Neighborhood Health Plan of Rhode Island durvalumab Coverage Update

Coverage Criteria for Durvalumab (Imfinzi)

Biliary Tract Cancer — Initial Therapy

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

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

Bladder Cancer — Perioperative/Adjuvant

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

Bladder perioperative use: Adult member with muscle invasive bladder cancer (MIBC); durvalumab (Imfinzi) used as neoadjuvant treatment 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.up to 4 cycles neoadjuvant; up to 8 cycles adjuvant

Endometrial Cancer — dMMR

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

Endometrial dMMR regimen: Adult member with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR); durvalumab (Imfinzi) 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 tremelimumab + durvalumab: Member has unresectable hepatocellular carcinoma (BCLC stage B or C) with Child‑Pugh Class A (policy restricts to Class A) and no prior systemic treatment including prior checkpoint inhibitors; durvalumab (Imfinzi) will be used as first‑line therapy in combination with tremelimumab (Imjudo) where tremelimumab is given for one cycle followed by single‑agent durvalumab maintenance.Child‑Pugh Class A only per eligibility note

References BCLC staging and Child‑Pugh scoring

NSCLC — Consolidation, First-line Metastatic, Neoadjuvant/Adjuvant

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

NSCLC consolidation: Member with unresectable stage II or III NSCLC who has completed definitive concurrent chemoradiation and post‑chemoradiation imaging (CT or PET/CT) documents no disease progression (complete response, partial response, or stable disease); single‑agent durvalumab (Imfinzi) may be used as consolidation for up to 1 year.up to 1 year

Imaging required (CT or PET/CT) showing CR/PR/SD

NSCLC first-line metastatic regimen: Adult member with metastatic (Stage IV) NSCLC with no prior systemic therapy and tumor negative for EGFR and ALK; durvalumab (Imfinzi) may be used in combination with tremelimumab (Imjudo) and platinum‑based chemotherapy for up to 4 cycles, followed by maintenance durvalumab with one dose of tremelimumab and optional pemetrexed.up to 4 cycles induction

PD‑L1 expression not required

NSCLC neoadjuvant/adjuvant:

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; durvalumab (Imfinzi) may be used in combination with carboplatin or cisplatin plus etoposide for first‑line therapy, followed by single‑agent durvalumab maintenance.

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 completion of concurrent platinum‑based chemotherapy and radiation therapy; durvalumab (Imfinzi) may be used as consolidation therapy.

Requests for durvalumab (Imfinzi) will be excluded or denied when the proposed use is investigational or lacks sufficient evidence as defined in this policy. Specific exclusion examples include: disease progression while receiving durvalumab or a prior PD-1/PD-L1 checkpoint inhibitor; absence of required post-chemoradiation imaging to confirm no progression for NSCLC consolidation; progression during or after concurrent chemoradiotherapy for locally advanced NSCLC; or use for an off-label indication without supportive evidence in CMS-recognized compendia or acceptable peer-reviewed literature. The policy defines sufficiency of evidence by whether patient and regimen characteristics are represented in published evidence, whether outcomes are clinically meaningful (ASCO-recommended benchmarks such as hazard ratio < 0.80 or survival benefits of at least 3 months), and by the methodological quality of the supporting studies (e.g., randomized trials preferred; case reports and abstracts without full articles do not adequately support accepted uses).

The references section provides the primary trial and guideline citations used to support coverage determinations and dosing/regimen decisions. Key cited trials and sources include randomized and phase III studies such as NIAGARA (perioperative bladder cancer), POSEIDON, ADRIATIC, AEGEAN, DUO-E, Abou-Alfa et al. for HCC, the CASPIAN and PACIFIC trials for lung cancer, and the Imfinzi prescribing information and major compendia (Clinical Pharmacology, Micromedex, NCCN, AHFS). These references are informational and should be consulted to verify regimen details, populations studied, and reported outcomes when evaluating off-label or borderline requests.

Dosing limits and maximum single-dose/regimen thresholds specified in this policy must be observed. Single-agent durvalumab dosing should not exceed 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks, and when combined with chemotherapy should not exceed 20 mg/kg every 3 weeks or a maximum of 1500 mg every 3 weeks. A total single-agent or combination regimen must also respect the policy-specified pediatric/weight-based exception when used with tremelimumab: if weight is <30 kg the maximum single dose is 20 mg/kg every 4 weeks; for weight ≥30 kg the maximum single dose is 1500 mg every 4 weeks. Exceeding these single-dose limits or the maximum duration for NSCLC consolidation (see coding thresholds) will render the request noncompliant with the policy.

The references list in this document does not itself state explicit not‑medically‑necessary determinations. Instead, it catalogs the clinical trials, prescribing information, and compendia (e.g., PACIFIC, CASPIAN, POSEIDON, NIAGARA, AEGEAN; Imfinzi prescribing information; Clinical Pharmacology; Micromedex; NCCN; AHFS) that inform the coverage criteria and the policy’s exclusion/denial rules. Coverage decisions and not‑medically‑necessary findings are derived from the policy language and evidence appraisal rather than from the reference list entries alone.

