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CLINICAL MEDICAL POLICY Policy Name: Keytruda® (Pembrolizumab) Policy Number: MP-014-MD-WV Approved By: Medical Management Provider Notice Date: 10/3/2016 Original Effective Date: 11/3/2016 Annual Approval Date: 6/2/2017 Revision Date: NA Products: WVFH Medicaid Application: All participating hospitals and providers Page Number(s): 1 of 5 Disclaimer West Virginia Family Health medical payment and prior-authorization policy is intended to serve only as a general reference resource regarding payment and coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT: West Virginia Family Health provides coverage under the medical benefits of the Company’s Medicaid products for medically necessary Keytruda® (Pembrolizumab) administration. This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrants individual consideration, based upon review of applicable medical records. The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and all applicable state and federal regulations. DEFINITIONS: Non-small cell lung cancer (NSCLC) – A group of lung cancers which are named by the kinds of cells found in the cancer and the appearance of those cells under a microscope. There are three main types of nonsmall cell lung cancer: squamous cell carcinoma, large cell carcinoma and adenocarcinoma. The most common form of lung cancer is non-small cell. Policy Number MP-014-MD-WV Page 1 of 5 ALK Gene Rearrangements – Anaplastic lymphoma kinase (ALK) function oncogene is a predictive biomarker that has been identified in a subset of patients with NSCLC. The presence of the ALK arrangement is predictive of treatment benefit with ALK targeted therapies. EGFR Mutation – Epithelial growth factor receptor (EGFR) mutation is predictive of treatment benefit from EGFR tyrosine kinase inhibitor therapy. PD-L1 – Cytotoxic T-cell inhibition occurs when binding of the programmed death 1 (PD-1) receptor to one of its ligands: ligand 1 (PD-L1) or 2 (PD-L2). Upregulation of the PD-L1 occurs in some tumors and it can inhibit active T-cell surveillance of tumors. Presence of the PD-L1 biomarker in tumor cells may be predictive of treatment benefit with PD-1 inhibitors. Melanoma – A type of cancer that begins in the melanocytes. Melanoma is also referred to as malignant melanoma and cutaneous melanoma. PROCEDURES: 1) Keytruda® is considered medically necessary as an intravenous infusion for the treatment of metastatic non-small cell lung cancer (NSCLC) when the member meets the following criteria: a) The patient must be 18 years or older; AND b) Treatment with Keytruda® is prescribed by an oncologist/hematologist; AND c) The drug will be used as monotherapy in a patient whose tumors express PD-L1 as determined by an FDA-approved test; AND d) The patient’s disease has progressed on or after platinum-containing chemotherapy; AND e) If the patient has EGRF or ALK mutations, the patient has had disease progression on FDAapproved therapy (EGRF- or ALK-directed therapy) for these mutations prior to receiving Keytruda®; AND f) The patient’s Eastern Cooperative Oncology Group (ECOG) performance status is documented as 0 – 2; AND g) The dosing is within the following prescribing-supported parameter: Dose does not exceed 2 mg/kg/dose every three weeks 2) Keytruda® is considered medically necessary for the treatment of unresectable or metastatic melanoma when the member meets the following criteria: a) The patient is age 18 years or older; AND b) The medication is being prescribed by an oncologist/hematologist; AND c) The medication will be used as monotherapy for metastatic or unresectable disease as first-line therapy; OR d) The medication will be used as monotherapy for metastatic or unresectable disease as secondline or subsequent therapy for disease progression or following maximum clinical benefit from BRAF targeted therapy for patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 2; AND e) The medication dosing is within the following prescribing-supported parameter: The dose does not exceed 2 mg/kg/dose every three weeks 3) Contraindications Safety and effectiveness of Keytruda® has not been established in pediatric patients. Policy Number MP-014-MD-WV Page 2 of 5 4) When Keytruda® is not covered For conditions other than those listed above scientific evidence has not been established. When non-formulary prior authorization criteria are not met, the request will be forwarded to a Medical Director for review. The physician reviewer must override criteria when, in their professional judgement, the requested medication is medically necessary. 5) Post-payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by West Virginia Family Health at any time pursuant to the terms of your provider agreement. 