ModifiedAnthemPolicy CC-0130

Imfinzi (durvalumab) — Clinical coverage criteria

Clinical coverage criteria for Imfinzi (durvalumab) across multiple oncologic indications defining when prior authorization/medical necessity is met for Anthem members.

Policy Summary

PayerAnthem

PolicyImfinzi (durvalumab) — Clinical coverage criteria

Policy CodePolicy CC-0130

Change TypeMaterial updates and indication additions

Effective Date

Next Review Date

Key ActionObtain prior authorization; approval requires meeting the indication-specific clinical criteria and documentation of prior therapies, ECOG status, biomarkers, and disease extent.

SourceLink

POLICY UPDATE CHANGES

Add new FDA indication for use in gastric or gastroesophageal junction cancer and NCCN 2A recommendations for use in Ampullary adenocarcinoma.

Add new FDA indication in bladder cancer (muscle-invasive bladder cancer).

Update existing clinical criteria with FDA label approval in limited stage small cell lung cancer as a single agent for those who have not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

Clarify existing criteria in NSCLC, SCLC, biliary tract cancer, hepatocellular cancer, and small NECC with NCCN recommendations and guidelines.

multipleIndications listed

0-2ECOG requirement

12 moConsolidation limit

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>=2019Doc history range

Coverage Criteria for Imfinzi (durvalumab)

Covered Indications with Specific Criteria

Requests for Imfinzi (durvalumab) may be approved when ALL of the following indication‑specific criteria are met for the listed diagnosis/setting.

Pediatric exclusion: Individual is under 19 years of age.

Age exclusion per policy.

Ampullary adenocarcinoma: Diagnosis of Ampullary adenocarcinoma (NCCN 2A) AND using in combination with gemcitabine and cisplatin.

NCCN 2A recommendation; combination with gemcitabine/cisplatin required.

Unresectable Stage III NSCLC — consolidation: Diagnosis of stage III locally advanced, unresectable NSCLC AND disease has not progressed after definitive chemoradiation AND using as consolidation single‑agent therapy until progression or a maximum of 12 months AND no prior anti‑PD‑1/PD‑L1 therapy AND ECOG performance status 0‑2 AND not receiving systemic immunosuppressant for autoimmune disease.max 12 months

Consolidation use after definitive chemoradiation; ECOG requirement and prior PD‑1/PD‑L1 exclusion.

Metastatic NSCLC with tremelimumab and chemotherapy: Recurrent, advanced, or metastatic NSCLC with no prior systemic therapy AND using in combination with Imjudo (tremelimumab‑actl) and platinum‑based chemotherapy AND negative for actionable molecular biomarkers (eg, EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, ERBB2) (KRAS G12C allowed) AND PD‑L1 expression ≥1% to 49% AND no prior anti‑PD‑1/PD‑L1 therapy AND not receiving systemic immunosuppressant for autoimmune disease.>= 1% to 49% PD‑L1

Biomarker and PD‑L1 restrictions required for combination regimen.

NSCLC — continuation maintenance: Use as continuation maintenance following initial systemic therapy with durvalumab/tremelimumab‑actl plus chemotherapy either as single‑agent maintenance or in combination with pemetrexed after initial combination therapy.

Applies after specified induction regimens with durvalumab/tremelimumab plus chemotherapy.

Resectable NSCLC — neoadjuvant/adjuvant: Neoadjuvant use in combination with platinum‑containing chemotherapy for resectable tumors ≥4 cm and/or node positive AND no known EGFR sensitizing mutations or ALK rearrangements; adjuvant single‑agent use after neoadjuvant durvalumab+platinum for completely resected tumors ≥4 cm and/or node positive with no known EGFR/ALK alterations.tumor >= 4 cm and/or node positive

Neoadjuvant with platinum chemotherapy; adjuvant single‑agent allowed after neoadjuvant durvalumab+platinum.

