BlueCross BlueShield of Tennessee Medical Policy Manual
Durvalumab (Imfinzi®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
All other indications are considered experimental/investigational and not medically necessary.
Submission of the following information is necessary to initiate the prior authorization review:
Coverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.
Authorization of 6 months may be granted for treatment of NSCLC when either of the following criteria are met:
Authorization of 6 months may be granted for first-line treatment of extensive-stage small cell lung cancer in combination with etoposide and either carboplatin or cisplatin followed by single agent maintenance.
Authorization of 6 months may be granted for treatment of persistent, recurrent or metastatic small cell neuroendocrine carcinoma of the cervix (NECC) when used in combination with etoposide and either cisplatin or carboplatin.
Authorization of 6 months may be granted for first-line treatment of unresectable or metastatic ampullary adenocarcinoma when both of the following criteria are met:
Authorization of 6 months may be granted for first-line treatment of unresectable pleural mesothelioma when used in combination with pemetrexed and either cisplatin or carboplatin.
Authorization of 6 months may be granted for treatment of hepatocellular carcinoma when either of the following criteria are met:
Authorization of 3 months for a total of 3 doses may be granted for treatment of esophageal, esophagogastric junction or gastric cancer when all of the following criteria are met:
Authorization of 6 months may be granted for treatment of advanced or recurrent endometrial cancer when all of the following criteria are met:
Authorization of 6 months may be granted for treatment of biliary tract cancer when the requested medication will be used in combination with cisplatin and gemcitabine to treat locally advanced, unresectable or resected gross residual (R2) disease, or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) or for disease recurrence after surgery and adjuvant therapy.
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for NSCLC when either of the following criteria are met:
Authorization of 3 months for a total of 3 doses may be granted for treatment of esophageal, esophagogastric junction or gastric cancer. Reauthorization may be granted only when the member did not receive a total of 3 doses from the initial approval.
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section IV when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Imfinzi (Durvalumab) |
Ampullary Adenocarcinoma |
Route of Administration: Intravenous ≥30kg Initial: 1500mg every 3 weeks for 8 cycles, followed by Maintenance: 1500mg every 4 weeks
<30kg Initial: 20mg/kg every 3 weeks for 8 cycles, followed by Maintenance: 20mg/kg every 4 weeks. |
|
Imfinzi (Durvalumab) |
Biliary Tract Cancer (Gallbladder Cancer, Intrahepatic/Extrahepatic Cholangiocarcinoma) |
Route of Administration: Intravenous ≥30kg Initial: 1500mg every 3 weeks for up to 8 cycles, followed by Maintenance: 1500mg every 4 weeks.
<30kg Initial: 20mg/kg every 3 weeks for 8 cycles, followed by Maintenance: 20mg/kg every 4 weeks. |
|
Imfinzi (Durvalumab) |
Cervical Cancer |
Route of Administration: Intravenous 1500mg every 3 or 4 weeks |
|
Imfinzi (Durvalumab) |
Hepatocellular Carcinoma |
Route of Administration: Intravenous ≥30kg 1500mg every 4 weeks
<30kg 20mg/kg every 4 weeks |
|
Imfinzi (Durvalumab) |
Non-Small Cell Lung Cancer (NSCLC) |
Route of Administration: Intravenous 10mg/kg every 2 weeks
<30kg Initial: 20mg/kg every 3 weeks for 4 cycles, followed by Maintenance: 20mg/kg every 4 weeks |
|
Imfinzi (Durvalumab) |
Non-Small Cell Lung Cancer or Small Cell Lung Cancer |
Route of Administration: Intravenous ≥30kg 1500mg every 3 or 4 weeks |
|
Imfinzi (Durvalumab) |
Small Cell Lung Cancer (SCLC) |
Route of Administration: Intravenous <30kg Initial: 20mg/kg every 3 weeks for 4 cycles, followed by Maintenance: 10mg/kg every 2 weeks
≥30kg Initial: 1500mg every 3 weeks Maintenance: 1500mg every 3 weeks. |
.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 6/1/2017
MOST RECENT REVIEW DATE: 10/31/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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