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Durvalumab (Imfinzi®)
MA08.123a

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

NON-SMALL CELL LUNG CARCINOMA (NSCLC)
Durvalumab (Imfinzi) is considered medically necessary and, therefore, covered for the treatment of individuals with non-small cell lung cancer (NSCLC with any of the following histology: squamous cell carcinoma, adenocarcinoma [with mixed subtypes], large cell carcinoma​) when all of the following criteria are met:
  • As consolidation therapy (i.e., a shorter and more intense treatment phase to further reduce the number of cancer cells; also called intensification therapy and postremission therapy)
  • Disease is unresectable stage II to III without progression after two or more cycles of definitive chemoradiation 
  • The individual has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
SMALL CELL LUNG CARCINOMA (SCLC)
Durvalumab (Imfinzi) is considered medically necessary and, therefore, covered for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin, as first-line treatment (National Comprehensive Cancer Network [​NCCN]-preferred regimen) followed by single-agent maintenance in individuals with any one of the following:
  • With localized symptomatic sites
  • Without localized symptomatic sites or brain metastases and the individual has an ECOG performance status (PS) 0-2
  • With brain metastases
  • Without localized symptomatic sites or brain metastases and the individual has an ECOG PS 3-4 due to the cancer​
EXPERIMENTAL/INVESTIGATIONAL

All other uses for durvalumab (Imfinzi) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, durvalumab (Imfinzi) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.
ECOG Performance Status
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work)
2
Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3
Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4
Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5
Dead
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Durvalumab (Imfinzi) was approved by the FDA on May 1, 2017 for the treatment individuals with locally advanced or metastatic urothelial carcinoma who either have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Supplemental approvals for durvalumab (Imfinzi) have since been issued by the FDA. Durvalumab (Imfinzi) is administered as an intravenous infusion over 60 minutes. The FDA removed the indication for urothelial carcinoma from the drug labeling on July 15, 2021.

PEDIATRIC USE
The safety and effectiveness of durvalumab (Imfinzi) have not been established in pediatric individuals.

Description

In a normal immune response, the body can recognize the presence of tumors and mount a response to eradicate them. The process of eradicating a tumor begins with antigen-presenting cells that gather and process the antigens released by tumors. This activates the T cells, which proliferate and attack the tumor.

Tumors have learned to evade the normal immune response by exploiting the immune checkpoint pathway. The Programmed Death Receptor-1 (PD-1) is a checkpoint protein expressed on the membrane of activated T cells. The Programmed Death-Ligand 1 (PD-L1) and The Programmed Death-Ligand 2 (PD-L2) are checkpoint proteins expressed on tumor cells and tumor-infiltrating immune cells. When PD-L1 and PD-L2 attach to PD-1 receptors on the T cells, the T cells become inhibited and will not attack the tumor; thus, the tumor can continue to proliferate.

Durvalumab (Imfinzi) is a human monoclonal antibodies and immune checkpoint inhibitor that binds to PD-L1 on tumor cells and tumor-infiltrating immune cells and block the interaction with PD-1 and B7.1 receptors on T cells and antigen-presenting cells. Consequently, the tumor is no longer able to inactivate the T cells and the antitumor response continues.

DURVALUMAB (IMFINZI) INDICATIONS

NON-SMALL CELL LUNG CARCINOMA ​(NSCLC)
On February 16, 2018, the ​US Food and Drug Administration ​(FDA) approved durvalumab (Imfinzi) for individuals with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

The efficacy of durvalumab (Imfinzi) was evaluated in the PACIFIC study (NCT02125461), a multicenter, randomized, double-blind, placebo-controlled phase 3 study in individuals with unresectable Stage III NSCLC who completed at least two cycles of concurrent platinum-based chemotherapy and definitive radiation within 42 days prior to initiation of the study drug and had an Eastern Cooperative Oncology Group (ECOG​)​​ performance status ​(PS) of 0 or 1. The study excluded individuals who had progressed following concurrent chemoradiation, individuals with active or prior documented autoimmune disease within two years of initiation of the study or individuals with medical conditions that required systemic immunosuppression. Randomization was stratified by sex, age (< 65 years versus 65 years ​or older), and smoking history (smoker versus non-smoker). Individuals were randomized 2:1 to receive durvalumab (Imfinzi) 10 mg/kg or placebo intravenously every two weeks for up to 12 months or until unacceptable toxicity or confirmed Response Evaluation Criteria in Solid Tumors (​RECIST) 1.1-defined progression. Assessment of tumor status was performed every eight weeks. The major efficacy outcome measures were progression-free survival (PFS) as assessed by a Blinded Independent Central Review (​BICR) RECIST 1.1, and overall survival (OS). Additional efficacy outcome measures included objective response rate (​ORR) and duration of response (DOR) assessed by BICR.

