atezolizumab (Tecentriq) coverage
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Medical policy governing prior authorization, coverage criteria, and administration of atezolizumab (Tecentriq) for AlohaCare Medicaid and Medicare members.
No material clinical or coverage changes in this revision.
Coverage Criteria for atezolizumab (Tecentriq)
Covered Indications and Criteria
Requests may be approved if one of the following diagnosis and condition groups is met:
Requests for atezolizumab (Tecentriq) will be excluded or denied when there is prior exposure to another programmed death‑1 (anti‑PD‑1) or programmed death‑ligand 1 (anti‑PD‑L1) inhibitor, or when the member is actively receiving systemic immunosuppressive therapy for an autoimmune disease or other chronic condition. These exclusions apply regardless of the requested indication and should be confirmed in the clinical history and medication list prior to authorization review.
Initial Therapy Authorization
Initial therapy
Initial authorization is granted when the requested use meets indication-specific criteria and prior authorization is obtained.
Continuation / Reauthorization Criteria
Continuation therapy
Reauthorization is allowed when criteria for clinical benefit or maintenance are met.
Coding: HCPCS, Biomarkers, and Test Thresholds
| J9022 | Injection, atezolizumab, 10 mg |
Provider Requirements, Documentation, and Denials
Prior authorization required; approval durations
Prior authorization is required for medical benefit coverage of Tecentriq (J9022). Initial request approval duration is 26 weeks; reauthorization/continuation approvals may be granted for up to 12 months. J9022 (Injection, atezolizumab, 10 mg) is payable under the medical benefit; the pharmacy benefit is excluded and directed to the medical benefit.
- HCPCS code: J9022 (Injection, atezolizumab, 10 mg); supplied as 840 mg and 1200 mg single-dose vials.
- Initial approval duration: 26 weeks; reauthorization/continuation duration: up to 12 months.
- Benefit: Medical benefit (Pharmacy benefit excluded).
Medicare Part B step therapy requirement and 90-day transition
For new Medicare Part B starts, Medicare Part B step therapy criteria must be met in addition to the Coverage Criteria before a request may be approved. A 90-day transition period applies for new Medicare members: during the first 90 days of enrollment, if the member is on an active course of the requested treatment (including out-of-network), Coverage and Step Therapy do not apply; after 90 days, criteria must be met for continued coverage.
- Step therapy requirement applies to new Medicare Part B starts in addition to coverage criteria.
- 90-day transition: active treatment continued for first 90 days of enrollment without applying Coverage or Step Therapy; thereafter criteria apply.
Use applicable LCD/NCD/LCA; follow FDA dosing & administration
Clinical review should use the most current LCD, NCD, or LCA that applies to the Hawaii region; if none is available, apply the general coverage criteria in this policy. Follow FDA prescribing information for dosing and administration: 840 mg q2w, 1200 mg q3w, or 1680 mg q4w (with pediatric dosing for ASPS of 15 mg/kg up to 1200 mg q3w for ages ≥2).
- Check CMS Medicare Coverage Database for applicable LCD/NCD/LCA for Hawaii; if none, use the policy's general coverage criteria.
- Dosing schedules: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks; pediatric ASPS dosing 15 mg/kg (max 1200 mg) q3w.
Exclusion triggers: prior anti–PD-1/PD-L1 or systemic immunosuppression
Requests will be excluded/denied if the member has previously received treatment with another anti-PD-1 or anti-PD-L1 inhibitor, or if the member is receiving therapy for an autoimmune disease or chronic condition that requires systemic immunosuppressant treatment.
- Prior treatment with another anti–PD-1 or anti–PD-L1 agent is an exclusion.
- Concurrent systemic immunosuppressant therapy for autoimmune or chronic conditions is an exclusion/contraindication.
Step Therapy Requirements
| Population | Requirement | Notes |
|---|---|---|
| Medicare Part B - new starts | Must meet Medicare Part B step therapy criteria in addition to the policy's coverage criteria | No specific step therapy protocols are listed in the policy; a 90-day transition period applies for new Medicare members on active treatment (see policy transition guidance). |
Quantity Limits and Dosing Schedules
Site of Care and Benefit Assignment
Medical benefit (infusion center); pharmacy excluded
Tecentriq is a medical-benefit drug; the pharmacy benefit is excluded and claims should be processed through the medical benefit (eg, infusion center billing).
Biosimilar and Combination Regimen Notes
Bevacizumab or biosimilar permitted in specified combination regimens
When used in combination regimens where bevacizumab is specified in the indication, bevacizumab or an approved bevacizumab biosimilar may be used as the partner agent per the regimen.
Background on atezolizumab (Tecentriq)
Atezolizumab (Tecentriq) is an anti‑PD‑L1 immune checkpoint inhibitor that binds programmed death‑ligand 1 and blocks its interaction with PD‑1, restoring anti‑tumor T‑cell activity. It is FDA‑labeled for multiple oncology indications including non‑small cell lung cancer (various settings), extensive‑stage small cell lung cancer, hepatocellular carcinoma (in combination with bevacizumab), unresectable or metastatic melanoma in combination regimens, alveolar soft part sarcoma, and certain gynecologic neuroendocrine carcinomas. Dosing schedules vary by indication (for example 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) and specific combination partners and biomarker requirements (such as PD‑L1 expression thresholds or BRAF mutation status) are indicated per FDA labeling and guideline recommendations.
Definitions and Required Tests
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