RXMP-12 Atezolizumab (Tecentriq) Form

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AlohaCare Medical Policy atezolizumab (Tecentriq)

Policy Number:
RXMP-12 Effective Date:
10/1/2023 (Medicaid), 1/1/2024 (Medicare) Review Date:
10/20/2025 Plans:
AlohaCare Medicaid & Medicare

PRODUCT(S): Tecentriq (atezolizumab)

HCPCS Code HCPCS Description How Supplied J9022 Injection atezolizumab 10 mg Tecentriq 840 mg/14 mL, 1200 mg/20 mL SDV

Formulary Status: Medical Benefit: Authorization Required
Pharmacy Benefit: Excluded to Medical Benefit Duration of Approval: Initial Request: 26 weeks COC/Reauthorization: 12 months
Quantity Limit: See dosing information

MEDICARE PART B COVERAGE CRITERIA: • Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/20/2025. Review using General Coverage Criteria below.

MEDICARE PART B 90-DAY TRANSITION PERIOD:
For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of- network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage.

MEDICARE PART B STEP THERAPY CRITERIA: • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

GENERAL COVERAGE CRITERIA:  Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

Requests may be approved if one of the following diagnosis and conditions are met:

1. First-line treatment of advanced, unresectable, or metastatic hepatocellular carcinoma (HCC) (Label, NCCN 2A); AND
2. All of the following are met: a. Member is using in combination with bevacizumab (or bevacizumab biosimilar);
   b. Member has Child-Pugh Class A;
   c. Member has an ECOG performance status of 0-2. OR
3. First-line treatment of recurrent, advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC) (Label, NCCN 2A); AND

Page 2 of 4 i. Member is using in a combination regimen with nab-paclitaxel (paclitaxel, protein-bound) and carboplatin; AND ii. Member does not have presence of actionable molecular markers*; AND iii. Member has a ECOG performance status of 0-2; OR

4. First-line treatment of recurrent, advanced or metastatic nonsquamous NSCLC (Label, NCCN 1, 2A); AND i. Member is using in a combination regimen with carboplatin, paclitaxel, and bevacizumab (or bevacizumab biosimilar); AND ii. Member does not have presence of actionable molecular markers*; AND iii. Member has a ECOG performance status of 0-1; OR
5. Continuation maintenance therapy for recurrent, advanced or metastatic nonsquamous NSCLC (Label, NCCN 1, 2A); AND i. Member is using in combination with or without bevacizumab (or bevacizumab biosimilar); AND ii. Member has confirmation of achievement of tumor response or stable disease following initial cytotoxic therapy (first-line atezolizumab/carboplatin/paclitaxel /bevacizumab regimen or atezolizumab/carboplatin/nab-paclitaxel regimen); AND iii. Member has a ECOG performance status of 0-2; OR
6. Subsequent treatment of recurrent, advanced or metastatic NSCLC (nonsquamous or squamous) (Label, NCCN 1, 2A); AND i. Disease has progressed during or following platinum-containing chemotherapy (e.g. cisplatin); AND ii. Member has a ECOG performance status of 0-2; OR
7. Subsequent treatment of recurrent, advanced or metastatic nonsquamous NSCLC (NCCN 1, 2A); AND i. Disease has progressed during or following treatment with a targeted agent for the expressed oncogene (for example, kinase inhibitors that target EGFR, ALK, ROS1, BRAF, NTRK, or MET mutations); AND ii. Member is using in a combination regimen with one of the following: a. Carboplatin, paclitaxel, and bevacizumab (or bevacizumab biosimilar); OR b. Carboplatin and nab-paclitaxel (albumin-bound paclitaxel); AND iii. Member has a ECOG performance status of 0-2;
   OR
8. First-line treatment of recurrent, advanced, or metastatic NSCLC (Label, NCCN 1); AND i. Member is using as monotherapy; AND ii. Member has one of the following: a. Member has PD-L1 expression on tumor cells [TC] that is greater than or equal to 50% [TC ≥ 50%], as confirmed through an FDA-approved test; OR b. Member has PD-L1 expression on tumor-infiltrating immune cells [IC] covering greater than or equal to 10% [IC ≥ 10%] of the tumor area, as confirmed by an FDA-approved test; AND iii. Member does not have presence of actionable molecular markers*; AND iv. Member has a ECOG performance status of 0-2; OR
9. Treatment of stage II to IIIB NSCLC; AND i. Member is using as adjuvant therapy following resection; AND

