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BIOPHARMACEUTICAL PHARMACY PROGRAM bsolute Total Care provides a number of biopharmaceutical products through the Biopharmaceutical Pharmacy Program. The program helps deliver medications to members or A provider offices that are not traditionally found at a local pharmacy. Most biopharmaceuticals and injectables billed for more than $250 require a prior authorization (PA) to be approved for payment by Absolute Total Care; however, PA requirements are programmed specific to the drug as indicated in the table below. Since the list of drugs requiring PA changes over time, due to new drug arrivals and other market conditions, the $250 amount is used as a reference gauge to help in determining whether to apply for PA. Some of these products can be delivered to the member or directly to the provider’s location for office administration through Acaria Health. Prescribers can submit requests for biopharmaceutical products to Absolute Total Care by filling out the Absolute Total Care Specialty Medications Prior Authorization Form that is available on the Coordinated Care website at www.absolutetotalcare.com. Fax the Absolute Total Care Specialty Medications Prior Authorization Form to 1-855-865-9469 or call Absolute Total Care at 1-866-433-6041 ext. 64455. If approved, Acaria Health Specialty Pharmacy will contact the member and/or the provider for delivery confirmation. Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Auth required for all GENERAL 90281 GLOBULIN, IMMUNE providers Auth required for all GENERAL 90283 GLOBULIN, IMMUNE providers GLOBULIN, IMMUNE SC Auth required for all GENERAL 90284 (ZLB BEHRING) providers GLOBULIN, IMMUNE SC Auth required for all GENERAL 90291 (ZLB BEHRING) providers Auth required for all GENERAL 90378 Synagis PALIVIZUMAB providers Auth required for all providers except HEM/ONC A9542 Zevalin IBRITUMOMAB TIUXETAN hospital, hematology, or oncology providers. Auth required for all providers except IODINE I 131 HEM/ONC A9545 Bexxar hospital, TOSITUMOMAB hematology, or oncology providers. Page 1 of 24 *As of 06/2015 BIOPHARMACEUTICAL PHARMACY PROGRAM Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Auth required for all HEM/ONC J9035 Avastin BEVACIZUMAB providers Auth required for all GENERAL J0485 Nulojix BELATACEPT providers Auth required for all providers except HEM/ONC J9042 Adcetris BRENTUXIMAB VEDOTIN hospital, hematology, or oncology providers. Auth required for all MISC C9399 MISC MISC CODES providers Auth required for all providers except HEM/ONC G3001 Bexxar TOSITUMOMAB hospital, hematology, or oncology providers. Auth required for all GENERAL J0129 Orencia ABATACEPT providers Auth required for all GENERAL J0135 Humira ADALIMUMAB providers Auth required for all GENERAL J0180 Fabrazyme AGALSIDASE BETA providers Auth required for all GENERAL J0205 Ceredase ALGLUCERASE providers Auth required for all GENERAL J0207 Ethyol AMIFOSTINE providers Auth required for all GENERAL J0215 Amevive ALEFACEPT providers Auth required for all GENERAL J0220 Myozyme ALGLUCOSIDASE ALFA providers Auth required for all GENERAL J0221 Lumizyme ALGLUCOSIDASE ALFA providers Prolastin; PROTEINASE INHIBITOR Auth required for all GENERAL J0256 Zemira (HUMAN) providers Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Page 2 of 24 *As of 06/2015 BIOPHARMACEUTICAL PHARMACY PROGRAM ALPHA 1 PROTEINASE Auth required for all GENERAL J0257 Glassia INHIBITOR (HUMAN) providers APOMORPHINE Auth required for all GENERAL J0364 Apokyn HYDROCHLORIDE providers Auth required for all GENERAL J0480 Simulect BASILIXIMAB providers Auth required for all GENERAL J0490 Benlysta BELIMUMAB