Tenncare Autoexempt List September 1, 2021 This Is a Current List of the Drugs and Supplies That Do Not Count Toward an Enrollee’S Monthly Drug Limit

Total Page:16

File Type:pdf, Size:1020Kb

Tenncare Autoexempt List September 1, 2021 This Is a Current List of the Drugs and Supplies That Do Not Count Toward an Enrollee’S Monthly Drug Limit TennCare AutoExempt List September 1, 2021 This is a current list of the drugs and supplies that do not count toward an enrollee’s monthly drug limit. This list is subject to change. Go to the following link to see the most current version: www.optumrx.com/tenncare ALZHEIMER’S AGENTS • donepezil • memantine • rivastigmine • galantamine • memantine-donepezil ANTI-ANXIETY AGENTS • buspirone ANTIDEPRESSANTS • citalopram • fluoxetine • sertraline • escitalopram • fluvoxamine • paroxetine ANTINEOPLASTICS • abemaciclib (Verzenio) • epirubicin (Ellence) • paclitaxel (Onxol, Abraxane, Taxol) • abiraterone acetate (Zytiga) • erdafitinib (Balversa) • palbociclib (Ibrance) • acalabrutinib (Calquence) • erlotinib (Tarceva) • panitumumab (Vectibix) • afatinib (Gilotrif) • estramustine (Emcyt) • panobinostat (Farydak) • alectinib (Alecensa) • etoposide (VP-16-213, Toposar, • pazopanib (Votrient) • alpelisib (Piqray) VePesid, Etopophos) • pegaspargase (Oncaspar) • anastrazole (Arimidex) • everolimus (Afinitor) • pembrolizumab (Keytruda) • apalutamide (Erleada) • exemestane (Aromasin) • pemetrexed (Alimta) • arsenic trioxide (Trisenox) • fedratinib (Inrebic) • pemigatinib (Pemazyre) • asparaginase (Elspar, Erwinaze) • floxuridine (FUDR) • pentostatin (DCF) (Nipent) • axitinib (Inlyta) • fludarabine (Fludara, Oforta) • pertuzumab (Perjeta) • azacitidine (Vidaza, Onureg) • fluorouracil (Adrucil, Carac, Tolak) • plicamycin (Mithracin) • bcg vaccine (TheraCys, TICE BCG) • flutamide (Eulexin) • pomalidomide (Pomalyst) • bendamustine (Treanda) • fulvestrant (Faslodex) • porfimer sodium (Photofrin) • bevacizumab (Avastin) • gallium nitrate (Ganite) • pralatrexate (Folotyn) • bexarotene (Targretin) • gefitinib (Iressa) • pralsetinib (Gavreto) • bicalutamide (Casodex) • gemcitabine (Gemzar) • procarbazine (Matulane) • binimetinib (Mektovi) • gemtuzumab (Mylotarg) • ramucirumab (Cyramza) • bleomycin (Blenoxane) • gilteritinib (Xospata) • regorafenib (Stivarga) • bortezomib (Velcade) • glasdegib (Daurismo) • relugolix (Orgovyx) • bosutinib (Bosulif) • goserelin (Zoladex) • ribociclib (Kisqali) • brentuximab (Adcetris) • hydroxyurea (Droxia, Hydrea, Mylocel) • ribociclib/letrozole (Kisqali/Femara) • busulfan (Busulfex, Myleran) • ibritumomab tiuxetan(Zevalin) • ripretinib (Qinlock) • cabazitaxel (Jevtana) • ibrutinib (Imbruvica) • rituximab (Rituxan) • cabozantinib (Cabometyx, Cometriq) • idarubicin (Idamycin PFS) • romidepsin (Istodax) • capecitabine (Xeloda) • idelalisib (Zydelig) • rucaparib (Rubraca) • carboplatin (Paraplatin) • ifosfamide (Ifex) • ruxolitinib (Jakafi) • carfilzomib (Kyprolis) • imatinib mesylate (Gleevec) • samarium SM 153 lexidronam • carmustine (BCNU, BiCNU, Gliadel) • ipilimumab (Yervoy) (Quadramet) • ceritinib (Zykadia) • irinotecan (Camptosar) • selumetinib (Koselugo) • cetuximab (Erbitux) • ivosidenib (Tibsovo) • selinexor (Xpovio) • chlorambucil (Leukeran) • ixabepilone (Ixempra) • siltuximab (Sylvant) • cisplatin (Platinol) • ixazomib (Ninlaro) • sonidegib (Odomzo) • cladribine (CdA) (Leustatin) • larotrectinib (Vitrakvi) • sorafenib (Nexavar) • clofarabine (Clolar) • lenalidomide (Revlimid) • streptozocin (Zanosar) • cobimetinib (Cotellic) • lenvatinib (Lenvima) • strontium-89 chloride (Metastron) • crizotinib (Xalkori) • letrozole (Femara) • sunitinib (Sutent) • cyclophosphamide (Cytoxan, Neosar) • leucovorin (Wellcovorin) • talazoparib (Talzenna) • cytarabine, conventional (Cytosar-U, • leuprolide (Eligard, Lupron, Lupron • talc powder, sterile (Sclerosol) Tarabine PFS) Depot, Viadur) • talimogene laherparepvec (Imlygic) • cytarabine, liposomal (DepoCyt) • lomustine (CeeNU, Gleostine) • tamoxifen (Nolvadex, Soltamox) • lorlatinib (Lorbrena) Proprietary & Confidential © 2021, OptumRx. All rights reserved. ANTINEOPLASTICS • dabrafenib (Tafinlar) • mercaptopurine (6-MP, Purinethol) • temozolomide (Temodar) • dacarbazine (DTIC-Dome) • mesna (Mesnex) • temsirolimus (Torisel) • dacomitinib (Vizimpro) • methotrexate (Mexate, Trexall, • tepotinib (Tepmetko) • dactinomycin (actinomycin D, Abitrexate, Folex, Otrexup, Rasuvo, • topotecan (Hycamtin) Cosmegen) Reditrex) • toremifene citrate (Fareston) • darolutamide (Nubeqa) • mitomycin (MTC, Mutamycin) • tositumomab (Bexxar) • dasatinib (Sprycel) • mitotane (Lysodren) • trabectedin (Yondelis) • daunorubicin (Cerubidine) • mitoxantrone (Novantrone) • trametinib (Mekinist) • daunorubicin citrate liposomal • nelarabine (Arranon) • trastuzumab (Herceptin) (DaunoXome) • neratinib (Nerlynx) • tretinoin • decitabine (Dacogen) • nilotinib (Tasigna) • trifluridine/tipiracil (Lonsurf) • degarelix (Firmagon) • nilutamide (Nilandron) • triptorelin pamoate (Trelstar) • denileukin diftitox (Ontak) • nintedanib (Ofev) • umbralisib (Ukoniq) • dexrazoxane (Zinecard, Totect) • niraparib (Zejula) • uracil mustard • dinutuximab (Unituxin) • nivolumab (Opdivo) • valrubicin (Valstar) • docetaxel (Taxotere) • ofatumumab (Arzerra) • vandetanib (Caprelsa) • doxorubicin (Adriamycin, Rubex) • olaparib (Lynparza) • vemurafenib (Zelboraf) • doxorubicin, liposomal (Doxil) • omacetaxine (Synribo) • venetoclax (Venclexta) • duvelisib (Copiktra) • osimertinib (Tagrisso) • vinblastine (Velban, Velsar) • enasidenib (Idhifa) • oxaliplatin (Eloxatin) • vincristine (Oncovin, Vincasar PFS) • encorafenib (Braftovi) • pexidartinib (Turalio) • vinorelbine tartrate (Navelbine) • enzalutamide (Xtandi) • teniposide (VM-26, Vumon) • vismodegib (Erivedge) • mechlorethamine (Mustargen) • thalidomide (Thalomid) • vorinostat (Zolinza) • melphalan (L-PAM) (Alkeran) • thioguanine (TG, Tabloid) • zanubrutinib (Brukinsa) • thiotepa (TSPA, Thioplex) • ziv-aflibercept (Zaltrap) ANTIPARKINSON’S AGENTS • benztropine (Cogentin) • carbidopa (Lodosyn) ANTITUBERCULAR AGENTS • aminosalicylic acid (PAS, Paser) • isoniazid (INH, Isohydrazide, Niazid, • rifampin/isoniazid (Rifamate) • capreomycin (Capastat) Nydrazid, Niazid-B6) • rifampin/pyrazinamide/isoniazid • cycloserine (Seromycin Pulvules) • pyrazinamide (Rifater) • ethambutol (Myambutol) • rifabutin (Mycobutin) • rifapentine (Priftin) • ethionamide (Trecator-SC) • rifampin (Rifadin) • streptomycin ANTIVIRALS • abacavir (Ziagen) • dolutegravir/abacavir/lamivudine • ganciclovir (DHPG, Cytovene IV) • abacavir/lamivudine (Epzicom) (Triumeq) • indinavir sulfate (Crixivan) • abacavir/lamivudine/zidovudine • dolutegravir/rilpivirine (Juluca) • lamivudine (3TC, Epivir, Epivir HBV) (Trizivir) • doravirine (Pifeltro) • lamivudine/tenofovir (Cimduo) • adefovir (Hepsera) • doravirine/lamivudine/tenofovir • lamivudine/zidovudine (Combivir) • amantadine (Delstrigo) • letermovir (Prevymis) • amprenavir (Agenerase) • efavirenz (Sustiva) • maraviroc (Selzentry) • atazanavir (Reyataz) • efavirenz/emtricitabine/tenofovir • nelfinavir (Viracept) • atazanavir/cobicistat (Evotaz) (Atripla) • nevirapine (Viramune, Viramune XR) • bictegravir/emtricitabine/tenofovir • efavirenz/lamivudine/tenofovir (Symfi, • raltegravir (Isentress, Isentress HD) (Biktarvy) Symfi Lo) • rilpivirine (Edurant) • cidofovir (Vistide) • elvitegravir (Vitekta) • ritonavir (Norvir) • cobicistat (Tybost) • emtricitabine (Emtriva) • ritonavir/lopinavir (Kaletra) • cobicistat/elvitegravir/ • emtricitabine/tenofovir (Descovy, • saquinavir (Fortovase, Invirase) emtricitabine/tenofovir (Stribild, Truvada) • stavudine (d4T, Zerit) Genvoya) • emtricitabine/rilpivirine/tenofovir • telbivudine (Tyzeka) • darunavir ethanolate (Prezista) (Complera, Odefsey) • tenofovir disoproxil fumarate (Viread) • darunavir/cobicistat (Prezcobix) • enfuvirtide (Fuzeon) • tenofovir alafenamide fumarate • darunavir/cobicistat/emtricitabine/ten • entecavir (Baraclude) (Vemlidy) ofovir (Symtuza) • etravirine (Intelence) • tipranavir (Aptivus) • delavirdine mesylate (Rescriptor) • fomivirsen (Vitravene) • valganciclovir (Valcyte) • didanosine (ddl) (Videx) • fosamprenavir calcium (Lexiva) • zalcitabine (ddC, Hivid) Effective Date: 9/1/2021 TennCare AutoExempt List | Page 2 ANTIVIRALS • dolutegravir (Tivicay and Tiviacy PD) • foscarnet (Foscavir) • zidovudine (AZT, Retrovir) CARDIOVASCULAR DISEASE (ORAL FORMULATIONS ONLY) Note: Brand names in this category are provided for reference only. Only generic cardiovascular medications are exempt from the script limit. If classified as a brand in Medispan, the product will not be exempt from the script limit. • acebutolol (Sectral) • ethacrynic acid (Edecrin) • olmesartan/HCTZ (Benicar HCT) • acetazolamide (Diamox) • felodipine ER • olmesartan (Benicar) • amiloride/HCTZ (Moduretic) • fosinopril (Monopril) • perindopril (Aceon) • amiloride (Midamor) • fosinopril/HCTZ (Monopril-HCT) • pindolol (Visken) • amlodipine (Norvasc, Katerzia) • furosemide (Lasix) • prazosin (Minipress) • amlodipine/benazepril (Lotrel) • HCTZ (Microzide, Oretic) • propranolol (Inderal) • atenolol (Tenormin) • hydralazine/isosorbide (BiDil) • propranolol LA (Inderal LA) • atenolol/chlorthalidone (Tenoretic) • indapamide • propranolol/HCTZ (Inderide) • benazepril (Lotensin) • irbesartan (Avapro) • quinapril (Accupril) • benazepril/HCTZ (Lotensin HCT) • irbesartan/HCTZ (Avalide) • quinapril/HCTZ (Accuretic) • betaxolol (Kerlone) • isradipine (DynaCirc) • ramipril (Altace) • bisoprolol fumarate (Zebeta) • labetalol (Trandate) • sacubitril-valsartan (Entresto) • bisoprolol/HCTZ (Ziac) • lisinopril (Prinivil, Zestril) • simvastatin (Flolipid) • bumetanide (Bumex) • lisinopril/HCTZ (Prinzide, Zestoretic) • sotalol (Betapace, Sorine, Sotylize ) • candesartan (Atacand) • losartan (Cozaar) • sotalol AF (Betapace AF) • candesartan/HCTZ (Atacand HCT) • losartan/HCTZ
Recommended publications
  • Antineoplastic Agents
    bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Pharmacy Policy Antineoplastic Agents Policy Number: 9.700 Version Number: 2.0 Version Effective Date: 9/1/2021 Product Applicability All Plan+ Products Well Sense Health Plan Boston Medical Center HealthNet Plan New Hampshire Medicaid MassHealth- MCO MassHealth- ACO Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options Note: Disclaimer and audit information is located at the end of this document. Prior Authorization Policy Products Affected: Daurismo™ (glasdegib tablet) Rubraca™ (rucaparib tablets) Erleada™ (apalutamide tablet) Sarclisa® (Isatuximab–IRFC injection) Farydak® (panobinostat capsule) Tazverik™ (tazemetostat tablet) Folotyn® (pralatrexate injection) Talzenna® (talazoparib capsule) Gleostine™ (lomustine capsule) Tibsovo® (ivosidenib tablet) Idhifa® (enasidenib mesylate tablet) Ukoniq (umbralisib tosylate tablet) Lonsurf® (tipiracil hcl and trifluridine tablet) Valchlor™ (mechlorethamine gel) Lynparza™ (olaparib capsule, and tablets) Zejula™ (niraparib capsules) Ninlaro® (ixazomib capsule) Zelboraf® (vemurafenib tablet) Odomzo® (sonidegib capsules) Zytiga® (abiraterone acetate tablet) Pomalyst® (pomalidomide capsule) + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. Antineoplastic Agents 1 of 4 The Plan may authorize coverage of the above products for members meeting the following criteria: Covered FDA approved indication Use Use supported by: o American Hospital Formulary Service Drug Information o DRUGDEX Information System o United States Pharmacopeia- Drug Information o National Comprehensive Cancer Network (categories 1,2a, and 2b) Medically accepted indications will also be considered for approval.
