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REVIEW REQUEST FOR: Pembrolizumab (Keytruda®) Provider Data Collection Tool Based on Medical Policy DRUG.00071 Complete this form in its entirety and fax to UM Call Center 404-848-2448 Policy Last Review Date: 11/05/2015 Request Date: Initial Request Buy and bill / Policy Effective Date: 11/09/2015 Provider Tool Effective Date: 11/09/2015 / 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: (mg/kg) Keytruda J9999 (other) C9027 J9271 (replacing C9027 1/1/16) Other: When did the individual first start this drug? / / Duration: (Weeks) 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 unresectable or metastatic melanoma and metastatic non-small cell lung cancer.. 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 an immunosuppressant REVIEW REQUEST FOR: Pembrolizumab (Keytruda®) Provider Data Collection Tool Based on Medical Policy DRUG.00071 Policy Last Review Date: 11/05/2015 Policy Effective Date: 11/09/2015 Provider Tool Effective Date: 11/09/2015 Individual does NOT have human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection Non-Small Cell Lung Cancer Individual is diagnosed with metastatic non-small cell lung cancer (NSCLC) Pembrolizumab (Keytruda®) is being used as a single agent treatment Tumors express PD-L1 gene with demonstrated disease progression on or after platinum-containing chemotherapy Individual with ALK or EGFR genomic tumor aberrations has 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 of 0-2 Individual is NOT receiving therapy for an autoimmune disease, chronic condition or interstitial lung disease with an 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 attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its designees may perform a routine audit and request the 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 2 of 2