DESCRIPTION: Zemdri (plazomicin) is an aminoglycoside, which acts by binding to bacterial 30S ribosomal subunit, inhibiting protein synthesis.

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1 What s New Medical Pharmaceutical Plicy March 2019 Updates MBP Zemdri (plazmicin)- New plicy DESCRIPTION: Zemdri (plazmicin) is an aminglycside, which acts by binding t bacterial 30S ribsmal subunit, inhibiting prtein synthesis. Zemdri (plazmicin) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Prescribed by r in cnsultatin with an infectius disease specialist AND Age f 18 years r greater AND Medical recrd dcumentatin f a diagnsis f cmplicated urinary tract infectins (cuti) including pyelnephritis caused by the fllwing susceptible micrrganisms: Escherichia cli, Klebsiella pneumniae, Prteus mirabilis, and Enterbacter clacae AND Medical recrd dcumentatin f culture and sensitivity shwing the patient s infectin is nt susceptible t ALL alternative antibitic treatments a dcumented histry f previus intlerance t r cntraindicatin t ALL ther antibitics shwn t be susceptible n the culture and sensitivity If initiated during an inpatient say: Medical recrd dcumentatin f a culture and sensitivity shwing the patient s infectin is nt susceptible t alternative antibitic treatments a dcumented histry f previus intlerance t r cntraindicatin t ther antibitics shwn t be susceptible n the culture and sensitivity AUTHIZATION DURATION: Up t a maximum f 7 days MBP Onpattr (patisiran)- New plicy DESCRIPTION: Onpattr (patisiran) is a duble-stranded small interfering ribnucleic acid (sirna) that causes degradatin f mutant and wild-type transthyretin (TTR) mrna thrugh RNA interference, which results in a reductin f serum TTR prtein and TTR prtein depsits in tissues. Serum TTR is a carrier f retinl binding prtein, which is invlved in the transprt f vitamin A in the bld. Onpattr (patisiran) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Prescriptin written by r in cnsultatin with a neurlgist, specialist at a hereditary transthyretinmediated amylidsis treatment center, r geneticist AND Medical recrd dcumentatin f age greater than r equal t 18 years AND Medical recrd dcumentatin f diagnsis f hereditary transthyretin-mediated amylidsis as cnfirmed by all f the fllwing: Bipsy f tissue/rgan t cnfirm amylid presence AND Immunhistchemistry r mass spectrscpy t differentiate ATTR amylidsis frm amylid light-chain amylidsis AND Genetic testing t differentiate between hereditary and wild-type ATTR amylidsis AND Medical recrd dcumentatin f Onpattr being used t treat plyneurpathy AND Medical recrd dcumentatin f familial amylid plyneurpathy (FAP) stage 1-2 and/r plyneurpathy disability scre f I, II, IIIA, r IIIB AND Medical recrd dcumentatin that Onpattr will nt be used in cmbinatin with ther RNA interference treatment 1

2 Nte: FAP stage: 1-unimpairmend ambulatin 2- assistance with ambulatin 3- wheelchair-bund r bedridden Plyneurpathy disability scre: I- preserved walking, sensry disturbances II- impaired walking withut need fr stick/crutches IIIa- walking with 1 stick/crutch IIIb- walking with 2 sticks/crutches IV-wheelchair-bund r bedridden AUTHIZATION DURATION: Initial apprval will be fr 12 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate. The medicatin will n lnger be cvered if the member prgresses t FAP stage 3 and/r plyneurpathy disability scre IV (wheelchair-bund r bedridden). QUANTITY LIMIT: 15 ml per 21 days MBP Lumxiti (mxetummab pasudtx-tdfk)- New plicy DESCRIPTION: Lumxiti (mxetummab pasudtx-tdfk) is a CD22-directed cyttxin cmpsed f a recmbinant murine immunglbulin genetically fused t truncated Pseudmnas extxin (PE38). Mxetummab pasudtx-tdfk binds CD22 n the cell surface f B-cells and is internalized. Mxetummab pasudtxtdfk internalizatin results in ADP-ribsylatin f elngatin factr 2, inhibitin f prtein synthesis, and appttic cell death. Lumxiti (mxetummab pasudtx-tdfk) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Hairy Cell Leukemia Prescriptin is written by a hematlgist/nclgist AND Medical recrd dcumentatin that member is 18 years f age r lder AND Medical recrd dcumentatin f a diagnsis f relapsed r refractry hairy cell leukemia (HCL) AND Medical recrd dcumentatin that member has received at least tw prir systemic therapies, ne f which must be a purine nucleside analg (e.g., cladribine, pentstatin (Nipent), etc.) AUTHIZATION DURATION: Initial apprval will be limited t 6 cycles (6 mnths) r less if the reviewing prvider feels it is medically necessary. Subsequent apprval fr treatment past 6 cycles (6 mnths) will require dcumentatin f well-cntrlled, peer-reviewed literature with evidence t supprt this request. Nte: FDA recmmended treatment duratin is fr a maximum f 6 cycles (The recmmended dse f Lumxiti is 0.04 mg/kg administered as a 30-minute intravenus infusin n Days 1, 3, and 5 f each 28- day cycle) 2

3 MBP Ilumya (tildrakizumab-asmn)- New plicy DESCRIPTION: Ilumya (tildrakizumab-asmn) is human IgG1/k mnclnal antibdy which selectively binds t the p19 subunit f interleukin (IL)-23, thereby inhibiting its interactin with the IL-23 receptr, resulting in inhibitin f the prinflammatry cytkines and chemkines assciated the binding f naturally ccurring IL-23. GRANDFATHER PROVISION Members already established n therapy are eligible fr apprval as lng as there is medical recrd dcumentatin that the safety and effectiveness f use fr the prescribed indicatin is supprted by Fd and Drug Administratin (FDA) apprval r adequate medical and scientific evidence in the medical literature Ilumya (tildrakizumab-asmn) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Prescribed by a dermatlgist AND Medical recrd dcumentatin that the patient is 18 years f age r lder AND Medical recrd dcumentatin f a diagnsis f mderate t severe plaque psriasis characterized by greater than r equal t 5% bdy surface area invlved r disease affecting crucial bdy areas such as the hands, feet, face, r genitals AND Medical recrd dcumentatin that Ilumya is nt being used cncurrently with a TNF blcker r ther bilgic agent AND Medical recrd dcumentatin f an inadequate respnse t, cntraindicatin t, r failure n at least 3 mnths f Humira AND Csentyx AUTHIZATION DURATION: Apprval will be given fr an initial duratin f six (6) mnths. Fr cntinuatin f cverage, medical recrd dcumentatin f clinical imprvement r lack f prgressin in the signs and symptms f the treated indicatin at six (6) mnths f Ilumya therapy is required. After the initial six (6) mnth apprval, subsequent apprvals fr cverage will be fr a duratin f ne (1) year. Reevaluatin f cverage will be every ne (1) year requiring medical recrd dcumentatin f cntinued r sustained imprvement in the signs and symptms f the treated indicatin while n Ilumya therapy. MBP 59.0 White Bld Cell Stimulating Factrs - Updated plicy Neupgen, Neulasta, Fulphila, Zarxi, Leukine, Granix: The use f white bld cell stimulating factr [Neupgen (filgrastim), Neulasta (pegfilgrastim), Fulphila (pegfilgrastim-jmdb), Granix (tb-filgrastim), Zarxi (filgrastim-sndz), r Leukine (sargramstim)] is cnsidered medically necessary in insured individuals with a diagnsis f cancer, and when any f the fllwing FDA labeled indicatins r uses supprted by clinical guidelines are present: 1. Primary Prphylaxis - the preventin f febrile neutrpenia (FN) when the risk f FN due t the myelsuppressive chemtherapy regimen is 20% r greater. Thse regimens include but are nt limited t: TC (paclitaxel/cisplatin, r cyclphsphamide/dcetaxel r dcetaxel/cisplatin r paclitaxel/carbplatin) MVAC (methtrexate, vinblastine, dxrubicin, cisplatin) AC (dxrubicin, cyclphsphamide, dcetaxel) 3