6) Place of Service-Inpatient or Outpatient The place of service for the administration of Keytruda® is outpatient. When non-formulary prior authorization criteria are not met, the request will be forwarded to a Medical Director for review. The physician reviewer must override criteria when, in their professional judgement, the requested medication is medically necessary. 7) Governing Bodies Approval The FDA approved Keytruda® (Pembrolizumab) in September 2014 for the treatment of unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Keytruda® was granted FDA approval in October 2015 for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors expressed programmed death ligand 1 )PD-L1) and who have disease progression on or after platinum-containing chemotherapy. The medication is also approved for patients with metastatic NSCLC epithelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) gene rearrangements who have disease progression on FDA-approved targeted therapy prior to receiving Keytruda®. A companion laboratory test was approved to detect PD-L1 expression in non-small cell lung tumors. CODING REQUIREMENTS: Procedure Codes HCPC Code Description J9271 Injection, pembrolizumab, 1 mg Diagnosis Codes ICD-10 Diagnosis Code C16.0 – C16.9 C33 C34.00 – C34.02 C34.10 – C34.12 C34.2 C34.30 – C34.32 C34.80 – C34.82 C34.90 – C34.92 C43.0 Description Malignant neoplasm of stomach Malignant neoplasm of trachea Malignant neoplasm of unspecified main bronchus Malignant neoplasm of upper lobe, unspecified bronchus or lung Malignant neoplasm of middle lobe, unspecified bronchus or lung Malignant neoplasm of lower lobe, unspecified bronchus or lung Malignant neoplasm of overlapping sites of unspecified bronchus and lung Malignant neoplasm of unspecified part of unspecified bronchus or lung Malignant melanoma of lip Policy Number MP-014-MD-WV Page 3 of 5 C43.10 C43.11 C43.12 C43.20 C43.21 C43.22 C43.30 C43.31 C43.39 C43.4 C43.51 C43.52 C43.59 C43.60 C43.61 C43.62 C43.70 C43.71 C43.72 C43.8 C43.9 C69.90 C69.91 C69.92 C79.31 C80.0 C80.1 D03.0 – D03.9 Z85.118 Z85.820 Malignant melanoma of unspecified eyelid, including canthus Malignant melanoma of right eyelid, including canthus Malignant melanoma of left eyelid, including canthus Malignant melanoma of unspecified ear and external auricular canal Malignant melanoma of right ear and external auricular canal Malignant melanoma of left ear and external auricular canal Malignant melanoma of unspecified part of face Malignant melanoma of nose Malignant melanoma of other parts of face Malignant melanoma of scalp and neck Malignant melanoma of anal skin Malignant melanoma of skin of breast Malignant melanoma of other part of trunk Malignant melanoma of unspecified upper limb, including shoulder Malignant melanoma of right upper limb, including shoulder Malignant melanoma of left upper limb, including shoulder Malignant melanoma of unspecified lower limb, including hip Malignant melanoma of right lower limb, including hip Malignant melanoma of left lower limb, including hip Malignant melanoma of overlapping sites of skin Malignant melanoma of skin, unspecified Malignant neoplasm of unspecified site of unspecified eye Malignant neoplasm of unspecified site of right eye Malignant neoplasm of unspecified site of left eye Secondary malignant neoplasm of brain Disseminated malignant neoplasm, unspecified Malignant (primary) neoplasm, unspecified Melanoma in situ Personal history of other malignant neoplasm of bronchus and lung Personal history of malignant melanoma of skin REIMBURSEMENT: Participating facilities will be reimbursed per their West Virginia Family Health contract. POLICY SOURCE(S): Keytruda (pembrolizumab) Prescribing Information. Whitehouse Station, NJ: Merck; Dec 2015. Pembrolizumab In: Micromedex® Solutions. US, Canada, UK: Truven Health Analytics Inc. Accessed 12/30/15. Ettinger DS, Wood DE, Akerley W et al. Non-small cell lung cancer. Version 4.2016. In National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines). Accessed: 1/14/16. Robert C, Schachter J, Long GV et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015; 372: 2521-32. Policy Number MP-014-MD-WV Page 4 of 5 National Cancer Institute. What you need to know about melanoma and other skin cancers. January 11, 2011. Available at: http://www.cancer.gov/cancerinfo/wyntk/melanoma. Accessed on April 27, 2016. National Comprehensive Cancer Network® NCCN Clinical Practice Guidelines in Oncology™. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on April 27, 2016. Melanoma (V.2.2016) Revised November 25, 2015 Non-small Cell Lung Cancer (V.4.2016) Revised January 12, 2016. Eastern Cooperative Oncology Group (ECOG) Performance Status Grade Description 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5 Dead Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982; 5(6):649-655. Policy Number MP-014-MD-WV Page 5 of 5