BlueCross BlueShield of Tennessee Medical Policy Manual

Nivolumab (Opdivo®)

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  

INDICATIONS

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.

FDA-Approved Indications

Unresectable or Metastatic Melanoma

Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

Adjuvant Treatment of Melanoma

Opdivo is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB, stage IIC, stage III, or stage IV melanoma.

Metastatic Non-Small Cell Lung Cancer

• Opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
• Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.
• Opdivo is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.

Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

Opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer

Opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery.

Malignant Pleural Mesothelioma

Opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

Advanced Renal Cell Carcinoma

• Opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
• Opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC.
• Opdivo, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.

Classical Hodgkin Lymphoma

Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:

• Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or
• Three or more lines of systemic therapy that includes autologous HSCT.

Squamous Cell Carcinoma of the Head and Neck

Opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Urothelial Carcinoma

• Opdivo is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
• Opdivo, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
• Opdivo is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:

• Have disease progression during or following platinum-containing chemotherapy
• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer

Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Hepatocellular Carcinoma

Opdivo, in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Esophageal Carcinoma

• Opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
• Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
• Opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
• Opdivo is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

Compendial Uses

• Cutaneous melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Classical Hodgkin lymphoma
• Head and neck cancers
• Urothelial carcinoma

• Bladder cancer
• Primary carcinoma of the urethra
• Upper genitourinary tract tumors
• Urothelial carcinoma of the prostate

• Colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma
• Hepatocellular carcinoma
• Uveal Melanoma
• Anal Carcinoma
• Merkel Cell Carcinoma
• Central Nervous System (CNS) brain metastases
• Gestational trophoblastic neoplasia
• Pleural mesothelioma
• Peritoneal mesothelioma
• Small bowel adenocarcinoma
• Ampullary Adenocarcinoma
• Extranodal NK/T-cell lymphoma
• Endometrial Carcinoma
• Vulvar Cancer
• Gastric Cancer
• Esophageal/Esophagogastric Junction Cancers

• Small cell lung cancer
• Cervical Cancer
• Pediatric Diffuse High-Grade Gliomas
• Pediatric Primary Mediastinal Large B-cell Lymphoma
• Kaposi Sarcoma
• Bone Cancer

• Biliary Tract Cancers

• Cholangiocarcinoma
• Gallbladder Cancer

• Soft Tissue Sarcoma

• Extremity/body wall sarcoma
• Head/neck sarcoma
• Retroperitoneal/intra-abdominal sarcoma
• Rhabdomyosarcoma
• Angiosarcoma

• Anaplastic Thyroid Carcinoma
• Histologic (Richter) transformation to diffuse large B-cell lymphoma

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

• Documentation of laboratory report confirming MSI-H, mismatch repair deficient (dMMR), or  polymerase epsilon/delta (POLE/POLD1) tumor status, where applicable.
• Documentation of programmed death ligand 1 (PD-L1) tumor expression, where applicable.
• Documentation of the presence of EGFR exon 19 deletions or exon 21 L858R mutations or ALK rearrangements, where applicable.

EXCLUSIONS

Coverage will not be provided for members who have experienced disease progression while on programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor therapy (other than when used as second-line or subsequent therapy for metastatic or unresectable melanoma in combination with ipilimumab following progression on single agent anti-PD-1 immunotherapy).

COVERAGE CRITERIA

Cutaneous Melanoma

Authorization of 6 months may be granted for treatment of cutaneous melanoma in either of the following settings:

• The requested medication will be used as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) for unresectable or metastatic disease.
• The requested medication will be used as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) as adjuvant treatment of stage III or IV disease following complete resection or no evidence of disease.
• The requested medication will be used as a single agent as adjuvant treatment of stage IIB and IIC disease following complete resection.
• The requested medication will be used as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) as neoadjuvant treatment of resectable disease.

Non-Small Cell Lung Cancer (NSCLC)

• Authorization of 6 months may be granted for treatment of recurrent, advanced or metastatic non-small cell lung cancer if either of the following criteria are met:

• There are no EGFR exon 19 deletions or exon 21 L858R mutations or ALK rearrangements (unless testing is not feasible due to insufficient tissue) and the requested medication will be used in a regimen containing ipilimumab.
• The requested medication will be used as single agent subsequent therapy.

• Authorization of 3 months (for up to 3 cycles total) may be granted for neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) in combination with platinum-doublet chemotherapy.

