Policy
Tecentriq™ (atezolizumab) and Tecentriq Hybreza™ are considered MEDICALLY NECESSARY for members with metastatic non-small cell lung cancer who meet at least one of the following criteria: 

Non-Small Cell Lung Cancer (NSCLC)

• Adjuvant treatment (as a single agent) following resection and platinum-based chemotherapy (4 cycles) in adults with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an approved test (atezolizumab duration up to 1 year)
• First-line treatment (single agent) of metastatic NSCLC in adults whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating IC covering ≥ 10%), as determined by an approved test, with no epidermal growth factor receptor (EGFR) or ALK genomic tumor aberrations
• First-line treatment (in combination with bevacizumab, paclitaxel, and carboplatin) of metastatic nonsquamous NSCLC in adults with no EGFR or ALK genomic tumor aberrations
• First-line treatment (in combination with paclitaxel [protein bound] and carboplatin) of metastatic nonsquamous NSCLC in adults with no EGFR or ALK genomic tumor aberrations
• Treatment (single agent) of metastatic NSCLC in adults with disease progression during or following platinum-containing chemotherapy (patients with EGFR or ALK genomic aberrations should have disease progression on approved therapy for EGFR or ALK genomic tumor mutations prior to receiving atezolizumab)

Alveolar Soft Part Sarcoma (ASPS)       

Tecentriq™ is considered MEDICALLY NECESSARY for treatment of Alveolar soft part sarcoma, unresectable or metastatic: Treatment of unresectable or metastatic alveolar soft part sarcoma in adult and pediatric patients ≥ 2 years of age.

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Tecentriq™ is considered MEDICALLY NECESSARY (in combination with carboplatin and etoposide for 4 cycles), for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

• Atezolizumab continues after combination treatment as single agent therapy until disease progression or unacceptable toxicity.

Hepatocellular Carcinoma (HCC)

Tecentriq™ is considered MEDICALLY NECESSARY in treatment of unresectable or metastatic hepatocellular carcinoma (in combination with bevacizumab) in patients who have not received prior systemic therapy.

• If bevacizumab is discontinued due to unacceptable toxicity, atezolizumab may be continued as a single agent until disease progression or unacceptable toxicity

Unresctable Metastatic Melanoma (MM)

Tecentriq™ is considered MEDICALLY NECESSARY in treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma (in combination with cobimetinib and vemurafenib). 

• Prior to initiating atezolizumab, administer a 28-day cycle of cobimetinib and vemurafenib

Muscle Invasive Bladder Cancer (MIBC)

As adjuvant treatment of adult patients with MIBC after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test. (Currently ONLY TECENTRIQ is approved for this indication).

Dosage for Tecentriq ^TM

• 3 clinically approved dosing schedules (all indications)
  • 840 mg once every 2 weeks
  • 1200 mg once every 3 weeks
  • 1680 mg once every 4 weeks
• Dilute prior to intravenous infusion. (2.3) 

Dosage for Tecentriq Hybreza^TM

NSCLC Dosage

• In the adjuvant setting, administer TECENTRIQ HYBREZA following resection and up to 4 cycles of platinum-based chemotherapy every 3 weeks for up to 1 year.

• In the metastatic setting, administer TECENTRIQ HYBREZA every 3 weeks.

• When administering with chemotherapy with or without bevacizumab, administer TECENTRIQ HYBREZA prior to chemotherapy and  bevacizumab when given on the same day.

SCLC Dosage

Administer TECENTRIQ HYBREZA every 3 weeks. When administering  with carboplatin and etoposide, administer TECENTRIQ HYBREZA prior to chemotherapy when given on the same day. (2.2)

HCC Dosage

• Administer TECENTRIQ HYBREZA every 3 weeks.

• Administer TECENTRIQ HYBREZA prior to bevacizumab when given on  the same day. Bevacizumab is administered intravenously at 15 mg/kg  every 3 weeks.

Melanoma Dosage

• Following completion of a 28-day cycle of cobimetinib and vemurafenib,  administer TECENTRIQ HYBREZA every 3 weeks with cobimetinib  60 mg orally once daily (21 days on / 7 days off) and vemurafenib 720 mg orally twice daily.

ASPS Dosage

• Administer TECENTRIQ HYBREZA every 3 weeks.

Use of Tecentriq^™ or Tecentriq Hybreza^TM or any use other than described above is considered INVESTIGATIONAL.

References 

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

2. http://www.gene.com/media/press-releases/14621/2016-03-14/fda-grants-genentechs-cancer-immunothera. FDA Grants Genentech’s Cancer Immunotherapy Atezolizumab Priority Review for Advanced Bladder Cancer.

3. Atezolizumab (Tecentriq™) prescribing information, 2016 available at: http://www.gene.com/download/pdf/tecentriq_prescribing.pdf

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community,and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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