DOCSLIB.ORG

Prior Authorization Criteria for Approval

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Prior Authorization Criteria for Approval VIRGINIA PREMIER ELITE PLUS PRIOR AUTHORIZATION DETAIL October 1, 2021 GENERAL DISCLAIMER: Virginia Premier does not recognize the use of drug samples to meet clinical criteria requirements for prior drug use for drugs covered under the pharmacy benefit or drugs administered in the physician office or other outpatient setting. A physician’s statement that samples have been used cannot be used as documentation of prior drug use. Non-Preferred products are subject to service authorization which requires trial and failure of two preferred products. Requests for continuing therapy that were approved by a previous Health Plan will be honored for at least 30 days upon receipt of documentation demonstrating that approval. Table of Contents ABACAVIR (GENERIC ZIAGEN) ..................................................................................................................... 12 ABILIFY (ARIPIPRAZOLE) ............................................................................................................................. 12 ABUSE DETERRENT OPIOID (ARYMO, HYSINGLA, MORPHABOND, ZOHYDRO, OXAYDO, EMBEDA, ROXYBOND, XTAMPZA)............................................................................................................... 13 ACNE AGE LIMIT............................................................................................................................................... 15 ACCRUFER (FERRIC MALTOL)...................................................................................................................... 16 ACTEMRA (TOCILIZUMAB) ........................................................................................................................... 16 ACTIQ (FENTANYL CITRATE) LOZENGE .................................................................................................... 17 ACTHAR HP (REPOSITORY CORTICOTROPIN) ........................................................................................ 18 ACZONE (DAPSONE)........................................................................................................................................ 19 ADEMPAS (RIOCIGUAT) ................................................................................................................................. 19 ADHD AGE LIMIT ............................................................................................................................................. 20 AEMCOLO (RIFAMYCIN) ................................................................................................................................. 21 AFINITOR (EVEROLIMUS) ............................................................................................................................. 22 ALFERON N (INTERFERON ALFA-N3)......................................................................................................... 23 ALOXI (PALONOSETRON) .............................................................................................................................. 23 AMITIZA (LUBIPROSTONE) .......................................................................................................................... 24 AMPYRA (DALFAMPRIDINE) ........................................................................................................................ 24 AKLlEF (TRIFAROTENE) ................................................................................................................................ 26 Anti-Migraine Non-preferred (AIMOVIG, EMGALITY 100 MG SYRINGE, NURTEC ODT, REYVOW) .............................................................................................................................................................................. 26 ANTI-MIGRAINE PREFERRED (EMGALITY PEN AND SYRINGE 120 MG, AJOVY, UBRELVY) ........ 27 ANTIPSYCHOTICS < 18 YEARS OF AGE....................................................................................................... 27 ANZEMET (DOLASETRON MESYLATE) VIAL............................................................................................. 28 ARCALYST (RILONACEPT)............................................................................................................................. 28 AREDIA (PAMIDRONATE DISODIUM) ........................................................................................................ 29 ARIKAYCE (AMIKACIN SULFATE)................................................................................................................ 30 ATRIPLA (EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE) ........................ 31 AUBAGIO (TERIFLUNOMIDE) ....................................................................................................................... 31 AURYXIA (FERRIC CITRATE) ........................................................................................................................ 