Outpatient Drug Services Handbook

Total Page:16

File Type:pdf, Size:1020Kb

Outpatient Drug Services Handbook Texas Medicaid Provider Procedures Manual August 2021 Provider Handbooks Outpatient Drug Services Handbook The Texas Medicaid & Healthcare Partnership (TMHP) is the claims administrator for Texas Medicaid under contract with the Texas Health and Human Services Commission. TEXAS MEDICAID PROVIDER PROCEDURES MANUAL: VOL. 2 AUGUST 2021 OUTPATIENT DRUG SERVICES HANDBOOK Table of Contents 1 General Information . 7 1.1 * About the Vendor Drug Program . 7 1.2 * Pharmacy Enrollment . 7 1.3 Program Contact Information. 8 2 Enrollment . 8 3 Services, Benefits, Limitations, and Prior Authorization. .8 3.1 Prior Authorization Requests . 8 3.2 Electronic Signatures in Prior Authorizations . 9 4 Reimbursement. 9 5 Injectable Medications as a Pharmacy Benefit. .10 6 National Drug Code (NDC) . .11 6.1 Calculating Billable HCPCS and NDC Units . .11 6.1.1 Single-Dose Vials Calculation Examples . 12 6.1.2 Multi-Dose Vials Calculation Examples . 12 6.1.3 Single and Multi-Use Vials . 13 6.1.4 Nonspecific, Unlisted, or Miscellaneous Procedure Codes . 13 7 Outpatient Drugs—Benefits and Limitations. .14 7.1 Abatacept (Orencia) . .14 7.1.1 Prior Authorization for Abatacept (Orencia) . 15 7.2 Adalimumab. .16 7.3 Ado-trastuzumab entansine (Kadcyla). .17 7.4 Alglucosidase Alfa (Myozyme) . .17 7.5 Amifostine . .18 7.6 Antibiotics and Steroids . .21 7.7 Antisense Oligonucleotides (eteplirsen, golodirsen, and nusinersen) . .22 7.7.1 Prior Authorization Requirements. 22 7.7.1.1 Initial Requests (for all Antisense Oligonucleotides) . 23 7.7.1.2 Recertification/Extension Requests (for all Antisense Oligonucleotides). 25 7.7.1.3 Exclusions . 26 7.8 Aripiprazole Lauroxil, (Aristada Initio). .26 7.9 Azacitidine (Vidaza) . .26 7.10 Belantamab Mafodontin-blmf . .26 7.11 Botulinum Toxin Type A and Type B . .26 7.12 Brexanolone (Zulresso) . .29 7.12.1 Risk Evaluation and Mitigation Strategy Program . 30 7.12.2 Prior Authorization Requirements. 30 7.13 Burosumab-Twza (Crysvita). .30 2 CPT ONLY - COPYRIGHT 2020 AMERICAN MEDICAL ASSOCIATION. ALL RIGHTS RESERVED. OUTPATIENT DRUG SERVICES HANDBOOK AUGUST 2021 7.14 Calaspargase Pegol-Mknl. .31 7.15 Cemiplimab-rwlc. .32 7.16 Chelating Agents . .32 7.16.1 Dimercaprol. 32 7.16.2 Edetate calcium disodium . 32 7.16.3 Deferoxamine mesylate (Desferal). 33 7.17 Chimeric Antigen Receptor (CAR) T-Cell Therapy . .33 7.17.1 Prior Authorization Criteria for Axicabtagene Ciloleucel (Yescarta). 34 7.17.2 Prior Authorization for Brexucabtagene autoleucel (Tecartus) . 34 7.17.3 Prior Authorization Criteria for Tisagenlecleucel (Kymriah) . 35 7.17.4 Exclusions. 36 7.18 Clofarabine . .36 7.18.1 Prior Authorization for Clofarabine . 36 7.19 Colony Stimulating Factors (Filgrastim, Pegfilgrastim, and Sargramostim). .36 7.20 Crizanlizumab-tmca (Adakveo) . .40 7.20.1 Prior Authorization . 40 7.21 Denileukin diftitox (Ontak) . .41 7.22 Dimethyl sulfoxide . .41 7.23 Eculizumab . .41 7.24 Edaravone (Radicava) . .41 7.25 Emapalumab-lzsg (Gamifant) . .41 7.25.1 Prior Authorization Requirements. 41 7.26 Enfortumab Vedotin-ejfv (Padcev) . .42 7.27 Eravacycline (Xerava) . .42 7.28 Esketamine (Spravato) . .42 7.28.1 Prior Authorization . 43 7.29 Fam-trastuzumab Deruxtecan-nxki . .44 7.30 Fluocinolone Acetonide (Retisert) . .44 7.31 Fremanezumab-vfrm. ..
