EmblemHealth Imfinzi coverage update: Prior Auth

Coverage Criteria for Imfinzi (durvalumab)

Biliary Tract Cancer — First-line

Covered when ALL of the following are met for biliary tract cancer (BTC):

BTC first-line: Member has unresectable or metastatic biliary tract cancer (e.g., extrahepatic/intrahepatic cholangiocarcinoma, gallbladder carcinoma) and has not received prior systemic therapy; durvalumab given in combination with cisplatin or carboplatin and gemcitabine as first-line therapy.

Bladder Cancer — Perioperative

Covered when ALL of the following are met for muscle invasive bladder cancer (MIBC):

Bladder neoadjuvant/adjuvant: Adult member with muscle invasive bladder cancer receiving neoadjuvant durvalumab in combination with gemcitabine and cisplatin for up to 4 cycles, followed by single‑agent durvalumab after radical cystectomy as adjuvant treatment for a maximum of 8 cycles.Neoadjuvant up to 4 cycles; adjuvant up to 8 cycles

Added as a new indication (May 2025 policy history).

Endometrial Cancer — dMMR

Covered when ALL of the following are met for endometrial cancer:

Endometrial dMMR: Adult member with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR); durvalumab used in combination with carboplatin and paclitaxel followed by single‑agent durvalumab.dMMR required

Hepatocellular Carcinoma — First-line

Covered when ALL of the following are met for hepatocellular carcinoma (HCC):

HCC first-line: Member has unresectable hepatocellular carcinoma (BCLC stage B or C) with Child‑Pugh Class A and no prior systemic treatment including prior checkpoint inhibitors; durvalumab used in combination with tremelimumab (tremelimumab given for one cycle) followed by single‑agent durvalumab as first‑line therapy.Child‑Pugh Class A only

References Barcelona Clinic Liver Cancer (BCLC) staging and Child‑Pugh score.

Non-Small Cell Lung Cancer — Consolidation, Metastatic, Perioperative

Covered when ALL of the following are met for non‑small cell lung cancer (NSCLC):

NSCLC consolidation: Single‑agent durvalumab as consolidation for a total of 1 year after completion of definitive chemoradiation for unresectable stage II or III disease when post‑chemoradiation imaging (CT or PET/CT) confirms no disease progression (complete response, partial response, or stable disease).Total duration = 1 year

Post‑chemoradiation imaging (CT or PET/CT) required.

NSCLC metastatic first-line: Durvalumab in combination with tremelimumab and platinum‑based chemotherapy for metastatic (stage IV) NSCLC in members who have not received prior systemic therapy and whose tumors are negative for EGFR mutations and ALK rearrangements, regardless of PD‑L1 expression.EGFR and ALK negative

PD‑L1 testing not required for this indication.

NSCLC perioperative:

Small Cell Lung Cancer — Extensive Stage

Covered when ALL of the following are met for extensive‑stage small cell lung cancer (ES‑SCLC):

ES-SCLC first-line: Adult member with extensive‑stage small cell lung cancer receiving durvalumab in combination with carboplatin or cisplatin plus etoposide followed by maintenance single‑agent durvalumab.

Small Cell Lung Cancer — Limited Stage

Covered when ALL of the following are met for limited‑stage small cell lung cancer (LS‑SCLC):

LS-SCLC consolidation: Adult member with limited‑stage SCLC whose disease has not progressed following concurrent platinum‑based chemotherapy and radiation therapy; durvalumab may be used as consolidation.

Indication added/clarified in policy history (2025).

Coverage exclusions include situations where the member experienced disease progression while receiving durvalumab (Imfinzi) or another PD‑1/PD‑L1 checkpoint inhibitor; evidence of progression during or after concurrent chemoradiotherapy for locally advanced NSCLC; or when there is no post‑chemoradiation imaging (CT or PET/CT) available to confirm complete response, partial response, or stable disease for NSCLC consolidation. Dosing that exceeds the single‑dose limits or the specified regimen durations is also excluded (see dosing limits in policy).

Investigational or off‑label use is excluded when the indication or regimen lacks sufficient supporting evidence as defined by the policy. Determinations of insufficient evidence include inadequate representation of the patient or tumor characteristics in published studies, regimens that are not represented in the published evidence, clinical outcomes that are not clinically meaningful (per ASCO thresholds such as hazard ratio ≥ 0.80 or survival benefit < 3 months), or study designs and publication types that do not provide adequate supportive evidence (for example, uncontrolled case reports or abstracts without full peer‑reviewed articles).

The procedure and drug code lists included in this guideline are provided for informational purposes and are not exhaustive. Inclusion of a code does not imply that the associated service or drug is covered for all members or in all situations. Providers must verify coverage and billing requirements for the member’s specific plan and follow applicable prior authorization and plan rules.

Use of durvalumab for investigational or off‑label indications is considered not medically necessary when sufficient evidence is lacking. Sufficient evidence is defined by the policy as support from FDA labeling, CMS‑recognized compendia, accepted clinical guidelines, or acceptable peer‑reviewed literature. Evidence may be deemed insufficient if the clinical characteristics of the patient or cancer are not adequately represented, the administered regimen is not represented in the literature, outcomes are not clinically meaningful (for example, not meeting ASCO benchmarks such as hazard ratio < 0.80 or ≥3 months survival benefit), or the evidence arises only from lower‑quality sources (e.g., case reports or abstracts without a full peer‑reviewed article).

