US.LIB.26.01.0090  01/26

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22 Health Health Exchange

Abilis Health Medicare

Aetna Commercial

Aetna Commercial Federal

Aetna Managed Medicaid Florida

Aetna Managed Medicaid Florida Healthy Kids

Aetna Managed Medicaid IL

Aetna Managed Medicaid Kentucky

Aetna Managed Medicaid Louisiana

Aetna Managed Medicaid Maryland

Aetna Managed Medicaid Michigan

Aetna Managed Medicaid New Jersey

Aetna Managed Medicaid Oklahoma

Aetna Managed Medicaid Texas

Aetna Managed Medicaid Virginia

Aetna Managed Medicaid West Virginia

Aetna Medicare MA

Aetna Medicare MAPD

Affinity Essential Plan NY

Affinity Health System New York Managed Medicaid NY

Affinity Health System Wisconsin Commercial

Affinity Health System Wisconsin Health Exchange

Affinity Health System Wisconsin Managed Medicaid WI

AgeRight Advantage

Alameda Alliance Health Medicare

Align Senior Care Medical

Alignment Health Plan Medicare Medical

AllCare Health Managed Medicaid OR

AllCare Medicare Advantage

Alliance Health Managed Medicaid North Carolina

AlohaCare Managed Medicaid HI

AlohaCare Medicare

Alterwood Advantage Medicare

American Health Advantage Medicare

Amerigroup Managed Medicaid Georgia

AmeriHealth Caritas Delaware Health Exchange

AmeriHealth Caritas Florida Health Exchange

AmeriHealth Caritas Louisiana Health Exchange

AmeriHealth Caritas Managed Medicaid Delaware

AmeriHealth Caritas Managed Medicaid District of Columbia

AmeriHealth Caritas Managed Medicaid Louisiana

AmeriHealth Caritas Managed Medicaid New Hampshire

AmeriHealth Caritas Managed Medicaid North Carolina

AmeriHealth Caritas Managed Medicaid Ohio

AmeriHealth Caritas Managed Medicaid Pennsylvania

AmeriHealth Caritas Managed Medicaid South Carolina

AmeriHealth Caritas Medicare Delaware

AmeriHealth Caritas Medicare Florida

AmeriHealth Caritas Medicare Louisiana

AmeriHealth Caritas Medicare Michigan

AmeriHealth Caritas Medicare North Carolina

AmeriHealth Caritas Medicare Pennsylvania

AmeriHealth Caritas Medicare South Carolina

AmeriHealth Caritas North Carolina Health Exchange

AmeriHealth Medicare New Jersey

Amida Care, Inc. Managed Medicaid NY

Anthem Blue Cross and Blue Shield Medicaid Ohio

Anthem Commercial

Anthem Health Exchange

Anthem Managed Medicaid California

Anthem Managed Medicaid Indiana

Anthem Managed Medicaid Missouri

Anthem Managed Medicaid Nevada

Anthem Managed Medicaid New York

Anthem Managed Medicaid Virginia

Anthem Managed Medicaid Wisconsin

Anthem Medicare Plan

Antidote Health Medical

Arkansas Blue Cross Blue Shield Commercial

Arkansas Blue Cross Blue Shield Health Exchange

Arkansas Blue Cross Blue Shield Medicare

Aspire Health Plan Medicare

Aspirus Health Plan Commercial HIX Medical

Aspirus Health Plan Medicare

Astiva Health Medicare Medical

ATRIO Health Plans, Inc. Medicare

AultCare Health Foundation Commercial

AultCare Health Foundation Medicare

Avera Health Commercial

Avera Health Health Exchange

AvMed Commercial Medical

Banner Health Medicare

BayCarePlus Medicare Medical

BCBS of North Dakota Commercial

BCBS of North Dakota Health Exchange

Blue Care Network of Michigan Commercial

Blue Care Network of Michigan FEHBP Commercial

Blue Care Network of Michigan Health Exchange

Blue Care Network of Michigan Medicare

Blue Cross and Blue Shield of Florida Commercial

Blue Cross and Blue Shield of Florida Health Exchange

Blue Cross and Blue Shield of Florida Medicare

Blue Cross and Blue Shield of Kansas Health Exchange

Blue Cross and Blue Shield of Kansas Commercial

Blue Cross and Blue Shield of Kansas Medicare

Blue Cross and Blue Shield of NE Health Exchange

Blue Cross and Blue Shield of Nebraska Commercial PDL 10

Blue Cross and Blue Shield of Nebraska Commercial PDL 20

Blue Cross and Blue Shield of Nebraska Commercial PDL 25

Blue Cross and Blue Shield of Nebraska Commercial PDL 30

Blue Cross and Blue Shield of Nebraska Commercial PDL 40

Blue Cross and Blue Shield of Nebraska Commercial PDL 50

Blue Cross and Blue Shield of New Mexico Managed Medicaid

Blue Cross and Blue Shield of Texas Health Exchange

Blue Cross and Blue Shield of Texas Managed Medicaid

Blue Cross Blue Shield Association Blue Focus Commercial

Blue Cross Blue Shield Association Commercial

Blue Cross Blue Shield Nebraska Medicare

Blue Cross Blue Shield of Alabama Commercial

Blue Cross Blue Shield of Alabama Health Exchange

Blue Cross Blue Shield of Alabama Medicare

Blue Cross Blue Shield of Arizona, Inc. Commercial

Blue Cross Blue Shield of Arizona, Inc. Health Exchange

Blue Cross Blue Shield of Arizona, Inc. Medicare

Blue Cross Blue Shield of Illinois Commercial

Blue Cross Blue Shield of Illinois Health Exchange

Blue Cross Blue Shield of Kansas City Commercial

Blue Cross Blue Shield of Kansas City HIX

Blue Cross Blue Shield of Massachusetts Commercial

Blue Cross Blue Shield of Massachusetts Health Exchange

Blue Cross Blue Shield of Massachusetts Medicare

Blue Cross Blue Shield of Michigan Commercial

Blue Cross Blue Shield of Michigan Health Exchange

Blue Cross Blue Shield of Michigan Managed Medicaid

Blue Cross Blue Shield of Michigan Medicare

Blue Cross Blue Shield of Minnesota Commercial

Blue Cross Blue Shield of Minnesota Health Exchange

Blue Cross Blue Shield of Minnesota Managed Medicaid

Blue Cross Blue Shield of Minnesota Medicare

Blue Cross Blue Shield of Mississippi Corporation Commercial

Blue Cross Blue Shield of Montana Commercial

Blue Cross Blue Shield of Montana Health Exchange

Blue Cross Blue Shield of New Mexico Commercial

Blue Cross Blue Shield of New Mexico Health Exchange

Blue Cross Blue Shield of North Carolina Commercial

Blue Cross Blue Shield of North Carolina Health Exchange

Blue Cross Blue Shield of North Carolina Healthy Blue and Medicare

Blue Cross Blue Shield of North Carolina Medicare

Blue Cross Blue Shield of North Dakota Managed Medicaid

Blue Cross Blue Shield of Oklahoma Commercial

Blue Cross Blue Shield of Oklahoma Health Exchange

