Download Keytruda

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
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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
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.
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