XX Keytruda 100 MG/4ML SOLN (MERCK SHARP & DOHME)

Transcription

1 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Pembrlizumab NDC CODE(S) XX Keytruda 100 MG/4ML SOLN (MERCK SHARP & DOHME) DESCRIPTION Pembrlizumab is a human prgrammed death receptr (PD-1)-blcking humanized mnclnal antibdy. It blcks the interactin between PD-1 and its ligands, PD-L1 and PD-L2 by binding t the PD-1 receptr which is fund n T-cells. This releases PD-1 pathway-mediated inhibitin f the immune respnse, including the anti-tumr immune respnse, which results in decreased tumr grwth. POLICY Pembrlizumab fr the treatment f the fllwing is cnsidered medically necessary if the medical apprpriateness criteria are met: (See Medical Apprpriateness belw.) Anal cancer Bladder Cancer/Urthelial Carcinma Central Nervus System Cancer Cervical cancer Gastric cancer Hdgkin Lymphma Melanma Merkel cell carcinma Mesthelima Micrsatellite Instability-High (MSI-H)/ Mismatch Repair Deficient (dmmr) Cancers Nn-small cell lung cancer (NSCLC) Primary Mediastinal Large B-Cell Lymphma (PMBCL) Squamus Cell Carcinma f the Head and Neck (SCCHN) T-Cell Lymphma/Extrandal NK Pembrlizumab fr the treatment f ther cnditins/diseases is cnsidered investigatinal. MEDICAL APPROPRIATENESS INITIAL APPROVAL Pembrlizumab is cnsidered medically apprpriate if ALL f the fllwing: Individual is 18 years f age r lder unless therwise specified Individual has nt received previus therapy with a prgrammed death (PD-1/PD-L1) -directed therapy (e.g., avelumab, nivlumab, atezlizumab, durvalumab, etc.) unless therwise specified Diagnsis f ANY ONE f the fllwing: Anal cancer as a single agent in secnd-line therapy fr metastatic squamus cell disease Bladder Cancer/Urthelial Carcinma if ALL f the fllwing: Used as a single agent Further diagnsed as ANY ONE f the fllwing: Recurrent r metastatic Primary Carcinma f the Urethra and individual des nt have recurrent stage T3-4 disease r palpable inguinal lymph ndes Lcally advanced r metastatic Urthelial Carcinma Disease recurrence pst-cystectmy Metastatic Upper GU Tract Tumrs Metastatic Urthelial Carcinma f the Prstate Used as ANY ONE f the fllwing: First-line therapy in cisplatin-ineligible patients and ANY ONE f the fllwing: This dcument has been classified as public infrmatin.

2 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Individual is carbplatin-ineligible Individual has a PD-L1 expressin f >10% (as cnfirmed using an immuntherapy assay such as the PD-L1 IHC 22C3 pharmdx) Subsequent therapy after previus platinum treatment* Central Nervus System Cancer if ALL f the fllwing: Used as a single agent fr newly diagnsed r recurrent disease fr brain metastases Pembrlizumab is active against the primary melanma r NSCLC tumr Cervical Cancer if ALL f the fllwing: Used as a single agent Individual has recurrent r metastatic disease Tumr expresses PD-L1 (CPS >1%) as determined by an FDA-apprved test Disease prgressed n r after chemtherapy Gastric cancer if ALL f the fllwing: Used as a single agent Diagnsis f gastric r gastr-esphageal junctin (GEJ) adencarcinma Disease is recurrent, lcally advanced r metastatic Tumr expresses PD-L1 (CPS 1%) as determined by an FDA-apprved test Disease prgressin n r after minimum f tw prir systemic treatments which must have included a flurpyrimidine and platinum-cntaining regimen Individuals with HER2 psitive disease must have previusly failed n HER2 directed therapy Gestatinal Trphblastic Neplasia if used as single agent therapy fr ANY ONE f the fllwing: Recurrent r prgressive intermediate trphblastic tumr (placental site trphblastic tumr r epitheliid trphblastic tumr) fllwing treatment with a platinum/etpside-cntaining regimen Methtrexate-resistant high-risk disease Hdgkin lymphma, diagnsed as classical Hdgkin lymphma (chl) if ALL f the fllwing: Individual is 2 years f age r lder Disease is relapsed r refractry Used as a single agent Used after three r mre prir lines f therapy OR as palliative therapy in patients ver 60 years ld Melanma as a single agent fr ANY ONE f the fllwing: Disease is metastatic r unresectable Used as re-treatment therapy (including re-treatment in individuals wh experienced disease cntrl, but subsequently have disease prgressin/relapse > 3 mnths after treatment discntinuatin) Individual has unresectable r metastatic Uveal Melanma Merkel cell carcinma as a single agent fr disseminated metastatic disease Mesthelima, Malignant Pleural, if used as subsequent therapy as a single agent Micrsatellite Instability-High (MSI-H) r mismatch repair deficient (dmmr) Cancer if ALL f the fllwing: Used as a single agent Individual is 2 years f age r lder Disease must be micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr) Pediatric individuals must NOT have a diagnsis f MSI-H central nervus system cancer Disease is ANY ONE f the fllwing: Bne Cancer (Ewing Sarcma, Mesenchymal Chndrsarcma, Ostesarcma, Dedifferentiated Chndrsarcma, r High-Grade Undifferentiated Plemrphic Sarcma) Used fr unresectable r metastatic disease after prgressin fllwing prir treatment and individual has n satisfactry alternative treatment ptins Cervical Cancer - Used fr recurrent r metastatic disease This dcument has been classified as public infrmatin.