Blue Cross Blue Shield of Rhode Island Commercial 4T Focused

Blue Cross Blue Shield of Rhode Island Commercial 4T Large Group

Blue Cross Blue Shield of Rhode Island Commercial 4T Results

Blue Cross Blue Shield of Rhode Island Commercial 4T Results Plus

Blue Cross Blue Shield of Rhode Island Commercial 5T Focused

Blue Cross Blue Shield of Rhode Island Commercial 5T Large Group

Blue Cross Blue Shield of Rhode Island Commercial 5T Results

Blue Cross Blue Shield of Rhode Island Commercial 5T Results Plus

Blue Cross Blue Shield of Rhode Island Commercial 6T Flex

Blue Cross Blue Shield of Rhode Island Commercial 6T Focused

Blue Cross Blue Shield of Rhode Island Commercial 6T Results

Blue Cross Blue Shield of Rhode Island Commercial 6T Results Plus

Blue Cross Blue Shield of Rhode Island Commercial Traditional

Blue Cross Blue Shield of Rhode Island, Inc. Health Exchange

Blue Cross Blue Shield of Rhode Island, Inc. Medicare

Blue Cross Blue Shield of South Carolina Commercial

Blue Cross Blue Shield of South Carolina Health Exchange

Blue Cross Blue Shield of South Carolina Managed Medicaid SC

Blue Cross Blue Shield of South Carolina Medicare

Blue Cross Blue Shield of Tennessee Commercial

Blue Cross Blue Shield of Tennessee Health Exchange

Blue Cross Blue Shield of Tennessee Managed Medicaid

Blue Cross Blue Shield of Tennessee Medicare

Blue Cross Blue Shield of Texas Commercial

Blue Cross Blue Shield of Vermont Commercial

Blue Cross Blue Shield of Vermont Health Exchange

Blue Cross Blue Shield Wyoming Commercial

Blue Cross Blue Shield Wyoming Health Exchange

Blue Cross Community Managed Medicaid

Blue Cross of Idaho Health Services, Inc. Commercial

Blue Cross of Idaho Health Services, Inc. Health Exchange

Blue Cross of Idaho Health Services, Inc. Medicare

Blue Shield of California Commercial

Blue Shield of California Health Exchange

Blue Shield of California Managed Medicaid Medi-Cal

Blue Shield of California Medicare

BlueCross BlueShield of Louisiana Commercial

BlueCross BlueShield of Louisiana Health Exchange

BlueCross BlueShield of Louisiana Medicare

CalOptima Managed Medicaid CA

CalOptima Medicare

CalViva Health Managed Medicaid CA

Cambia BridgeSpan Health Exchange

Cambia Regence Health Exchange

Capital BlueCross, Inc. Commercial

Capital BlueCross, Inc. Medicare

Capital District Physicians Health Plan, Inc. Commercial

Capital District Physicians Health Plan, Inc. Health Exchange

Capital District Physicians Health Plan, Inc. Managed Medicaid NY

Capital District Physicians Health Plan, Inc. Medicare

Capital Health Plan Commercial

Capital Health Plan FEHBP Commercial

Capital Health Plan Medicare

Care Oregon, Inc. Managed Medicaid OR

Care Oregon, Inc. Medicare

CareFirst Medicare Advantage

CareFirst Commercial

CareFirst Community Health Plan Maryland Medicaid

CareFirst Health Exchange

CareFirst Medicare Advantage Dual Prime Medical

CareMore Medical Group Medicare

CarePartners of Connecticut Medical

CareSource Health Exchange GA

CareSource Health Exchange IN

CareSource Health Exchange OH

CareSource Health Exchange WV

CareSource Managed Medicaid Georgia

CareSource Managed Medicaid Indiana

CareSource Managed Medicaid Mississippi

CareSource Managed Medicaid Nevada

CareSource Managed Medicaid Ohio

CareSource Medicare Medical

Cascade Managed Medicaid OR

CenCal Health Managed Medicaid CA

CenCal Health Medicare Medical

Centene Health Exchange Alabama

Centene Health Exchange Arizona

Centene Health Exchange Arkansas

Centene Health Exchange Delaware

Centene Health Exchange Florida

Centene Health Exchange Georgia

Centene Health Exchange Illinois

Centene Health Exchange Indiana

Centene Health Exchange Iowa

Centene Health Exchange Kansas

Centene Health Exchange Kentucky

Centene Health Exchange Louisiana

Centene Health Exchange Michigan

Centene Health Exchange Mississippi

Centene Health Exchange Missouri

Centene Health Exchange Nebraska

Centene Health Exchange Nevada

Centene Health Exchange New Hampshire

Centene Health Exchange New Jersey

Centene Health Exchange North Carolina

Centene Health Exchange Ohio

Centene Health Exchange Oklahoma

Centene Health Exchange Pennsylvania

Centene Health Exchange South Carolina

Centene Health Exchange Tennessee

Centene Health Exchange Texas

Centene Health Exchange Washington

Centene Managed Medicaid Arizona

Centene Managed Medicaid Florida

Centene Managed Medicaid Georgia

Centene Managed Medicaid Indiana

Centene Managed Medicaid Iowa

Centene Managed Medicaid Kansas

Centene Managed Medicaid Louisiana

Centene Managed Medicaid Mississippi

Centene Managed Medicaid Missouri

Centene Managed Medicaid Nebraska

Centene Managed Medicaid Nevada

Centene Managed Medicaid New Hampshire

Centene Managed Medicaid North Carolina

Centene Managed Medicaid Ohio

Centene Managed Medicaid Oklahoma

Centene Managed Medicaid South Carolina

Centene Managed Medicaid Texas

Centene Managed Medicaid Washington

Centene Managed Medicaid Wisconsin

Central California Alliance for Health IHSS Medical

Central California Alliance for Health Managed Medicaid CA

Central California Alliance for Health TotalCare Medicare

Central Health Health Exchange

Central Health Plan of California, Inc. Medicare

Champion Health Plan Medicare

Children's Hospital and Health System Managed Medicaid WI

Children's Medical Services Managed Medicaid FL

Chinese Community Health Plan Corporation Commercial

Chinese Community Health Plan Corporation Health Exchange

Chinese Community Health Plan Corporation Medicare

CHRISTUS Spohn Health System Health Exchange

CHRISTUS Spohn Health System Medicare

Cigna Commercial

Cigna Health Exchange

Clear Spring Health

Clever Care Health Plan Medicare

Clover Health Medical Medicare

Colorado Access Corporation Managed Medicaid CO CHP+

Common Ground Healthcare Cooperative Health Exchange

Commonwealth Care Alliance, Inc. Medicare

Commonwealth of Puerto Rico ADAP

CommuniCare Advantage Medical

Community Advantage Plus Medicare CA

Community Care, Inc. Commercial

