Blue Cross Blue Shield TN durvalumab Coverage Update

Coverage criteria by indication

Endometrial Carcinoma (advanced or recurrent)

Endometrial carcinoma — authorization may be granted when ALL of the following are met

Endometrial carcinoma criteria: The requested medication will be used in combination with carboplatin and paclitaxel followed by use as a single agent.

Authorization of 6 months may be granted.

Endometrial carcinoma biomarker: The tumor is deficient mismatch repair (dMMR).

Authorization of 6 months may be granted.

Bladder Cancer (stage II or IIIA perioperative)

Bladder cancer perioperative/sandwich treatment — authorization may be granted when the following is met

Bladder cancer perioperative: Requested medication will be used in combination with gemcitabine and cisplatin prior to cystectomy followed by single agent therapy after surgery.

Authorization of 6 months may be granted for stage II or IIIA bladder cancer.

Gastric/GEJ/Esophageal Adenocarcinoma

Gastric, GEJ, and Esophageal Adenocarcinoma — neoadjuvant and perioperative scenarios

Neoadjuvant with tremelimumab-actl: The member is medically fit for surgery.

Authorization of 3 months for a total of 3 doses may be granted when used in combination with tremelimumab-actl for neoadjuvant treatment; reauthorization only if the member did not receive 3 doses from initial approval.

Neoadjuvant with tremelimumab-actl - biomarker: The tumor is microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).dMMR / MSI-H

Authorization of 3 months (3 doses) may be granted.

Neoadjuvant combination: Requested medication will be used in combination with tremelimumab-actl (Imjudo) for neoadjuvant treatment.

Authorization of 3 months (3 doses) may be granted.

Ampullary Adenocarcinoma (first-line metastatic)

Ampullary adenocarcinoma — first-line metastatic

Ampullary adenocarcinoma criteria: The requested medication will be used in combination with cisplatin and gemcitabine.

Authorization of 6 months may be granted.

Ampullary adenocarcinoma histology: The disease is pancreatobiliary or mixed type.

Authorization of 6 months may be granted.

Cervical Cancer (NECC)

Cervical cancer — small cell neuroendocrine carcinoma

Cervical NECC criteria: Requested medication will be used in combination with etoposide and either cisplatin or carboplatin and continued as single agent maintenance therapy.

Authorization of 6 months may be granted for persistent, recurrent, or metastatic NECC.

Colorectal and Small Bowel Adenocarcinoma

Colorectal and small bowel adenocarcinoma (draft items) — resectable/advanced settings

Colorectal adenocarcinoma draft: Requested medication will be used as a single agent.

Authorization of 6 months may be granted (draft - Do Not Implement).

Colorectal adenocarcinoma biomarker: The tumor is mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) or polymerase epsilon/delta (POLE/POLD1) mutation with ultra-hypermutated phenotype (TMB > 50 mut/Mb).TMB > 50 mut/Mb for POLE/POLD1 ultra-hypermutated phenotype

Authorization of 6 months may be granted (draft - Do Not Implement).

Small bowel adenocarcinoma: Requested medication will be used as a single agent; the tumor is dMMR/MSI-H or POLE/POLD1 mutation with ultra-hypermutated phenotype.TMB > 50 mut/Mb

Pleural Mesothelioma

Pleural mesothelioma — first-line unresectable

Pleural mesothelioma criteria: Requested medication will be used in combination with pemetrexed and either cisplatin or carboplatin.

Authorization of 6 months may be granted.

Reauthorization / Continued Treatment

Continued treatment / reauthorization rules

NSCLC reauthorization: Any of: 1) Member has recurrent, advanced or metastatic NSCLC with no evidence of unacceptable toxicity or disease progression while on the current regimen; 2) Member has unresectable stage II or III NSCLC with no evidence of unacceptable toxicity or disease progression while on the current regimen (up to 12 months total); 3) Member has resectable NSCLC with no evidence of unacceptable toxicity or disease progression while on the current regimen (up to 12 cycles after surgery).

Authorization of 6 months may be granted for continued treatment.

Limited stage SCLC reauthorization: No evidence of unacceptable toxicity or disease progression while on the current regimen.

Up to 24 months total; authorization of 6 months may be granted for continued treatment.

Bladder cancer reauthorization: No evidence of unacceptable toxicity or disease progression while on the current regimen (up to 12 cycles).

Authorization of 6 months may be granted (draft line indicates Do Not Implement for some items).

Some entries in the coverage criteria are labeled "Medical Policy Manual Draft Revision Policy: Do Not Implement". These labels indicate that the associated items are draft language and are not to be used for authorization decisions until the draft status is removed and the policy finalized. Draft text may appear alongside finalized criteria in this document; when a draft label is present, treat the item as informational only and do not implement it for prior authorization or clinical decision-making.

When submitting requests referencing criteria that include draft-labeled language, providers should rely on the finalized coverage criteria in this policy and supporting documentation rather than any draft items. The presence of a draft label does not change or override explicit coverage rules elsewhere in this policy.

Requests for continued treatment (reauthorization) will be denied when there is evidence of unacceptable toxicity or disease progression while the member is receiving the current durvalumab regimen. Examples include worsening clinical status attributable to treatment-related adverse events or radiographic/clinical progression documented during the prior authorization period.