3 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Clrectal Cancer fr initial therapy in individuals with unresectable r metastatic disease wh are nt candidates fr intensive therapy OR Used as primary treatment in patients with unresectable r metastatic disease wh failed adjuvant treatment with FOLFOX (flururacil, leucvrin and xaliplatin) r CapeOX (capecitabine-xaliplatin) in the previus 12 mnths OR fr unresectable r metastatic disease that has prgressed fllwing treatment with a flurpyrimidine, xaliplatin and irintecan Gastric adencarcinma OR esphageal/esphaggastric junctin adencarcinma r squamus cell carcinma fr subsequent therapy fr unresectable (r nt a candidate fr) lcally advanced, recurrent, r metastatic disease Hepatbiliary Cancer (Gall bladder cancer, intra- /extra-hepatic chlangicarcinma) used as initial therapy fr unresectable r metastatic disease Ovarian Cancer (included Epithelial Ovarian Cancer, Fallpian Tube Cancer and Primary Peritneal Cancers) fr persistent r recurrent disease and patient is nt experiencing an immediate bichemical relapse Pancreatic Adencarcinma fr Secnd-line therapy fr lcally advanced, recurrent r metastatic disease after prgressin fr patients with gd perfrmance status Penile Cancer fr subsequent treatment f unresectable r metastatic disease that is prgressive and there are n ther satisfactry treatment ptins Testicular Cancer fr third-line therapy r after prgressin with high-dse chemtherapy Uterine Cancer (Endmetrial Carcinma) fr individuals with high risk tumrs, r recurrent r metastatic disease, that have prgressed fllwing prir cyttxic chemtherapy Vulvar Cancer (squamus cell carcinma) secnd line as a single agent fr advanced, recurrent r metastatic disease after prgressin n r after chemtherapy if tumr expresses PD-L1 (CPS 1%) as determined by an FDA-apprved test Other Slid Tumr (e.g., adrenal gland tumrs, etc.) used fr unresectable r metastatic disease prgressin fllwing prir treatment and there are n satisfactry alternative treatment ptins Nn-small cell lung cancer fr ANY ONE f the fllwing: Metastatic r disseminated recurrent disease with a tumr that has high PD-L1 expressin (Tumr Prprtin Scre [TPS] 50%) as determined by an FDA-apprved test as a single agent fr firstline therapy fr genmic tumr aberratin (e.g., EGFR, ALK, ROS1 and BRAF) negative r unknwn Metastatic disease with tumr that has PD-L1 expressin (TPS 1%) as determined by an FDAapprved test with ALL f the fllwing: Used as a single agent Disease prgressin n r after cyttxic therapy Individual with genmic tumr aberratins must have prgressed fllwing systemic therapy fr thse aberratins (e.g., EGFR, ALK, etc.) Used in ne f the fllwing regimens in fr metastatic r disseminated recurrent disease: In cmbinatin with pemetrexed and either carbplatin r cisplatin fr nnsquamus cell histlgy OR In cmbinatin with carbplatin and paclitaxel fr squamus cell histlgy fr ANY ONE f the fllwing: First-line therapy fr genmic tumr aberratin (e.g., EGFR, ALK, ROS1 and, BRAF) negative r unknwn**, and PD-L1 expressin <50% r unknwn First-line therapy fr BRAF V600E-mutatin psitive tumrs Subsequent therapy fr genmic tumr aberratin (e.g., EGFR, BRAF V600E, ALK, and ROS1) psitive and prir targeted therapy (See Targeted Therapies chart belw) Subsequent therapy if PD-L1 expressin-psitive ( 50%) and, fr genmic tumr aberratin (e.g., EGFR, ALK, ROS1 and BRAF) negative r unknwn** Used as cntinuatin maintenance therapy if ALL f the fllwing: Individual has a perfrmance status f 0-2 Individual achieved tumr respnse r stable disease fllwing initial therapy This dcument has been classified as public infrmatin.