Regimens and Combination Therapies Included

Regimen	Indication	Notes/Caveats
Tremelimumab (single cycle) followed by durvalumab maintenance
Unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy
Child-Pugh Class A only per eligibility; tremelimumab given for one cycle then single-agent durvalumab

Regimen	Indication	Notes/Caveats
Durvalumab + tremelimumab + platinum-based chemotherapy for up to 4 cycles, followed by maintenance durvalumab ± one dose tremelimumab and optional pemetrexed
Metastatic or Stage IV non–small cell lung cancer (NSCLC) in adults with tumors negative for EGFR and ALK
Induction up to 4 cycles; maintenance with durvalumab with one dose tremelimumab and optional histology-based pemetrexed; PD-L1 expression not required

Regimen	Indication	Notes/Caveats
Durvalumab + carboplatin or cisplatin + etoposide followed by durvalumab maintenance
Extensive-stage small cell lung cancer (ES-SCLC) in adults
Regimen supported by CASPIAN and other trials; followed by single-agent durvalumab maintenance

Regimen (trial or source)	Tumor type / Setting	Source / Notes
Perioperative durvalumab with neoadjuvant chemotherapy (AEGEAN)
Resectable NSCLC (perioperative)
AEGEAN trial; see Heymach JV et al., N Engl J Med 2023; referenced in policy references
Durvalumab + platinum–etoposide (CASPIAN)
First-line extensive-stage SCLC
CASPIAN phase 3 trial; referenced in policy references
Durvalumab after chemoradiotherapy (PACIFIC)
Unresectable stage III NSCLC — consolidation
PACIFIC phase 3 trial; referenced in policy references
Durvalumab + gemcitabine + cisplatin (NIAGARA)
Perioperative/neoadjuvant in bladder cancer / biliary tract cancer contexts as applicable
NIAGARA/NEJM Evid and other trial publications cited in references; consult prescribing information and trial reports for dosing specifics

Billing and Coding

HCPCS CodesHCPCSCovered

J9173

Injection, durvalumab, 10 mg

Maximum NSCLC consolidation duration

Maximum consolidation durationUp to 12 months (single-agent durvalumab after definitive chemoradiation)

Required post-chemoradiation imagingCT or PET/CT documenting no disease progression (CR/PR/SD) prior to starting consolidation

Applicable disease stageUnresectable stage II or III NSCLC following definitive chemoradiation

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization references

Prior authorization is required for Imfinzi (durvalumab) requests. Authorization decisions must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards. Prescribing information and drug compendia cited in the policy (e.g., Imfinzi prescribing information; Clinical Pharmacology; Micromedex; NCCN Drugs & Biologics Compendium; AHFS) are acceptable reference sources.

Support authorization with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.
Acceptable compendia and references listed in policy: Imfinzi PI; Clinical Pharmacology; Micromedex; NCCN; AHFS.

Denial Risk

Triggers for denial

Denial may be triggered when documentation shows disease progression on the requested medication or on a prior checkpoint inhibitor (PD‑1/PD‑L1), when required post‑chemoradiation imaging for NSCLC consolidation is missing or does not confirm no progression, when dosing or duration exceed specified limits, or when the requested use is investigational/off‑label without sufficient supporting evidence.

Line-of-Therapy Designations

first-line

Covered when ALL of the following are met for first‑line therapy:

First‑line general: Indication corresponds to first‑line use as specified in the disease‑specific criteria (member naive to prior systemic therapy for the indication).

first-line

Covered when ALL of the following are met for first‑line therapy:

HCC first‑line: Unresectable hepatocellular carcinoma with no prior systemic treatment; durvalumab with single‑cycle tremelimumab induction followed by durvalumab maintenance (Child‑Pugh A eligibility restriction applies).

Child‑Pugh A restriction

salvage

Covered when ANY of the following salvage or subsequent‑therapy scenarios are met:

Biomarkers and Eligibility

dMMR requirement for endometrial cancer

Biomarker requiredTumor must be mismatch repair deficient (dMMR)

Indication contextPrimary advanced or recurrent endometrial cancer

RegimenDurvalumab in combination with carboplatin and paclitaxel followed by single-agent durvalumab

EGFR and ALK negative tumor requirement for NSCLC

Tumor biomarker requirementTumor must be negative for EGFR and ALK for first-line metastatic/Stage IV NSCLC regimen

Regimen contextDurvalumab + tremelimumab + platinum-based chemotherapy for up to 4 cycles followed by maintenance durvalumab

Definitions and Reference Terms

Child-Pugh score classification

Child-Pugh Class A5–6 points

Child-Pugh Class B7–9 points

Child-Pugh Class C10–15 points

Imfinzi prescribing information (AstraZeneca) — 2025 citation

Manufacturer prescribing information (Imfinzi)Imfinzi prescribing information. AstraZeneca Pharmaceuticals LP. Wilmington, DE 2025.

Supporting compendia listedClinical Pharmacology Elsevier Gold Standard 2025; Micromedex Drugdex 2025; AHFS Drug Information 2025

Use in document

References and Evidence Cited

Selected references cited in this guideline include pivotal randomized trials and major sources used to support the coverage criteria: PACIFIC (durvalumab after chemoradiotherapy in stage III NSCLC), CASPIAN (durvalumab plus platinum‑etoposide in ES‑SCLC), POSEIDON (durvalumab ± tremelimumab with chemotherapy in metastatic NSCLC), NIAGARA (perioperative durvalumab in bladder cancer), AEGEAN (perioperative durvalumab in resectable NSCLC), ADRIATIC (durvalumab consolidation in LS‑SCLC), DUO‑E (durvalumab in advanced endometrial cancer), and pivotal HCC and BTC studies (Abou‑Alfa et al.; Oh et al.). The Imfinzi prescribing information and major compendia (Clinical Pharmacology, Micromedex, NCCN, AHFS) are also listed for dosing, safety, and regulatory context.

Policy Revision History

June 2025material_changeLatest

Updated NSCLC indication to allow maintenance therapy with tremelimumab +/- pemetrexed after first-line platinum‑based chemotherapy plus tremelimumab and durvalumab when restaging shows stability or response; marked as a material change.

May 2025administrative_and_substantive

Converted to the new Evolent guideline template and replaced prior guideline UM ONC_1314; added a new indication for bladder cancer and updated references.

January 2025

OpenPayer

Imfinzi (durvalumab) — Coverage Criteria