Limited‑stage SCLC — consolidation: Limited‑stage (Stage I‑III) SCLC whose disease has not progressed following concurrent platinum‑based chemotherapy and radiation AND using durvalumab single‑agent up to 24 months AND ECOG performance status 0‑1.up to 24 months

Single‑agent consolidation after concurrent chemoradiation; ECOG requirement specified.

Extensive‑stage SCLC — first‑line: Extensive‑stage SCLC using durvalumab with etoposide and cisplatin or carboplatin for four cycles followed by maintenance durvalumab monotherapy; no prior anti‑PD‑1/PD‑L1 therapy AND not receiving systemic immunosuppressant for autoimmune disease.four cycles then maintenance

First‑line combination followed by maintenance monotherapy.

NECC (cervix) use: Persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) (NCCN 2A) using durvalumab in combination with etoposide and platinum for four cycles OR as monotherapy for maintenance; no prior anti‑PD‑1/PD‑L1 therapy AND not receiving systemic immunosuppressant.

NCCN 2A; combination or maintenance pathways allowed.

Esophageal/GEJ/Gastric resectable: Resectable gastric or gastroesophageal junction adenocarcinoma using durvalumab with FLOT as neoadjuvant and adjuvant treatment OR monotherapy post neoadjuvant/adjuvant FLOT for up to 10 cycles AND ECOG 0‑1 AND no prior anti‑PD‑1/PD‑L1 therapy; subset includes MSI‑H/dMMR tumors when using with Imjudo in the neoadjuvant setting.up to 10 cycles; ECOG 0-1

FLOT combination or post‑FLOT monotherapy; MSI‑H/dMMR required when combined with Imjudo neoadjuvantly.

Endometrial cancer (dMMR): Primary advanced or recurrent endometrial cancer using durvalumab in combination with carboplatin and paclitaxel followed by durvalumab single agent AND mismatch repair deficient (dMMR) disease.

dMMR required for this regimen per label/NCCN.

Biliary tract cancer (including pancreatobiliary and mixed type) using durvalumab in combination with gemcitabine and cisplatin or carboplatin as neoadjuvant, systemic, or subsequent systemic therapy AND not receiving systemic immunosuppressant AND no prior anti‑PD‑1/PD‑L1 therapy.

Multiple treatment settings allowed; prior PD‑1/PD‑L1 exclusion applies.

Hepatocellular carcinoma (uHCC): Unresectable HCC using durvalumab in combination with Imjudo (tremelimumab‑actl) as first‑line therapy for unresectable or liver‑confined inoperable disease OR using until progression or unacceptable toxicity following response or stable disease after initial systemic therapy; ECOG 0‑2; additional constraints about prior Imjudo or CTLA‑4‑based combinations apply.ECOG 0-2

First‑line combination with Imjudo or single‑agent pathways; prior CTLA‑4 combination exclusions noted.

Muscle‑invasive bladder cancer (MIBC): MIBC using durvalumab in combination with gemcitabine and cisplatin as neoadjuvant treatment OR as adjuvant single‑agent after radical cystectomy following neoadjuvant treatment; no prior anti‑PD‑1/PD‑L1 therapy AND not receiving systemic immunosuppressant.

Neoadjuvant combination or adjuvant single‑agent after cystectomy allowed.

HCC single‑agent or combination (NCCN 2A): HCC using durvalumab with Imjudo or as single agent for first‑line or subsequent‑line systemic therapy; additional constraints about prior Imjudo or prior CTLA‑4‑based combinations apply.

NCCN 2A recommendation; sequencing constraints apply.

Covered with criteria

Covered when the following indication‑specific criteria are met as described in the policy.

General restrictions: Individual has not received treatment with another anti‑PD‑1 or anti‑PD‑L1 agent; individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant.

Applies across multiple indications per policy general criteria.

Disease extent criteria: Individual has metastatic disease OR extensive liver tumor burden OR unresectable disease OR liver‑confined inoperable disease by performance status/comorbidity/minimal or uncertain extrahepatic disease.

Multiple disease extent pathways described for first‑line or other settings.