Community Care, Inc. HIX

Community Care, Inc. Medicare

Community First Health Plans Commercial

Community First Health Plans Managed Medicaid Texas

Community First Health Plans Medical Medicare

Community Health Choice Medicare

Community Health Choice, Inc. Health Exchange

Community Health Choice, Inc. Managed Medicaid TX

Community Health Group Managed Medicaid CA

Community Health Group Medicare Medical

Community Health Network of Washington Health Exchange

Community Health Network of Washington Managed Medicaid WA

Community Health Network of Washington Medicare

Community Health Plan of Imperial Valley Managed Medicaid CA

ConnectiCare Commercial

ConnectiCare Health Exchange

ConnectiCare Medicare

Contra Costa Health Services Commercial

Contra Costa Health Services Managed Medicaid CA

Contra Costa Health Services Medicare

Cook Children's Health Care System Managed Medicaid TX

Cook County Health and Hospital System Managed Medicaid IL

County Medical Services Program (CMSP) Commercial

Cox Health Commercial

Cox Health HIX

CoxHealth Medicare

Curative Commercial Medical

Dean Health System Commercial

Dean Health System Health Exchange

Dean Health System Managed Medicaid WI

Dean Health System Medicare

Delaware First Health Managed Medicaid

Dell Childrens Health Plan Managed Medicaid Texas

Denver Health Medical Plan Health Exchange

Denver Health Medical Plan Managed Medicaid CO

Denver Health Medical Plan Medicare

Department of Defense TriCare

Department of Veterans Affairs VHA

Devoted Health Medicare

District of Columbia ADAP

District of Columbia State Medicaid

Doctors HealthCare Plans Medicare

Douglas County IPA, Inc. Managed Medicaid OR

Driscoll Children's Health Plan Managed Medicaid TX

Eastern Oregon CCO, LLC Managed Medicaid OR

El Paso First HealthPlans, Inc. Managed Medicaid TX

El Paso Health Medicare

Elderplan, Inc. Medicare

ElderServe Medicare

Elite Health Plan Medical Medicare

EmblemHealth Commercial Medical

EmblemHealth Health Exchange

EmblemHealth Managed Medicaid

EmblemHealth Medicare

EMI Health Medical

Essence, Inc. Medicare

eternalHealth Medicare Medical

Excellus Commercial

Excellus Essential HIX

Excellus Health Exchange

Excellus Managed Medicaid

Excellus Managed Medicaid Child Health Plus

Excellus Medicare Medical

Excellus Medicare SNP Medical

Fallon Community Health Plan, Inc. Commercial

Fallon Community Health Plan, Inc. Managed Medicaid MA

Fallon Community Health Plan, Inc. Medicare

Family Care Partnership Medicare

FCC Medicaid Florida

Fidelis Care Essential Plan NY

Fidelis Care Health Exchange

Fidelis Care Managed Medicaid Child Health Plus

Fidelis Care Managed Medicaid Medicaid

First Choice South Carolina Health Exchange

First Medical Health Plan, Inc. Commercial

First Medical Health Plan, Inc. Managed Medicaid PR

FirstCare Health Plans Managed Medicaid TX

Florida Complete Care Medicare

Florida Health Care Plans Commercial

Florida Health Care Plans Health Exchange

Florida Health Care Plans Medicare

Freedom Health, Inc. Medicare

Geisinger Health System Corporation CHIP

Geisinger Health System Corporation Commercial

Geisinger Health System Corporation Health Exchange

Geisinger Health System Corporation Managed Medicaid PA

Geisinger Health System Corporation Medicare

GlobalHealth, Inc. Medicare

Gold Coast Health Plan Medicare Medical

Gold Coast Health Plan, Inc. Managed Medicaid CA

Gold Kidney Health Plan Medicare

Government Employees Health Association (GEHA) Commercial

Great Plains Medicare

Group Health Cooperative Eau Claire Managed Medicaid WI

Group Health Cooperative of Eau Claire Medicare

Group Health Cooperative of South Central Wisconsin Commercial

Group Health Cooperative of South Central Wisconsin Health Exchange

Group Health Cooperative of South Central Wisconsin Managed Medicaid WI

Hamaspik Medicare

HAP CareSource Medicare

HAP CareSource Michigan Medicaid

Harbor Health Exchange Medical

Harvard Pilgrim Commercial

Harvard Pilgrim Health Exchange

Hawaii Medical Service Association Commercial

Hawaii Medical Service Association Health Exchange

Hawaii Medical Service Association Managed Medicaid HI

Hawaii Medical Service Association Medicare

Health Alliance Plan HAP (Henry Ford Health System) Commercial

Health Alliance Plan HAP (Henry Ford Health System) Medicare

Health Care Service Corporation Medicare

Health Choice Managed Medicaid AZ

Health Choice Managed Medicaid UT

Health Choice Pathway Arizona Medicare

Health First, Inc. Florida Health Exchange

Health First, Inc. Florida Medicare

Health Net Managed Medicaid Medi-Cal

Health Net of California Commercial

Health Net of California Health Exchange

Health Net of Oregon Commercial

Health New England, Inc. Commercial

Health New England, Inc. Health Exchange

Health New England, Inc. Managed Medicaid MA

Health New England, Inc. Medicare

Health One Alliance Commercial

Health Partners Plans Managed Medicaid PA

Health Partners Plans Managed Medicaid PA CHIP

Health Plan Nevada Commercial

Health Plan Nevada Health Exchange

Health Plan Nevada Managed Medicaid

Health Plan of San Joaquin Managed Medicaid CA

Health Plan of San Joaquin Medicare Medical

Health Plan of San Mateo, Inc. Managed Medicaid CA

Health Plan of San Mateo, Inc. Medicare

Healthfirst Health Exchange

Healthfirst Managed Medicaid

Healthfirst Managed Medicaid Child Health Plus

Healthfirst Medicare

HealthPartners, Inc. Commercial

HealthPartners, Inc. Managed Medicaid MN

HealthPartners, Inc. Medicare

HealthSpring Medicare

Healthsun Health Plans, Inc. Medicare

HealthTeam Advantage Plan Medicare

Healthy Blue Kansas

Healthy Blue Louisiana Managed Medicaid

Healthy Blue North Carolina Managed Medicaid

Healthy Mississippi Medicare Medical

HEB

Highmark BCBS Delaware Commercial

Highmark BCBS Delaware Health Exchange

Highmark Commercial

Highmark Health Exchange

Highmark Health Options Medicare

Highmark Managed Medicaid

Highmark Managed Medicaid WV

Highmark Medicare

Highmark New York Commercial

Highmark New York Health Exchange