Recommended publications
  • Neurotransmitter Resource Guide
    NEUROTRANSMITTER RESOURCE GUIDE Science + Insight doctorsdata.com Doctor’s Data, Inc. Neurotransmitter RESOURCE GUIDE Table of Contents Sample Report Sample Report ........................................................................................................................................................................... 1 Analyte Considerations Phenylethylamine (B-phenylethylamine or PEA) ................................................................................................. 1 Tyrosine .......................................................................................................................................................................................... 3 Tyramine ........................................................................................................................................................................................4 Dopamine .....................................................................................................................................................................................6 3, 4-Dihydroxyphenylacetic Acid (DOPAC) ............................................................................................................... 7 3-Methoxytyramine (3-MT) ............................................................................................................................................... 9 Norepinephrine ........................................................................................................................................................................
    [Show full text]
  • WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
    [Show full text]
  • Pros and Cons of Entry and Fusion Inhibitors (Review)
    MOLECULAR MEDICINE REPORTS 19: 1987-1995, 2019 Investigational drugs in HIV: Pros and cons of entry and fusion inhibitors (Review) EMMANUELE VENANZI RULLO1,2, MANUELA CECCARELLI1, FABRIZIO CONDORELLI3, ALESSIO FACCIOLÀ1, GIUSEPPA VISALLI4, FRANCESCO D'ALEO1, IVANA PAOLUCCI1, BRUNO CACOPARDO5, MARILIA RITA PINZONE2-5, MICHELE DI ROSA6, GIUSEPPE NUNNARI1 and GIOVANNI F. PELLICANÒ7 1Department of Clinical and Experimental Medicine, Unit of Infectious Diseases, University of Messina, I-90124 Messina, Italy; 2Department of Pathology and Laboratory Medicine, School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; 3Department of Pharmacological Sciences, University of Eastern Piedmont ‘A. Avogadro’, I-13100 Novara; 4Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, I-90124 Messina; 5Department of Clinical and Experimental Medicine, University of Catania, I-95123 Catania; 6Department of Biomedical and Biotechnological Sciences, Human Anatomy and Histology Section, University of Catania, I-95123 Catania; 7Department of Human Pathology of the Adult and the Developmental Age ‘G. Barresi’, Unit of Infectious Diseases, University of Messina, I-98122 Messina, Italy Received September 2, 2018; Accepted November 29, 2018 DOI: 10.3892/mmr.2019.9840 Abstract. Despite the profound changes and improve- 4. Gp41 antagonists ments reached in the field of HIV treatment, tolerability and 5. CD4 antagonists adherence to highly active antiretroviral therapy remains a 6. Discussion challenge. Furthermore, multi-experienced patients could take advantage of drugs with different mechanisms of action to combat the spread of resistance to actual therapy. For these 1. Introduction reasons identification of new HIV drugs is crucial. Among all the molecules that at present are under investigation, entry HIV continues to be an important challenge and a major and fusion inhibitors pose an interesting class owing to their global public health issue.
    [Show full text]
  • Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
    antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution.