4 AT (dxrubicin, paclitaxel) TIC (paclitaxel, ifsfamide, mesna, cisplatin) VAPEC-B (vincristine, dxrubicin, prednislne, etpside, cyclphsphamide, blemycin) A(N)CVB (dxrubicin r mitxantrne, cyclphsphamide, vindesine, blemycin) DHAP (dexamethasne, cisplatin, cytarabine) NOTE: Regimens nt specified in this dcument must be listed n a natinally recgnized guideline stating risk f FN f greater than 20%. MBP 85.0 Cinryze (C1 esterase inhibitr, human)- Updated plicy DESCRIPTION: Cinryze (C1 esterase inhibitr, human) is indicated fr rutine prphylaxis against angiedema attacks in adult and adlescent patients with Hereditary Angiedema. GRANDFATHER PROVISION Members already established n therapy are eligible fr apprval as lng as there is medical recrd dcumentatin that the safety and effectiveness f use fr the prescribed indicatin is supprted by Fd and Drug Administratin (FDA) apprval r adequate medical and scientific evidence in the medical literature Cinryze (C1 esterase inhibitr, human) will be cnsidered medically necessary fr prphylaxis against attacks f hereditary angiedema in adults and adlescents when the fllwing criteria are met: Member is 6 13 years f age r lder; and Prescriptin is written by an allergist, immunlgist, hematlgist r dermatlgist; and Medicatin is being used as prphylactic therapy fr HAE attacks; and Diagnsis f hereditary angiedema has been established and supprted by physician prvided dcumentatin f: Recurrent, self-limiting nn-inflammatry subcutaneus angiedema withut urticaria, lasting mre than 12 hurs; r Laryngeal edema; r Recurrent, self-remitting abdminal pain lasting mre than 6 hurs, withut clear rganic etilgy And the presence f specific abnrmalities in cmplement prteins, in the setting f a suggestive clinical histry f episdic angiedema withut urticaria; supprted by Medical recrd dcumentatin f 2 r mre sets f cmplement studies, separated by ne mnth r mre, shwing cnsistent results f Lw C4 levels and Less than 50% f the lwer limit f nrmal C1-INH antigenic prtein levels Less than 50% f the lwer limit f nrmal C1-INH functin levels AND Physician prvided dcumentatin f failure n, intlerance t, r cntraindicatin t danazl; and Physician prvided dcumentatin f histry f mre than ne (1) severe event per mnth a histry f laryngeal attacks 4

5 MBP Keytruda (pembrlizumab)- Updated plicy Keytruda (pembrlizumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Unresectable r Metastatic Melanma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f unresectable r metastatic melanma AND Medical recrd dcumentatin that Keytruda is nt being used in cmbinatin with any ther agents fr the treatment f unresectable r metastatic melanma. 2. Metastatic Nn-Small Cell Lung Cancer (NSCLS) Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f metastatic NSCLC meeting ne f the fllwing situatins: Medical recrd dcumentatin that Keytruda is being given as mntherapy AND Medical recrd dcumentatin that tumrs have high PD-L1 expressin (Tumr Prprtin Scre (TPS) 50% as determined by an FDA-apprved test AND Medical recrd dcumentatin that tumrs d nt have EGFR r ALK genmic tumr aberratins Medical recrd dcumentatin that Keytruda is being given as mntherapy AND Medical recrd dcumentatin that tumrs express PD-L1 (TPS) 1% as determined by an FDA-apprved test AND Medical recrd dcumentatin f disease prgressin n r after platinum-cntaining