providers CLOSTRIDIUM Auth required for all GENERAL J0585 Botox BOTULINUM TOXIN TYPE providers A Auth required for all GENERAL J0586 Dysport ABOBOTULINUMTOXINA providers CLOSTRIDIUM Auth required for all GENERAL J0587 Myobloc BOTULINUM TOXIN TYPE providers B INCOBOTULINUMTOXIN Auth required for all GENERAL J0588 Xeomin A providers Auth required for all providers except HEM/ONC J0594 Busulfex BUSULFAN hospital, hematology, or oncology providers. Auth required for all GENERAL J0597 Berinert C 1 ESTERASE, BERINERT providers Auth required for all GENERAL J0598 Cinryze C1 INHIBITOR (HUMAN) providers Auth required for all GENERAL J0638 Ilaris CANAKINUMAB providers LEVOLEUCOVORIN Auth required for all GENERAL J0641 Fusilev CALCIUM providers COLLAGENASE, CLOST Auth required for all GENERAL J0775 Xiaflex HIST providers Auth required for all GENERAL J0800 HP Acthar Gel CORTICOTROPIN providers Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Page 3 of 24 *As of 06/2015 BIOPHARMACEUTICAL PHARMACY PROGRAM CYTOMEGALOVIRUS Auth required for all GENERAL J0850 CytoGam IMMUNE GLOBULIN providers Aranesp (non Auth required for all GENERAL J0881 DARBEPOETIN ALFA ESRD) providers Auth required for all GENERAL J0882 Aranesp (ESRD) DARBEPOETIN ALFA providers Epogen; Procrit Auth required for all GENERAL J0885 EPOETIN ALFA (non ESRD) providers Epogen; Procrit Auth required for all GENERAL J0886 EPOETIN ALFA (ESRD) providers Auth required for all providers except HEM/ONC J0894 Dacogen DECITABINE hospital, hematology, or oncology providers. DEFEROXAMINE Auth required for all GENERAL J0895 Desferal MESYLATE providers Auth required for all GENERAL J0897 Prolia; Xgeva DENOSUMAB INJECTION providers Auth required for all GENERAL J1190 Zinecard DEXRAZOXANE providers Auth required for all GENERAL J1290 Kalbitor ECALLANTIDE providers Auth required for all GENERAL J1300 Soliris ECULIZUMAB providers Auth required for all GENERAL J1324 Fuzeon ENFUVIRTIDE providers Auth required for all GENERAL J1325 Flolan EPOPROSTENOL SODIUM providers Auth required for all GENERAL J1438 Enbrel ETANERCEPT providers Neupogen Auth required for all GENERAL J1442 300mcg & FILGRASTIM providers 480mcg Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Auth required for all GENERAL J1458 Naglazyme GALSULFASE providers Page 4 of 24 *As of 06/2015 BIOPHARMACEUTICAL PHARMACY PROGRAM GLOBULIN, IMMUNE IV Auth required for all GENERAL J1459 Privigen (BAXTER/AM RED CROS) providers Auth required for all GENERAL J1460 GamaSTAN S/D GLOBULIN, IMMUNE providers Auth required for all GENERAL J1557 Gammaplex GLOBULIN, IMMUNE providers Auth required for all GENERAL J1559 Hizentra HIZENTRA providers Auth required for all GENERAL J1560 GamaSTAN S/D GLOBULIN, IMMUNE providers GLOBULIN, IMMUNE IV Auth required for all GENERAL J1561 Gamunex (TALECRIS) providers GLOBULIN, IMMUNE SC Auth required for all GENERAL J1562 Vivaglobin (ZLB BEHRING) providers Auth required for all GENERAL J1566 Carimune GLOBULIN, IMMUNE providers GLOBULIN, IMMUNE IV Auth required for all GENERAL J1568 Octagam (OCTAPHARM) providers Gammagard GLOBULIN, IMMUNE IV Auth required for all GENERAL J1569 Liquid (BAXTER/AM RED CROS) providers Auth required for all GENERAL J1572 Febogamma GLOBULIN, IMMUNE providers Auth required for all GENERAL J1595 Copaxone GLATIRAMER ACETATE providers IVIG NON LYOPHILIZED, Auth required for all MISC J1599 MISC NOS providers Auth required for all GENERAL J1640 Panhematin HEMIN providers Auth required for all GENERAL J1645 Fragmin DALTEPARIN SODIUM providers Auth required for all GENERAL J1650 Lovenox ENOXAPARIN SODIUM providers Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Auth required for all