New Technology Terms

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Terms to Device / Substance / Technology

Afamitresgene Autoleucel Immunotherapy

Includes:

• afami-cel

AGN1 Bone Void Filler

Includes:

• OSSURE(tm) implant material

Amivantamab Monoclonal Antibody

Includes:

• RYBREVANT(tm)

Anacaulase-bcdb

Includes:

• Bromelain-enriched Proteolytic Enzyme
• NexoBrid(tm)

Antibiotic-eluting Bone Void Filler

Includes:

• CERAMENT(R) G

Atezolizumab Antineoplastic

Includes:

• TECENTRIQ(R)

Axicabtagene Ciloleucel Immunotherapy

Includes:

• Axicabtagene Ciloleucel
• Yescarta(R)

Baricitinib

Includes:

• Olumiant(R)

Betibeglogene Autotemcel

Includes:

• beti-cel
• ZYNTEGLO(R)

Bioengineered Allogeneic Construct

Includes:

• StrataGraft(R)

Bioengineered Human Acellular Vessel in New Technology

Includes:

• HAV(tm) (Human Acellular Vessel)
• Human Acellular Vessel(tm) (HAV)

Branched Intraluminal Device, Manufactured Integrated System, Four or More Arteries in New Technology

Includes:

• GORE(R) EXCLUDER(R) TAMBE Device (Thoracoabdominal Branch Endoprosthesis)
• TAMBE Device (Thoracoabdominal Branch Endoprosthesis), GORE(R) EXCLUDER(R)

Branched Synthetic Substitute with Intraluminal Device in New Technology

Includes:

• Thoraflex(tm) Hybrid device

Brexanolone

Includes:

• ZULRESSO(tm)

Brexucabtagene Autoleucel Immunotherapy

Includes:

• Brexucabtagene Autoleucel
• Tecartus(tm)

Broad Consortium Microbiota-based Live Biotherapeutic Suspension

Includes:

• REBYOTA(R)

Carbon/PEEK Spinal Stabilization Device, Pedicle Based in New Technology

Includes:

• BlackArmor(R) Carbon/PEEK fixation system
• VADER(R) Pedicle System

Cefiderocol Anti-infective

Includes:

• FETROJA(R)

Ceftolozane/Tazobactam Anti-infective

Includes:

• ZERBAXA(R)

Ciltacabtagene Autoleucel

Includes:

• CARVYKTI(tm)
• cilta-cel

Coagulation Factor Xa, Inactivated

Includes:

• Andexanet Alfa, Factor Xa Inhibitor Reversal Agent
• Andexxa
• Coagulation Factor Xa, (Recombinant) Inactivated
• Factor Xa Inhibitor Reversal Agent, Andexanet Alfa

Conduit through Femoral Vein to Popliteal Artery in New Technology

Includes:

• DETOUR(R) System

Conduit through Femoral Vein to Superficial Femoral Artery in New Technology

Includes:

• DETOUR(R) System

Conduit to Short-term External Heart Assist System in New Technology

Includes:

• Impella(R) 5.5 with SmartAssist(R) System

COVID-19 Vaccine

Includes:

• COMIRNATY(R)
• SPIKEVAX(tm)

COVID-19 Vaccine Booster

Includes:

• COMIRNATY(R)
• SPIKEVAX(tm)

COVID-19 Vaccine Dose 1

Includes:

• COMIRNATY(R)
• SPIKEVAX(tm)

COVID-19 Vaccine Dose 2

Includes:

• COMIRNATY(R)
• SPIKEVAX(tm)

COVID-19 Vaccine Dose 3

Includes:

• COMIRNATY(R)
• SPIKEVAX(tm)

Cytarabine and Daunorubicin Liposome Antineoplastic

Includes:

• VYXEOS(tm)

Daratumumab and Hyaluronidase-fihj

Includes:

• Darzalex Faspro(R)

Donislecel-jujn Allogeneic Pancreatic Islet Cellular Suspension

Includes:

• Lantidra(tm)

Durvalumab Antineoplastic

Includes:

• IMFINZI(R)

Eculizumab

Includes:

• Soliris(R)

Elranatamab Antineoplastic

Includes:

• ELREXFIO(tm)

Endothelial Damage Inhibitor

Includes:

• DuraGraft(R) Endothelial Damage Inhibitor

Engineered Allogeneic Thymus Tissue

Includes:

