in the ITT population. 74% patients treated with Tecentriq experienced an event compared to 92% in those treated with placebo (HR 0.6 95CI 0.48 – 0.77, p<0.0001). Objective response rate was 53% in Tecentriq group compared to 33% in placebo. Duration of response was 9.2 months in Tecentriq group compared to 6.2months in placebo.

In March 2019, the FDA approval of Tecentriq for the first-line treatment of adult patients with extensive-stage small cell lung cancer (SCLC), with carboplatin and etoposide. This was based on a randomized, multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC. Patients were randomized to 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 investigator in the ITT population. 52% of patients treated with Tecentriq died compared to those treated with placebo (HR 0.70 95CI 0.54 – 0.91, p =0.0069). The duration of response was 4.2 months in Tecentriq group compared to 3.9 months in placebo group.

In December 2019, the FDA approved Tecentriq for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EFGR or ALK genomic tumor aberrations, in combination with paclitaxel protein-bound and carboplatin. This was based on a multicenter, randomized (2:1), open-label trial in patients with stage IV non-squamous NSCLC. Patients were randomized to one of the following treatment regimens: Tecentriq, paclitaxel protein-bound, and carboplatin for a maximum of 4 or 6 cycles followed by Tecentriq until disease progression or unacceptable toxicity, or Paclitaxel protein-bound and carboplatin for a maximum of 4 or 6 cycles followed by best supportive care or pemetrexed. Major efficacy outcome measures were PFS by RECIST v1.1 and OS in the subpopulation of patients evaluated for and documented to have no EGFR or ALK genomic tumor aberrations (ITT-WT). A total of 724 patients were enrolled; of these, 681 (94%) were in the ITT-WT population. Baseline ECOG performance status was 0 (41%) or 1 (58%). 50% of patients treated with Tecentriq died compared to 57% treated with placebo (HR 0.80 95CI 0.64-0.99, p =0.0384). The duration of response was 10.8 months in the Tecentriq group compared to 7.8 months in the placebo group.

The most common side effects of treatment with Tecentriq (atezolizumab) were fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation. Tecentriq (atezolizumab) also has the potential to cause infection and serious immune-mediated side effects.

On May 18, 2020, the FDA approved Tecentriq for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations. Efficacy was evaluated in IMpower110 (NCT02409342), a multicenter, international, randomized, open-label trial in patients with stage IV NSCLC whose tumors express PD-L1 (TC ≥ 1% or IC ≥ 1%), who had received no prior chemotherapy for metastatic disease. Patients were randomized (1:1) to receive atezolizumab 1200 mg every 3 weeks until disease progression or unacceptable toxicity or platinum-based chemotherapy. The main efficacy outcome measure was overall survival (OS). The trial demonstrated a statistically significant improvement in OS for patients with high PD-L1 tumor expression receiving atezolizumab compared to those treated with platinum-based chemotherapy. Median OS was 20.2 months (95% CI: 16.5, NE) for patients in the atezolizumab arm compared with 13.1 months (95% CI: 7.4, 16.5) in the chemotherapy arm (HR 0.59; 95% CI: 0.40, 0.89; p=0.0106). There was no statistically significant difference in OS for the other two PD-L1 subgroups (TC ≥5% or IC ≥5%; and TC ≥1% or IC ≥1%) at the interim or final analyses. Median progression-free survival (PFS) per investigator was 8.1 months (95% CI: 6.8, 11.0) in the atezolizumab arm and 5.0 months (95% CI: 4.2, 5.7) in the platinum-based chemotherapy arm (HR 0.63; 95%CI: 0.45, 0.88). Confirmed overall response rate (ORR) per investigator was 38% (95% CI: 29, 48) and 29% (95% CI: 20, 39), respectively. The most common adverse reaction (≥ 20%) with atezolizumab as a single-agent in IMpower110 was fatigue/asthenia. The recommended atezolizumab dose for treatment of NSCLC is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks, administered intravenously over 60 minutes.

