Imfinzi (durvalumab) — Coverage Criteria for Oncology Indications
Defines prior authorization, coverage criteria, dosing, and duration for Imfinzi (durvalumab) across FDA-approved and select evidence-supported oncology indications for adult patients; applies to CareSource medical benefit management and providers requesting coverage.
Biliary Tract Cancers: Patient has resectable locally advanced disease added as new option of approval with a total duration of approval of 6 months.
Non-Small Cell Lung Cancer: Exon 21 was added as descriptor for exon 21 L858R mutation positive disease.
Ampullary Adenocarcinoma and Cervical Cancer: Added new conditions of approval.
Recommended Authorization and Coverage Criteria
Initial and indication-specific therapy
Covered when patients meet the specific indication-specific criteria below (age, diagnosis, line of therapy, biomarker status, combination regimen, prescriber requirement, and dosing).
FDA-Approved Indications
- Biliary Tract Cancer (neoadjuvant or metastatic): Neoadjuvant: Patient >=18 years; gallbladder cancer; medication used as neoadjuvant; prescribed by or in consultation with an oncologist; OR medication used in combination with cisplatin and gemcitabine. Metastatic/recurrent: Patient >=18 years; recurrent disease occurred >=6 months after surgery and >=6 months after adjuvant therapy when applicable; tumor subtype is gallbladder, intrahepatic, or extrahepatic cholangiocarcinoma as specified; medication used in combination with cisplatin and gemcitabine; prescribed by or in consultation with an oncologist.
Dosing: For body weight >=30 kg: 1,500 mg IV every 3 weeks; for body weight <30 kg: 20 mg/kg IV every 3 weeks. Duration: approve as noted; history adds 6 months for resectable locally advanced disease option.
- Endometrial Cancer: Patient >=18 years; primary advanced or recurrent disease; tumor is mismatch repair deficient (dMMR); medication used in combination with carboplatin and paclitaxel (for 6 cycles) OR used as a single agent as specified; prescribed by or in consultation with an oncologist.
Dosing: In combination with carboplatin+paclitaxel: 1,120 mg IV every 3 weeks (or 15 mg/kg IV every 3 weeks) for 6 cycles. Single-agent dosing: for >=30 kg: 1,500 mg IV every 4 weeks (or 20 mg/kg IV every 4 weeks for <30 kg). Approve for 1 year.
- Hepatocellular Carcinoma: Patient >=18 years; first-line use for liver-confined unresectable disease in patients not eligible for transplant OR metastatic/extrahepatic disease where prescriber indicates patient is not eligible for resection, transplant, or locoregional therapy; Imfinzi used as monotherapy OR in combination with tremelimumab (Imjudo); prescribed by or in consultation with an oncologist.
Dosing: For >=30 kg: 1,500 mg IV every 4 weeks; for <30 kg: 20 mg/kg IV every 4 weeks. Approve for 1 year.
- Non-Small Cell Lung Cancer (NSCLC): Patient >=18 years AND either: (A) unresectable Stage III disease with no progression after concurrent platinum-based chemoradiation for use as consolidation therapy (per guidelines; performance status 0–1 recommended) OR (B) recurrent/advanced/metastatic disease where the tumor is negative for actionable molecular markers OR fits specified mutation-positive scenarios with prior targeted therapy requirements as noted; medication prescribed by or in consultation with an oncologist.
Dosing options include: 10 mg/kg IV every 2 weeks OR 1,500 mg IV every 3 weeks OR 20 mg/kg IV every 3 weeks depending on body weight and indication. Note: Examples of actionable markers include EGFR, ALK, ROS1; KRAS G12C is not considered an actionable mutation for excluding first-line use without targeted therapy.
- Small Cell Lung Cancer (SCLC): Patient >=18 years with extensive-stage disease; medication used in combination with etoposide and platinum chemotherapy as first-line therapy; medication may be used as single-agent maintenance after chemotherapy; prescribed by or in consultation with an oncologist.
Dosing: For >=30 kg: 1,500 mg IV every 3 weeks OR 20 mg/kg IV every 3 weeks in combination; alternative 10 mg/kg IV every 2 weeks. Approve for 1 year.
Other uses with supportive evidence
Other uses with supportive evidence — coverage allowed when criteria are met
Evidence-supported indications
- Ampullary Adenocarcinoma: Patient >=18 years; unresectable localized or metastatic pancreatobiliary or mixed-type disease; medication used in combination with gemcitabine and cisplatin as first-line therapy; prescribed by or in consultation with an oncologist.
Dosing: For >=30 kg: 1,500 mg IV every 3 weeks; for <30 kg: 20 mg/kg IV every 3 weeks. Approve for 1 year.
- Esophageal/Esophagogastric Junction and Gastric Cancer (neoadjuvant): Patient >=18 years; adenocarcinoma (esophageal) or locoregional gastric disease; tumor is microsatellite instability-high (MSI-H) or dMMR; Imfinzi used as neoadjuvant therapy in combination with tremelimumab (Imjudo); patient is medically fit for surgery; prescribed by or in consultation with an oncologist.