chemtherapy AND Fr patients with EGFR r ALK genmic tumr aberratins: medical recrd dcumentatin f disease prgressin n FDA-apprved therapy fr these aberratins prir t receiving Keytruda. Medical recrd dcumentatin f metastatic nnsquamus NSCLC AND Medical recrd dcumentatin that Keytruda will be given in cmbinatin with pemetrexed AND either carbplatin r cisplatin AND Medical recrd dcumentatin that tumrs d nt have EGFR r ALK genmic tumr aberratins Medical recrd dcumentatin that Keytruda will be given in cmbinatin with carbplatin AND either paclitaxel r nab-paclitaxel AND Medical recrd dcumentatin that Keytruda, carbplatin, and paclitaxel (r nabpaclitaxel) are being used as first-line treatment. 3. Head and Neck Squamus Cell Carcinma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f Head and Neck Squamus Cell Carcinma that is recurrent r metastatic and had disease prgressin n r after platinum-cntaining chemtherapy 4. Classical Hdgkin Lymphma Medical recrd dcumentatin f Classical Hdgkin Lymphma AND One f the fllwing: 5

6 a. Medical recrd dcumentatin f a diagnsis f refractry Classical Hdgkin Lymphma b. Medical recrd dcumentatin f relapse fllwing three (3) r mre prir lines f therapy 5. Micrsatellite Instability-High Cancer Medical recrd dcumentatin f unresectable r metastatic micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr) slid tumrs clrectal cancer AND Fr slid tumrs: Medical recrd dcumentatin f prgressin fllwing prir treatment(s) AND Medical recrd dcumentatin f n satisfactry alternative treatment ptins Fr clrectal cancer: Medical recrd dcumentatin f prgressin fllwing treatment with flurpyrimidine, xaliplatin, and irintecan 6. Urthelial Carcinma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f lcally advanced r metastatic urthelial carcinma AND Medical recrd dcumentatin f ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy Disease prgressin within 12 mnths f neadjuvant r adjuvant treatment with platinum-cntaining chemtherapy Patient is nt eligible cisplatin-cntaining chemtherapy* AND Tumrs express PD-L1 (cmbined psitive scre [CPS] greater than r equal t 10) as determined by an FDA-apprved test Patient is nt eligible fr any platinum-cntaining chemtherapy (regardless f PD-L1 status) *Nte: In clinical trials, patients wh were nt cnsidered cisplatin-eligible had the fllwing characteristics: baseline creatinine clearance f <60 ml/min, ECOG perfrmance status f 2, ECOG 2 and baseline creatinine clearance f <60 ml/min, ther reasns (Class III heart failure, Grade 2 r greater peripheral neurpathy, and Grade 2 r greater hearing lss). 7. Gastric Cancer Medical recrd dcumentatin f a diagnsis f recurrent lcally advanced r metastatic gastric r gastresphageal junctin adencarcinma AND Medical recrd dcumentatin that tumrs express PD-L1 (cmbined psitive scre [CPS] greater than r equal t 1) as determined by an FDA-apprved test AND Medical recrd dcumentatin f disease prgressin n r after tw r mre prir lines f therapy (including flurpyrimidine- and platinum-cntaining chemtherapy)* AND If patient has HER2-psitive disease, medical recrd dcumentatin f disease prgressin n r after HER2/neu-targeted therapy (including but nt limited t trastuzumab (Herceptin))* *Nte t reviewer: Current recmmendatins intend Keytruda t be used as third-line treatment (i.e. patient is t have 2 prir lines f therapy, ne f which must include HER2/neu-targeted therapy if the patient has HER-2 psitive disease) 8. Cervical Cancer 6