4 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Used as ANY ONE f the fllwing: In cmbinatin with pemetrexed if pembrlizumab was given first-line in cmbinatin with pemetrexed and either carbplatin r cisplatin fr disease f nn-squamus cell histlgy As a single agent if pembrlizumab was given first-line in cmbinatin with carbplatin and paclitaxel fr disease f squamus cell histlgy Primary Mediastinal Large B-Cell Lymphma (PMBCL) fr ALL f the fllwing: Individual must be at least 2 years f age r lder Used as single agent Individual has relapsed r refractry disease Used after tw r mre prir lines f therapy Squamus cell carcinma f the head and neck (SCCHN) if ALL f the fllwing: Disease prgressin n r after platinum-cntaining chemtherapy Used as a single agent Disease is unresectable, recurrent, persistent r metastatic Individual has nn-naspharyngeal disease T-Cell Lymphma/Extrandal NK if ALL f the fllwing: Individual has nasal type disease that is relapsed r refractry Disease prgressed fllwing additinal treatment with asparaginase-based chemtherapy, clinical trials r ther best supprtive care *If platinum treatment ccurred greater than 12 mnths ag, the individual shuld be re-treated with platinum-based therapy. An individual with cmrbidities (e.g., hearing lss, neurpathy, pr PS, renal insufficiency, etc.) may nt be eligible fr cisplatin. Carbplatin may be substituted fr cisplatin particularly in thse with a GFR <60 ml/min r a PS f 2. ** Every effrt needs t be made t establish the genetic alteratin status. A bld assay may be used if a tissue assay is nt feasible. Genmic Aberratin Targeted Therapies (nt all inclusive) Sensitizing EGFR mutatin-psitive tumrs Erltinib Afatinib Gefitinib Osimertinib ALK rearrangement-psitive tumrs Criztinib Ceritinib Brigatinib Alectinib ROS1 rearrangement-psitive tumrs Criztinib Ceritinib BRAF V600E-mutatin psitive tumrs Dabrafenib/Trametinib PD-L1 expressin-psitive tumrs ( 50%) Pembrlizumab This dcument has been classified as public infrmatin.

5 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 RENEWAL CRITERIA Pembrlizumab is cnsidered medically apprpriate fr renewal if ALL f the fllwing criteria are met: Individual cntinues t meet initial apprval criteria Tumr respnse as defined by lack f tumr prgressin, imprvement in tumr size and/r imprvement in symptms Absence f unacceptable txicity frm the agent, e.g., severe infusin reactins, immune-mediated adverse reactins such as pneumnitis, hepatitis, clitis, endcrinpathies, nephritis and renal dysfunctin, skin reactins, etc. Fr a diagnsis f ANY ONE f the fllwing, the individual has nt exceeded a maximum f twenty-fur (24) mnths f therapy: Anal Cancer Cervical Cancer Classical Hdgkin Lymphma (chl) Gastric/GEJ Adencarcinma Malignant Pleural Mesthelima MSI-H Cancer (including the fllwing cancers: clrectal, pancreatic, bne, gastric/gastresphageal, varian, uterine, penile, testicular, hepatbiliary and ther slid tumrs) Nn-small cell lung cancer (NSCLC) Primary Mediastinal Large B-Cell Lymphma (PMBCL) Squamus Cell Carcinma f the Head and Neck (SCCHN) Urthelial Carcinma/Bladder Cancer Melanma (metastatic r unresectable disease) and used fr re-treatment f individuals wh experienced disease cntrl but subsequently have disease prgressin/relapse > 3 mnths after treatment discntinuatin INDICATION(S) DOSAGE & ADMINISTRATION NSCLC, SCCHN, Gastric/GEJ Carcinma, Anal, 200 mg every 21 days fr a maximum f 24 mnths f in Cervical & Urthelial Carcinma patients withut disease prgressin Adults*: 200 mg every 21 days Pediatrics*: 2 mg/kg (up t 200 mg) every 21 days chl, PMBCL & MSI-H/dMMR Cancer *Up T a maximum f 24 mnths in patients withut disease prgressin Melanma & CNS Metastases 200 mg every 21 days 10 mg/kg every 2 weeks fr up t 2 years r until cnfirmed MPM & Uterine Cancer prgressin r unacceptable txicity Merkel Cell Carcinma & NK/T-Cell Lymphma 2 mg/kg every 21 days Dsing shuld be calculated using actual bdy weight and nt flat dsing (as applicable) based n the fllwing: Standard dse 200 mg IV every 3 weeks fr patients > 50 kg Use 100 mg IV every 3 weeks fr patients 50 kg Nte: This infrmatin is nt meant t replace clinical decisin making when initiating r mdifying medicatin therapy and shuld nly be used as a guide. Patient-specific variables shuld be taken int accunt. LENGTH OF AUTHORIZATION Cverage will be prvided fr six mnths and may be renewed. SCCHN, chl, NSCLC, Urthelial Carcinma, MPM, MSI-H/dMMR, PMBCL, Cervical, Anal & Gastric Cancers can be authrized up t a maximum f 24 mnths f therapy This dcument has been classified as public infrmatin.