• Authorization of 6 months may be granted for neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) when both of the following conditions are met:

• There are no EGFR exon 19 deletions or exon 21 L858R mutations or ALK rearrangements (unless testing is not feasible due to insufficient tissue) 

• The requested medication is used in combination with platinum-doublet chemotherapy (for up to 4 cycles total), followed by single agent adjuvant therapy (for up to 13 cycles)

Renal Cell Carcinoma

Authorization of 6 months may be granted for treatment of relapsed, advanced, or stage IV renal cell carcinoma, in any of the following settings:

• The requested medication will be used as a single agent for clear cell histology as subsequent therapy.
• The requested medication will be used as a single agent for non-clear cell histology.
• The requested medication will be used in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) for disease with clear cell histology.
• The requested medication will be used in combination with cabozantinib.

Classical Hodgkin Lymphoma (cHL)

Authorization of 6 months may be granted for treatment of classical Hodgkin lymphoma when either of the following criteria is met:

• The requested medication will be used as single agent subsequent therapy and the member

has relapsed or refractory disease that was either heavily pretreated or there was a decrease in cardiac function.

• The requested medication will be used in combination with brentuximab vedotin or in combination with ICE (ifosfamide, carboplatin, etoposide) for relapsed or refractory disease.
• The requested medication will be used as a single agent for disease refractory to at least three lines of prior therapy.
• The requested medication will be used in combination with AVD (doxorubicin, vinblastine, and dacarbazine) for stage III-IV disease.

Head and Neck Cancers

Authorization of 6 months may be granted for treatment of head and neck cancers in members who meet either of the following criteria:

• For unresectable, recurrent, persistent or metastatic disease.
• For nasopharyngeal cancer in combination with cisplatin and gemcitabine for unresectable, recurrent, persistent or metastatic disease.

Urothelial Carcinoma – Bladder Cancer

• Authorization of 6 months may be granted in combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance therapy as first line treatment of bladder cancer.
• Authorization of 6 months may be granted as a single agent for treatment of bladder cancer when any of the following conditions are met:

• As subsequent therapy for locally advanced, recurrent, persistent, or metastatic disease.
• As adjuvant therapy in members who are at high risk of recurrence after undergoing resection.

Urothelial Carcinoma – Primary Carcinoma of the Urethra

• Authorization of 6 months may be granted in combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance therapy as first line treatment of primary carcinoma of the urethra.
• Authorization of 6 months may be granted as a single agent for treatment of primary carcinoma of the urethra when either of the following are met:

• As subsequent therapy for recurrent, locally advanced, or metastatic disease.
• As adjuvant therapy in members who are at high risk of recurrence after undergoing resection.

Urothelial Carcinoma – Upper Genitourinary Tract Tumors or Urothelial Carcinoma of the Prostate

• Authorization of 6 months may be granted in combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance therapy as first line treatment of metastatic upper genitourinary (GU) tract tumors or urothelial carcinoma of the prostate.
• Authorization of 6 months may be granted as a single agent for treatment of upper genitourinary (GU) tract tumors or urothelial carcinoma of the prostate when either of the following are met:

• As subsequent therapy for locally advanced or metastatic disease.
• As adjuvant therapy in members who are at high risk of recurrence after undergoing resection.

Colorectal Cancer

Authorization of 6 months may be granted for treatment of colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, for microsatellite-instability high (MSI-H), mismatch repair deficient (dMMR) or polymerase epsilon/delta (POLE/POLD1) tumors when used as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent).

Small Bowel Adenocarcinoma

Authorization of 6 months may be granted as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) for treatment of advanced or metastatic small bowel adenocarcinoma for microsatellite-instability high (MSI-H), mismatch repair deficient (dMMR) or polymerase epsilon/delta (POLE/POLD1) tumors.

Ampullary Adenocarcinoma

Authorization of 6 months may be granted in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) for treatment of progressive, unresectable, or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ampullary adenocarcinoma.

Hepatocellular Carcinoma

Authorization of 6 months may be granted as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) for treatment of hepatocellular carcinoma.

Uveal Melanoma

Authorization of 6 months may be granted as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) for treatment of uveal melanoma for unresectable or metastatic disease.

Anal Carcinoma

Authorization of 6 months may be granted as a single agent for subsequent treatment of metastatic anal carcinoma.

