Keytruda. Keytruda (pembrolizumab) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Keytruda Page: 1 of 5 Last Review Date: June 24, 2016 Keytruda Description Keytruda (pembrolizumab) Background Keytruda is a monoclonal antibody for the treatment of patients with advanced or unresectable melanoma and metastatic non-small cell lung cancer (NSCLC), who are no longer responding to other drugs. Keytruda blocks a cellular pathway known as PD-1, human programmed death receptor-1, which restricts the body s immune system from attacking melanoma cells (1-3). Keytruda is intended for use following treatment with Yervoy (ipilimumab), a type of immunotherapy for advanced or unresectable melanoma. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations (1). Keytruda is used to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body s immune system fight the cancer cells (2). Regulatory Status FDA-approved indication: Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: (3) 1. Patients with unresectable or metastatic melanoma

2 Subject: Keytruda Page: 2 of 5 2. Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD- L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials (3). Clinically significant immune-mediated adverse reactions may occur with Keytruda therapy including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered. Patients should be monitored for signs and symptoms of pheumonitis, colitis, hypophysitis, thyroid disorders, and changes in liver and renal function. Keytruda may cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus (3). Safety and effectiveness of Keytruda have not been established in pediatric patients (3). Related Policies Avastin, Cyramza, Cotellic, Gilotrif, Imlygic, Iressa, Mekinist, Opdivo, Sylatron, Tafinlar, Xalkori, Yervoy, Zelboraf, Zykadia Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Keytruda may be considered medically necessary in patients 18 years of age or older for unresectable or metastatic melanoma and for metastatic non-small cell lung cancer (NSCLC) if the patient has PD-L1 tumor expression determined by a FDA-approved test and has disease progression on or after platinum-containing chemotherapy; and if the patient has EGFR or ALK tumor expression and has disease progression after FDA-approved therapy. Keytruda is considered investigational in patients less than 18 years of age and in patients with all other indications.

3 Subject: Keytruda Page: 3 of 5 Prior-Approval Requirements Age 18 years of age and older Diagnoses Patient must have ONE of the following: 1. Unresectable or metastatic melanoma 2. Metastatic non-small cell lung cancer (NSCLC) a. PD-L1 tumor expression determined by a FDA-approved test i. Disease progression on or after platinum-containing chemotherapy b. If EGFR or ALK tumor expression ii. Disease progression after FDA-approved therapy Prior Approval Renewal Requirements Diagnoses Patient must have ONE of the following: 1. Unresectable or metastatic melanoma 2. Metastatic non-small cell lung cancer (NSCLC) AND the following: a. Prescriber agrees to discontinue treatment for any immune mediated adverse reaction (encephalitis, nephritis, rash, decreased renal function and endocrinopathies) or disease progression. Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 6 months

4 Subject: Keytruda Page: 4 of 5 Prior Approval Renewal Limits Duration 12 months Rationale Summary Keytruda is a monoclonal antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Clinically significant immune-mediated adverse reactions may occur with Keytruda therapy including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered. Keytruda may cause fetal harm when administered to a pregnant woman. Safety and effectiveness of Keytruda have not been established in pediatric patients (2). Prior authorization is required to ensure the safe, clinically appropriate and cost-effective use of Keytruda while maintaining optimal therapeutic outcomes. References 1. FDA News Release. FDA approves Keytruda for advanced melanoma. September 4, FDA News Release. FDA approves Keytruda for advanced non-small cell lung cancer. October 2, Keytruda [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp. December Policy History Date September 2014 December 2014 June 2015 October 2015 Action New Policy and reference update Addition of Metastatic non-small cell lung cancer (NSCLC) if the patient has PD-L1 tumor expression determined by a FDA-approved test and has disease progression on or after platinum-containing chemotherapy; or the patient has EGFR or ALK tumor expression and has disease progression

5 Subject: Keytruda Page: 5 of 5 December 2015 March 2016 June 2016 after FDA-approved therapy Annual review Removal of disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor and no concurrent therapy with other agents for the treatment of unresectable or metastatic melanoma Policy number change from to Addition of Prescriber agrees to discontinue treatment for any immune mediated adverse reaction (encephalitis, nephritis, rash, decreased renal function and endocrinopathies) or disease progression in renewal section per SME Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on June 24, 2016 and is effective on July 1, Deborah M. Smith, MD, MPH