On May 29, 2020, the FDA approved Tecentriq in combination with bevacizumab (Avastin) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular carcinoma who had not received prior systemic therapy. A total of 501 patients were randomized (2:1) to receive either atezolizumab 1200 mg as an intravenous infusion (IV) 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 progression-free survival (PFS) per RECIST 1.1. Additional efficacy outcome measures were IRF-assessed overall response rate (ORR) per RECIST 1.1 and mRECIST. Median OS was not reached in the patients who received atezolizumab plus bevacizumab and was 13.2 months (95% CI: 10.4, NE) in the patients who received sorafenib (HR 0.58; 95% CI: 0.42, 0.79; p=0.0006). Estimated median PFS was 6.8 months (95% CI: 5.8, 8.3) vs. 4.3 months (95% CI: 4.0, 5.6), respectively (HR  0.59; 95% CI: 0.47, 0.76; p<0.0001). The ORR per RECIST 1.1 was 28% (95% CI: 23, 33) in the atezolizumab plus bevacizumab group compared with 12% (95% CI: 7,17) in the sorafenib group (p<0.0001). The ORR per mRECIST was 33% (95% CI: 28, 39) vs. 13% (95% CI: 8, 19), respectively (p<0.0001). The most common adverse reactions (reported in ≥20% of patients) with atezolizumab plus bevacizumab in patients with HCC were hypertension, fatigue and proteinuria. The recommended atezolizumab dose is 1,200 mg, followed by 15 mg/kg bevacizumab on the same day every 3 weeks. If bevacizumab is discontinued, atezolizumab should be given either as 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks.

On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Efficacy in combination with cobimetinib and vemurafenib was evaluated in a double-blind, randomized (1:1), placebo-controlled, multicenter trial (IMspire150, NCT02908672) in 514 patients. After a 28-day cycle of cobimetinib and vemurafenib, patients received atezolizumab 840 mg intravenous infusion every 2 weeks in combination with cobimetinib 60 mg orally once daily and vemurafenib 720 mg orally twice daily, or placebo in combination with cobimetinib 60 mg orally once daily (21 days on/7 days off) and vemurafenib 960 mg orally twice daily. The primary efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST 1.1. Median PFS was 15.1 months (95% CI: 11.4, 18.4) in the atezolizumab arm and 10.6 months (95% CI: 9.3, 12.7) in the placebo arm (HR 0.78; 95% CI: 0.63, 0.97; p=0.0249). The most common adverse reactions (≥ 20%) with atezolizumab in combination with cobimetinib and vemurafenib in patients with melanoma were rash, musculoskeletal pain, nausea, fatigue, hepatotoxicity, pyrexia, nausea pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction. The recommended atezolizumab dose, following completion of a 28-day cycle of cobimetinib and vemurafenib, is 840 mg every 2 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.

Policy:

(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

The requirements of the Horizon BCBSNJ Atezolizumab (Tecentriq) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).

1. Prior to initiating therapy with Tecentriq (atezolizumab), the following must be documented:

    • Member must be at least 18 years of age
    • Member does not have active autoimmune disease or medical condition that requires immunosuppression
    • Member does not have history of Human Immunodeficiency Virus (HIV) or active Hepatitis B (HBV) or Hepatitis (HCV) infection
    • Member has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g. nivolumab, avelumab, durvalumab, pembrolizumab, etc.)
    • The prescriber is a specialist in the area of the patient's diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient's diagnosis

2. Tecentriq (atezolizumab) is medically necessary for the treatment of the following FDA-approved indications when all of the following are met:

