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REVIEW REQUEST FOR: Pembrolizumab (Keytruda®) Provider Data Collection Tool Based on Medical Policy DRUG.00071 Policy Last Review Date: 11/03/2016 Request Date: Initial Request Buy and bill / Policy Effective Date: 11/17/2016 Provider Tool Effective Date: 11/17/2016 / Subsequent Request Individual’s Name: Date of Birth: / / Individual’s Phone Number: Insurance Identification Number: Primary Diagnosis: Diagnosis Code(s) (if known): Ordering Provider Name & Specialty: Individual’s Weight (lbs) (kg) Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Servicing Provider Name & Specialty (If different than Ordering Provider): Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Place of Service: Home Office Dialysis Center Outpatient Hospital Ambulatory Infusion Ambulatory Infusion Center Other: Drug Name/HCPCS Code (if known) Dose to be administered: Keytruda (mg/kg) J9271 Other: When did the individual first start this drug? / / Duration: (Weeks) (other) Frequency (Days, Wks, Months) Start Date For This Request: / / This Medical Policy based provider data collection tool is intended to facilitate a UM medical necessity review request for use of pembrolizumab (Keytruda) in the treatment of recurrent, unresectable, or metastatic head and neck squamous cell carcinoma, unresectable or metastatic melanoma, metastatic non-small cell lung cancer, metastatic or recurrent locoregional Merkel cell carcinoma, and relapsed or refractory Hodgkin lymphoma. Please check all that apply to the individual. Melanoma Individual is diagnosed with unresectable or metastatic melanoma Pembrolizumab (Keytruda®) is being used as a single agent treatment Keytruda® is being used as first-line therapy in untreated disease Keytruda® is being used as second-line or subsequent therapy for documented disease progression while receiving or since completing most recent therapy Individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Individual has NOT received treatment with another PD-1 agent (for example, nivolumab) Individual is NOT receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection REVIEW REQUEST FOR: Pembrolizumab (Keytruda®) Provider Data Collection Tool Based on Medical Policy DRUG.00071 Policy Last Review Date: 11/03/2016 Policy Effective Date: 11/17/2016 Provider Tool Effective Date: 11/17/2016 Non-Small Cell Lung Cancer Individual is diagnosed with advanced (metastatic) non-small cell lung cancer (NSCLC) Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection Pembrolizumab (Keytruda®) is being used as first-line treatment Pembrolizumab (Keytruda®) is being used as a single agent Individual has cytologically confirmed stage IV NSCLC Tumor expresses PD-L1 gene on at least 50% of tumor cells There are NO sensitizing epidermal growth factor recptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations Individual has NOT received another PD-1 agent (for example, nivolumab) and has not undergone previous systemic therapy for metastatic disease Individual’s current ECOG performance status is 0-2 Individual is not receiving therapy for an autoimmune disease, chronic condition or interstitial lung disease with a systemic immunosuppressant Pembrolizumab (Keytruda®) will be used as second or subsequent line of treatment Pembrolizumab (Keytruda®) is being used as a single agent Tumors with PD-L1 gene expression level greater equal to or greater than 1% with demonstrated disease progression on or after platinum-containing chemotherapy Anaplastic lymphoma kinase (ALK) or epidermal growth factor receptor (EGFR) genomic tumor aberrations have demonstrated disease progression on U.S. Food and Drug Administration (FDA) approved therapy for the aberrations prior to receiving pembrolizumab (Keytruda®) Individual has NOT received another PD-1 agent (for example, nivolumab) Individual’s current ECOG performance status is 0-2 Individual is NOT receiving therapy for an autoimmune disease, chronic condition or interstitial lung disease with a systemic immunosuppressant. Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection Recurrent, unresectable or metastatic head and neck squamous cell carcinoma Individual is diagnosed with: (Mark the following that apply to the individual) Recurrent, unresectable head and neck squamous cell carcinoma Metastatic head and neck squamous cell carcinoma Pembrolizumab (Keytruda®) is being used as a single agent Tumor expresses PD-L1 gene Individual has demonstrated disease progression on or after platinum-containing chemotherapy Individual has NOT received treatment with another PD-1 agent (for example, nivolumab) Individual’s current ECOG performance status is 0-2 Individual is NOT receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection Page 2 of 3 REVIEW REQUEST FOR: Pembrolizumab (Keytruda®) Provider Data Collection Tool Based on Medical Policy DRUG.00071 Policy Last Review Date: 11/03/2016 Policy Effective Date: 11/17/2016 Provider Tool Effective Date: 11/17/2016 Hodgkin lymphoma Individual is diagnosed with relapsed or refractory Hodgkin lymphoma Individual is diagnosed with lymphocyte-predominant Hodgkin lymphoma Individual is NOT receiving therapy for an autoimmune disease, chronic condition or interstitial lung disease with a systemic immunosuppressant Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection Merkel-cell Carcinoma (MCC) Individual is diagnosed with Merkel-cell carcinoma (MCC) Pembrolizumab (Keytruda®) is being used as a single agent Individual has metastatic or recurrent locoregional MCC determined to be not amenable to definitive surgery or radiation therapy Individual has NOT received another PD-1 agent (for example, nivolumab) Individual’s current ECOG performance status is 0-2 Individual is NOT receiving therapy for an autoimmune disease, chronic condition or interstitial lung disease with a systemic immunosuppressant. Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection Other indication not specified above. (Please specify and submit all supporting documents including labs, progress notes, imaging, etc., for review.) This request is being submitted: Pre-Claim Post–Claim. If checked, please attach the claim or indicate the claim number I confirm that the information entered on this form is accurate and complete based on the records available at the time of this request. I understand the health plan or its designees may request medical documentation to verify the accuracy of the information reported on this form. Name and Title of Provider or Provider Representative Completing Form and Attestation (Please Print)* Date *The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted. Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization management services on behalf of your health benefit plan or the administrator of your health benefit plan. Page 3 of 3