For reauthorization requests, documentation must demonstrate absence of unacceptable toxicity and no disease progression on the current regimen for the indication-specific reauthorization period. If evidence of either toxicity or progression is present, continued treatment is not supported under this policy.

Approved dosing regimens and administration

Diagnosis / Setting	Initial (≥30 kg)	Initial (<30 kg)	Initial cycles / duration	Maintenance (≥30 kg)	Maintenance (<30 kg)
Small bowel / Colorectal adenocarcinoma (draft items: dMMR/MSI-H or POLE/POLD1 ultra-hypermutated)
1500 mg IV every 3 weeks or other listed schedules
20 mg/kg IV every 3 weeks or other listed schedules
Initial examples include 20 mg/kg every 3 weeks for 4 cycles for some listings (draft items vary)
1500 mg every 4 weeks
20 mg/kg every 4 weeks (or 10 mg/kg every 2 weeks for specific schedules)

Medication coding and weight thresholds

Medication dosing (product-level)mixed

Imfinzi (Durvalumab) dosing regimens

Multiple weight-based and fixed IV regimens listed per diagnosis (e.g., ≥30 kg: Initial 1500 mg every 3 weeks for up to 8 cycles then maintenance 1500 mg every 4 weeks; <30 kg: Initial 20 mg/kg every 3 weeks for up to 8 cycles then maintenance 20 mg/kg every 4 weeks; bladder-specific: Initial 1500 mg every 3 weeks for 4 doses then maintenance 1500 mg every 4 weeks; cervical: Initial 1500 mg every 3 weeks for 4 cycles then maintenance 1500 mg every 4 weeks; endometrial: ≥30 kg Initial 1120 mg every 3 weeks for 6 doses then maintenance 1500 mg every 4 weeks; <30 kg Initial 15 mg/kg every 3 weeks for 6 doses then maintenance 20 mg/kg every 4 weeks; additional diagnosis-specific variations and alternative maintenance regimens as listed).

Weight-based dosing threshold

Weight thresholdPolicy distinguishes members weighing ≥ 30 kg versus < 30 kg for dosing and maintenance regimens.

Fixed dosing (≥ 30 kg)Initial and maintenance regimens specified as fixed mg doses for members ≥ 30 kg (e.g., 1500 mg q3w initial, then 1500 mg q4w maintenance for many indications).

Weight-based dosing (< 30 kg)Initial and maintenance regimens specified per kg for members < 30 kg (e.g., 20 mg/kg q3w initial, then 20 mg/kg q4w maintenance for many indications).

Diagnosis-specific initial cyclesInitial number of doses varies by diagnosis (examples in medication limits: bladder 4 doses; endometrial 6 doses).

Prior authorization, documentation, and denial triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Documentation must show the member meets the indication-specific criteria for the requested indication (for example, perioperative bladder cancer must be used in combination with gemcitabine and cisplatin prior to cystectomy and continued as single-agent therapy after surgery). Authorization durations described in the coverage criteria apply (e.g., 3 or 6 months as specified).

Applicable to indications listed in the coverage criteria (see section content).
Provide regimen details and supporting clinical documentation at time of request.

Note

Informational

This section contains only reference information and public classification; it does not add additional provider documentation obligations beyond the prior authorization and indication-specific requirements already listed.

Indication by line of therapy

first-line — 1 top-level node

First-line ampullary: Use in combination with cisplatin and gemcitabine for pancreatobiliary or mixed type disease.

Authorization of 6 months may be granted.

first-line — 2 top-level nodes

Perioperative bladder cancer: Perioperative/sandwich use in combination with gemcitabine and cisplatin prior to cystectomy, then single-agent after surgery.

Authorization of 6 months may be granted.

Neoadjuvant gastric/GEJ/esophageal: Combination with tremelimumab-actl for neoadjuvant treatment in MSI-H/dMMR tumors; member must be medically fit for surgery.dMMR / MSI-H

Genomic and protein biomarker thresholds required

dMMR / MSI-H biomarker requirement

BiomarkerDeficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).

Indications requiring dMMR/MSI-HEndometrial carcinoma (advanced/recurrent), neoadjuvant gastric/GEJ/esophageal adenocarcinoma, colorectal and small bowel adenocarcinoma (draft items).

Role in authorizationAuthorization granted only when tumor is documented as dMMR or MSI-H for the listed indications.

Draft items noteSome colorectal/small bowel items are marked as draft ('Do Not Implement') but still reference dMMR/MSI-H as a requirement.

PD-L1 tumor expression threshold

PD-L1 thresholdTumor PD-L1 expression ≥ 1 is required for perioperative use of durvalumab with FLOT in gastric/GEJ/esophageal adenocarcinoma.

Clinical background

Durvalumab (Imfinzi) is used across multiple tumor types and treatment settings, including as combination therapy in perioperative or first-line metastatic regimens and as single-agent maintenance or continuation therapy. Several indications in this policy require specific tumor biomarker status (for example, dMMR/MSI-H or POLE/POLD1 ultra-hypermutated phenotype) or a PD-L1 expression threshold for perioperative use.

OpenPayer

Durvalumab (Imfinzi) — oncology indications and authorization criteria

Coverage criteria by indication

Approved dosing regimens and administration

Medication coding and weight thresholds

Prior authorization, documentation, and denial triggers

Indication by line of therapy

Genomic and protein biomarker thresholds required

Clinical background