Esophageal/Esophagogastric/Gastric neoadjuvant combination criteria: Diagnosis of esophageal and esophagogastric junction cancers or gastric cancer (NCCN 2A); using as neoadjuvant therapy AND in combination with Imjudo (tremelimumab‑actl) AND current ECOG performance status 0‑1 AND has not received treatment with another anti‑PD‑1 or anti‑PD‑L1 agent AND has MSI‑H/dMMR tumors.ECOG 0-1

Requests for Imfinzi (durvalumab) may not be approved when the above indication-specific criteria are not met. In addition, coverage will not be provided for uses outside the listed indications and clinical scenarios described in this policy.

Examples of scenarios that may be denied include, but are not limited to: neoadjuvant use of durvalumab in combination with Imjudo (tremelimumab-actl) for esophageal, esophagogastric junction, or gastric cancer when the tumor is not MSI-H/dMMR; neoadjuvant or adjuvant use where ECOG performance status is outside the required 0–1; and any request where the member has prior exposure to another anti–PD‑1 or anti–PD‑L1 agent without meeting a specific indication exception.

Durvalumab is excluded from coverage in individuals who have previously received treatment with another anti–PD‑1 or anti–PD‑L1 agent for indications where prior exposure is disqualifying. Requests will also not be approved for members who are currently receiving therapy for an autoimmune disease or chronic condition that requires treatment with a systemic immunosuppressant, unless the applicable indication-specific criteria explicitly allow it.

Regimens and Permitted Combinations

Indication	Regimen details	Coverage status
Extensive-stage small cell lung cancer (ES-SCLC)
Durvalumab in combination with etoposide and cisplatin or carboplatin for four cycles, followed by maintenance durvalumab monotherapy until disease progression
Covered

Indication	Regimen details	Coverage status
Resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma
Durvalumab in combination with FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) as neoadjuvant and adjuvant treatment; OR durvalumab monotherapy post neoadjuvant/adjuvant FLOT for up to 10 cycles
Covered

Indication	Regimen details / biomarker & PD-L1 restrictions	Coverage status
Recurrent, advanced, or metastatic non–small cell lung cancer (NSCLC)
Durvalumab in combination with tremelimumab-actl (Imjudo) and platinum-based chemotherapy; patient must be negative for actionable molecular biomarkers (EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, ERBB2; KRAS G12C allowed) and have PD-L1 expression 1–49%
Covered

Indication	Regimen details	Coverage status
Muscle-invasive bladder cancer (MIBC)
Durvalumab in combination with gemcitabine and cisplatin as neoadjuvant therapy; OR durvalumab single-agent adjuvant therapy following radical cystectomy after neoadjuvant treatment
Covered

Indication	Regimen details / eligibility	Coverage status
Resectable esophageal, esophagogastric junction (EGJ), or gastric cancer — neoadjuvant setting
Durvalumab in combination with Imjudo (tremelimumab-actl) as neoadjuvant therapy for MSI-H/dMMR tumors; patient must have ECOG performance status 0–1 and no prior anti–PD-1/PD-L1 therapy
Covered

Indication	Regimen details / eligibility	Coverage status
Unresectable, metastatic, or liver-confined inoperable disease — first-line single-agent use
Durvalumab single-agent as first-line therapy for unresectable disease OR liver-confined inoperable disease OR metastatic disease/extensive liver tumor burden, when general criteria are met (no prior anti–PD-1/PD-L1 therapy; not receiving systemic immunosuppressants)
Covered

Billing and Diagnosis Codes; Treatment Durations

HCPCSHCPCS

J9173

Injection, durvalumab, 10 mg [Imfinzi]