    [Show full text]
  • Stanford Chem-H Presentation (PDF)
    KiNativ® In situ kinase profiling Stanford University ChEM-H confidential @KiNativPlatform Principle of the KiNativ platform • ATP (or ADP) acyl phosphate binds to, and covalently modifies Lysine residues in the active site • Thus, ATP acyl phosphate with a desthiobiotin tag can be used capture and quantitate kinases in a complex lysate Acyl phosphate Desthiobiotin tag ATP 2 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 3 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 4 Samples trypsinized, probe-labeled peptides captured with streptavidin, and analyzed by targeted LC-MS2 Identification Quantitation Explicit determination of peptide Integration of signal from MS2 sequence and probe modification site fragment ions from MS2 spectrum 5 Comprehensive Coverage of Protein and Lipid Kinases Protein kinases Atypical kinases Green: Kinases detected on KiNativ Red: Kinases not detected on KiNativ ~80% of known protein and atypical kinases identified on the platform http://www.kinativ.com/coverage/protein-lipid.html 6 Profiling compound(s) on the KiNativ platform Control sample – add probe Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor followed by probe Inhibited kinase Green: Kinases Blue: Probe Gray: Non-kinases Red: Inhibitor 7 Profiling compound(s) on the KiNativ platform Control sample – add probe MS signalMS Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor
    [Show full text]
  • How to Take Your Phosphate Binders
    How to take your phosphate binders Information for renal patients Oxford Kidney Unit Page 2 What are phosphate binders? To reduce the amount of phosphate you absorb from your food you may have been prescribed a medicine called a phosphate binder. Phosphate binders work by binding (attaching) to some of the phosphate in food. This will reduce the amount of phosphate being absorbed into your blood stream. A list of phosphate binders and how to take them is shown below. Phosphate binder How to take it Calcichew (calcium carbonate) Chew thoroughly 10-15 minutes before or immediately before food Renacet (calcium acetate) Phosex (calcium acetate) Osvaren (calcium acetate and magnesium carbonate) Swallow whole after the first Renagel 2-3 mouthfuls of food (sevelemer hydrochloride) Renvela tablets (sevelemer carbonate) Alucaps (aluminium hydroxide) Renvela powder Dissolve in 60ml of water and (sevelemer carbonate) take after the first 2-3 mouthfuls of food Fosrenol tablets Chew thoroughly towards the (lanthanum carbonate) end/immediately after each meal Fosrenol powder Mix with a small amount of (lanthanum carbonate) food and eat immediately Velphoro Chew thoroughly after the first (sucroferric oxyhydroxide) 2-3 mouthfuls The phosphate binder you have been prescribed is: ……………………………………………………………………………………………………………………………………………………….. Page 3 How many phosphate binders should I take? You should follow the dose that has been prescribed for you. Your renal dietitian can advise how best to match your phosphate binders to your meal pattern, as well as which snacks require a phosphate binder. What happens if I forget to take my phosphate binder? For best results, phosphate binders should be taken as instructed.