32 AUSTEDO (DEUTETRABENAZINE) .............................................................................................................. 33 AUVI-Q (EPINEPHRINE) ................................................................................................................................. 33 AVASTIN (BEVACIZUMAB) ............................................................................................................................ 34 AVSOLA, REMICADE, INFLECTRA (INFLIXIMAB)..................................................................................... 36 AYVAKIT (AVAPRITINIB) .............................................................................................................................. 37 BANZEL (RUFINAMIDE) ................................................................................................................................. 37 BELBUCA (BUPRENOPRHINE FILM) ........................................................................................................... 38 BEOVU (BROLUCIZUMAB-DBLL) ................................................................................................................. 40 Requests for continuing therapy that were approved by a previous Health Plan will be honored for at least 30 days upon receipt of documentation demonstrating that approval. BONIVA (IBANDRONATE) SYRINGE............................................................................................................ 40 BOTOX (ONABOTULINUMTOXINA) ............................................................................................................ 41 BRUKINSA (ZANUBRUTINIB) ....................................................................................................................... 45 BUPRENORPHINE (GENERIC BUPRENEX, GENERIC SUBUTEX) ........................................................... 45 BUTORPHANOL (GENERIC STADOL) .......................................................................................................... 47 CABENUVA (CABOTEGRAVIR/RILPIVIRINE)......................................................................................................... 47 CABLIVI (CAPLACIZUMAB-yhdp) ................................................................................................................ 48 CALQUENCE (ACALABRUTINIB) .................................................................................................................. 48 CAPLYTA (LUMATEPERONE)........................................................................................................................ 49 CARIMUNE NF (IMMUNE GLOBULIN, HUMAN INTRAVENOUS) ........................................................... 50 CARISOPRODOL TABLET (SOMA) ............................................................................................................... 53 CELEBREX (CELECOXIB) STEP THERAPY .......................................................................................... 53 CHENODAL (CHENODIOL) ............................................................................................................................. 53 CIALIS (TADALAFIL ) 5MG ONLY ................................................................................................................. 54 CIMZIA (CERTOLIZUMAB PEGOL) ............................................................................................................... 54 CINQAIR (RESLIZUMAB) ................................................................................................................................ 57 COMBIVIR (LAMIVUDINE/ZIDOVUDINE) .................................................................................................. 57 COMPLERA (EMTRICITABINE/RILPIVIRINE/TENOFOVIR DISOPROXIL FUMARATE) .................. 58 COMPOUNDED MEDICATIONS ..................................................................................................................... 58 COPEGUS (RIBAVIRIN) ................................................................................................................................... 63 CORLANOR (IVABRADINE)............................................................................................................................ 67 COSENTYX (SECUKINUMAB)......................................................................................................................... 67 CRESEMBA (ISAVUCONAZONIUM)......................................................................................................... 70 CRYSVITA (BUROSUMAB-TWZA) ................................................................................................................ 70 CUMULATIVE MED GREATER
Load more

Recommended publications
  • IDSA Guideline Review