Highmark New York Managed Medicaid

Highmark New York Medicare

Highmark Wholecare Medicare

Highmark Wholecare Pennsylvania Medical

HMAA

Hometown Health, Inc. Commercial

Hometown Health, Inc. Medicare

Horizon BCBS Commercial

Horizon BCBS Health Exchange

Horizon Medicare

Horizon NJ Health Managed Medicaid

Humana Managed Medicaid Florida

Humana Managed Medicaid Kentucky

Humana Managed Medicaid Louisiana

Humana Managed Medicaid Ohio

Humana Managed Medicaid Oklahoma

Humana Managed Medicaid South Carolina

Humana Managed Medicaid Virginia

Humana Medicare

Humana Medicare MA only

iCircle Advantage

IHC Health Plans Corp Commercial

IHC Health Plans Corp Health Exchange

IHC Health Plans Corp Managed Medicaid UT

IHC Health Plans Corp Medicare

IMCare Classic Medicare

Imperial Health Medicare

Imperial Health Plan Health Exchange

Independence Blue Cross Commercial

Independence Blue Cross Health Exchange

Independence Blue Cross Medicare

Independent Care Health Plan Managed Medicaid WI

Independent Care Health Plan Medicare

Independent Health Association, Inc. Commercial

Independent Health Association, Inc. Health Exchange

Independent Health Association, Inc. Managed Medicaid NY

Independent Health Association, Inc. Medicare

Indian Health Services Commercial

Indiana University Health, Inc. Commercial

Inland Empire Health Plan Health Exchange

Inland Empire Health Plan Managed Medicaid Medi-Cal

Inland Empire Health Plan Medicare

InnovaCare Health Managed Medicaid PR

InnovaCare Health Medicare

ITASCA Medical Care Managed Medicaid MN

JAI Medical Systems, Inc. Managed Medicaid MD

Jefferson Health Plans Health Exchange

Jefferson Health Plans Medicare Advantage

Johns Hopkins HealthCare LLC Medicare

Kaiser Permanente Commercial California

Kaiser Permanente Commercial Colorado

Kaiser Permanente Commercial Georgia

Kaiser Permanente Commercial Hawaii

Kaiser Permanente Commercial Mid-Atlantic

Kaiser Permanente Commercial Northwest

Kaiser Permanente Commercial Washington

Kaiser Permanente Health Exchange California

Kaiser Permanente Health Exchange Colorado

Kaiser Permanente Health Exchange Georgia

Kaiser Permanente Health Exchange Hawaii

Kaiser Permanente Health Exchange Mid-Atlantic

Kaiser Permanente Health Exchange Northwest

Kaiser Permanente Health Exchange Washington

Kaiser Permanente Managed Medicaid California

Kaiser Permanente Managed Medicaid Hawaii

Kaiser Permanente Managed Medicaid Mid-Atlantic

Kaiser Permanente Medicare

Kaiser Permanente Medicare Washington

Kansas Health Advantage Medicare

KelseyCare Advantage Medicare MA

KelseyCare Advantage, Inc. Medicare

Kern County Health Managed Medicaid CA

KeyCare Medicare

KFHC Medicare CA

LA Care Health Exchange

LA Care Managed Medicaid Medi-Cal

LA Care Medicare MMP

Lagniappe Advantage Medicare Medical

Leon Health Plan Medicare

Liberty Advantage Medicare

LifeWorks Advantage Medicare

Longevity Health Plan Medicare

MAC Jurisdiction 15

MAC Jurisdiction 5

MAC Jurisdiction 6

MAC Jurisdiction 8

MAC Jurisdiction E

MAC Jurisdiction F

MAC Jurisdiction H

MAC Jurisdiction J

MAC Jurisdiction K

MAC Jurisdiction L

MAC Jurisdiction M

MAC Jurisdiction N

Maine Community Health Options Health Exchange

Mapfre Praico Corporation Commercial

Martin's Point Health Care Medicare

Maryland Physicians Care (MPC) Managed Medicaid MD

Mass Advantage Medicare Medical

Mass General Brigham Commercial

Mass General Brigham Health Exchange

Mass General Brigham Health Plan Medicare

Mass General Brigham Managed Medicaid MA

McLaren Health Care Corporation Health Exchange

McLaren Health Care Corporation Managed Medicaid MI

McLaren Health Care Medicare

MCS Life Insurance Company Commercial

MCS Life Insurance Company Medicare

Medica Commercial

Medica Health Plans Health Exchange

Medica Health Plans Medicare

Medica Medicaid Minnesota

Medical Associates Health Plan Medicare

Medical Associates Health Plan, Inc. Commercial

Medical Mutual of Ohio Commercial

Medical Mutual of Ohio Health Exchange

Medical Mutual of Ohio Medicare

MedStar Health Managed Medicaid MD

MedStar Managed Medicaid DC

Memorial Hermann Healthcare System Commercial

Memorial Hermann Healthcare System Medicare

Mending Health Exchange

Mennonite Commercial

Mennonite Managed Medicaid Puerto Rico

Mercy Care Managed Medicaid AZ

Mercy Care Medicare

Mercy Health System Corporation Commercial

Mercy Health System Corporation Health Exchange

Mercy Health System Corporation Managed Medicaid

Meridian Health Plan Managed Medicaid IL

Meridian Health Plan Managed Medicaid MI

MetroPlus Health Exchange

MetroPlus Health Plan Medicare

MetroPlus Managed Medicaid NY

Metropolitan Health Plan, Inc. Managed Medicaid MN

Moda Health Commercial

Moda Health Health Exchange

Molina Complete Care Managed Medicaid Arizona

Molina Health Care Health Exchange Utah

Molina Health Care Managed Medicaid Mississippi

Molina Health Link Iowa

Molina Healthcare Essential Plan New York

Molina Healthcare Health Exchange California

Molina Healthcare Health Exchange Florida

Molina Healthcare Health Exchange Idaho

Molina Healthcare Health Exchange Illinois

Molina Healthcare Health Exchange Kentucky

Molina Healthcare Health Exchange Mississippi

Molina Healthcare Health Exchange Nevada

Molina Healthcare Health Exchange New Mexico

Molina Healthcare Health Exchange Ohio

Molina Healthcare Health Exchange South Carolina

Molina Healthcare Health Exchange Texas

Molina Healthcare Health Exchange Washington

Molina Healthcare Managed Medicaid California

Molina Healthcare Managed Medicaid Florida

Molina Healthcare Managed Medicaid Illinois

Molina Healthcare Managed Medicaid Michigan

Molina Healthcare Managed Medicaid Nebraska

Molina Healthcare Managed Medicaid Nevada

Molina Healthcare Managed Medicaid NM

Molina Healthcare Managed Medicaid NY

Molina Healthcare Managed Medicaid Ohio

Molina Healthcare Managed Medicaid South Carolina

Molina Healthcare Managed Medicaid Texas

Molina Healthcare Managed Medicaid Utah