GENERAL J1652 Arixtra FONDAPARINUX SODIUM providers Auth required for all GENERAL J1655 Innohep TINZAPARIN SODIUM providers Page 5 of 24 *As of 06/2015 BIOPHARMACEUTICAL PHARMACY PROGRAM FIBRINOGEN Auth required for all GENERAL J7178 RiaSTAP CONCENTRATE (HUMAN) providers HYDROXYPROGESTERONE Auth required for all GENERAL J1725 Makena CAPROATE providers Auth required for all GENERAL J1740 Boniva IBANDRONATE SODIUM providers Auth required for all GENERAL J1743 Elaprase IDURSULFASE providers Auth required for all GENERAL J1745 Remicade INFLIXIMAB providers Auth required for all GENERAL J1786 Cerezyme IMUGLUCERASE providers Auth required for all GENERAL J1826 Avonex INTERFERON BETA 1A providers Auth required for all GENERAL J1830 Betaseron INTERFERON BETA 1B providers Auth required for all GENERAL J1930 Somatuline LANREOTIDE ACETATE providers Auth required for all GENERAL J1931 Aldurazyme LARONIDASE providers Eliguard; Lupron; Lupron Auth required for all GENERAL J1950 LEUPROLIDE ACETATE 3; Lupron 4; providers Lupron Depot Auth required for all GENERAL J2170 Iplex; Increlex MECASERMIN providers Auth required for all GENERAL J2278 Prialt ZICONOTIDE ACETATE providers Auth required for all GENERAL J2315 Vivitrol NALTREXONE providers Updated PA Requirement Trade Name (if Additional (PL Codes) HCPCS Code applicable) HCPCS Desription Information Auth required for all GENERAL J2323 Tysabri NATALIZUMAB providers Auth required for all GENERAL J2325 Natrecor NESIRITIDE providers Page 6 of 24 *As of 06/2015 BIOPHARMACEUTICAL PHARMACY PROGRAM Sandostatin Auth required for all GENERAL J2353 OCTREOTIDE ACETATE LAR providers Auth required for all GENERAL J2354 Sandostatin OCTREOTIDE ACETATE providers Auth required for all GENERAL J2355 Neumega OPRELVEKIN providers Auth required for all GENERAL J2357 Xolair OMALIZUMAB providers Zyprexa OLANZAPINE LONG Auth required for all GENERAL J2358 Relprevv ACTING
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  • Eisai Submits Marketing Authorization Application in Japan

    Eisai Submits Marketing Authorization Application in Japan

    N o. 20-15 March 26, 2020 Eisai Co., Ltd. EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION IN JAPAN FOR ANTICANCER AGENT DENILEUKIN DIFTITOX (GENETIC RECOMBINANT) FOR CUTANEOUS T-CELL LYMPHOMA AND PERIPHERAL T-CELL LYMPHOMA Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted in Japan a marketing authorization application of the anticancer agent denileukin diftitox (genetic recombinant) (generic name, development code: E7777) for relapsed or refractory Cutaneous T-cell Lymphoma (CTCL) and Peripheral T-cell Lymphoma (PTCL). This application is based on data from a multicenter, open-label, single-arm Phase II clinical study (study 205) conducted in Japan for patients with relapsed or refractory CTCL or PTCL to evaluate the efficacy and safety of this agent. This study achieved the primary endpoint and exceeded a predetermined threshold with statistical significance: the objective response rate (ORR) of CTCL and PTCL patients in total (n=36) was 36.1% (95% confidence interval (CI): 20.8-53.8). The ORRs of each subtype were 31.6% (95% CI：12.6-56.6) for CTCL (n=19) and 41.2% (95%CI: 18.4-67.1) for PTCL (n=17). The five most frequent adverse events observed in this study were increased aspartate aminotransferase (AST) (89.2%), increased alanine aminotransferase (ALT) (86.5%), hypoalbuminaemia (70.3%), lymphopenia (70.3%), and pyrexia (51.4%). Denileukin diftitox (genetic recombinant) is a fusion protein of the receptor-binding portion of interleukin-2 (IL-2) and diphtheria toxin that specifically binds to the IL-2 receptor on the surface of tumoral lymphocyte.