CurrentCentenePolicy CP.PHAR.339

Durvalumab (Imfinzi)

Centene clinical policy CP.PHAR.339 defines medical necessity, initial and continuation approval criteria, dosing limits, approval durations, and related requirements for durvalumab (Imfinzi) across multiple oncologic indications for Commercial, HIM/ICHRA, and Medicaid lines of business. This part (1 of 2) includes FDA-approved indications, many off-label supported indications, detailed indication-specific criteria, dose limits by weight, and approval durations.

Policy Summary

PayerCentene

PolicyDurvalumab (Imfinzi)

Policy CodePolicy CP.PHAR.339

Change TypeMultiple annual and RT4 revisions (2022-2026)

Effective DateJul 1, 2017

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added multiple FDA-approved indications over time (BTC, metastatic NSCLC, HCC, dMMR endometrial cancer, neoadjuvant/adjuvant resectable NSCLC, LS-SCLC, MIBC, resectable GC/GEJC).

Revised Commercial continued approval duration for injectables from 12 months to 6 months or to member's renewal date, whichever is longer.

Clarified NSCLC use constraints: must be prescribed as single agent for certain stages and exclude EGFR exon 19/21 L858R mutations in stage II-III; added first-line use for NRG1 fusion positive tumors; removed subsequent therapy uses for certain actionable alterations.

Added requirement for HCC use as single agent or in combination with Imjudo and added subsequent-line therapy option.

Clarified that the prior 12-month continued approval duration applied only to stage II-III NSCLC (01.05.23).

2Q 2022 annual review: for continued therapy, added requirement emphasizing NSCLC approval duration: 'For NSCLC requests, member has not received more than 12 months of Imfinzi therapy'; updated HCPCS code; references reviewed and updated.

References updated to include Imfinzi Prescribing Information November 2025 and multiple recent NCCN guideline versions (accessed Jan 2026).

Added HCPCS coding implication: J9173 (durvalumab 10 mg) for informational purposes.

Added ICHRA line of business.

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12+Indications addressed (FDA and off-label)

6 monthsCommercial continued approval duration

J9173Primary HCPCS code referenced

16Max cycles resectable NSCLC (revised)

<30kg/≥30kgWeight-based dosing scenarios

Coverage Summary

Coverage stance: covered with criteria for durvalumab (Imfinzi) across multiple FDA-approved and NCCN-supported off-label oncologic indications per clinical policy CP.PHAR.339. The policy applies to the following lines of business: Commercial, HIM/ICHRA, and Medicaid. Coverage is tied to indication-specific approval criteria and includes weight-based dosing limits and indication-specific duration caps (examples include ≤ 12 months for unresectable stage II-III NSCLC, up to 16 cycles for resectable NSCLC, and ≤ 24 months for LS-SCLC). When a requested use is not listed in the policy, the policy redirects requests to the appropriate off-label or formulary/no-coverage policies as described in the policy guidance.

Key thresholds

Age≥ 18 years

Weight cutoff< 30 kg vs ≥ 30 kg

Max duration — NSCLC (unresectable)≤ 12 months

Max cycles — NSCLC (resectable)Adjuvant up to 12 cycles after surgery (16 total cycles allowed by policy)

Max duration — LS-SCLC≤ 24 months

MIBC adjuvantUp to 8 cycles after surgery (12 total cycles allowed by policy)

Small bowel biomarker threshold> 50 mut/Mb (tumor mutational burden) for POLE/POLD1 ultra-hypermutated phenotype

Commercial continued approval duration6 months or to the member's renewal date, whichever is longer

Initial Therapy Criteria (by indication)

Continuation Therapy Criteria

Other / Off‑Label Routing and Exclusions

Requests for uses not listed in Section I are routed per the policy: if the drug had a recent label change within the last 6 months not yet reflected in CP.PHAR.339, follow the designated formulary/no-coverage or non-formulary policies (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16). If the requested use is not listed and no recent label change applies, refer to the off-label use policies for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53). The policy guidance specifies these exact policy references for routing and decision-making.