ICD-10 DiagnosisICD-10

C15.3-C15.9	Malignant neoplasm of esophagus
C16.0-C16.9	Malignant neoplasm of stomach
C22.0	Liver cell carcinoma
C22.1	Intrahepatic bile duct carcinoma
C22.8	Malignant neoplasm of liver, primary, unspecified as to type
C22.9	Malignant neoplasm of liver, not specified as primary or secondary
C23	Malignant neoplasm of gallbladder
C24.0	Malignant neoplasm of extrahepatic bile duct
C24.1	Malignant neoplasm of ampulla of Vater
C24.8	Malignant neoplasm of overlapping sites of biliary tract

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1/3

inv-08: Maximum duration for consolidation in unresectable Stage III NSCLC

Maximum consolidation durationDurvalumab single-agent consolidation for unresectable Stage III NSCLC: until disease progression or a maximum of 12 months of treatment (NCCN 2A)

Condition for useDisease has not progressed after definitive chemoradiation

Prior PD-1/PD-L1 therapyIndividual has not previously received treatment with another anti-PD-1 or anti-PD-L1 agent

inv-09: Maximum duration for limited-stage SCLC single-agent use

Maximum durationDurvalumab single-agent use in limited-stage SCLC (post‑cCRT): up to 24 months

Disease status

Biomarker and Molecular Eligibility

inv-28: PD-L1 — PD-L1 threshold details (>=1% to 49%)

PD-L1 threshold rangePD-L1 expression specified as greater than or equal to 1% to 49% for certain metastatic NSCLC regimens

Context of useApplied for durvalumab in combination with tremelimumab-actl and platinum chemotherapy in metastatic NSCLC

Associated requirementsAlso requires negative actionable molecular biomarkers and no prior anti‑PD‑1/PD‑L1 therapy

inv-29: EGFR / ALK — requirement for no known sensitizing EGFR mutations or ALK rearrangements

Required molecular statusNo known sensitizing EGFR mutations or ALK rearrangements for neoadjuvant/adjuvant resectable NSCLC uses

ContextSpecifically required for neoadjuvant use in resectable NSCLC (tumors ≥4 cm and/or node positive) and adjuvant single-agent use post‑neoadjuvant

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization/clinical review is required for Imfinzi (durvalumab) and approval is contingent on meeting the detailed clinical criteria below. Requests may be denied when criteria are not met.

Prior authorization/clinical review required when Imfinzi is billed under the medical benefit.
Denial risk if documentation does not demonstrate required clinical elements.

Documentation Required

Clinical Review Requirement

Clinical documentation submitted with the request should clearly demonstrate the disease setting, tumor burden, prior therapies (including any prior anti–PD-1/PD-L1 agents), ECOG performance status, concurrent autoimmune disease or need for systemic immunosuppression, and any relevant biomarker status (e.g., PD-L1, MSI-H/dMMR, actionable genomic alterations).

Documentation must show disease stage (including unresectable, locally advanced, metastatic, or liver-confined disease) and whether disease progressed after definitive chemoradiation where applicable.

Line of Therapy Designations

first-line | maintenance

First‑line: Durvalumab used as first‑line therapy in combination with chemotherapy ± tremelimumab (per indication‑specific regimens) for approved tumor types (examples include extensive‑stage SCLC, uHCC combination with Imjudo, biliary tract cancer, MIBC neoadjuvant, metastatic NSCLC with Imjudo).

Refer to indication‑specific nodes for biomarker and regimen restrictions.

Maintenance/Continuation: Durvalumab used as maintenance or continuation therapy following induction with a specified durvalumab‑containing regimen (eg, maintenance after four cycles of etoposide plus platinum in ES‑SCLC; continuation maintenance after durvalumab/tremelimumab‑actl plus chemotherapy in NSCLC), including single‑agent maintenance or combination with pemetrexed where specified.