    [Show full text]
  • The TP53 Apoptotic Network Is a Primary Mediator of Resistance to BCL2 Inhibition in AML Cells
    Published OnlineFirst May 2, 2019; DOI: 10.1158/2159-8290.CD-19-0125 RESEARCH ARTICLE The TP53 Apoptotic Network Is a Primary Mediator of Resistance to BCL2 Inhibition in AML Cells Tamilla Nechiporuk1,2, Stephen E. Kurtz1,2, Olga Nikolova2,3, Tingting Liu1,2, Courtney L. Jones4, Angelo D’Alessandro5, Rachel Culp-Hill5, Amanda d’Almeida1,2, Sunil K. Joshi1,2, Mara Rosenberg1,2, Cristina E. Tognon1,2,6, Alexey V. Danilov1,2, Brian J. Druker1,2,6, Bill H. Chang2,7, Shannon K. McWeeney2,8, and Jeffrey W. Tyner1,2,9 ABSTRACT To study mechanisms underlying resistance to the BCL2 inhibitor venetoclax in acute myeloid leukemia (AML), we used a genome-wide CRISPR/Cas9 screen to identify gene knockouts resulting in drug resistance. We validated TP53, BAX, and PMAIP1 as genes whose inactivation results in venetoclax resistance in AML cell lines. Resistance to venetoclax resulted from an inability to execute apoptosis driven by BAX loss, decreased expression of BCL2, and/or reliance on alternative BCL2 family members such as BCL2L1. The resistance was accompanied by changes in mitochondrial homeostasis and cellular metabolism. Evaluation of TP53 knockout cells for sensitivities to a panel of small-molecule inhibitors revealed a gain of sensitivity to TRK inhibitors. We relate these observations to patient drug responses and gene expression in the Beat AML dataset. Our results implicate TP53, the apoptotic network, and mitochondrial functionality as drivers of venetoclax response in AML and suggest strategies to overcome resistance. SIGNIFICANCE: AML is challenging to treat due to its heterogeneity, and single-agent therapies have universally failed, prompting a need for innovative drug combinations.
    [Show full text]
  • PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects
    International Journal of Molecular Sciences Review PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects Rosalin Mishra , Hima Patel, Samar Alanazi , Mary Kate Kilroy and Joan T. Garrett * Department of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267-0514, USA; [email protected] (R.M.); [email protected] (H.P.); [email protected] (S.A.); [email protected] (M.K.K.) * Correspondence: [email protected]; Tel.: +1-513-558-0741; Fax: +1-513-558-4372 Abstract: The phospatidylinositol-3 kinase (PI3K) pathway is a crucial intracellular signaling pathway which is mutated or amplified in a wide variety of cancers including breast, gastric, ovarian, colorectal, prostate, glioblastoma and endometrial cancers. PI3K signaling plays an important role in cancer cell survival, angiogenesis and metastasis, making it a promising therapeutic target. There are several ongoing and completed clinical trials involving PI3K inhibitors (pan, isoform-specific and dual PI3K/mTOR) with the goal to find efficient PI3K inhibitors that could overcome resistance to current therapies. This review focuses on the current landscape of various PI3K inhibitors either as monotherapy or in combination therapies and the treatment outcomes involved in various phases of clinical trials in different cancer types. There is a discussion of the drug-related toxicities, challenges associated with these PI3K inhibitors and the adverse events leading to treatment failure. In addition, novel PI3K drugs that have potential to be translated in the clinic are highlighted. Keywords: cancer; PIK3CA; resistance; PI3K inhibitors Citation: Mishra, R.; Patel, H.; Alanazi, S.; Kilroy, M.K.; Garrett, J.T.