    1 Infectious Diseases Society of America Antimicrobial Resistant Treatment Guidance: Gram- Negative Bacterial Infections A Focus on Extended-Spectrum β-lactamase Producing Enterobacterales (ESBL-E), Carbapenem- Resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with Difficult-to-Treat Resistance (DTR- P. aeruginosa) Guideline Summary by Kendra Suder, PharmD Candidate General Recommendations Considerations for choosing empiric therapy: o Local susceptibility patterns/ antibiogram o Patient’s previous organisms isolated & susceptibility data in the last 6 months o Antibiotic exposure in the last 30 days What if a patient was empirically placed on an antibiotic regimen that is now considered inactive against the organism based on susceptibility data? o If an inactive agent was started empirically for cystitis and patient improves, no change in antibiotic or extension of therapy is necessary o However, for other types of infections, guidelines recommend a change to an active regimen for a full treatment course (dated from the start of active therapy) Extended-Spectrum β-Lactamase-Producing Enterobacterales (ESBL-E) Extended-spectrum β-lactamase o Enzymes that inactivate most penicillins, cephalosporins, and aztreonam o Most commonly produced by Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, and Proteus mirabilis (guideline recommendations refer to ESBL-E infections caused by these organisms) o Most common type in the US is the CTX-M, especially CTX-M-15 In institutions that do not perform ESBL testing, a lack of
    [Show full text]
  • Efficacy and Safety of the MC4R Agonist Setmelanotide in POMC
    Efficacy and Safety of the MC4R Agonist Setmelanotide in POMC Deficiency Obesity: A Phase 3 Trial TT-P-LB-3712 Presenting Author: Karine Clément,1,2 Jesús Argente,3 Allison Bahm,4 Hillori Connors,5 Kathleen De Waele,6 Sadaf Farooqi,7 Gregory Gordon,5 James Swain,8 Guojun Yuan,5 Peter Kühnen9 Peter Kühnen 1Sorbonne Université, INSERM, Nutrition and Obesities Research Unit, Paris, France; 2Assistance Publique Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Nutrition Department, Paris, France; 3Department of Pediatrics & Pediatric Endocrinology, Universidad Autónoma de Madrid University, Madrid, Spain; 4Peel Memorial Hospital, Toronto, Ontario, Canada; 5Rhythm Pharmaceuticals, Inc., Boston, MA; [email protected] 6Ghent University Hospital, Ghent, Belgium; 7Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre, University of Cambridge, Cambridge, United Kingdom; 8HonorHealth Bariatric Center, Scottsdale, AZ; 9Institute for Experimental Pediatric Endocrinology Charité Universitätsmedizin Berlin, Berlin, Germany Summary ¡ In this phase 3 trial, setmelanotide was associated with clinically meaningful weight loss and reduction in hunger scores in individuals with proopiomelanocortin (POMC) or proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency obesity ¡ No new safety concerns emerged, and setmelanotide was generally well tolerated in individuals with POMC or PCSK1 deficiency obesity ¡ Further evaluation of setmelanotide is warranted in other disorders resulting from variants in the central melanocortin pathway that cause impaired melanocortin 4 receptor (MC4R) activation ¡ Participants were instructed to not change their regular diet or exercise regimen Table 1. Baseline Participant Characteristics ¡ During the placebo withdrawal period, participants gained an average of 5.52 kg (n=8), and Introduction participants’ mean “most hunger” score (n=6) increased from 4.87 during the first open-label active Figure 2.
    [Show full text]
  • Efficacy and Safety of the MC4R Agonist Setmelanotide in POMC Deficiency Obesity: a Phase 3 Trial
    Efficacy and Safety of the MC4R Agonist Setmelanotide in POMC Deficiency Obesity: A Phase 3 Trial Karine Clément,1,2 Jesús Argente,3 Allison Bahm,4 Hillori Connors,5 Kathleen De Waele,6 Sadaf Farooqi,7 Greg Gordon,5 James Swain,8 Guojun Yuan,5 Peter Kühnen9 1Sorbonne Université, INSERM, Nutrition and Obesities Research Unit, Paris, France; 2Assistance Publique Hôpitaux de Paris, Pitié- Salpêtrière Hospital, Nutrition Department, Paris, France; 3Department of Pediatrics & Pediatric Endocrinology Universidad Autónoma de Madrid University, Madrid, Spain; 4Peel Memorial Hospital, Toronto, Canada; 5Rhythm Pharmaceuticals, Inc., Boston, MA; 6Ghent University Hospital, Ghent, Belgium; 7Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre, University of Cambridge, Cambridge, United Kingdom; 8HonorHealth Bariatric Center, Scottsdale, AZ; 9Institute for Experimental Pediatric Endocrinology Charité Universitätsmedizin Berlin, Berlin, Germany Melanocortin Signaling Is Crucial for Regulation of Body Weight1,2 • Body weight is regulated by the hypothalamic central melanocortin pathway • In response to leptin signaling, POMC is produced in POMC neurons and is cleaved by protein convertase subtilisin/kexin type 1 into α-MSH and β-MSH • α-MSH and β-MSH bind to the MC4R, which decreases food intake and increases energy expenditure, thereby promoting a reduction in body weight Hypothalamus AgRP/NPY Neuron LEPR Hunger AgRP Food Intake ADIPOSE Weight TISSUE MC4R- Energy Expressing Expenditure MC4R Neuron LEPTIN PCSK1 BLOOD-BRAIN BARRIER POMC α-MSH LEPR POMC Neuron AgRP, agouti-related protein; LEPR, leptin receptor; MC4R, melanocortin 4 receptor; MSH, melanocyte-stimulating hormone; NPY, neuropeptide Y; PCSK1, proprotein convertase subtilisin/kexin type 1; POMC, proopiomelanocortin. 2 1. Yazdi et al.