Maintenance durations and prior induction requirements are indication dependent (see specific criteria).

first-line

Definitions and Clinical Terms

inv-21: Consolidation therapy — definition and synonyms

DefinitionConsolidation therapy: Any drug or medical treatment used to kill remaining cancer cells; also called intensification therapy or post‑remission therapy

SynonymsIntensification therapy; post‑remission therapy

Contextual useReferenced as the treatment approach for unresectable Stage III NSCLC after definitive chemoradiation

inv-22: ECOG performance status — definition and scale reference

DefinitionECOG (Eastern Cooperative Oncology Group) Performance Status: a scale to assess functional status, ranges 0 (fully active) to 5 (dead)

Scale examples0 = fully active; 1 = restricted in physically strenuous activity but ambulatory; 2 = ambulatory and capable of self‑care but unable to work; up to 5 = dead

Background

Imfinzi (durvalumab) is a programmed death ligand‑1 (PD‑L1) blocking monoclonal antibody used across multiple oncology indications. The policy includes FDA‑approved and guideline‑supported uses such as single‑agent consolidation after definitive chemoradiation in unresectable Stage III non‑small cell lung cancer, combination regimens with chemotherapy (and in some settings with tremelimumab‑actl) for metastatic or perioperative disease, and neoadjuvant/adjuvant applications in select gastrointestinal and genitourinary cancers. Coverage under this policy depends on meeting the indication‑specific requirements described in the clinical criteria, including biomarker status (for example, MSI‑H/dMMR where specified), performance status, prior therapy history, and disease extent.

Policy Revision History

2025-12-08select_reviewLatest

Added new FDA indication for gastric/gastroesophageal junction cancer; added NCCN 2A recommendations for ampullary adenocarcinoma; clarified criteria in NSCLC, SCLC, biliary tract cancer, hepatocellular cancer, and small NECC; administrative age update; coding reviewed (no changes).

2025-05-16annual_review

Added new FDA indication for muscle-invasive bladder cancer (MIBC); added NCCN recommendation for subsequent systemic therapy in hepatocellular carcinoma with Imjudo or as single agent; updated ICD-10-CM code descriptions and made multiple ICD-10 code additions/removals.

Policy Summary

PayerAnthem

PolicyImfinzi (durvalumab) — Clinical coverage criteria

Policy CodePolicy CC-0130

Change TypeMaterial updates and indication additions

Effective Date

Next Review Date

Key ActionObtain prior authorization; approval requires meeting the indication-specific clinical criteria and documentation of prior therapies, ECOG status, biomarkers, and disease extent.

SourceLink

On This Page

Specific combination requirement with Imjudo and MSI‑H/dMMR biomarker requirement for neoadjuvant use.

Disease has not progressed following concurrent platinum-based chemotherapy and radiation

ECOG requirementECOG performance status required: 0-1

inv-10: PD-L1 expression requirement for durvalumab+tremelimumab+chemo in metastatic NSCLC

PD-L1 thresholdPD-L1 expression required: greater than or equal to 1% to 49% for durvalumab + tremelimumab + platinum chemotherapy in metastatic NSCLC

Molecular biomarker requirementNegative for actionable molecular biomarkers required (see separate biomarker block); KRAS G12C may be positive

Prior therapyNo prior anti-PD-1 or anti-PD-L1 therapy

inv-11: ECOG performance status

Common ECOG requirementECOG performance status commonly required: 0-1 for many indications (notably limited-stage SCLC, neoadjuvant esophageal/GEJ/gastric), and 0-2 where specified

Definition sourceECOG (Eastern Cooperative Oncology Group) performance status scale 0–5 used to assess functional status

Use in documentationDocumentation should demonstrate current ECOG performance status where required

Other general requirementIndividual must not have received prior anti‑PD‑1/PD‑L1 therapy

inv-30: MSI-H / dMMR — MSI-H/dMMR or mismatch repair deficient status required for certain neoadjuvant/adjuvant uses

Required tumor statusMicrosatellite instability‑high (MSI‑H) or deficient mismatch repair (dMMR) tumor status required for certain neoadjuvant/adjuvant uses (e.g., esophageal/GEJ/gastric neoadjuvant combination with tremelimumab)

Specific indicationMSI‑H/dMMR required when durvalumab is used with tremelimumab in neoadjuvant esophageal/esophagogastric/gastric cancers (NCCN 2A pathway)