    [Show full text]
  • LGM-Pharma-Regulatory-1527671011
    Pipeline Products List Specialty Portfolio Updated Q2 2018 Updated Q2 2018 See below list of newly approved API’s, samples are readily available for your R&D requirements: Inhalation Ophthalmic Transdermal Sublingual Abaloparatide Defibrotide Sodium Liraglutide Rituximab Abciximab Deforolimus Lixisenatide Rivastigmine Aclidinium Bromide Azelastine HCl Agomelatine Alprazolam Abemaciclib Delafloxacin Lumacaftor Rivastigmine Hydrogen Tartrate Beclomethasone Dipropionate Azithromycin Amlodipine Aripiprazole Acalabrutinib Denosumab Matuzumab Rizatriptan Benzoate Budesonide Besifloxacin HCl Apomorphine Eletriptan HBr Aclidinium Bromide Desmopressin Acetate Meloxicam Rocuronium Bromide Adalimumab Difluprednate Memantine Hydrochloride Rolapitant Flunisolide Bimatoprost Clonidine Epinephrine Aflibercept Dinoprost Tromethamine Micafungin Romidepsin Fluticasone Furoate Brimonidine Tartrate Dextromethorphan Ergotamine Tartrate Agomelatine Dolasetron Mesylate Mitomycin C Romosozumab Fluticasone Propionate Bromfenac Sodium Diclofenac Levocetrizine DiHCl Albiglutide Donepezil Hydrochloride Mometasone Furoate Rotigotine Formoterol Fumarate Cyclosporine Donepezil Meclizine Alectinib Dorzolamide Hydrochloride Montelukast Sodium Rucaparib Iloprost Dexamethasone Valerate Estradiol Melatonin Alemtuzumab Doxercalciferol Moxifloxacin Hydrochloride Sacubitril Alirocumab Doxorubicin Hydrochloride Mycophenolate Mofetil Salmeterol Xinafoate Indacaterol Maleate Difluprednate Fingolimod Meloxicam Amphotericin B Dulaglutide Naldemedine Secukinumab Levalbuterol Dorzolamide
    [Show full text]
  • 2 Total Pharmaceutical Sales
    OECD Health Statistics 2021 Definitions, Sources and Methods Total pharmaceutical sales Total sales of pharmaceutical products on the domestic market, in total and by selected Anatomical Therapeutic Chemical (ATC) classification groups, based on retail prices (which means the final price paid by the customer). The ATC codes below are based on the 2021 version of the ATC Index. All alterations implemented from January 2021 are available on the WHO Collaborating Centre for Drug Statistics Methodology website at http://www.whocc.no/atc/lists_of_new_atc_ddds_and_altera/alterations_in_atc_ddd/. Note: There are at least three possible sources of under-reporting of drug sales in different countries: 1) sales data may only cover those drugs that are reimbursed by public insurance schemes; 2) they may be based on ex-factory or wholesale prices rather than retail prices; and 3) sales data may exclude drug consumption in hospitals. Data for the following countries under-estimate pharmaceutical sales reported in this section because of one of these limitations: Australia, Austria, France, Germany, Greece, Japan, Luxembourg, the Netherlands, the Slovak Republic (before 2016) and Spain. (For further information, see the country-specific information below). Please also note that depending on the allocation of pharmaceutical products with more than one use, differences in reporting of specific drugs may occur across countries, thereby affecting the relative size of specific ATC groups. Data should reflect total sales for each drug category, based on
    [Show full text]
  • PRIOR AUTHORIZATION CRITERIA for APPROVAL Initial Evaluation Target Agent(S) Will Be Approved When ONE of the Following Is Met: 1