Dosing: 1,500 mg IV administered by infusion not more frequently than three times in a single 12-week cycle. Esophageal approval duration: 3 months; gastric criteria similar.
- Cervical small cell neuroendocrine carcinoma: Patient >=18 years with persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix; medication used in combination with etoposide and platinum chemotherapy OR used as single-agent maintenance as specified; prescribed by or in consultation with an oncologist.
Dosing: weight-based dosing options per general dosing guidance; approve for 1 year.
Coverage of Imfinzi (durvalumab) is limited to the circumstances specifically described in the Recommended Authorization Criteria. Coverage is not recommended for circumstances that are not listed in those criteria; the criteria will be updated as new published data become available.
Any request for Imfinzi that does not meet the applicable Recommended Authorization Criteria is not recommended for approval and may be considered not medically necessary. Requests outside the stated criteria are subject to denial.
Specified Combination and Single-Agent Regimens
| Regimen / Setting | Indication (age & disease) | Combination or Maintenance Use | Dosing options (weight-dependent) | Coverage status |
|---|---|---|---|---|
| Cisplatin + gemcitabine (with Imfinzi) | Biliary tract cancer (gallbladder, intrahepatic, extrahepatic cholangiocarcinoma); patient ≥18 years for neoadjuvant or metastatic disease | Used as neoadjuvant therapy or for metastatic/recurrent disease (combination with cisplatin + gemcitabine) | For combination: 1,500 mg IV every 3 weeks OR 20 mg/kg IV every 3 weeks (weight-dependent options noted) | Covered |
| Gemcitabine + cisplatin (with Imfinzi) | Ampullary adenocarcinoma; patient ≥18 years with unresectable localized or metastatic pancreatobiliary/mixed type disease | First-line combination with gemcitabine + cisplatin | For patients ≥30 kg: 1,500 mg IV every 3 weeks; for patients <30 kg: 20 mg/kg IV every 3 weeks | Covered (evidence-supported) |
| Carboplatin + paclitaxel (with Imfinzi) | Endometrial cancer, primary advanced or recurrent disease with dMMR; patient ≥18 years | Combination for 6 cycles followed by single‑agent Imfinzi maintenance as specified | Combination: 1,120 mg IV every 3 weeks OR 15 mg/kg IV every 3 weeks for combination; Maintenance single‑agent: 1,500 mg IV every 4 weeks OR 20 mg/kg IV every 4 weeks (weight-dependent) | Covered |
| Tremelimumab (Imjudo) + Imfinzi | Hepatocellular carcinoma (unresectable or metastatic) and neoadjuvant esophageal/EGJ or gastric adenocarcinoma with MSI‑H/dMMR; patient ≥18 years | HCC: monotherapy or in combination with tremelimumab per indication; Esophageal/EGJ and gastric (neoadjuvant): used in combination with tremelimumab for patients fit for surgery | HCC and other weight-based options: 1,500 mg IV every 4 weeks OR 20 mg/kg IV every 4 weeks; Neoadjuvant esophageal/EGJ/gastric: 1,500 mg IV administered not more frequently than three times in a 12‑week cycle | Covered (HCC) / Covered (neoadjuvant esophageal/gastric, evidence-supported) |
| Etoposide + platinum (cisplatin or carboplatin) with Imfinzi | Small cell lung cancer (extensive-stage) and cervical small cell neuroendocrine carcinoma; patient ≥18 years | First-line combination with etoposide + platinum; single‑agent Imfinzi may be used as maintenance after chemotherapy | For combination/maintenance: 1,500 mg IV every 3 weeks OR 20 mg/kg IV every 3 weeks; alternative dosing: 10 mg/kg IV every 2 weeks as noted | Covered (SCLC) / Covered (cervical small cell, evidence-supported) |
| Single‑agent Imfinzi (maintenance or monotherapy) | Indication-specific single‑agent use per approval (e.g., NSCLC consolidation after chemoradiation; maintenance after SCLC chemotherapy; endometrial maintenance after combo); patient ≥18 years | Used as consolidation or maintenance or single‑agent therapy as specified by indication and prescriber | Dosing varies by indication and weight: examples include 1,500 mg IV every 3 or 4 weeks, 20 mg/kg IV every 3 or 4 weeks, or 10 mg/kg IV every 2 weeks per indication-specific guidance | Covered |
Drug and Billing Codes
| durvalumab | Imfinzi (durvalumab) - HCPCS/NDC not explicitly listed in document |
Prior Authorization, Prescribing, and Documentation Requirements
Prior Authorization Required
Prior Authorization is recommended for medical benefit coverage of Imfinzi. Approval is recommended for members who meet the conditions of coverage in the Criteria and Dosing for the listed indications. Approvals are provided for the duration noted in the policy; extended approvals may be allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Imfinzi, approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, an oncologist for cancer indications). Automation: None.