A. Locally advanced or metastatic urothelial carcinoma in members who meet either of the following criteria:
        • ECOG score < 2; AND
        • Member has disease progression during or following platinum-containing chemotherapy; OR
        • Member has disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; OR
        • Member's 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 and member is not eligible for cisplatin-containing chemotherapy due to one or more of the following:
          · Impaired renal function (creatinine clearance of >30 but <50 mL/min)
          · ECOG score of 2
          · Hearing loss of> 25 dB at two contiguous frequencies
          · Grade 2 or higher peripheral neuropathy
        • Member is not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
        • Used as a single agent
      B. Metastatic non-small cell lung cancer (NSCLC)
        a. First-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations when ALL of the following criteria are met:
            · Must be used in combination with bevacizumab, paclitaxel, and carboplatin; OR
            · Must be used in combination with paclitaxel protein-bound and carboplatin; AND
            · ECOG score <2
        b. Subsequent treatment of adult patients with metastatic NSCLC after platinum-based chemotherapy when ALL of the following criteria are met:
            • ECOG score < 2; AND
            • Members with disease progression during or following platinum-containing chemotherapy; AND
            • Members with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberration
        c. First-line treatment of adult patients with metastatic NSCLC when the following criteria are met:
            • Used as a single agent for tumors that have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA approved test, with no EGFR or ALK genomic tumor aberrations; AND
            • ECOG score of 0 or 1
      C. Locally advanced or metastatic Triple-negative breast cancer (TNBC) when all of the following criteria are met:
          · Member must have unresectable locally advanced or metastatic disease whose tumors 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
          · Must be used in combination with paclitaxel protein-bound
          · Member had not received prior chemotherapy for metastatic disease
      D. First line treatment of extensive-stage Small Cell Lung Cancer (SCLC) when all of the following criteria are met:
          · Must be used in combination with carboplatin and etoposide
          · ECOG score < 2
          · Used as first-line treatment in patients with extensive-stage disease
      E. First line treatment of hepatocellular carcinoma (HCC) in adult patients with unresectable or metastatic HCC when all of the following criteria are met:
          · Must be used in combination with bevacizumab; OR
          · Used as a single agent if bevacizumab is discontinued for toxicity; AND
          · Member has not received prior systemic therapy; AND
          · ECOG score of 0 or 1
      E. Unresectable or metastatic melanoma when all of the following criteria are met:
          · Must be used in combination with cobimetinib and vemurafenib; AND
          · Member must have BRAF V600 mutation-positive unresectable or metastatic melanoma; AND
          · Member has not received prior systemic anti-cancer therapy; AND
          · ECOG score of 0 or 1
3. Tecentriq (atezolizumab) is considered medically necessary for off-label indications that have in effect a rating of 'Category 1' or 'Category 2A' in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - atezolizumab. Available at: [https://www.nccn.org/professionals/drug_compendium/content/].