    Self-Administered Oncology Agents Through Preferred Prior Authorization Program Summary FDA APPROVED INDICATIONS3-104 Please reference individual agent product labeling. CLINICAL RATIONALE For the purposes of the Self -Administered Oncology Agents criteria, indications deemed appropriate are those approved in FDA labeling and/or supported by NCCN Drugs & Biologics compendia with a category 1 or 2A recommendation, AHFS, or DrugDex with level of evidence of 1 or 2A. SAFETY3-104 Agent(s) Contraindication(s) Afinitor/Afinitor Disperz Hypersensitivity to everolimus, to other rapamycin (everolimus) derivatives None Alecensa (alectinib) Alunbrig (brigatinib) None Ayvakit (avapritinib) None Balversa (erdafitinib) None Hypersensitivity to bosutinib Bosulif (bosutinib) Braftovi (encorafenib) None Brukinsa (zanubrutinib) None Cabometyx None (cabozantinib) Calquence None (acalabrutinib) Caprelsa Congenital long QT syndrome (vandetanib) Cometriq None (cabozantinib) Copiktra (duvelisib) None Cotellic (cobimetinib) None Daurismo (glasdegib) None None Erivedge (vismodegib) Erleada (apalutamide) Pregnancy None Farydak (panobinostat) Fotivda (tivozanib) None Gavreto (pralsetinib) None None Gilotrif (afatinib) Gleevec None (imatinib) Hycamtin Severe hypersensitivity to topotecan (topotecan) None Ibrance (palbociclib) KS_PS_SA_Oncology_PA_ProgSum_AR1020_r0821v2 Page 1 of 19 © Copyright Prime Therapeutics LLC. 08/2021 All Rights Reserved Effective: 10/01/2021 Agent(s) Contraindication(s) None Iclusig (ponatinib) Idhifa (enasidenib) None Imbruvica (ibrutinib)
    [Show full text]
  • Refractory Early T-Cell Precursor Acute Lymphoblastic Leukemia
    Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2019 Venetoclax and Bortezomib in Relapsed/Refractory Early T-Cell Precursor Acute Lymphoblastic Leukemia La Starza, Roberta ; Cambò, Benedetta ; Pierini, Antonio ; Bornhauser, Beat ; Montanaro, Anna ; Bourquin, Jean-Pierre ; Mecucci, Cristina ; Roti, Giovanni DOI: https://doi.org/10.1200/PO.19.00172 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-198023 Journal Article Published Version The following work is licensed under a Creative Commons: Attribution 4.0 International (CC BY 4.0) License. Originally published at: La Starza, Roberta; Cambò, Benedetta; Pierini, Antonio; Bornhauser, Beat; Montanaro, Anna; Bourquin, Jean-Pierre; Mecucci, Cristina; Roti, Giovanni (2019). Venetoclax and Bortezomib in Relapsed/Refrac- tory Early T-Cell Precursor Acute Lymphoblastic Leukemia. JCO precision oncology, 3:PO.19.00172. DOI: https://doi.org/10.1200/PO.19.00172 case report Venetoclax and Bortezomib in Relapsed/ Refractory Early T-Cell Precursor Acute Lymphoblastic Leukemia Roberta La Starza, MD, PhD1; Benedetta Cambo,` MD2; Antonio Pierini, MD, PhD1; Beat Bornhauser, PhD3; Anna Montanaro2; Jean-Pierre Bourquin, MD, PhD3; Cristina Mecucci, MD, PhD1; and Giovanni Roti, MD, PhD2 INTRODUCTION CD2, CD4, CD8, and CD1a and positive for human Although in the past three decades we welcomed the leukocyte antigen (HLA-DR), CD38, CD117, CD33, advent of targeted therapies in
    [Show full text]
  • A Phase I Study of Pexidartinib, a Colony-Stimulating Factor 1 Receptor Inhibitor, in Asian Patients with Advanced Solid Tumors
    Investigational New Drugs https://doi.org/10.1007/s10637-019-00745-z PHASE I STUDIES A phase I study of pexidartinib, a colony-stimulating factor 1 receptor inhibitor, in Asian patients with advanced solid tumors Jih-Hsiang Lee1 & Tom Wei-Wu Chen2 & Chih-Hung Hsu2,3 & Yu-Hsin Yen2 & James Chih-Hsin Yang2,3 & Ann-Lii Cheng2,3 & Shun-ichi Sasaki4 & LiYin (Lillian) Chiu5 & Masahiro Sugihara4 & Tomoko Ishizuka4 & Toshihiro Oguma4 & Naoyuki Tajima4 & Chia-Chi Lin2,6 Received: 15 January 2019 /Accepted: 7 February 2019 # The Author(s) 2019 Summary Background Pexidartinib, a novel, orally administered small-molecule tyrosine kinase inhibitor, has strong selectivity against colony- stimulating factor 1 receptor. This phase I, nonrandomized, open-label multiple-dose study evaluated pexidartinib safety and efficacy in Asian patients with symptomatic, advanced solid tumors. Materials and Methods Patients received pexidartinib: cohort 1, 600 mg/d; cohort 2, 1000 mg/d for 2 weeks, then 800 mg/d. Primary objectives