Obtain prior authorization (initial validity 6 months)

Prior authorization is required before initiating atezolizumab; initial approvals are valid for 6 months (180 days). Some indications have maximum cumulative renewal limits (e.g., adjuvant colon and small bowel up to 12 months; NSCLC and urothelial adjuvant up to 12 months; thymic carcinoma up to 24 months; CLL/SLL up to 18 cycles).

• Initial PA validity: 6 months (180 days).
• Specified maximum renewal durations apply per indication (see Section I for details).

Renew PA only when criteria, response, and duration conditions met

Renewal requests may be granted every 6 months if the member continues to meet universal and indication-specific criteria, the prior authorization duration has not been exceeded, disease response is documented, and there is no unacceptable toxicity.

• Member must still meet universal and indication-specific criteria (including concomitant therapy/PS requirements).
• Duration of authorization must not have been exceeded (refer to Section I).
• Documented disease response (stable disease or tumor decrease) and absence of unacceptable toxicity required.

PA may be required due to indication and drug cost (NQTL)

Prior authorization is applied based on Non‑Quantitative Treatment Limitation (NQTL) factors; the policy identifies indication and cost of the drug as considerations when implementing PA requirements.

• NQTL checklist lists Indication = Yes (consider for PA).
• Cost of drug = Yes (consider for PA).

Adhere to indication-specific clinical sequencing and combinations

Follow the policy-specified sequencing for indications — e.g., NSCLC and SCLC specify first‑line, subsequent, or maintenance settings and permitted combinations with chemotherapy or targeted agents as conditions for coverage.

• NSCLC: first-line single-agent or combination regimens and adjuvant settings tied to PD-L1/biomarker and PS criteria.
• SCLC: first-line with carboplatin+etoposide, maintenance after first-line atezolizumab+carboplatin+etoposide, or subsequent therapy per policy.

Use atezolizumab only with specified combination in CLL/SLL (Richter)

For CLL/SLL with Richter transformation, use of atezolizumab is specified only in combination with venetoclax and obinutuzumab; prior therapies including immune checkpoint inhibitors may be part of the member's history and are noted in sequencing.

• Atezolizumab must be used in combination with venetoclax and obinutuzumab for histologic transformation (Richter).
• Prior treatment could have included immune checkpoint inhibitor therapy.

Utilization management applied per NQTL checklist

Utilization management (including prior authorization) was applied using the NQTL checklist and is intended to be comparable across drug benefits; the checklist documents factors considered in designing PA.

• Appendix A states utilization management NQTL applies comparably to MH/SUD and M/S drug benefits.
• Checklist indicates which factors (e.g., indication, cost) were considered in applying PA.

Provide complete actionable biomarker testing (biopsy and/or plasma)

Document complete biomarker testing results to support treatment decisions and authorization: testing should include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2) via biopsy and/or plasma.

• Complete molecular assessment of EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, ERBB2 (HER2) is expected.
• If an actionable marker is found, treatment may be guided by that result; if unknown, treat as though driver oncogenes are absent.

Submit indication-specific clinical documentation for authorization and renewals

Include indication-specific supporting documentation with initial authorization and renewal requests — for example, evidence of muscle‑invasive bladder cancer and ctDNA MRD status for adjuvant urothelial carcinoma, documentation of continued meeting of criteria, disease response, and absence of unacceptable toxicity.

• For urothelial adjuvant use: submit ctDNA MRD results from an FDA‑approved or CLIA‑compliant test.
• For renewals: provide documentation of continued eligibility, disease stabilization or tumor decrease, and absence of unacceptable toxicity (see examples).

Follow CMS NCDs/LCDs/LCAs for Medicare members

For Medicare beneficiaries, ensure compliance with applicable CMS coverage determinations: follow National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) where applicable.

• Medicare coverage for Part B drugs is governed by CMS manuals; search the Medicare Coverage Database for applicable NCDs/LCDs/LCAs.
• Plan may apply additional indications at its discretion but CMS determinations must be followed when applicable.

Verify no prior PD‑1/PD‑L1 therapy unless exception applies

Do not initiate or continue therapy for members who have received prior PD‑1/PD‑L1‑directed therapy unless the policy or indication specifically allows it — prior PD‑1/PD‑L1 therapy may violate the universal criterion and render the request ineligible.

• Universal criteria state member has not received previous PD‑1/PD‑L1‑directed therapy unless otherwise specified.
• Exceptions are noted only where the policy explicitly permits prior PD‑1/PD‑L1 therapy.

Expect denials/non‑renewal for exceeded duration, progression, or unacceptable toxicity

Renewal requests may be denied or not renewed if the authorization duration has been exceeded, disease progression is documented, or unacceptable toxicity from atezolizumab is present (examples include serious immune‑mediated adverse reactions, severe infusion reactions, or HSCT complications).

• Authorization duration must not be exceeded (see Section I for limits).
• Documented disease progression or unacceptable toxicity (listed examples) are grounds for denial or non‑renewal.

Be prepared to justify PA based on indication and drug cost (NQTL)

The NQTL checklist identifies 'Cost of drug' and 'Indication' as drivers considered for prior authorization; include cost/indication justification as needed for PA submission.

• Appendix A lists Indication = Yes and Cost of drug = Yes for consideration in PA design.
• Use the policy’s indication-based criteria in the submission to address these NQTL considerations.