Of the 713 individuals who underwent randomization, 709 received the assigned intervention (473 individuals received durvalumab (Imfinzi) and 236 received placebo). As of March 22, 2018, the median follow-up was 25.2 months. The 24-month overall survival rate was 66.3 percent (95 percent confidence interval [CI], 61.7 to 70.4) in the durvalumab (Imfinzi) group, as compared with 55.6 percent (95 percent CI, 48.9 to 61.8) in the placebo group (two-sided p=0.005). Durvalumab (Imfinzi) significantly prolonged OS, as compared with placebo (stratified hazard ratio ​[HR] for death, 0.68; 99.73 percent CI, 0.47 to 0.997; p=0.0025). Updated analyses regarding PFS were similar to those previously reported, with a median duration of 17.2 months in the durvalumab (Imfinzi) group and 5.6 months in the placebo group (stratified HR for disease progression or death, 0.51; 95 percent CI, 0.41 to 0.63). The median time to death or distant metastasis was 28.3 months in the durvalumab (Imfinzi) group and 16.2 months in the placebo group (stratified hazard ratio, 0.53; 95 percent CI, 0.41 to 0.68). Consolidation therapy with durvalumab (Imfinzi) resulted in significantly prolonged median OS, PFS, and a greater ORR compared with placebo in a study in individuals with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy.

SMALL CELL LUNG CARCINOMA (SCLC)
On March 27, 2020, the FDA granted approval for durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of individuals with extensive-stage small cell lung cancer (ES-SCLC).The efficacy of durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin in previously untreated ES-SCLC was investigated in CASPIAN, a randomized, multicenter, active-controlled, phase 3, open-label trial (NCT03043872). The study population characteristics were: median age of 63 years (range: 28 to 82); 65 percent ECOG PS of 1; and 93 percent were former/current smokers. Ninety percent of individuals had Stage IV disease and 10 percent had brain metastasis at baseline. A total of 25 percent of the individuals received cisplatin and 74 percent of the individuals received carboplatin. In the chemotherapy alone arm, 57 percent of the individuals received six cycles of chemotherapy, and 8 percent of the individuals received prophylactic cranial irradiation.

The evaluation was based on the comparison of individuals randomized to durvalumab (Imfinzi) plus chemotherapy versus chemotherapy alone. The major efficacy outcome measure was OS. Additional efficacy outcome measures were investigator-assessed PFS and ORR per RECIST 1.1. Median OS was 13.0 months (95 percent CI: 11.5 ​to 14.8) in the durvalumab (Imfinzi) plus chemotherapy arm compared with 10.3 months (95 percent CI: 9.3 to 11.2) in the chemotherapy alone arm (HR 0.73; 95 percent CI: 0.59 to 0.91; p=0.0047). The study demonstrated first-line durvalumab (Imfinzi) plus platinum-etoposide significantly improved OS in patients with ES-SCLC versus a clinically relevant control group.

References

American Hospital Formulary Service (AHFS). Durvalumab (Imfinzi®). AHFS Drug Information 2021. [LexiComp Web site]. 02/26/2021. Available at: https://online.lexi.com/lco/action/home# [via subscription only]. Accessed October 15, 2021.

ClinicalTrial.gov. A global study to assess the effects of MEDI4736 following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer (PACIFIC). ClinicalTrials.gov Identifier: NCT02125461. First Posted: April 29, 2014. Last Update Posted: September 9, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02125461?term=NCT02125461&draw=2&rank=1. Accessed October 15, 2021.

ClinicalTrial.gov. Durvalumab +/- tremelimumab in combination with platinum based chemotherapy in untreated extensive-stage small cell lung cancer. ClinicalTrials.gov Identifier: NCT03043872. First Posted: February 6, 2017. Last Update Posted: October 4, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03043872?term=NCT03043872&draw=2&rank=1. Accessed October 15, 2021.

Durvalumab (Imfinzi®) Package Insert. Wilmington, DE​: AstraZeneca Pharmaceuticals LP. 09/2021. Available at: https://www.imfinzi.com/. Accessed October 15, 2021.

Elsevier's Clinical Pharmacology Compendium. Durvalumab (Imfinzi®). [Clinical Key Web site]. 07/29/2021. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed October 15, 2021.

Goldman JW, Dvorkin M, Chen Y, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomized, controlled, open-label, phase 3 trial. Lancet Oncol. 2021;22(1):51-65.​

IBM Micromedex® DRUGDEX® (electronic version). Durvalumab (Imfinzi®). [Micromedex Web site]. IBM Watson Health, Greenwood Village, Colorado, USA. 08/12/2021. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed October 15, 2021.

Lexi-Drugs Compendium. Durvalumab (Imfinzi®). [Lexicomp Web site]. 08/17/2021. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed October 15, 2021.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® – Non-small cell lung cancer. V5.2021. [NCCN Web site]. 06/15/2021. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. [via subscription only]. Accessed October 15, 2021.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® – Small cell lung cancer. V1.2022 [NCCN Web site]. 08/09/2021. Available from: https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. [via subscription only]. Accessed October 15, 2021.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. [NCCN Web site]. Durvalumab (Imfinzi®). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed October 15, 2021.

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.

Ouwens M, Darilay A, Zhang Y, et al. Assessing the influence of subsequent immunotherapy on overall survival in patients with unresectable stage III non-small cell lung cancer from the PACIFIC study. Curr Ther Res Clin Exp. 2021;95:100640.

Paz-Ares L , Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019;394(10212):1929-1939.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Durvalumab (Imfinzi®) Prescribing Information. [FDA Web site]. 07/15/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed October 15, 2021​

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
See Attachment A

HCPCS Level II Code Number(s)
J9173 Injection, durvalumab, 10 mg

Revenue Code Number(s)
N/A



Coding and Billing Requirements


Policy History

1/3/2022
1/3/2022
MA08.123
Medical Policy Bulletin
Medicare Advantage
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No