assessed pexidartinib safety and tolerability, and determined the recommended phase 2 dose; secondary objectives evaluated efficacy and pharmacokinetic profile. Results All11patients(6males,5 females; median age 64, range 23–82; cohort 1 n = 3; cohort 2 n = 8) experienced at least one treatment-emergent adverse event; 5 experienced at least one grade ≥ 3 adverse event, most commonly (18%) for each of the following: increased aspartate aminotransfer- ase, blood alkaline phosphatase, gamma-glutamyl transferase, and anemia. Recommended phase 2 dose was 1000 mg/d for 2 weeks and800mg/dthereafter.Pexidartinibexposure,areaundertheplasmaconcentration-timecurvefromzeroto8h(AUC0-8h), and maximum observed plasma concentration (Cmax) increased on days 1 and 15 with increasing pexidartinib doses, and time at Cmax (Tmax) was consistent throughout all doses.
    [Show full text]
  • Press Release
    Press Release Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo’s HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201) Collaboration combines Daiichi Sankyo’s scientific and technological excellence with AstraZeneca’s global experience and resources in oncology to accelerate and expand the potential of [fam-] trastuzumab deruxtecan as monotherapy and combination therapy across a spectrum of HER2 expressing cancers AstraZeneca to pay Daiichi Sankyo up to $6.90 billion in total consideration, including $1.35 billion upfront payment and up to an additional $5.55 billion contingent upon achievement of future regulatory and sales milestones as well as other contingencies Companies to share equally development and commercialization costs as well as profits worldwide from [fam-] trastuzumab deruxtecan with Daiichi Sankyo maintaining exclusive rights in Japan Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates; AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia Tokyo, Munich and Basking Ridge, NJ – (March 28, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer. Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.
    [Show full text]
  • Hyperphosphataemia in Adults with Chronic Kidney Disease on Dialysis: Sucroferric Oxyhydroxide
    pat hways Hyperphosphataemia in adults with chronic kidney disease on dialysis: sucroferric oxyhydroxide Evidence summary Published: 6 January 2015 nice.org.uk/guidance/esnm51 Key points from the evidence The content of this evidence summary was up-to-date in January 2015. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Summary Sucroferric oxyhydroxide (Velphoro) is an iron-based phosphate binder. In 1 open-label, randomised controlled trial (RCT), sucroferric oxyhydroxide at a mean dose of 1500 mg iron (3 tablets) per day was non-inferior to sevelamer carbonate at a mean dose of 6.4 g (8 tablets) per day for lowering phosphate levels in adults with chronic kidney disease (CKD) who were on haemodialysis or peritoneal dialysis. More people in the sucroferric oxyhydroxide group withdrew from the study because of adverse events. The most common adverse events with sucroferric oxyhydroxide were gastrointestinal, particularly diarrhoea and discoloured faeces. Regulatory status: Sucroferric oxyhydroxide (Velphoro) is the first iron-based phosphate binder to be licensed in Europe for the control of serum phosphate levels in adults with CKD who are on haemodialysis or peritoneal dialysis. It was launched in the UK in January 2015. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 1 of conditions#notice-of-rights). 22 Hyperphosphataemia in adults with chronic kidney disease on dialysis: sucroferric oxyhydroxide (ESNM51) Effectiveness Safety Sucroferric oxyhydroxide Sucroferric oxyhydroxide is contraindicated in people with at a mean dose of haemochromatosis and any other iron accumulation 1500 mg (3 tablets) per disorder.
    [Show full text]