Molina Healthcare Managed Medicaid Washington

Molina Healthcare Managed Medicaid Wisconsin

Molina Healthcare Medicare

Mountain Health Cooperative Commercial

Mountain Health Cooperative Health Exchange

Mt. Carmel Health Plan, Inc. Medicare

MVP Health Care, Inc. Commercial

MVP Health Care, Inc. Health Exchange

MVP Health Care, Inc. Managed Medicaid NY

MVP Health Care, Inc. Medicare

My Choice Wisconsin Medicare

MyAdvocate Medicare

MyTruAdvantage Medical Medicare

Nascentia Health Plus Medicare

NC State Health Plan for Teachers and State Employees

Neighborhood Health Plan of Rhode Island Health Exchange

Neighborhood Health Plan of Rhode Island Managed Medicaid RI

Neighborhood Health Plan of Rhode Island Medicare

Network Health Medicare

New York Hotel Trades Council Commercial

NextBlue North Dakota Medicare

NHC Advantage Medicare

Optimum HealthCare, Inc. Medicare

Oscar Insurance Health Exchange

PacificSource Health Plan Commercial

PacificSource Health Plan Health Exchange

PacificSource Health Plan Managed Medicaid OR

PacificSource Health Plan Medicare

Paramount Health Care, Inc. Commercial

Paramount Health Care, Inc. Health Exchange

Paramount Health Care, Inc. Medicare

Parkland Community Health Plan, Inc. Managed Medicaid TX

Partners Managed Medicaid North Carolina

Partnership HealthPlan of California, Inc. Managed Medicaid CA

Passport Health Plan Managed Medicaid KY

Passport Health Plan Medicare

Patrius Health Medicare

Peak Health Medicare

Peoples Health Medicare

Peoples Health Medicare MA

Perennial Advantage Medicare

Physicians Health Plan of Northern Indiana, Inc Commercial

Positive Healthcare Medicare

Preferred Care Network Medicare

Preferred Care Partners, Inc. Medicare

Premera Commercial Essential

Premera Commercial Preferred

Premera Health Exchange

Presbyterian Health Care Services Commercial

Presbyterian Health Care Services HIX

Presbyterian Health Care Services Managed Medicaid NM

Presbyterian Health Care Services Medicare

Prevea360 Commercial

Prevea360 HIX

Prime West Central County Based Purchasing Initiative Inc. Managed Medicaid MN

Prime West Central County Based Purchasing Initiative Inc. Medicare

Priority Health, Inc. Commercial

Priority Health, Inc. Health Exchange

Priority Health, Inc. Managed Medicaid MI

Priority Health, Inc. Medicare

Priority Partners MCO Managed Medicaid MD

ProCare Advantage Medicare

Prominence Commercial

Prominence Medicare

Providence Health System Commercial

Providence Health System Health Exchange

Providence Health System Managed Medicaid OR

Providence Health System Medicare

Provider Partners Health Plan Medicare

PruittHealth Corporation Medicare

QualChoice of Arkansas, Inc Commercial

Quartz Health Solutions Commercial

Quartz Health Solutions Managed Medicaid WI

Quartz Health Solutions Medicare

Regence Commercial

Regence Medicare

Rocky Mountain Health Plans Corporation Health Exchange

Rocky Mountain Health Plans Corporation Managed Medicaid CO MCO

Samaritan Health Services Choice Commercial

Samaritan Health Services Large Group Commercial

Samaritan Health Services Managed Medicaid OR

Samaritan Health Services Medicare

San Francisco Health Plan (SFHP) Managed Medicaid CA

San Francisco Health Plan Medicare Medical

Sanford Health Plan Commercial

Sanford Health Plan Health Exchange

Sanford Health Plan Medicare

Santa Clara Family Health Plan Managed Medicaid CA

Santa Clara Family Health Plan Medicare

SCAN Health Plan, Inc. Medicare

Scott & White Health Plan Commercial

Scott & White Health Plan Managed Medicaid TX

Scott & White Health Plan Medicare

Scripps Health Medical

SECUR Medicare

Security Health Plan Commercial

Security Health Plan Health Exchange

Security Health Plan Managed Medicaid WI

Security Health Plan Medicare Plans

Senior Whole Health LLC Medicare

Sentara Health System Corporation Commercial

Sentara Health System Corporation Health Exchange

Sentara Health System Corporation Managed Medicaid VA

Sentara Health System Corporation Medicare

Sharp HealthCare, Inc. Commercial

Sharp HealthCare, Inc. Health Exchange

Sharp HealthCare, Inc. Medicare

Sierra Health and Life Commercial

Simply HealthCare Managed Medicaid Florida Healthy Kids

Simply Healthcare Plans Managed Medicaid FL

Simply Healthcare Plans Medicare

Simpra Advantage Medicare

Solis Health Plan Medicare

South Country Health Alliance, Inc. Managed Medicaid MN

South Country Health Alliance, Inc. Medicare

South Florida Community Care Network (SFCCN) Managed Medicaid FL

Southeastern Indiana Health Organization, Inc. Commercial

St. Luke's Health Plan Health Exchange

State Medicaid California

State Medicaid New York

State Medicaid North Carolina

State of Alabama ADAP

State of Alabama State Medicaid

State of Alaska ADAP

State of Alaska State Medicaid

State of Arizona ADAP

State of Arizona State Medicaid

State of Arkansas ADAP

State of Arkansas State Medicaid

State of California ADAP

State of Colorado ADAP

State of Colorado State Medicaid

State of Connecticut ADAP

State of Connecticut State Medicaid

State of Delaware ADAP

State of Delaware State Medicaid

State of Florida ADAP

State of Florida State Medicaid

State of Georgia ADAP

State of Georgia State Medicaid

State of Hawaii ADAP

State of Idaho ADAP

State of Idaho State Medicaid

State of Illinois ADAP

State of Illinois State Medicaid

State of Indiana ADAP

State of Indiana State Medicaid

State of Iowa ADAP

State of Iowa State Medicaid

State of Kansas ADAP

State of Kentucky ADAP

State of Kentucky State Medicaid

State of Louisiana ADAP

State of Louisiana State Medicaid

State of Maine ADAP

State of Maine State Medicaid

State of Maryland ADAP

State of Maryland State Medicaid

State of Massachusetts State Medicaid

State of Michigan ADAP

State of Michigan State Medicaid

State of Minnesota ADAP

State of Minnesota State Medicaid

State of Mississippi ADAP

State of Mississippi State Medicaid

State of Missouri ADAP

State of Missouri State Medicaid

