Tecentriq™ (atezolizumab) - CAM 150
Policy
Tecentriq™ (atezolizumab) is considered MEDICALLY NECESSARY for members with metastatic non-small cell lung cancer who meet at least one of the following criteria:
-
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
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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
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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)
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.
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.
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
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
Dosage
-
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
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Dilute prior to intravenous infusion. (2.3)
Use of Tecentriq™ for any use other than described above is considered INVESTIGATIONAL.
References
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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm501762.htm. FDA approves new, targeted treatment for bladder cancer.
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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.
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Atezolizumab (Tecentriq™) prescribing information, 2016 available at: http://www.gene.com/download/pdf/tecentriq_prescribing.pdf
Coding Section
Codes |
Number |
Description |
CPT |
96413 |
Chemo administration, IV infusion technique; up to 1 hour, single or initial substance/drug |
|
96415 |
each additional hour |
|
96416 |
Initiation of prolonged chemo infusion (more than 8 hours), requiring use of a portable or implantable pump |
|
96417 |
each additional sequential infusion (different substance/drug), up to 1 hour (List separately in addition to code for primary procedure) |
HCPCS |
C9483 (effective 10/1/16) |
Injection, atezolizumab Injection, atezolizumab, 10 mg |
|
J3490 |
Unclassified Drugs |
|
J9022 (effective 1/1/2018) |
Injection, atezolizumab, 10 mg |
ICD10 |
C67.0 |
Malignant neoplasm of trigone of bladder |
|
C67.1 |
Malignant neoplasm of dome of bladder |
|
C67.2 |
Malignant neoplasm of lateral wall of bladder |
|
C67.3 |
Malignant neoplasm of anterior wall of bladder |
|
C67.4 |
Malignant neoplasm of posterior wall of bladder |
|
C67.5 |
Malignant neoplasm of bladder neck |
|
C67.6 |
Malignant neoplasm of ureteric orifice |
|
C67.7 |
Malignant neoplasm of urachus |
|
C67.8 |
Malignant neoplasm of overlapping sites of bladder |
|
C67.9 |
Malignant neoplasm of bladder, unspecified |
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.
"Current Procedural Terminology © American Medical Association. All Rights Reserved"
History From 2016 Forward
06/21/2024 | Annual review, adding specificity of 4 cycles to medical necessity criteria, adding verbiage for combination treatment and discontinuation of bevacizumab to policy section, updating dosage criteria, removing " administer 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks" and "injection: 1,200mg/20mL (60mg/mL) solution in a single dose vial" from dosage section of policy. |
06/28/2023 | Annual review, removed paragraph 1 medical necessity criteria for locally advanced or metastatic urothelial carcinoma, removed paragraph 3 medically necessity criteria for treatment of adult patients with unreselectable locally advanced or metastatic TNBC 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, adding coverage for: treatment of Alveolar soft part sarcoma, unreselectable or metastatic: Treatment of unreselectable or metastatic alveolar soft part sarcoma in adult and pediatric patients ≥ 2 years of age. |
06/22/2022 |
Annual review, updating criteria for use with metastatic non small cell lung cancer, adding criteria for unresectable or metastatic hepatoceullular carcinoma and BRAF V600 mutation positive unresectable or metastatic melanoma. No other changes. |
06/23/2021 |
Annual review, no change to policy intent. |
06/18/2020 |
Annual review, no change to policy intent |
06/01/2019 |
Annual review adding coverage for: Tecentriq™ is considered MEDICALLY NECESSARY in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC 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, and Tecentriq™ is considered MEDICALLY NECESSARY in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). No other changes made. |
06/13/2018 |
Annual review, adding coverage for FDA-approved use in NSCLC. No other changes to policy. |
11/27/2017 |
Updating with 2018 coding. No other changes. |
06/07/2017 |
Annual review, no change to policy intent. |
09/01/2016 |
Updating to add investigational statement. |
08/08/2016 |
Added HCPCS code C9483 to coding section. |
06/15/2016 |
NEW POLICY |