Applicable Codes

HCPCS - Primary drug code referencedHCPCS

J9173

Injection, durvalumab, 10 mg

HCPCS (informational)HCPCS

J9173

Injection, durvalumab, 10 mg

Provider Actions

Prior Authorization

Prior authorization required per clinical policy

Requests require prior authorization per the clinical policy. Prior authorization submissions must document the indication, disease stage, actionable biomarker status, line of therapy, and prior treatments. Specific duration limits apply by indication and line of therapy (example: Commercial continued approval duration for injectables = 6 months or to the member's renewal date; NSCLC continued therapy limits also noted).

Documentation Required

Submit supporting documentation

Providers must submit office chart notes, laboratory results, or other clinical information supporting that the member has met all approval criteria when requesting coverage.

Documentation Required

Biomarker and staging documentation

Clinical Evidence and References

Key evidence references include the Imfinzi Prescribing Information (Nov 2025) and the NCCN drug compendium and disease-specific guidelines for the relevant malignancies (NSCLC, SCLC, HCC, BTC, Bladder, Gastric/Esophageal), with guideline versions and compendium access dates through 2025–2026 cited in the policy references.

Background

Background: Durvalumab (Imfinzi) is a PD-L1 blocking antibody with multiple FDA-approved indications (including unresectable stage III NSCLC after concurrent chemoradiation, resectable NSCLC in the neoadjuvant/adjuvant setting, LS-SCLC, ES-SCLC in combination with chemotherapy, BTC, HCC, dMMR endometrial cancer, MIBC, and GC/GEJC) and several additional off-label or NCCN-supported uses. The policy aligns coverage to indication-specific clinical criteria, requires documentation and prescriber attestation where applicable, enforces weight-based dose limits (<30 kg vs ≥30 kg scenarios), and sets duration caps by indication. When requested uses are not listed or there is a recent label change, the policy refers requests to the applicable off-label or formulary/no-coverage policies.

Definitions

dMMRMismatch repair deficient

MSI-HMicrosatellite instability-high

MIBCMuscle invasive bladder cancer

Policy Revision History

02.15.22revised

2Q 2022 annual review: for continued therapy, added requirement reemphasizing NSCLC approval duration that member has not received more than 12 months of Imfinzi therapy; updated HCPCS coding and references reviewed/updated.

09.09.22added

RT4: Added criteria for newly FDA-approved indication of biliary tract cancer (BTC); added off-label criteria for hepatocellular carcinoma (HCC) per NCCN 2A; added age ≥18 requirement for NSCLC and ES-SCLC; template changes applied across indications.

12.02.22added

Policy Summary

PayerCentene

PolicyDurvalumab (Imfinzi)

Policy CodePolicy CP.PHAR.339

Change TypeMultiple annual and RT4 revisions (2022-2026)

Effective DateJul 1, 2017

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member has met all approval criteria.

SourceLink

On This Page

Documentation must include actionable molecular biomarker status (e.g., EGFR exon 19/21, ALK, ROS1, NRG1, dMMR/MSI-H and other listed biomarkers), disease stage (for example stage II-III NSCLC, LS-SCLC), prior therapies (e.g., adjuvant chemoradiation, platinum-based regimens), and treatment intent (curative/resectable/unresectable) as required by the indication-specific criteria.

Billing Rule

Dose limits by weight

Dose must not exceed the policy's specified mg/kg or flat-dose limits by weight category (<30 kg vs ≥30 kg) for each indication. Requests for dose increases must meet the new-dose limits described in the continued-therapy/dose-increase sections. Detailed weight-based limits and thresholds are provided in the criteria trees and the Dosage and Administration/dose scenarios sections of the policy.

Billing Rule

Code usage and coding guidance

HCPCS code J9173 (Injection, durvalumab, 10 mg) is referenced for durvalumab for informational coding purposes; inclusion does not guarantee coverage. Providers should reference the most current professional coding guidance prior to claim submission.