State of Montana Commercial ADAP

State of Montana State Medicaid

State of Nebraska ADAP

State of Nebraska State Medicaid

State of Nevada ADAP

State of Nevada State Medicaid

State of New Hampshire ADAP

State of New Hampshire State Medicaid

State of New Jersey Commercial

State of New Jersey State Medicaid

State of New Mexico ADAP

State of New Mexico State Medicaid

State of New York ADAP

State of North Carolina ADAP

State of North Carolina Medicare

State of North Dakota ADAP

State of North Dakota State Medicaid

State of Ohio ADAP

State of Ohio State Medicaid

State of Oklahoma ADAP

State of Oklahoma Commercial

State of Oklahoma State Medicaid

State of Oregon ADAP

State of Oregon State Medicaid

State of Pennsylvania ADAP

State of Pennsylvania State Medicaid

State of Rhode Island ADAP

State of Rhode Island State Medicaid

State of South Carolina ADAP

State of South Carolina State Medicaid

State of South Dakota ADAP

State of South Dakota State Medicaid

State of Tennessee ADAP

State of Texas ADAP

State of Texas State Medicaid

State of Utah ADAP

State of Utah State Medicaid

State of Vermont ADAP

State of Vermont State Medicaid

State of Virginia ADAP

State of Virginia State Medicaid

State of Washington ADAP

State of Washington State Medicaid

State of West Virginia ADAP

State of West Virginia State Medicaid

State of Wisconsin ADAP

State of Wisconsin State Medicaid

State of Wyoming ADAP

State of Wyoming State Medicaid

SummaCare, Inc. Commercial

SummaCare, Inc. Health Exchange

SummaCare, Inc. Medicare

Sutter Health Plus Commercial

Texas Children's Health Plan Managed Medicaid TX

The Alliance Commercial

The Alliance Managed Medicaid CA

The Health Plan of the Upper Ohio Valley, Inc. Commercial

The Health Plan of the Upper Ohio Valley, Inc. Managed Medicaid WV

The Health Plan of the Upper Ohio Valley, Inc. Medicare

Tribute Health Plans Medicare

Trillium Health Managed Medicaid North Carolina

Trillium Managed Medicaid

Triple-S Commercial Medical

Triple-S FEHBP Medical

Triple-S Managed Medicaid PR

Triple-S Medicare

Troy Medicare Medical

Tufts Health Plan Commercial

Tufts Health Plan Health Exchange

Tufts Health Plan Managed Medicaid RI

Tufts Health Plan Medicare

Tufts Health Plan Medicare SNP

UCare Minnesota, Inc. Health Exchange

UCare Minnesota, Inc. Managed Medicaid MN

UCLA Health Medicare Medical

Ultimate Health Plans, Inc. Medicare

UnitedHealthcare Commercial

UnitedHealthcare Community Plan Managed Medicaid Texas

UnitedHealthcare Community Plan Managed Medicaid Arizona

UnitedHealthcare Community Plan Managed Medicaid Florida

UnitedHealthcare Community Plan Managed Medicaid Hawaii

UnitedHealthcare Community Plan Managed Medicaid Indiana

UnitedHealthcare Community Plan Managed Medicaid Kansas

UnitedHealthcare Community Plan Managed Medicaid Kentucky

UnitedHealthcare Community Plan Managed Medicaid Louisiana

UnitedHealthcare Community Plan Managed Medicaid Maryland

UnitedHealthcare Community Plan Managed Medicaid Michigan

UnitedHealthcare Community Plan Managed Medicaid Missouri

UnitedHealthcare Community Plan Managed Medicaid Nebraska

UnitedHealthcare Community Plan Managed Medicaid New Jersey

UnitedHealthcare Community Plan Managed Medicaid NM

UnitedHealthcare Community Plan Managed Medicaid North Carolina

UnitedHealthcare Community Plan Managed Medicaid NY

UnitedHealthcare Community Plan Managed Medicaid NY CHIP

UnitedHealthcare Community Plan Managed Medicaid Ohio

UnitedHealthcare Community Plan Managed Medicaid Pennsylvania

UnitedHealthcare Community Plan Managed Medicaid Rhode Island

UnitedHealthcare Community Plan Managed Medicaid Tennessee

UnitedHealthcare Community Plan Managed Medicaid Virginia

UnitedHealthcare Community Plan Managed Medicaid Washington

UnitedHealthcare Community Plan Managed Medicaid Wisconsin

UnitedHealthcare Erickson Medicare

UnitedHealthcare Essential Plan New York

UnitedHealthcare FEHBP Commercial

UnitedHealthcare Health Exchange

UnitedHealthcare Health Exchange Alabama

UnitedHealthcare Health Exchange Arizona

UnitedHealthcare Health Exchange Florida

UnitedHealthcare Health Exchange Georgia

UnitedHealthcare Health Exchange Illinois

UnitedHealthcare Health Exchange Indiana

UnitedHealthcare Health Exchange Iowa

UnitedHealthcare Health Exchange Kansas

UnitedHealthcare Health Exchange Louisiana

UnitedHealthcare Health Exchange Maryland

UnitedHealthcare Health Exchange Massachusetts

UnitedHealthcare Health Exchange Michigan

UnitedHealthcare Health Exchange Mississippi

UnitedHealthcare Health Exchange Missouri

UnitedHealthcare Health Exchange Nebraska

UnitedHealthcare Health Exchange New Jersey

UnitedHealthcare Health Exchange New Mexico

UnitedHealthcare Health Exchange North Carolina

UnitedHealthcare Health Exchange Ohio

UnitedHealthcare Health Exchange Oklahoma

UnitedHealthcare Health Exchange South Carolina

UnitedHealthcare Health Exchange Tennessee

UnitedHealthcare Health Exchange Texas

UnitedHealthcare Health Exchange Virginia

UnitedHealthcare Health Exchange Washington

UnitedHealthcare Health Exchange Wisconsin

UnitedHealthcare Health Exchange Wyoming

UnitedHealthcare Medicare

UnitedHealthcare Medicare MA

UnitedHealthcare Oxford Commercial

University Family Care Medical

University Health Alliance Commercial

University of Utah Health Plans Commercial

University of Utah Health Plans Health Exchange

University of Utah Health Plans Managed Medicaid UT

UPMC FEHBP Commercial

UPMC Health Exchange

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Zing Medicare Medical

US.LIB.26.01.0090  01/26

Information contained on this website comes directly from the payer’s medical policy, is subject to change, and is not a guarantee of insurance coverage. This information is provided for your education only, and it should not be construed as medical advice. Patient-specific coverage may vary from the medical policy. Refer to the LIBTAYO Surround® benefits verification or your patient's plan document to verify patient-specific coverage.