Merkel Cell Carcinoma

Authorization of 6 months may be granted for treatment of Merkel cell carcinoma in either of the following settings:

• Metastatic disease.
• Neoadjuvant treatment of node positive disease and node negative locally advanced disease when used as a single agent.
• Unresectable, recurrent, or stage IV disease when used in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent).

CNS Brain Metastases

Authorization of 6 months may be granted for treatment of CNS brain metastases when either of the following criteria are met:

• The requested medication will be used as a single agent or in combination with ipilimumab (4 doses of ipilimumab, followed by Opdivo as a single agent) in members with melanoma.
• The requested medication will be used as a single agent in members with PD-L1 positive non-small cell lung cancer.

Gestational Trophoblastic Neoplasia

Authorization of 6 months may be granted as a single agent for treatment of gestational trophoblastic neoplasia for multiagent chemotherapy-resistant disease when either of the following criteria is met:

• Member has recurrent or progressive intermediate trophoblastic tumor (placental site trophoblastic tumor or epithelioid trophoblastic tumor).
• Member has high-risk disease.

Pleural or Peritoneal Mesothelioma

Authorization of 6 months may be granted for the treatment of pleural or peritoneal mesothelioma, including pericardial mesothelioma and tunica vaginalis testis mesothelioma, in either of the following settings:

• The requested medication will be used as first line therapy in combination with ipilimumab.
• The requested medication will be used as subsequent therapy as a single agent or in combination with ipilimumab.

Esophageal and Esophagogastric Junction Cancer

• Authorization of 6 months may be granted for treatment of esophageal or esophagogastric junction cancer in members who are not surgical candidates or have unresectable locally advanced, recurrent or metastatic disease when the requested medication will be used in combination with ipilimumab or chemotherapy or will be used as subsequent therapy.
• Authorization of 6 months may be granted for adjuvant treatment of completely resected esophageal or esophagogastric junction cancer with residual pathologic disease.
• Authorization of 6 months may be granted as a single agent or in combination with ipilimumab for neoadjuvant or perioperative treatment of esophageal or esophagogastric junction adenocarcinoma if tumor is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and member is medically fit for surgery.

Extranodal NK/T-Cell Lymphoma

Authorization of 6 months may be granted for treatment of relapsed or refractory extranodal NK/T-cell lymphoma.

Endometrial Carcinoma

Authorization of 6 months may be granted as a single agent for subsequent treatment of recurrent or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial carcinoma. 

Vulvar Cancer

Authorization of 6 months may be granted for treatment of HPV-related advanced recurrent, or metastatic vulvar cancer as subsequent therapy as a single agent.

Gastric Cancer

Authorization of 6 months may be granted for treatment of gastric cancer in any of the following settings:

• When the requested medication is being used in members who are not surgical candidates or have unresectable, recurrent, or metastatic disease, when the requested medication will be used in combination with ipilimumab or chemotherapy.
• When the requested medication will be used as a single agent or in combination with ipilimumab for neoadjuvant or perioperative treatment of gastric adenocarcinoma if tumor is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and member is medically fit for surgery. 
• When the requested medication will be used in combination with ipilimumab or chemotherapy in members with early stage microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors and completed endoscopic resection.
• When the requested medication will be used in combination with chemotherapy in members with early stage HER-2 overexpression negative disease and completed endoscopic resection.

Small Cell Lung Cancer

Authorization of 6 months may be granted for subsequent treatment of relapsed or progressive small cell lung cancer as a single agent.

Cervical Cancer

Authorization of 6 months may be granted for subsequent treatment of recurrent or metastatic cervical cancer as a single agent if PD-L1 positive (combined positive score [CPS] ≥1).

Pediatric Diffuse High-Grade Gliomas

Authorization of 6 months may be granted for hypermutant tumor pediatric diffuse high-grade glioma as adjuvant treatment or for recurrent or progressive disease.

Pediatric Primary Mediastinal Large B-Cell Lymphoma

Authorization of 6 months may be granted as a single agent or in combination with brentuximab vedotin for treatment of relapsed or refractory primary mediastinal large B-cell lymphoma.

 Kaposi Sarcoma

Authorization of 6 months may be granted in combination with ipilimumab for subsequent treatment of relapsed/refractory classic Kaposi Sarcoma.