Prior Authorization

Prior authorization required and regimen restrictions

Prior authorization is required and prescribed regimens must be FDA‑approved or recommended by NCCN. For off‑label dosing or regimens, the prescriber must submit supporting evidence (practice guidelines or peer‑reviewed literature). When generic durvalumab is available, use of generic product is expected unless contraindicated or clinically significant adverse effects are documented.

Documentation Required

Provider attestation for surgical fitness

For certain neoadjuvant or adjuvant uses (for example GC/GEJ, esophageal/GEJ dysphagia, and resectable NSCLC/MIBC), the provider must attest that the member is medically fit for surgery; when indicated (esophageal/GEJ induction therapy) the provider must attest the patient is planned for esophagectomy.

RT4: Added criteria for newly FDA-approved indications for metastatic NSCLC and HCC and converted HCC from off-label to FDA-approved status.

01.05.23clarified

Clarified that the maximum 12-month continued approval duration applies only to unresectable stage II-III NSCLC (policy applies only to stage II-III NSCLC).

2Q 2023revised

Per NCCN Compendium: added recurrent/advanced NSCLC uses and additional actionable molecular biomarkers for combination with Imjudo and platinum therapy; added off-label continuation maintenance therapy and off-label cervical cancer use; clarified continued approval duration applicability.

02.06.24revised

2Q 2024 annual review: for NSCLC, added recommended uses when actionable molecular biomarkers are present; BTC: added resected gross residual (R2); added off-label uses for gastric, esophageal/GEJ, and ampullary adenocarcinoma; added redirection to generic if available.

06.20.24added

RT4: Added criteria for newly FDA-approved indication of dMMR endometrial cancer (including FDA-approved testing language).

08.22.24added/revised

RT4: Added criteria for newly FDA-approved neoadjuvant/adjuvant use in resectable NSCLC; revised Commercial continued approval duration from 12 months to standard injectable duration (6 months or to member's renewal date, whichever is longer).

12.11.24added

RT4: Added criteria for newly FDA-approved indication for limited-stage small cell lung cancer (LS-SCLC).

2Q 2025revised

Per NCCN (2Q 2025): For NSCLC, required Imfinzi be prescribed as a single agent for stage II-III and disease must not have EGFR exon 19 deletion or exon 21 L858R mutation; added first-line use for NRG1 fusion positive tumors; removed subsequent therapy uses for certain actionable alterations; added qualifiers for HCC (extrahepatic) and endometrial cancer staging; added MIBC criteria; revised continued approval durations and cycle counts (resectable NSCLC cycles revised to include neoadjuvant).

12.02.25added/revised

RT4: Added criteria for newly FDA-approved neoadjuvant/adjuvant indication for resectable GC/GEJC with FLOT; added off-label induction therapy for esophageal/GEJ adenocarcinoma; adjusted initial approval durations for Medicaid/HIM (extended from 6 to 12 months) and updated Commercial wording for renewal date; references updated; Imfinzi Prescribing Information noted November 2025.

03.30.26revisedLatest

2Q 2026 annual review: Per NCCN, added option for NSCLC after completion of adjuvant chemoradiation; SCLC: option for combination with etoposide plus carboplatin/cisplatin as subsequent therapy if prolonged disease-free interval; BTC: allow carboplatin if cisplatin ineligible; HCC: added subsequent-line therapy option and specified use as single agent or with Imjudo; endometrial cancer: option for pMMR disease with Lynparza; GC/GEJC: removed PD-L1 CPS/TAP requirement; added off-label small bowel adenocarcinoma criteria; added ICHRA line of business; references reviewed/updated (NCCN versions through Jan 2026).

ongoingaddedLatest

References updated to include Imfinzi Prescribing Information (Nov 2025) and multiple NCCN guideline versions accessed January 2026; HCPCS coding J9173 included for informational purposes; policy documents indicate coding inclusion does not guarantee coverage.