Regimens and Combination Therapies

Regimen	Indication	Coverage
Durvalumab in combination with tremelimumab (tremelimumab given for one cycle) followed by single-agent durvalumab.	Unresectable hepatocellular carcinoma (HCC) — first‑line; member with Child‑Pugh Class A and BCLC stage B or C; no prior systemic treatment including checkpoint inhibitors.	Covered

Regimen	Indication	Coverage
Durvalumab in combination with cisplatin or carboplatin and gemcitabine.	Unresectable or metastatic biliary tract cancer (BTC) — first‑line; members who have not received prior systemic therapy (e.g., intrahepatic/extrahepatic cholangiocarcinoma, gallbladder carcinoma).	Covered

Regimen	Indication	Coverage
Durvalumab with carboplatin or cisplatin plus etoposide followed by maintenance single‑agent durvalumab.	Extensive‑stage small cell lung cancer (ES‑SCLC) — first‑line; adult members receiving combination chemotherapy.	Covered

Regimen	Indication	Coverage
Neoadjuvant durvalumab in combination with gemcitabine and cisplatin for up to 4 cycles; adjuvant single‑agent durvalumab after radical cystectomy for up to 8 cycles.	Muscle‑invasive bladder cancer (MIBC) — perioperative (neoadjuvant plus adjuvant).	Covered

Coding and Duration Limits

HCPCS CodesHCPCSCovered

J9173

Injection, durvalumab, 10 mg

NSCLC consolidation duration

NSCLC consolidation maximum durationMaximum duration of 12 months for single-agent durvalumab consolidation after definitive chemoradiation

Required post-chemoradiation imagingCT or PET/CT performed after chemoradiation must confirm no disease progression (CR/PR/SD)

Eligible disease stageUnresectable stage II or III NSCLC

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imfinzi (durvalumab) requests processed by Evolent on behalf of the Plan. Continuation requests may be exempt when all continuation conditions are met (no disease progression on the medication, prior use within the last year without a lapse >30 days of active authorization, and no additional medications are being added). Authorization requirements and coverage may vary by member plan; check member benefits and obtain prior authorization when indicated.

Continuation exemption conditions: member has not experienced disease progression on the requested medication; medication used within last year without >30-day lapse of active authorization; no additional medications added to the continuation request.

Note

Provider Responsibilities and Documentation

Treating providers are responsible for establishing and documenting the member’s diagnosis, prior treatments, and rationale for Imfinzi. Providers should verify member coverage and prior authorization status with the Plan or Evolent prior to initiating therapy.

Providers are responsible for diagnosis, treatment decisions, and medical advice.

Line of Therapy Specifications

inv-23: first-line

First‑line use when ALL of the following are met:

First‑line regimen: Durvalumab used in combination with specified chemotherapy as first‑line treatment when the member has not received prior systemic therapy for the indicated cancer (examples: cisplatin/carboplatin + gemcitabine for BTC; tremelimumab + durvalumab for HCC with tremelimumab given for one cycle; carboplatin/cisplatin + etoposide for ES‑SCLC).

Applies to indications listed as first‑line in the policy.

inv-24: first-line

First‑line (perioperative/neoadjuvant) when ALL of the following are met:

Perioperative/neoadjuvant first‑line: Durvalumab used neoadjuvantly in combination with platinum‑containing chemotherapy followed by adjuvant single‑agent durvalumab after surgery for resectable disease (examples include bladder cancer: neoadjuvant gemcitabine + cisplatin up to 4 cycles with adjuvant durvalumab up to 8 cycles; NSCLC perioperative as described).Neoadjuvant up to 4 cycles (bladder); adjuvant up to 8 cycles (bladder)

Biomarker and Diagnostic Requirements

EGFR, ALK — biomarker considerations

EGFR and ALK status for metastatic NSCLCTumor must be negative for EGFR mutations and ALK rearrangements for durvalumab + tremelimumab + platinum chemotherapy in metastatic (stage IV) NSCLC

Perioperative NSCLC biomarker requirementNo known EGFR mutations or ALK rearrangements required for neoadjuvant/adjuvant (perioperative) durvalumab use

PD-L1 expressionPD-L1 expression not required for the metastatic NSCLC combination regimen

dMMR — mismatch repair deficiency requirement

dMMR requirementPrimary advanced or recurrent endometrial cancer must be mismatch repair deficient (dMMR) for durvalumab in combination with carboplatin and paclitaxel followed by single-agent durvalumab

Indication context

Definitions and Scoring

Child-Pugh Score — liver function classification

Child-Pugh class for HCC eligibilityMember must have Child-Pugh Class A (policy limits hepatocellular carcinoma eligibility to Child-Pugh A only)

Child-Pugh score componentsIncludes encephalopathy, ascites, albumin, prothrombin time/INR, and bilirubin parameters used to calculate score

HCC disease contextApplies to unresectable HCC (BCLC stage B or C) with no prior systemic treatment including checkpoint inhibitors

Background

Durvalumab (Imfinzi) is an anti–PD‑L1 immune checkpoint inhibitor indicated for use across multiple tumor types as monotherapy or in combination with other anticancer agents. Clinical use includes first‑line combinations with chemotherapy or other immunotherapies, neoadjuvant and adjuvant settings, and consolidation after definitive chemoradiation in NSCLC, when specific clinical criteria are met. Providers are responsible for diagnosis and treatment decisions and should follow plan requirements for prior authorization and documentation; coverage varies by member plan and clinical circumstances.

OpenPayer

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