Tecentriq®

Drug - Tecentriq® (atezolizumab injection) [Genentech, Inc.]

July 2019

Therapeutic area - Oncology

Approval criteria

• Patient must be at least 18 years old AND
• Patient must meet one of the following criteria:
  • Patient has locally advanced or metastatic urothelial carcinoma AND
    • One of the following:
      • Is not eligible for cisplatin-containing chemotherapy and tumors express PD-L1 covering ≥5% of the tumor area OR
      • Is not eligible for any platinum-containing chemotherapy (regardless of PD-L1 expression status) OR
      • Disease has progressed during or following any platinum-containing chemotherapy AND
        • Patient has tried and failed pembrolizumab OR
        • Patient is not a candidate for pembrolizumab OR
      • Disease has progressed within 12 months of neoadjuvant or adjuvant chemotherapy AND
        • Patient has tried and failed pembrolizumab OR
        • Patient is not a candidate for pembrolizumab AND
    • Tecentriq® is used as a single agent
  • Patient has metastatic non-squamous non-small cell lung cancer (NSCLC) AND
    • Has no EGFR or ALK genomic tumor aberrations AND
    • Tecentriq® is used in combination with bevacizumab + paclitaxel + carboplatin for first-line treatment OR
    • Tecentriq® is used as a single agent OR with bevacizumab after completing 4-6 cycles of paclitaxel + carboplatin
  • Patient has metastatic NSCLC AND
    • Disease has progressed during or following platinum-containing chemotherapy AND
    • If the patient has an EGFR or ALK genomic tumor aberration, has already received the appropriate FDA-approved targeted therapy prior to receiving Tecentriq® AND
    • Tecentriq® is used as a single agent
  • Patient has unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) AND
    • Tumors express PD-L1 ≥1% of the tumor area AND
    • Tecentriq® is used in combination with paclitaxel protein-bound
  • Patient has extensive stage small cell lung cancer (ES-SCLC) AND
    • Tecentriq® is used in combination with carboplatin + etoposide for first-line treatment OR
    • Tecentriq® is used as a single agent after completing 4 cycles of carboplatin + etoposide

Renewal criteria

• Tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
• Absence of unacceptable toxicity from the drug (e.g.; fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, constipation, etc.)
• Renewal approval is for 6 months

Quantity limits

• Urothelial carcinoma
  • 840 mg (1 vial) every 14 days
  • 1200 mg (1 vial) every 21 days
  • 1680 mg (2 vials) every 28 days
• NSCLC
  • In combination with bevacizumab + paclitaxel + carboplatin: 1200 mg (1 vial) every 21 days
  • As a single agent OR in combination with bevacizumab
    • 840 mg (1 vial) every 14 days
    • 1200 mg (1 vial) every 21 days
    • 1680 mg (2 vials) every 28 days
• TNBC
  • 840 mg (1 vial) every 14 days
• ES-SCLC
  • In combination with carboplatin + etoposide: 1200 mg (1 vial) every 21 days
  • As a single agent
    • 840 mg (1 vial) every 14 days
    • 1200 mg (1 vial) every 21 days
    • 1680 mg (2 vials) every 28 days

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411