Bone Cancer

Authorization of 6 months may be granted in combination with ipilimumab for unresectable or metastatic disease when all of the following are met:

• Disease has tumor mutation burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] tumors

• Disease has progressed following prior treatment and has no satisfactory alternative treatment options

Biliary Tract Cancers (Cholangiocarcinoma and Gallbladder Cancer)

Authorization of 6 months may be granted as subsequent treatment in combination with ipilimumab for unresectable or resected gross residual (R2) disease, or metastatic disease that is tumor mutation burden-high (TMB-H).

Soft Tissue Sarcoma

Authorization of 6 months may be granted for treatment of soft tissue sarcoma in the following settings:

• The requested medication will be used as a single agent or in combination with ipilimumab for treatment of extremity/body wall sarcomas, head/neck sarcomas and retroperitoneal/intra-abdominal sarcomas and rhabdomyosarcoma.
• The requested medication will be used in combination with ipilimumab for the treatment of angiosarcoma.  

Anaplastic Thyroid Carcinoma

Authorization of 6 months may be granted as a single agent for treatment of stage IVC anaplastic thyroid carcinoma.

Histologic (Richter) Transformation to Diffuse Large B-cell Lymphoma

Authorization of 6 months may be granted for treatment of Histologic (Richter) transformation to diffuse large B-cell lymphoma as a single agent or in combination ibrutinib.

CONTINUATION OF THERAPY  

Adjuvant Treatment of Melanoma

Authorization of 6 months may be granted (up to 12 months total) for continued treatment in members requesting reauthorization for cutaneous melanoma who have not experienced disease recurrence or an unacceptable toxicity.

Urothelial Carcinoma

• Authorization of 6 months may be granted (up to 12 months total) for continued treatment in members requesting reauthorization for adjuvant treatment of urothelial carcinoma who have not experienced disease recurrence or an unacceptable toxicity.
• Authorization of 6 months may be granted (up to 24 months total) for continued treatment in members requesting reauthorization for urothelial carcinoma when the requested medication is used in combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance therapy when the member has not experienced disease progression or an unacceptable toxicity.

Non-Small Cell Lung Cancer or Pleural Mesothelioma

• Authorization of 6 months may be granted (up to 24 months total when used in combination with ipilimumab) for continued treatment in members requesting reauthorization for non-small cell lung cancer (NSCLC) or pleural or peritoneal mesothelioma, including pericardial mesothelioma and tunica vaginalis testis mesothelioma subtypes, when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
• Neoadjuvant treatment of resectable NSCLC will be approved for a total of 3 months of therapy (up to 3 cycles) when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
• Authorization of 6 months may be granted for neoadjuvant treatment of resectable NSCLC (up to 4 cycles in combination with chemotherapy, followed by single agent adjuvant treatment up to 13 cycles) when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Renal Cell Carcinoma

Authorization of 6 months may be granted (up to 24 months total when used in combination with cabozantinib) for continued treatment in members requesting reauthorization for renal cell carcinoma when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Gastric Cancer, Esophageal Cancer, and Esophagogastric Junction Carcinoma

Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for gastric cancer, esophageal cancer, and esophagogastric junction carcinoma when there is no evidence of unacceptable toxicity or disease progression while on the current regimen for the following durations of therapy:

• Esophageal squamous cell carcinoma in combination with ipilimumab or chemotherapy for up to 24 months
• Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma as a single agent until disease progression or unacceptable toxicity
• Adjuvant treatment of resected esophageal or esophagogastric junction cancer as a single agent for up to 12 months
• Gastric cancer, esophagogastric junction cancer, and esophageal adenocarcinoma in combination with chemotherapy for up to 24 months
• Gastric cancer in members who have completed endoscopic resection for up to 24 months

All Other Indications

Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for all other indications listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

MEDICATION QUANTITY LIMITS

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

1. Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; October 2024.   
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 4, 2024.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma. Version 1.2024. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf Accessed  March 4, 2024.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Melanoma: Cutaneous. Version 1.2024. https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed March 4, 2024.
5. Lexicomp [database online]. Hudson, OH: Lexi-Comp, Inc.; https://online.lexi.com/lco/action/home [available with subscription]. Accessed March 4, 2024.

ORIGINAL EFFECTIVE DATE: 2/5/2015

MOST RECENT REVIEW DATE: 4/20/2025

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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