DocumentationDocumentation should demonstrate MSI‑H/dMMR status when required by the criteria

inv-31: Actionable molecular biomarkers — negative for actionable biomarkers (EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, ERBB2) with KRAS G12C exception note

Actionable biomarker negativityNegative for actionable molecular biomarkers required for metastatic NSCLC treated with durvalumab + tremelimumab + chemo (includes EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, ERBB2)

KRAS exceptionKRAS G12C mutation may be present (allowed) despite requirement for negative actionable biomarkers

PurposeEnsures absence of targetable alterations that would direct alternative targeted therapy

inv-32: MSI-H/dMMR — additional MSI-H/dMMR mention (empty summary in inventory)

MSI‑H/dMMR mentionMSI‑H/dMMR is cited as a required biomarker for neoadjuvant use in esophageal/esophagogastric junction or gastric cancer when used with tremelimumab (NCCN 2A)

No additional thresholdThe inventory entry has no separate numeric threshold beyond MSI‑H/dMMR status

Reference to documentationPolicy requires demonstration of MSI‑H/dMMR status where applicable

Provide details of prior systemic therapy regimens, dates, and responses; explicitly state whether the individual has received any prior anti–PD-1 or anti–PD-L1 agent.

Include ECOG performance status and reason for ineligibility for surgery when claiming inoperable disease.

Step Therapy

Prior Therapy / Induction Requirements

Prior therapy and induction requirements must be met for specific indications. Requests will be evaluated to ensure the individual meets the induction/initial therapy conditions or prior-treatment prerequisites in the clinical criteria.

For consolidation after definitive chemoradiation (e.g., unresectable stage III NSCLC): documentation that disease has not progressed following definitive concurrent chemoradiation and that durvalumab is being used as consolidation; maximum duration rules (e.g., up to 12 months for certain NSCLC indications) should be documented.
For maintenance therapy after initial combination regimens: documentation of initial systemic therapy (e.g., durvalumab/tremelimumab-actl plus chemotherapy) and that continuation maintenance use matches the approved pathway (single agent or combination with pemetrexed as specified).
For adjuvant use following neoadjuvant durvalumab with platinum-containing chemotherapy: documentation of completely resected tumor ≥4 cm and/or node-positive disease and absence of EGFR mutation or ALK rearrangement as required.
For first-line extensive-stage SCLC: documentation of use in combination with etoposide and platinum for the specified number of cycles followed by planned maintenance monotherapy as applicable.

Documentation Required

Provider Actions — Required Individual-Level Criteria

Criteria require that the individual has not received prior treatment with another anti–PD-1 or anti–PD-L1 agent for the specified indications unless the criteria explicitly allow prior use. Also confirm the individual is not receiving treatment for an autoimmune disease or chronic condition that requires systemic immunosuppressants when the indication excludes such concurrent therapy.

Many indications explicitly require no prior anti–PD-1/PD-L1 exposure (e.g., consolidation in unresectable stage III NSCLC, certain first-line and maintenance NSCLC and SCLC uses, and neoadjuvant/adjuvant pathways); verify prior immunotherapy history.
Where biomarker requirements exist (e.g., PD-L1 expression thresholds or MSI-H/dMMR), provide test results and date of testing.
Concurrent use notes: specify whether Imfinzi is being used as a single agent or in combination (e.g., with tremelimumab-actl, pemetrexed, platinum-based chemotherapy, etoposide) per the indication.

Denial Risk

Denial Risk / Not Approved Uses

Examples of uses that may not be approved: neoadjuvant Imfinzi in certain tumor types without required biomarker status (e.g., MSI-H/dMMR where specified), uses inconsistent with induction/maintenance pathways, or requests lacking documentation of prior therapies, tumor staging, performance status, or prior anti–PD-1/PD-L1 exposure.

Requests lacking documentation of ECOG performance status (required 0-1 or 0-2 depending on indication) risk denial.
Requests for indications or regimens not listed in the clinical criteria or without required biomarker proof may be denied.
Failure to document absence of concurrent systemic immunosuppression or active autoimmune disease where contraindicated may result in denial.