LIBTAYO® and LIBTAYO Surround® are registered trademarks of Regeneron Pharmaceuticals, Inc.

Other trademarks or registered trademarks are the property of their respective owners.

Important Safety Information

Warnings and Precautions

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-mediated adverse reactions usually occur during treatment, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue LIBTAYO depending on severity of the adverse reaction (see Section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

The incidence and severity of immune-mediated adverse reactions were similar when LIBTAYO was administered as a single agent or in combination with chemotherapy.

Immune-mediated pneumonitis: LIBTAYO can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 2.6% (33/1281) of patients receiving LIBTAYO, including Grade 4 (0.3%), Grade 3 (0.6%), and Grade 2 (1.6%). Pneumonitis led to permanent discontinuation in 1.3% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was withheld, 10 reinitiated after symptom improvement; of these, 4/10 (40%) had recurrence of pneumonitis.

Immune-mediated colitis: LIBTAYO can cause immune-mediated colitis. The primary component of immune-mediated colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory immune-mediated colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2% (25/1281) of patients receiving LIBTAYO, including Grade 3 (0.8%) and Grade 2 (0.9%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.2% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 56% of the 25 patients. Of the 16 patients in whom LIBTAYO was withheld, 6 reinitiated LIBTAYO after symptom improvement; of these, 4/6 (67%) had recurrence.

Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.4% (31/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 4 (0.3%), Grade 3 (1.6%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 0.7% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 13% (4/31) of these patients. Hepatitis resolved in 39% of the 31 patients. Of the 9 patients in whom LIBTAYO was withheld, 5 reinitiated LIBTAYO after symptom improvement; of these, 1/5 (20%) had recurrence.

Immune-mediated endocrinopathies:

  • Adrenal insufficiency: LIBTAYO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold LIBTAYO depending on severity. Adrenal insufficiency occurred in 0.5% (6/1281) of patients receiving LIBTAYO, including Grade 3 (0.5%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient. LIBTAYO was withheld in 1 (<0.1%) patient due to adrenal insufficiency and not reinitiated. Systemic corticosteroids were required in 83% (5/6) patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency had resolved in 17% of the 6 patients
  • Hypophysitis: LIBTAYO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue depending on severity. Hypophysitis occurred in 0.5% (7/1281) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.3%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient and withholding of LIBTAYO in 2 (0.2%) patients. Systemic corticosteroids were required in 86% (6/7) of patients with hypophysitis. Hypophysitis resolved in 14% of the 7 patients. Of the 2 patients in whom LIBTAYO was withheld for hypophysitis, none of the patients reinitiated
  • Thyroid disorders: LIBTAYO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management as clinically indicated. Withhold or permanently discontinue LIBTAYO depending on severity
  • Thyroiditis: Thyroiditis occurred in 0.6% (8/1281) of patients receiving LIBTAYO, including Grade 2 (0.3%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 (<0.1%) patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis resolved in 13% of the 8 patients. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported
  • Hyperthyroidism: Hyperthyroidism occurred in 3% (39/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (0.9%). No patient discontinued treatment and LIBTAYO was withheld in 7 (0.5%) patients due to hyperthyroidism. Systemic corticosteroids were required in 8% (3/39) of patients. Hyperthyroidism resolved in 56% of 39 patients. Of the 7 patients in whom LIBTAYO was withheld for hyperthyroidism, 2 patients reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of hyperthyroidism
  • Hypothyroidism: Hypothyroidism occurred in 7% (87/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (6%). Hypothyroidism led to permanent discontinuation of LIBTAYO in 3 (0.2%) patients. Hypothyroidism led to withholding of LIBTAYO in 9 (0.7%) patients. Systemic corticosteroids were required in 1.1% (1/87) of patients with hypothyroidism. Hypothyroidism resolved in 6% of the 87 patients. Majority of the patients with hypothyroidism required long-term thyroid hormone replacement. Of the 9 patients in whom LIBTAYO was withheld for hypothyroidism, 1 reinitiated LIBTAYO after symptom improvement and did not have recurrence of hypothyroidism
  • Type 1 diabetes mellitus, which can present with diabetic ketoacidosis: Monitor for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold LIBTAYO depending on severity. Type 1 diabetes mellitus occurred in <0.1% (1/1281) of patients (Grade 4). No patient discontinued treatment due to Type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients, treatment was reinitiated after symptom improvement. Patient received long-term insulin therapy

Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.7% (9/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 3 (<0.1%), and Grade 2 (0.5%). Nephritis led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 78% of the 9 patients. Of the 5 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 1/4 (25%) had recurrence.

Immune-mediated dermatologic adverse reactions: LIBTAYO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1–blocking antibodies. Immune-mediated dermatologic adverse reactions occurred in 1.9% (24/1281) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% of the 24 patients. Of the 17 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 13 reinitiated LIBTAYO after symptom improvement; of these, 5/13 (38%) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 1281 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

  • Cardiac/vascular: Myocarditis, pericarditis, and vasculitis. Permanently discontinue for Grades 2, 3, or 4 myocarditis
  • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
  • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis
  • Musculoskeletal and connective tissue: Myositis/polymyositis/dermatomyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
  • Endocrine: Hypoparathyroidism
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection

Infusion-Related Reactions

Severe or life-threatening infusion-related reactions occurred in 0.2% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. Common symptoms of infusion-related reaction include nausea, pyrexia, and vomiting. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction.

Complications of Allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.

Adverse Reactions

The most common adverse reactions (≥15%) are:

  • As a single agent in mCSCC or laCSCC, mBCC or laBCC, and NSCLC with high PD-L1 expression: fatigue, musculoskeletal pain, rash, diarrhea, and anemia
  • As a single agent in adjuvant CSCC at high risk of recurrence: rash and pruritus
  • In combination with platinum-based chemotherapy in NSCLC: alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite

Use in Specific Populations

  • Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO
  • Females and males of reproductive potential: Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO

Please see full Prescribing Information.

Information contained on this website comes directly from the payer's medical policy, is subject to change, and is not a guarantee of insurance coverage. This information is provided for your education only, and it should not be construed as medical advice. Patient-specific coverage may vary from the medical policy. Refer to the LIBTAYO Surround® benefits verification or your patient's plan document to verify patient-specific coverage.

