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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Tecentriq 1766-A SGM P2025
Policy: IndicationsThe indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-approved Indications1Non-small cell lung cancer (NSCLC)Tecentriq, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients 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 FDA-approved test. Tecentriq, as a single-agent, is indicated for the first line treatment of adult patients with metastatic 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%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Tecentriq, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment, of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Tecentriq, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Tecentriq, as a single agent, is indicated for the treatment of adult patients with metastatic NSCLC who have 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 NSCLC harboring these aberrations prior to receiving Tecentriq. Small cell lung cancer (SCLC)Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Hepatocellular Carcinoma (HCC)Tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy. MelanomaTecentriq, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Alveolar Soft Part Sarcoma (ASPS)Tecentriq, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS. Compendial Uses2
All other indications are considered experimental/investigational and not medically necessary. DocumentationSubmission of the following information is necessary to initiate the prior authorization review:
ExclusionsCoverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy. Coverage Criteria1,2Non-Small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)Authorization of 6 months may be granted for treatment of small cell lung cancer when the requested medication will be used as initial treatment in combination with etoposide and carboplatin (followed by single agent maintenance) for extensive-stage disease. Hepatocellular Carcinoma (HCC)
MelanomaAuthorization of 6 months may be granted for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma when the requested medication will be used in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf). MesotheliomaAuthorization of 6 months may be granted for the subsequent treatment of peritoneal mesothelioma, pericardial mesothelioma, or tunica vaginalis testis mesothelioma when used in combination with bevacizumab. Alveolar Soft Part Sarcoma (ASPS)Authorization of 6 months may be granted for the treatment of unresectable or metastatic alveolar soft part sarcoma when used as a single agent. Cervical CancerAuthorization of 6 months may be granted for the treatment of cervical cancer when either of the following criteria is met:
Continuation of TherapyAdjuvant treatment of Hepatocellular Carcinoma (HCC) and Non-Small Cell Lung Cancer (NSCLC)Authorization of 6 months may be granted (up to 12 months total) for continued treatment in members requesting reauthorization of adjuvant treatment of hepatocellular carcinoma and non-small cell lung cancer who have not experienced disease recurrence or an unacceptable toxicity. All other indicationsAuthorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the Coverage Criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen. Place of Service: Outpatient The above policy is based on the following references:
July 19, 2025 |
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