6 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Click here t view DOSAGE LIMITS APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS BlueCrss BlueShield f Tennessee s Medical Plicy cmplies with Tennessee Cde Anntated Sectin regarding cverage f ff-label indicatins f Fd and Drug Administratin (FDA) apprved drugs when the ff-label use is recgnized in ne f the statutrily recgnized standard reference cmpendia r in the published peer-reviewed medical literature. IMPORTANT REMINDER We develp Medical Plicies t prvide guidance t Members and Prviders. This Medical Plicy relates nly t the services r supplies described in it. The existence f a Medical Plicy is nt an authrizatin, certificatin, explanatin f benefits r a cntract fr the service (r supply) that is referenced in the Medical Plicy. Fr a determinatin f the benefits that a Member is entitled t receive under his r her health plan, the Member's health plan must be reviewed. If there is a cnflict between the Medical Plicy and a health plan, the express terms f the health plan will gvern. ADDITIONAL INFORMATION Fr apprpriate chemtherapy regimens, dsage infrmatin, cntraindicatins, precautins, warnings, and mnitring infrmatin, please refer t ne f the standard reference cmpendia (e.g., the NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) published by the Natinal Cmprehensive Cancer Netwrk, Drugdex Evaluatins f Micrmedex Slutins at Truven Health, r The American Hspital Frmulary Service Drug Infrmatin). GRADE ECOG PERFORMANCE STATUS 0 Fully active, able t carry n all pre-disease perfrmance withut restrictin Restricted in physically strenuus activity but ambulatry and able t carry ut wrk f a light r sedentary 1 nature, e.g., light huse wrk, ffice wrk Ambulatry and capable f all selfcare but unable t carry ut any wrk activities; up and abut mre than 2 50% f waking hurs 3 Capable f nly limited selfcare; cnfined t bed r chair mre than 50% f waking hurs 4 Cmpletely disabled; cannt carry n any selfcare; ttally cnfined t bed r chair 5 Dead SOURCES Eastern Cperative Onclgy Grup. (2015, May) ECOG Perfrmance Status. Retrieved May 1, 2015 frm Lexicmp Online. (2018, June). AHFS DI. Pembrlizumab. Retrieved Octber 5 frm Lexicmp Online with AHFS. MICROMEDEX Healthcare Series. Drugdex Evaluatins. (2018, September). Pembrlizumab. Retrieved Octber 5, Natinal Cmprehensive Cancer Netwrk. (2018). NCCN Drugs & Bilgics Cmpendium. Pembrlizumab. Retrieved Octber 5, 2018 frm the Natinal Cmprehensive Cancer Netwrk. This dcument has been classified as public infrmatin.

7 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 U. S. Fd and Drug Administratin. (2018, August). Center fr Drug Evaluatin and Research. Keytruda (pembrlizumab) fr injectin. Retrieved Octber 5, 2018 frm EFFECTIVE DATE 1/31/2019 ID_MRx This dcument has been classified as public infrmatin.