7 Medical recrd dcumentatin f recurrent r metastatic cervical cancer AND Medical recrd dcumentatin that tumrs express PD-L1 (CPS 1) AND Medical recrd dcumentatin f disease prgressin after receiving at least ne prir line f therapy 9. Primary Mediastinal Large B-cell Lymphma (PMBCL) Medical recrd dcumentatin f refractry primary mediastinal large B-cell lymphma (PMBCL) AND Medical recrd dcumentatin f relapse fllwing tw (2) prir lines f therapy 10. Hepatcellular Carcinma (HCC) Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f hepatcellular carcinma AND Medical recrd dcumentatin f a therapeutic failure n r intlerance t srafenib (Nexavar) 11. Merkel Cell Carcinma (MCC) Medical recrd dcumentatin f a diagnsis f Merkel Cell Carcinma AND Medical recrd dcumentatin f metastatic and/r recurrent disease MBP Tecentriq (atezlizumab)- Updated plicy Tecentriq (atezlizumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Lcally Advanced r Metastatic Urthelial Carcinma: Prescriptin written by an nclgist AND Medical recrd dcumentatin f a diagnsis f lcally advanced r metastatic urthelial carcinma AND Medical recrd dcumentatin f ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy Patient is nt eligible fr cisplatin-cntaining therapy AND Tumrs express PD-L1 (greater than r equal t 5%) as determined by an FDAapprved test Patient is nt eligible fr any platinum-cntaining chemtherapy (regardless f PD-L1 status) 2. Nn-Small Cell Lung Cancer: Prescriptin written by an nclgist AND Medical recrd dcumentatin f a diagnsis f nn-small cell lung cancer meeting ne f the fllwing situatins: AND Medical recrd dcumentatin that the patient has had either: Disease prgressin during r fllwing platinum-cntaining chemtherapy Disease prgressin n at least ne FDA-apprved therapy targeting EGFR r ALK if the patient has EGFR r ALK genmic tumr aberratins (e.g. mutatin, deletin, insertin, etc.). Medical recrd dcumentatin f disease prgressin during r fllwing platinumcntaining chemtherapy 7

8 Medical recrd dcumentatin f disease prgressin n at least ne FDA-apprved therapy targeting EGFR r ALK if the patient has EGFR r ALK genmic tumr aberratins (e.g. mutatin, deletin, insertin, etc.) Medical recrd dcumentatin f a nn-squamus histlgic subtype AND Medical recrd dcumentatin that Tecentriq will be given as first-line treatment AND Medical recrd dcumentatin that Tecentriq will be given in cmbinatin with bevacizumab, paclitaxel, AND carbplatin AND Medical recrd dcumentatin that the patient des nt have an EGFR r ALK genmic tumr aberratin. MBP Kymriah (tisagenlecleucel)- Updated plicy Kymriah (tisagenlecleucel) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Acute Lymphblastic Leukemia (ALL) Medical recrd dcumentatin that patient is less than 26 years f age AND Medical recrd dcumentatin f a diagnsis f B-cell precursr acute lymphblastic leukemia (ALL) that is refractry r in secnd (r later) relapse AND Medical recrd dcumentatin that the member has nt received prir treatment with CAR-T cell therapy r ther genetically mdified T cell therapy Nte: The indicatin f Kymriah fr Acute Lymphblastic Leukemia (ALL) is intended t treat patients up t the age f 25 years 364 days. Upn reaching 26 years f age the patient is n lnger a candidate fr Kymriah treatment. Per Nvartis, Kymiah will nt be manufactured fr any patient wh des nt meet the specific FDA apprved indicatin, including these age restrictins. (This des nt apply t Large B-Cell Lymphma) Large B-Cell Lymphma Medical recrd dcumentatin that patient is 18 years f age r greater AND Medical recrd dcumentatin f ne f the fllwing diagnses: High grade B-cell lymphma Diffuse Large B-Cell Lymphma (DLBCL) arising frm fllicular lymphma Diffuse Large B-cell Lymphma (DLBCL) nt therwise specified AND Medical recrd dcumentatin f relapsed r refractry disease after at least tw lines f systemic therapy AND Medical recrd dcumentatin that the member has nt received prir treatment with CAR-T cell therapy r ther genetically mdified T cell therapy Limitatin f use: Kymriah is nt indicated fr treatment f patients with primary central nervus system lymphma. AUTHIZATION DURATION: (Fr all indicatins) Apprved requests will be fr a One-time authrizatin fr ne administratin f Kymriah. 8