Page 3 of 4 ii. Member has PD-L1 expression on tumor cells [TC] that is greater than or equal to 1% [TC ≥ 1%], as confirmed through an FDA-approved test;
OR

10. Treatment of unresectable or metastatic Melanoma; AND i. Member is using in combination with cobimetinib and vemurafenib; AND ii. Member has BRAF V600 mutation positive disease with test result confirmed; AND iii. Member has ECOG performance status of 0-2; OR
11. First-line treatment of extensive-stage Small Cell Lung Cancer (SCLC) (Label, NCCN 1); AND i. Member is using in combination with etoposide and carboplatin (followed by maintenance atezolizumab monotherapy); OR
12. Treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS); AND i. Member is 2 years of age or older; AND ii. Member is using as monotherapy; OR
13. Treatment of unresectable or metastatic alveolar soft part sarcoma; AND i. Member has not received treatment with another anti-PD-1 or anti-PD-L1 inhibitor; AND ii. Member is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; OR

14. Treatment of persistent, recurrent or metastatic small cell neuroendocrine carcinoma of the cervical cancer (NECC); AND i. Member is using in combination with etoposide and platinum-therapy (NCCN 2A).

    *Note: Actionable molecular markers include EGFR, ALK, ROS1, BRAF, NTRK, MET and RET mutations. The NCCN panel recommends testing prior to initiating therapy to help guide appropriate treatment. If there is insufficient tissue to allow testing for all of these markers, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes (NCCN 1, 2A).

    EXCLUSIONS:

15. Member has received treatment with another anti-PD-1 or anti-PD-L1 inhibitor.

16. Member is receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant.

    FDA INDICATIONS, DOSING & ADMINISTRATION: Indication Dosing/Administration Non-Small Cell Lung Cancer • In the adjuvant setting, administer following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks for up to 1 year.
    • In the metastatic setting, administer as 840 mg every 2weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
    Small Cell Lung Cancer • Administer as 840 mg every 2 weeks, 1200 mg every 3weeks, or 1680 mg every 4 weeks.
    Hepatocellular Carcinoma • Administer as 840 mg every 2 weeks, 1200 mg every 3weeks, or 1680 mg every 4 weeks. Administer prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.

Page 4 of 4 Melanoma • Following completion of a 28 day cycle of cobimetinib and vemurafenib, administer 840 mg every 2 weeks, 1200 mg every 3 weeks,or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21days on /7 days off) and vemurafenib 720 mg orally twice daily. Alveolar Soft Part Sarcoma • Adults: Administer 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
• Pediatric patients 2 years of age and older: 15 mg/kg (up to a maximum of 1200 mg), every 3 weeks.

REFERENCES:

1. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: September 19, 2023.

2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology, Plymouth Meeting, PA: NCCN. http://www.nccn.org/index.asp. a. Bladder Cancer. V1.2023. Revised February 9, 2023.
   b. Cervical Cancer. V1.2023. Revised January 6, 2023. c. Melanoma. V2.2023. Revised March 10, 2023. d. Mesothelioma: Peritoneal. V1.2023. Revised December 15, 2022. e. Hepatocellular Cancers. V1.2023. Revised March 10, 2023. f. Malignant Peritoneal Mesothelioma. V1.2022. Revised December 22, 2021. g. Non-Small Cell Lung Cancer. V2.2023. Revised February 17, 2023. h. Small Cell Lung Cancer. V3.2023. Revised December 21, 2022. i. Soft Tissue Sarcoma. V1.2023. Revised March 13, 2023.

   CHANGE HISTORY: 9/20/2023 DS/PH: New