- Prior authorization recommended for medical benefit coverage of Imfinzi.
- Approvals issued only when member meets the policy's Criteria and Dosing; extended approvals allowed if criteria continue to be met.
- Dose exceptions (requests outside established dosing) reviewed case-by-case by clinician (Medical Director or Pharmacist).
- Prescribing requirement: must be prescribed by or in consultation with a specialist in the treated condition (e.g., oncologist).
Targeted Therapy Before Immunotherapy (NSCLC)
For non-small cell lung cancer (NSCLC) with actionable driver mutations, Imfinzi coverage requires that targeted therapy appropriate to the detected mutation has been received prior to initiation of Imfinzi when specified in the Criteria. Examples of targeted therapies include afatinib (Gilotrif), osimertinib (Tagrisso), erlotinib, gefitinib (Iressa), crizotinib (Xalkori), ceritinib (Zykadia), alectinib (Alecensa), brigatinib (Alunbrig), lorlatinib (Lorbrena), entrectinib (Rozlytrek), and dacomitinib (Vizimpro). Documentation of the mutation status and prior targeted therapy must be provided in the medical record.
- Targeted therapy must have been received prior to Imfinzi for patients with EGFR exon 19 deletion or exon 21 L858R mutation, ALK rearrangement, ROS1 rearrangement, MET exon 14 skipping mutation, RET rearrangement when required by the Criteria.
- Provide documentation of mutation testing results and prior targeted drug therapy in the medical record.
Specialist Prescribing Requirement
Because of the complexity of diagnosis, treatment selection, and adverse event management for conditions treated with Imfinzi, the drug should be prescribed by — or in consultation with — a physician who specializes in the treated condition (for example, an oncologist for cancer indications). The specialist requirement applies to initial and subsequent therapy and must be documented in the prior authorization request and the member's medical record.
- Prescriber must be a specialist in the treated condition or the prescription must document consultation with such a specialist.
- Specialist prescribing/consultation must be evident in submitted documentation for prior authorization.
Non‑listed Indications — Not Recommended for Approval
Coverage of Imfinzi is not recommended for indications and circumstances not explicitly listed in the Recommended Authorization Criteria. Requests for use outside these listed indications may be denied. The Criteria will be updated as new published data become available; clinicians may review off-label requests on a case-by-case basis but such requests do not imply coverage.
- Coverage not recommended for circumstances not listed in the Recommended Authorization Criteria.
- Requests for off-label or non-listed indications may be denied; provide full supporting documentation if requesting review.
- Policy Criteria will be updated when new published evidence is available; dose or indication exceptions are reviewed case-by-case by clinical staff.
Indication-Specific Line of Therapy Rules
first-line | neoadjuvant | consolidation | maintenance
Line of therapy examples
- First-line: Used as first-line in hepatocellular carcinoma (monotherapy or in combination with tremelimumab), biliary tract cancer in combination with cisplatin+gemcitabine, ampullary adenocarcinoma first-line with gemcitabine+cisplatin, and small cell lung cancer first-line with etoposide+platinum.
- Neoadjuvant use described for esophageal/EGJ and gastric MSI-H/dMMR disease in combination with tremelimumab for patients medically fit for surgery; biliary tract neoadjuvant use also included.
- Consolidation/Maintenance: Consolidation: NSCLC after definitive concurrent platinum-based chemoradiation for unresectable stage II–III disease with no progression. Maintenance: SCLC as single-agent maintenance after chemotherapy as specified in guidelines.
Biomarker and Molecular Testing Requirements
Background and Drug Information
Imfinzi (durvalumab) is a programmed cell death ligand 1 (PD-L1) blocking antibody used as monotherapy or in combination regimens across multiple tumor types. It is applied in settings that include first-line, neoadjuvant, consolidation, and maintenance therapy for cancers such as biliary tract, endometrial (dMMR), hepatocellular, non-small cell and small cell lung cancers, as well as select evidence-supported indications. National guidelines (NCCN) and the product prescribing information guide indication-specific use, dosing, and duration.
Key Definitions and Drug Identifier
Policy Revision History
Biliary tract cancers: patient has resectable locoregionally advanced disease added as new option of approval with a total duration of approval of 6 months; Non‑Small Cell Lung Cancer: exon 21 added as descriptor for exon 21 L858R mutation–positive disease; Ampullary adenocarcinoma and cervical cancer: added new conditions of approval.
Esophageal and esophagogastric junction cancer and gastric cancer: added new conditions of approval.
Biliary tract cancers: revised wording to 'resectable locoregionally advanced disease' and updated options for unresectable/resected gross residual/metastatic disease; Endometrial cancer: added new condition of approval; Hepatocellular carcinoma: updated liver‑confined/unresectable and added prescriber‑based eligibility options; NSCLC: specified KRAS G12C is not considered an actionable mutation and removed KRAS G12C as an approval option; Cervical cancer: added single‑agent maintenance as an approval option.
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