9 MBP Yescarta (axicabtagene cilleucel)- Updated plicy Yescarta (axicabtagene cilleucel) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Large B-Cell Lymphma Medical recrd dcumentatin that patient is 18 years f age r lder AND Medical recrd dcumentatin f ne f the fllwing diagnses: Relapsed r refractry diffuse large B-cell lymphma (DLBCL) Relapsed r refractry primary mediastinal large B-cell lymphma Relapsed r refractry high-grade B-cell lymphma AND Medical recrd dcumentatin f a therapeutic failure n tw r mre previus lines f therapy AND Medical recrd dcumentatin that the member has nt received prir treatment with CAR-T cell therapy r ther genetically mdified T cell therapy Nte: Yescarta is nt indicated fr the treatment f patients with primary central nervus system lymphma. AUTHIZATION DURATION: Yescarta will be apprved fr a ne-time authrizatin fr ne administratin f Yescarta. MBP Adcetris (brentuximab vedtin)- Updated plicy GRANDFATHER PROVISION Members already established n therapy are eligible fr apprval as lng as there is medical recrd dcumentatin that the safety and effectiveness f use fr the prescribed indicatin is supprted by Fd and Drug Administratin (FDA) apprval r adequate medical and scientific evidence in the medical literature Adcetris (brentuximab vedtin) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Classical Hdgkin Lymphma (chl) Medical recrd dcumentatin that patient is at least 18 years f age AND Medical recrd dcumentatin f a diagnsis f classical Hdgkin Lymphma meeting ne f the fllwing situatins: Medical recrd dcumentatin f failure f autlgus hematpietic stem cell transplant (aut-hsct) Medical recrd dcumentatin f failure f at least 2 multi-agent chemtherapy regimens in patients wh are nt candidates fr aut-hsct Medical recrd dcumentatin f use as cnslidatin treatment fllwing aut-hsct in patients with high risk f relapse r prgressin pst-aut-hsct (high risk patients 9

10 include: refractry t first line therapy, relapse within 12 mnths f first line therapy, presence f extrandal disease) Medical recrd dcumentatin f previusly untreated Stage III r IV chl AND Medical recrd dcumentatin that Adcetris will be used in cmbinatin with dxrubicin, vinblastine, and dacarbazine. Systemic Anaplastic Large Cell Lymphma (salcl) Medical recrd dcumentatin that patient is at least 18 years f age AND Medical recrd dcumentatin f a diagnsis f systemic anaplastic large cell lymphma (salcl) meeting ne f the fllwing situatins: Medical recrd dcumentatin f failure f at least 1 prir multi-agent chemtherapy regimen Medical recrd dcumentatin f previusly untreated salcl AND Medical recrd dcumentatin that Adcetris will be used in cmbinatin with cyclphsphamide, dxrubicin, and prednisne Primary Cutaneus Anaplastic Large Cell Lymphma (pcalcl) Medical recrd dcumentatin that patient is at least 18 years f age AND Medical recrd dcumentatin f a diagnsis f primary cutaneus anaplastic large cell lymphma (pcalcl) CD30-expressing mycsis fungides (MF) AND Medical recrd dcumentatin f failure f prir radiatin r systemic therapy Peripheral T-cell Lymphmas (PTCL) Medical recrd dcumentatin that patient is at least 18 years f age AND Medical recrd dcumentatin f a diagnsis f a CD30-expressing peripheral T-cell lymphma (PTCL), including angiimmunblastic T-cell lymphma and PTCL nt therwise specified