• RETHYMIC(R)

Epcoritamab Monoclonal Antibody

Includes:

• EPKINLY(tm)

Exagamglogene Autotemcel

Includes:

• CASGEVY(tm)
• CTX001(tm)

Facet Joint Fusion Device, Paired Titanium Cages in New Technology

Includes:

• Facet FiXation implant
• FFX(R) (Facet FiXation) implant

Glofitamab Antineoplastic

Includes:

• Columvi(tm)

High-Dose Intravenous Immune Globulin

Includes:

• GAMUNEX-C, for COVID-19 treatment
• hdIVIG (high-dose intravenous immunoglobulin), for COVID-19 treatment
• High-dose intravenous immunoglobulin (hdIVIG), for COVID-19 treatment
• Octagam 10%, for COVID-19 treatment

Hyperimmune Globulin

Includes:

• Anti-SARS-CoV-2 hyperimmune globulin
• HIG (hyperimmune globulin), for COVID-19 treatment
• hIVIG (hyperimmune intravenous immunoglobulin), for COVID-19 treatment
• Hyperimmune intravenous immunoglobulin (hIVIG), for COVID-19 treatment
• IGIV-C, for COVID-19 treatment

Idecabtagene Vicleucel Immunotherapy

Includes:

• ABECMA(R)
• Ide-cel
• Idecabtagene Vicleucel

Inebilizumab-cdon

Includes:

• UPLIZNA(R)

Interbody Fusion Device, Custom-Made Anatomically Designed in New Technology

Includes:

• aprevo(tm)

Internal Fixation Device with Tulip Connector in New Technology

Includes:

• iFuse Bedrock(tm) Granite Implant System

Internal Fixation Device, Gyroid-Sheet Lattice Design in New Technology

Includes:

• restor3d TIDAL(tm) Fusion Cage

Internal Fixation Device, Open-truss Design in New Technology

Includes:

• Ankle Truss System(tm) (ATS)

Intracardiac Pacemaker, Dual-Chamber in New Technology

Includes:

• Aveir(tm) AR, as dual chamber
• Aveir(tm) DR, dual chamber

Intraluminal Device, Bioprosthetic Valve in New Technology

Includes:

• TricValve(R) Transcatheter Bicaval Valve System
• VenoValve(R)

Intraluminal Device, Everolimus-eluting Resorbable Scaffold(s) in New Technology

Includes:

• Drug-eluting resorbable scaffold intraluminal device
• Esprit(tm) BTK (scaffold) (stent)
• Everolimus Eluting Resorbable Scaffold System

Iobenguane I-131 Antineoplastic

Includes:

• AZEDRA(R)
• Iobenguane I-131, High Specific Activity (HSA)

Lefamulin Anti-infective

Includes:

• XENLETA(tm)

Lifileucel Immunotherapy

Includes:

• AMTAGVI(tm)
• Lifileucel

Lisocabtagene Maraleucel Immunotherapy

Includes:

• Breyanzi(R)
• Lisocabtagene Maraleucel

Lovotibeglogene Autotemcel

Includes:

• LYFGENIA(tm)

Lurbinectedin

Includes:

• ZEPZELCA(tm)

Magnetically Controlled Growth Rod(s) in New Technology

Includes:

• MAGEC(R) Spinal Bracing and Distraction System
• Spinal growth rods, magnetically controlled

Maribavir Anti-infective

Includes:

• LIVTENCITY(tm)

Marnetegragene Autotemcel

Includes:

• RP-L201

Melphalan Hydrochloride Antineoplastic

Includes:

• HEPZATO(tm) KIT (melphalan hydrochloride Hepatic Delivery System)

Mineral-based Topical Hemostatic Agent

Includes:

• Hemospray(R) Endoscopic Hemostat

Mosunetuzumab Antineoplastic

Includes:

• LUNSUMIO(tm)

Multi-plane Flex Technology Bioprosthetic Valve in New Technology

Includes:

• Edwards EVOQUE tricuspid valve replacement system

Nafamostat Anticoagulant

Includes:

• LTX Regional Anticoagulant
• Niyad(tm)

Nerinitide

Includes:

• NA-1 (Nerinitide)

Neurostimulator Lead in New Technology

Includes:

• Ischemic Stroke System (ISS500)
• ISS500 (Ischemic Stroke System)