LIBTAYO® and LIBTAYO Surround® are registered trademarks of Regeneron Pharmaceuticals, Inc.

Other trademarks or registered trademarks are the property of their respective owners.

Indications and Usage

LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.

LIBTAYO as a single agent is indicated for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.

LIBTAYO is indicated for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

LIBTAYO is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

LIBTAYO is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

Important Safety Information

Warnings and Precautions

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-mediated adverse reactions usually occur during treatment, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue LIBTAYO depending on severity of the adverse reaction (see Section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

The incidence and severity of immune-mediated adverse reactions were similar when LIBTAYO was administered as a single agent or in combination with chemotherapy.

Immune-mediated pneumonitis: LIBTAYO can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 2.6% (33/1281) of patients receiving LIBTAYO, including Grade 4 (0.3%), Grade 3 (0.6%), and Grade 2 (1.6%). Pneumonitis led to permanent discontinuation in 1.3% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was withheld, 10 reinitiated after symptom improvement; of these, 4/10 (40%) had recurrence of pneumonitis.

Immune-mediated colitis: LIBTAYO can cause immune-mediated colitis. The primary component of immune-mediated colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory immune-mediated colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2% (25/1281) of patients receiving LIBTAYO, including Grade 3 (0.8%) and Grade 2 (0.9%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.2% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 56% of the 25 patients. Of the 16 patients in whom LIBTAYO was withheld, 6 reinitiated LIBTAYO after symptom improvement; of these, 4/6 (67%) had recurrence.

Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.4% (31/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 4 (0.3%), Grade 3 (1.6%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 0.7% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 13% (4/31) of these patients. Hepatitis resolved in 39% of the 31 patients. Of the 9 patients in whom LIBTAYO was withheld, 5 reinitiated LIBTAYO after symptom improvement; of these, 1/5 (20%) had recurrence.

Immune-mediated endocrinopathies:

  • Adrenal insufficiency: LIBTAYO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold LIBTAYO depending on severity. Adrenal insufficiency occurred in 0.5% (6/1281) of patients receiving LIBTAYO, including Grade 3 (0.5%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient. LIBTAYO was withheld in 1 (<0.1%) patient due to adrenal insufficiency and not reinitiated. Systemic corticosteroids were required in 83% (5/6) patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency had resolved in 17% of the 6 patients
  • Hypophysitis: LIBTAYO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue depending on severity. Hypophysitis occurred in 0.5% (7/1281) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.3%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient and withholding of LIBTAYO in 2 (0.2%) patients. Systemic corticosteroids were required in 86% (6/7) of patients with hypophysitis. Hypophysitis resolved in 14% of the 7 patients. Of the 2 patients in whom LIBTAYO was withheld for hypophysitis, none of the patients reinitiated
  • Thyroid disorders: LIBTAYO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management as clinically indicated. Withhold or permanently discontinue LIBTAYO depending on severity
  • Thyroiditis: Thyroiditis occurred in 0.6% (8/1281) of patients receiving LIBTAYO, including Grade 2 (0.3%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 (<0.1%) patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis resolved in 13% of the 8 patients. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported
  • Hyperthyroidism: Hyperthyroidism occurred in 3% (39/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (0.9%). No patient discontinued treatment and LIBTAYO was withheld in 7 (0.5%) patients due to hyperthyroidism. Systemic corticosteroids were required in 8% (3/39) of patients. Hyperthyroidism resolved in 56% of 39 patients. Of the 7 patients in whom LIBTAYO was withheld for hyperthyroidism, 2 patients reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of hyperthyroidism
  • Hypothyroidism: Hypothyroidism occurred in 7% (87/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (6%). Hypothyroidism led to permanent discontinuation of LIBTAYO in 3 (0.2%) patients. Hypothyroidism led to withholding of LIBTAYO in 9 (0.7%) patients. Systemic corticosteroids were required in 1.1% (1/87) of patients with hypothyroidism. Hypothyroidism resolved in 6% of the 87 patients. Majority of the patients with hypothyroidism required long-term thyroid hormone replacement. Of the 9 patients in whom LIBTAYO was withheld for hypothyroidism, 1 reinitiated LIBTAYO after symptom improvement and did not have recurrence of hypothyroidism
  • Type 1 diabetes mellitus, which can present with diabetic ketoacidosis: Monitor for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold LIBTAYO depending on severity. Type 1 diabetes mellitus occurred in <0.1% (1/1281) of patients (Grade 4). No patient discontinued treatment due to Type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients, treatment was reinitiated after symptom improvement. Patient received long-term insulin therapy

Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.7% (9/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 3 (<0.1%), and Grade 2 (0.5%). Nephritis led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 78% of the 9 patients. Of the 5 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 1/4 (25%) had recurrence.

Immune-mediated dermatologic adverse reactions: LIBTAYO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1–blocking antibodies. Immune-mediated dermatologic adverse reactions occurred in 1.9% (24/1281) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% of the 24 patients. Of the 17 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 13 reinitiated LIBTAYO after symptom improvement; of these, 5/13 (38%) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 1281 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

  • Cardiac/vascular: Myocarditis, pericarditis, and vasculitis. Permanently discontinue for Grades 2, 3, or 4 myocarditis
  • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
  • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis
  • Musculoskeletal and connective tissue: Myositis/polymyositis/dermatomyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
  • Endocrine: Hypoparathyroidism
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection

Infusion-Related Reactions

Severe or life-threatening infusion-related reactions occurred in 0.2% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. Common symptoms of infusion-related reaction include nausea, pyrexia, and vomiting. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction.

Complications of Allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.

Adverse Reactions

The most common adverse reactions (≥15%) are:

  • As a single agent in mCSCC or laCSCC, mBCC or laBCC, and NSCLC with high PD-L1 expression: fatigue, musculoskeletal pain, rash, diarrhea, and anemia
  • As a single agent in adjuvant CSCC at high risk of recurrence: rash and pruritus
  • In combination with platinum-based chemotherapy in NSCLC: alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite

Use in Specific Populations

  • Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO
  • Females and males of reproductive potential: Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO

Please see full Prescribing Information.

Information contained on this website comes directly from the payer's medical policy, is subject to change, and is not a guarantee of insurance coverage. This information is provided for your education only, and it should not be construed as medical advice. Patient-specific coverage may vary from the medical policy. Refer to the LIBTAYO Surround® benefits verification or your patient's plan document to verify patient-specific coverage.

LIBTAYO® and LIBTAYO Surround® are registered trademarks of Regeneron Pharmaceuticals, Inc.

Other trademarks or registered trademarks are the property of their respective owners.

Indications and Usage

LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.

LIBTAYO as a single agent is indicated for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic.

LIBTAYO is indicated for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

LIBTAYO is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

LIBTAYO is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.