    [Show full text]
  • THE BIOSYNTHESIS of SOME PHENOLIC ALKALOIDS a Thesis Submitted by GEOFFREY MELVILLE THOMAS for the Degree of DOCTOR of PHILOSOPH
    /1 THE BIOSYNTHESIS OF SOME PHENOLIC ALKALOIDS a thesis submitted by GEOFFREY MELVILLE THOMAS for the degree of DOCTOR OF PHILOSOPHY of THE UNIVERSITY OF LONDON Imperial College, June 1963. London, S. W.7. ABSTRACT A brief review of the biosynthesis of alkaloids, other than those of the Amaryllidaceae and morphine groups, is given. The biosynthesis of these two groups is discussed more fully with particular reference to the evidence for the Barton and Cohen concept of phenol oxidation as a biogenetic mechanism. The incorporation of labelled phenolic precursors, derivatives of norbelladine, has been shown and by means of multiple labelled experiments incorporation as a whole, without degradation, has been proved. Other experiments described have thrown light on the earlier stages of biogenesis. The norlaudanosine derivative, (±) reticuline, has been shown to be incorporated into morphine, and an in vitro synthesis of thebaine from (±) reticuline using a radiochemical dilution method is de-scribed. I am deeply grateful to Professor D. H. R. Barton and Dr. G. W. Kirby for the privilege and pleasure of working under their supervision and for their great help in matters chemical and non-chemical. To the Salters Company I would like to express my sincere thanks for the award of a scholarship and for their interest during the tenure of it. My thanks are also due to Dr. D. W. Turner for advice on counting techniques, Mr. D. Aldrich and his staff for valuable technical assistance, Miss J. Cuckney for microanalyses, Mr. R.H. Young who grew the daffodils and poppies and to my many friends and co-workers at Imperial College.
    [Show full text]
  • Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®)
    UnitedHealthcare® Commercial Medical Benefit Drug Policy Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®) Policy Number: 2021D0088F Effective Date: July 1, 2021 Instructions for Use Table of Contents Page Community Plan Policy Coverage Rationale ....................................................................... 1 • Intravenous Iron Replacement Therapy (Feraheme®, Definitions ...................................................................................... 3 Injectafer®, & Monoferric®) Applicable Codes .......................................................................... 3 Background.................................................................................... 4 Benefit Considerations .................................................................. 4 Clinical Evidence ........................................................................... 5 U.S. Food and Drug Administration ............................................. 7 Centers for Medicare and Medicaid Services ............................. 8 References ..................................................................................... 8 Policy History/Revision Information ............................................. 9 Instructions for Use ....................................................................... 9 Coverage Rationale See Benefit Considerations This policy refers to the following intravenous iron replacements: Feraheme® (ferumoxytol) Injectafer® (ferric carboxymaltose) Monoferric® (ferric derisomaltose)* The following
    [Show full text]
  • Keeping up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A
    Keeping Up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A. Shlom, PharmD, BCPS Senior Vice President & Director Clinical Pharmacy Program | Acurity, Inc. Privileged and Confidential April 10, 2019 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ▪ Identify orphan drugs and first-in-class medications approved by the FDA in 2018. ▪ List five new drugs and their indications. ▪ Identify the place in therapy for three novel monoclonal antibodies. ▪ Discuss at least two new medications that address public health concerns. Dr. Shlom does not have any conflicts of interest in regard to this presentation. Both trade names and generic names will be discussed throughout the presentation Privileged and Confidential 2018 NDA Approvals (NMEs/BLAs) ▪ Lutathera (lutetium Lu 177 dotatate) ▪ Braftovi (encorafenib) ▪ Vizimpro (dacomitinib) ▪ Biktarvy (bictegravir, emtricitabine, ▪ TPOXX (tecovirimat) ▪ Libtayo (cemiplimab-rwic) tenofovir, ▪ Tibsovo (ivosidenib) ▪ Seysara (sarecycline) alafenamide) ▪ Krintafel (tafenoquine) ▪ Nuzyra (omadacycline) ▪ Symdeko (tezacaftor, ivacaftor) ▪ Orilissa (elagolix sodium) ▪ Revcovi (elapegademase-lvir) ▪ Erleada (apalutamide) ▪ Omegaven (fish oil triglycerides) ▪ Tegsedi (inotersen) ▪ Trogarzo (ibalizumab-uiyk) ▪ Mulpleta (lusutrombopag) ▪ Talzenna (talazoparib) ▪ Ilumya (tildrakizumab-asmn) ▪ Poteligeo (mogamulizumab-kpkc) ▪ Xofluza (baloxavir marboxil) ▪ Tavalisse (fostamatinib disodium) ▪ Onpattro (patisiran)