Neurostimulator Lead with Paired Stimulation System in New Technology

Includes:

• Vivistim(R) Paired VNS System Lead

Non-Chimeric Antigen Receptor T-cell Immune Effector Cell Therapy

Includes:

• T-cell Antigen Coupler T-cell (TAC-T) Therapy
• T-cell Receptor-Engineered T-cell (TCR-T) Therapy
• Tumor-Infiltrating Lymphocyte (TIL) Therapy

Obecabtagene Autoleucel

Includes:

• obe-cel

Omadacycline Anti-infective

Includes:

• NUZYRA(tm)

Omidubicel

Includes:

• Omisirge(R)

Other New Technology Therapeutic Substance

Includes:

• STELARA(R)
• Ustekinumab

Posterior (Dynamic) Distraction Device in New Technology

Includes:

• ApiFix(R) Minimally Invasive Deformity Correction (MID-C) System

Posterior Spinal Motion Preservation Device in New Technology

Includes:

• TOPS(tm) System

Posterior Vertebral Tether in New Technology

Includes:

• LigaPASS 2.0(tm) PJK Prevention System

Prademagene Zamikeracel, Genetically Engineered Autologous Cell Therapy in New Technology

Includes:

• EB-101 gene-corrected autologous cell therapy
• EB-101 gene-corrected keratinocyte sheets
• LZRSE-COL7A1 engineered autologous epidermal sheets
• pz-cel

Reduction Device in New Technology

Includes:

• Neovasc Reducer(tm)
• Reducer(tm) System

REGN-COV2 Monoclonal Antibody

Includes:

• Casirivimab (REGN10933) and Imdevimab (REGN10987)
• Imdevimab (REGN10987) and Casirivimab (REGN10933)

Remdesivir Anti-infective

Includes:

• GS-5734
• Veklury

Sarilumab

Includes:

• KEVZARA(R)

Satralizumab-mwge

Includes:

• ENSPRYNG(tm)

SER-109

Includes:

• VOWST(tm)

Spesolimab Monoclonal Antibody

Includes:

• SPEVIGO(R)

Sulbactam-Durlobactam

Includes:

• SUL-DUR
• Xacduro(R)

Synthetic Substitute, Extraluminal Support Device in New Technology

Includes:

• VasQ(tm) External Support device

Synthetic Substitute, Lateral Meniscus in New Technology

Includes:

• NUsurface(R) Meniscus Implant

Synthetic Substitute, Mechanically Expandable (Paired) in New Technology

Includes:

• SpineJack(R) system

Synthetic Substitute, Medial Meniscus in New Technology

Includes:

• NUsurface(R) Meniscus Implant

Synthetic Substitute, Talar Prosthesis in New Technology

Includes:

• Total Ankle Talar Replacement(tm) (TATR)

Synthetic Substitute, Ultrasound Penetrable in New Technology

Includes:

• Longeviti ClearFit(R) Cranial Implant
• Longeviti ClearFit(R) OTS Cranial Implant

Tabelecleucel Immunotherapy

Includes:

• EBVALLO(tm)
• tab-cel(R)

Tagraxofusp-erzs Antineoplastic

Includes:

• ELZONRIS(tm)

Talquetamab Antineoplastic

Includes:

• TALVEY(tm)

Taurolidine Anti-infective and Heparin Anticoagulant

Includes:

• DefenCath(tm)

Teclistamab Antineoplastic

Includes:

• TECVAYLI(tm)

Terlipressin

Includes:

• TERLIVAZ(R)

Tibial Extension with Motion Sensors in New Technology

Includes:

• Canturio(tm) te (Tibial Extension)

Tisagenlecleucel Immunotherapy

Includes:

• KYMRIAH(R)
• Tisagenlecleucel

Tixagevimab and Cilgavimab Monoclonal Antibody

Includes:

• EVUSHELD(tm)

Tocilizumab

Includes:

• ACTEMRA(R)

Trilaciclib

Includes:

• COSELA(tm)

Uridine Triacetate

Includes:

• Vistogard(R)

Vancomycin Hydrochloride and Tobramycin Sulfate Anti-Infective, Temporary Irrigation Spacer System

Includes:

• VT-X7 (Irrigation System) (Spacer)

Vein Graft Extraluminal Support Device(s) in New Technology

Includes:

• VEST(tm) Venous External Support device