First‑line combination regimens:

Durvalumab in combination with platinum‑based chemotherapy ± tremelimumab (Imjudo) as first‑line therapy for indications where the policy lists combination use (eg, extensive‑stage SCLC, unresectable or liver‑confined uHCC with Imjudo, biliary tract cancer, MIBC neoadjuvant, metastatic NSCLC with Imjudo).

Biomarker restrictions (eg, PD‑L1, actionable molecular biomarkers, MSI‑H/dMMR) apply where specified in indication‑specific criteria.

first-line — additional document history

First‑line — document history / updated indications: Recent document history additions include FDA indications for gastric/GEJ cancer (12/08/2025), bladder cancer (MIBC, 05/16/2025), and prior updates clarifying limited‑stage SCLC single‑agent consolidation (12/09/2024) and neoadjuvant/adjuvant NSCLC criteria (09/09/2024). Clinical use should follow the corresponding indication‑specific criteria in the policy.

Material changes listed in document history — see revisions for effective dates and scope.

Use in policyUsed as an eligibility requirement in multiple indications (e.g., ECOG 0‑1 or 0‑2 as specified) and must be documented

inv-23: Extensive liver tumor burden — definition and contextual use in policy

Definition and useExtensive liver tumor burden referenced as a disease‑extent criterion for metastatic or liver‑confined inoperable disease; specific quantitative definition not provided in the policy excerpt

Contextual applicationUsed to determine eligibility for first‑line single‑agent durvalumab in unresectable/metastatic or liver‑confined inoperable disease

DocumentationPolicy notes documentation should demonstrate extensive liver tumor burden where applicable

inv-24: MSI-H/dMMR — definition and relevance to eligibility

DefinitionMSI‑H/dMMR: Microsatellite instability‑high or deficient mismatch repair tumor status

RelevanceRequired biomarker status for durvalumab in certain neoadjuvant/adjuvant regimens (e.g., esophageal/GEJ/gastric with tremelimumab; endometrial dMMR use)

Documentation requirementDocumentation should demonstrate MSI‑H/dMMR status when indicated by criteria

2024-12-09select_review

Updated clinical criteria to reflect FDA label approval for limited-stage small cell lung cancer single-agent use after concurrent chemoradiation (cCRT); references updated; coding reviewed (no changes).

2024-09-09select_review

Added FDA indication for neoadjuvant combination with platinum chemotherapy followed by adjuvant durvalumab for resectable NSCLC (tumors ≥4 cm and/or node positive) with no known EGFR/ALK alterations; included NCCN guidance for limited-stage SCLC and added hepatocellular carcinoma ICD-10-CM codes.

2024-08-16select_review

Added FDA indication for primary advanced or recurrent endometrial cancer and added ASCO 2024-related criteria for limited-stage SCLC; coding reviewed with several ICD-10-CM code additions.

2024-05-17annual_review

Updated criteria with NCCN recommendations and guidelines for NSCLC, biliary tract cancer, hepatocellular carcinoma, small NECC, esophageal/esophagogastric, and gastric cancers; added pancreatobiliary and mixed type disease to biliary tract cancer criteria and updated ICD-10-CM codes.

2024-02-23annual_review

Added NCCN 2A recommendation for pancreatobiliary and mixed type ampullary adenocarcinoma; references updated; coding reviewed (no changes).

2023-11-19select_review

Added NCCN 2A criteria for recurrent NSCLC combination use with Imjudo and clarified molecular biomarker requirements; added NCCN 2A criteria for Imjudo combinations in esophageal and esophagogastric junction cancers and gastric cancer.

2023-02-24annual_review

Added criteria for Stage II unresectable NSCLC, expanded use in advanced/metastatic NSCLC with Imjudo, added NCCN recommendations for continuation maintenance in NSCLC after Imjudo combination therapy, and added a 2A recommendation for first-line NECC of the cervix.