  • 4. When Tecentriq (atezolizumab) is medically necessary, therapy will be approved for 6 months based on FDA-approved recommendations:
      a. For the treatment of urothelial carcinoma and NSCLC (single agent), the recommended dosage is:
      · 840 mg IV every 2 weeks or
      · 1200 mg IV every 3 weeks or
      · 1680 mg IV every 4 weeks or
        · Administered as an intravenous infusion over 60 minutes until disease progression or unacceptable toxicity. If tolerated, all subsequent infusions may be delivered over 30 minutes.
      b. For the treatment of NSCLC in combination with bevacizumab, paclitaxel, and carboplatin, the recommended dosage is:
        • 1200 mg every 3 weeks intravenously, until disease progression or unacceptable toxicity. Administer Tecentriq prior to chemotherapy or other antineoplastic drugs when given on the same day.
        • Following the completion of 4-6 cycles of paclitaxel and carboplatin, and if bevacizumab is discontinued, the recommended dosage of Tecentriq is:
            • 840 mg IV every 2 weeks or
            • 1200 mg IV every 3 weeks or
            • 1680 mg every 4 weeks
            • Administered intravenously until disease progression or unacceptable toxicity.
      c. For the treatment of locally advanced or metastatic TNBC:
        · Administer 840 mg IV over 60 minutes, followed by 100mg/m2 paclitaxel protein-bound.
        · For each 28 day cycle, Tecentriq is administered on days 1 and 15, and paclitaxel protein-bound is administered on days 1, 8 and 15.
      d. For the treatment of SCLC, the recommended dosage is:
        • 1200 mg intravenously every 3 weeks, when administered in combination with carboplatin and etoposide, until disease progression or unacceptable toxicity. Administer Tecentriq prior to chemotherapy when given on the same day.
        • Following the completion of 4 cycles of carboplatin and etoposide, the recommended dosage of Tecentriq is:
            • 840 mg IV every 2 weeks or
            • 1200 mg IV every 3 weeks or
            • 1680 mg every 4 weeks
            • Administered intravenously until disease progression or unacceptable toxicity.
      e. For the treatment of HCC, in combination with bevacizumab, the recommended dosage is:
        • 1200 mg every 3 weeks intravenously, followed by 15 mg/kg of bevacizumab on the same day every 3 weeks until disease progression or unacceptable toxicity.
        • If bevacizumab is discontinued for toxicity, the recommended dosage of Tecentriq is:
            • 840 mg IV every 2 weeks or
            • 1200 mg IV every 3 weeks or
            • 1680 mg every 4 weeks
            • Administered intravenously until disease progression or unacceptable toxicity.
      f. For the treatment of melanoma, in combination with cobimetinib and vemurafenib, the recommended dosage is:
        • 840 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity, when administered with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily
          • If the first infusion of Tecentriq is tolerated, all subsequent infusions may be delivered over 30 minutes
        • Prior to initiating Tecentriq, patients should receive a 28 day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28
      [INFORMATIONAL NOTE: Permanently discontinue for any of the following: pneumonitis (grade 3 or 4), AST or ALT > 5 times ULN, diarrhea or colitis (grade 4), hypophysitis (grade 4), myasthenic syndrome, ocular inflammatory toxicity (grade 3 or 4), recurrent pancreatitis (grade 3 or 4), infusion-related reactions (grade 3 or 4), rash (grade 4)]

    5. Continued therapy with Tecentriq (atezolizumab) will be approved every 12 months based on treatment response and absence of intolerable adverse effects (i.e. immune-mediated pneumonitis, immune-mediated hepatitis, immune-mediated colitis, immune mediated endocrinopathies, serious infections, severe infusion related reactions, etc.).

    6. Tecentriq (atezolizumab) for the treatment of other conditions/diseases is considered investigational.

    Medicare Coverage

    There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.

    Medicaid Coverage

    For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

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    Horizon BCBSNJ Medical Policy Development Process:

    This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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    Index:
    Atezolizumab (Tecentriq)
    Tecentriq (Atezolizumab)

    References:
    1. Tecentriq [package insert]. Genentech, Inc. South San Francisco, CA. July 2020.

    2. FDA approves new, targeted treatment for bladder cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm501762.htm

    3. Rosenberg JE, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 Mar 4. pii: S0140-6736(16)00561-4.

    4. ClinicalTrials.gov. Accessed May 20 2016 at: https://clinicaltrials.gov/ct2/results?term= Atezolizumab=Search

    5. Fehrenbacher L, Spira A, Ballinger M, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicenter, open-label, phase 2 randomised controlled trial. Lancet 2016;387:1837−46.

    6. ClinicalTrials.gov. Accessed November 1 2016 at : https://clinicaltrials.gov/ct2/show/record/NCT02008227?term=OAK+tecentriq&rank=1

    7. National Comprehensive Cancer Network: Drugs and Biologics Compendium. 2020. Available at https://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=443428

    8. FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma. U.S. Food & Drug Administration. June 1, 2020. Available at:https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-atezolizumab-plus-bevacizumab-unresectable-hepatocellular-carcinoma

    9. FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression. U.S. Food & Drug Administration. May 18, 2020. Available at:
    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-first-line-treatment-metastatic-nsclc-high-pd-l1-expression

    10. FDA approved atezolizumab for BRAF V600 unresectable or metastatic melanoma. U.S. Food & Drug Administration. July 31, 2020. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-braf-v600-unresectable-or-metastatic-melanoma

    Codes:
    (The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

    CPT*
      HCPCS
        J9022

      * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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      Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

      The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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