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
    [Show full text]
  • Mrx CLINICAL ALERT
    MRx AUGUST 2018 CLINICAL ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS HOT TOPIC: potential to placebo in non-dependent FIRST DRUG COMPRISED adult recreational drug users. EDITORIAL OF ACTIVE MARIJUANA DERIVATIVE APPROVED Cannabidiol oral solution was studied STAFF in 3 randomized, double-blind, placebo- Under Priority review, the United States controlled clinical trials including 516 (US) Food and Drug Administration (FDA) patients with either LGS or Dravet EDITOR IN CHIEF approved cannabidiol oral solution syndrome. Cannabidiol taken with ® Maryam Tabatabai (Epidiolex ) for the treatment of the patient’s current anticonvulsant PharmD seizures associated with Lennox-Gastaut regimen was shown to be effective syndrome (LGS) or Dravet syndrome in in reducing the frequency of seizures patients ≥ 2 years of age. It is the only when compared with placebo. Over EXECUTIVE EDITOR drug approved to treat Dravet syndrome the 12-week treatment period, the Carole Kerzic and the FDA designated it as an Orphan reduction in median number of LGS RPh drug and Rare pediatric disease drug seizures ranged from 37% to 44% with to treat both serious, difficult-to-treat CBD and 17% to 22% with placebo. DEPUTY EDITORS childhood seizure disorders. Dravet For Dravet syndrome, seizure reductions Stephanie Christofferson syndrome is diagnosed in approximately were 39% and 13% with CBD and PharmD 1 in 15,700 individuals in the US and placebo, respectively. Common side is characterized by frequent prolonged effects (≥ 10%) reported with CBD Jessica Czechowski seizures and developmental delays. LGS were increased liver transaminases PharmD involves frequent drop seizures and (particularly with concurrent use of impaired intellectual development.
    [Show full text]
  • An HIV Clinician's View
    HIV Meets Oncology: An HIV Clinician’s View Merceditas S. Villanueva MD Director, HIV/AIDS Program Yale University School of Medicine HIV and Cancer Retreat April 30, 2019 Financial Disclosures • None Case Presentation • 58 year old man diagnosed with HIV in 1996 • Early years: serial ART mono and dual therapy with multidrug resistance • Moved to CT 2005-worked in pharmaceutical field (ART development) • I met him in 2009-applying for disability ART Over Time Saquinavir Tenofovir Emtricitabine Stavudine Ritonavir Atazanavir Maraviroc Elvitegravir Zidovudine Doravirine Indinavir Enfuvirtide Raltegravir Nelfinavir Ibalizumab 1985 1990 1995 2000 2005 2010 2015 2018 Didanosine Tenofovir Lamivudine Efavirenz Darunavir Rilpivirine alafenamide Abacavir Fosemprenavir Dolutegravir Nevirapine Lopinavir+Ritonavir Etravirine ART in Single Tablet Regimen Now 1 pill a Day 2-3 ARVs co-formulated ART Simpler and Safer AN AIDS TIMELINE: The 1st Decade RONALD REAGAN GEORGE H.W. BUSH 1981-1989 1989-1993 ’85 ’87 AZT ’82 First approved HIV “AIDS” ’83 Virus test isolation 1981 AN AIDS TIMELINE: The 2nd Decade GEORGE H.W. BUSH WILLIAM CLINTON 1989-1993 1993-2000 92’ ddl/ddC 93’ d4t Dual NRTI’s HAART ’97: NEL, DLV, Combivir ’95: Saquinavir ’96: NVP, IDV, RIT ’92 AIDS ’96 HIV leading cause viral load of death approved adults 25-44 yrs old AIDS Deaths Red down Ribbon 40% due Tony to Awards HAART 19901 1994 1995 ‘96 My Pt was diagnosed HIV+ AN AIDS TIMELINE: THE 3rd Decade … GEORGE W. BUSH BARACK H. OBAMA 2001-2008 2009 - 2016 ’00 ’01 ’03 ‘04 ’05 ‘06 Darunavir ’07 ’08 Trizivir Tenofo Fuzeon Truvada Tipranavir Maraviroc Etravirine -Atripla vir Raltegravir Lopinavir ’00 13th Int’l AIDS : Conf in PEPFAR 25 30 Durban SA $15B/5 yrs years years 2000 AN AIDS TIMELINE: THE 4th Decade … DONALD J.
    [Show full text]
  • 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.
    [Show full text]