AND Medical recrd dcumentatin that Adcetris will be used in cmbinatin with cyclphsphamide, dxrubicin, and prednisne AUTHIZATION DURATION: Fr treatment f Stage III r IV chl: Initial apprval will be limited t 12 dses (6 mnths) r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprval fr treatment past the initial 12 dses will require dcumentatin f well-cntrlled, peer-reviewed literature with evidence t supprt this request. Fr all ther indicatins: Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. Adcetris will n lnger be cvered if the member experiences unacceptable txicity r wrsening f disease. AUTHIZATION DURATION: Indicatin Initial Authrizatin Subsequent Authrizatins Initial apprval will be limited Subsequent apprval fr treatment past the Previusly t 12 dses (6 mnths) r initial 12 dses will require dcumentatin f Untreated Stage III less if the reviewing prvider well-cntrlled, peer-reviewed literature with r IV chl feels it is medically evidence t supprt this request. apprpriate. 10

11 chl Cnslidatin Previusly Untreated salcl r Other CD30- expressing PTCLs Relapsed chl Relapsed salcl Relapsed pcalcl r CD30- expressing MF Initial apprval will be limited t 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Initial apprval will be limited t 8 dses (6 mnths) r less if the reviewing prvider feels it is medically apprpriate. Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprval will be fr ne additinal 6-mnth authrizatin t allw fr a ttal f 16 cycles f treatment. Subsequent apprval fr treatment past 16 cycles will require dcumentatin f wellcntrlled, peer-reviewed literature with evidence t supprt this request. Subsequent apprval fr treatment past the initial 8 dses will require dcumentatin f well-cntrlled, peer-reviewed literature with evidence t supprt this request. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. Adcetris will n lnger be cvered if the member experiences unacceptable txicity r wrsening f disease. MBP Vabmere (merpenem/vabrbactam)- Updated plicy Vabmere (merpenem/vabrbactam) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Prescribed by r in cnsultatin with an infectius disease specialist AND Age f 18 years r greater AND Medical recrd dcumentatin f a diagnsis f cmplicated urinary tract infectins (cuti) including pyelnephritis caused by the fllwing susceptible micrrganisms: Enterbacter clacae species cmplex, Escherichia cli, r Klebsiella pneumniae AND Medical recrd dcumentatin f culture and sensitivity shwing the patient s infectin is nt susceptible t alternative antibitic treatments a dcumented histry f previus intlerance t r cntraindicatin t ther antibitics shwn t be susceptible n the culture and sensitivity If initiated during an inpatient say: Medical recrd dcumentatin f a culture and sensitivity shwing the patient s infectin is nt susceptible t alternative antibitic treatments a dcumented histry f previus intlerance t r cntraindicatin t ther antibitics shwn t be susceptible n the culture and sensitivity AUTHIZATION DURATION: Apprvals will be made fr a ne-time authrizatin f 14 days. QUANTITY LIMIT: 6 vials per day 11

12 The fllwing plicies were reviewed with n changes: MBP 60.0 Cerezyme (imiglucerase) MBP 64.0 Arrann (nelarabine) MBP 65.0 Trisel (temsirlimus) MBP 90.0 Benlysta (belimumab) MBP 93.0 Nuljix (belatacept) MBP 96.0 Vraxaze (glucarpidase) MBP VPRIV (velaglucerase alfa) MBP Kadcyla (ad-trastuzumab emtansine) MBP Marqib (vincristine sulfate lipsme injectin) MBP Beledaq (belinstat) MBP Entyvi (vedlizumab) MBP Csentyx (secukinumab) MBP Parsabiv (etelcalcetide) MBP Baxdela IV (delaflxacin) MBP Lutathera (lutetium Lu 177 dtatate) MBP Trisenx (arsenic trixide) 12