    [Show full text]
  • Obesity Pharmacotherapy: Options and Applications in Clinical Practice
    Obesity Pharmacotherapy: Options and Applications in Clinical Practice Scott Kahan, MD, MPH Obesity Pharmacotherapy • Few providers prescribe pharmacotherapy. • Few patients use pharmacotherapy. • Pharmacotherapy can be extremely effective but also misused, overused, or underused. • Patients respond differently to each medication. • Combining therapeutic options significantly improves weight loss and other outcomes. • Pharmacotherapy can be effective for weight maintenance, not just weight loss. Few Eligible Patients Use Obesity Pharmacotherapy 2 1.8 1.6 1.4 1.3 1.2 1 0.9 0.8 0.7 0.6 0.6 0.4 12 months after the index date, % 0.2 0.2 Use of pharmacotherapy for weight loss within 0 >27‐<30 >30‐<35 >35‐<40 >40 Overall Body mass index at index (kg m2) Zhang S, et al. Obesity Science & Practice.2016;2:104-114. FDA-approved Pharmacotherapy Options for the Treatment of Obesity • Phentermine and other noradrenergic agents • Orlistat • Phentermine/topiramate ER • Lorcaserin • Naltrexone SR/bupropion SR • Liraglutide 3.0mg ER = extended release; SR = sustained release. Phentermine • Sympathomimetic amine, NE release • Blunts appetite • Approved in 1959 for short-term use, schedule IV • Dosing: 8 to 37.5 mg qAM; use lowest effective dose • Contraindications: pregnancy, nursing, MAOIs, glaucoma, drug abuse history, hyperthyroidism • Relative contraindications: uncontrolled hypertension, tachycardia, history of CAD, CHF, stroke, arrhythmia • Warnings: primary pulmonary hypertension, valvular heart disease, tolerance, risk of abuse, concomitant use with alcohol CAD = coronary artery disease; CHF = congestive heart failure; HTN = hypertension; MAOIs = monoamine oxidase inhibitors; NE = norepinephrine. Phentermine [package insert]. Cranford, NJ: Alpex Pharma SA; 2011; Munro JF, et al. Br Med J.
    [Show full text]
  • Neuromyelitis Optica Spectrum Disorder
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 Drug Class Review with New Drug Evaluation: Biologics for Autoimmune Disorders-Neuromyelitis Optica Spectrum Disorder Date of Review: April 2021 Date of Last Review: n/a Dates of Literature Search: 1/1/1996 – 1/20/2021 Generic Name: Brand Name (Manufacturer): Eculizumab Soliris® (Alexion Pharmaceuticals) Inebilizumab-cdon Uplizna™ (Viela Bio) Satralizumab-mwge Enspryng™ (Genentech/Roche) Dossiers Received: Yes Current Status of PDL Class: See Appendix 1. Purpose for Class Update: To define place in therapy for 3 immunosuppressive agents, eculizumab, inebilizumab-cdon, and satralizumab-mwge, recently approved by the Food and Drug Administration (FDA) for the treatment adults with neuromyelitis optica spectrum disorder (NMOSD). Research Questions: 1. What is the effectiveness of eculizumab, inebilizumab, and satralizumab in reducing time to relapse in adult patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody positive? 2. What are the harms of eculizumab, inebilizumab-cdon and satralizumab in adults with NMOSD? 3. Is there comparative evidence that eculizumab, inebilizumab, and satralizumab differ in efficacy or harms for management of NMOSD? 4. Are there certain sub-populations (based on age, gender, ethnicity, comorbidities, disease duration or severity) in which eculizumab, inebilizumab, or satralizumab may be beneficial
    [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]
  • Recarbrio, INN-Imipenem / Cilastatin / Relebactam
    EMA/572792/2020 EMEA/H/C/004808 Recarbrio (imipenem / cilastatin / relebactam) An overview of Recarbrio and why it is authorised in the EU What is Recarbrio and what is it used for? Recarbrio is an antibiotic for treating adults with the following infections: • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught while on a ventilator, which is a machine that helps a patient to breathe); • infection that has spread into the blood (bacteraemia) as a likely complication of hospital-acquired pneumonia or ventilator-associated pneumonia; • infections caused by bacteria classed as aerobic Gram-negative bacteria when other treatments might not work. Official guidance on the appropriate use of antibiotics should be considered when using the medicine. Recarbrio contains the active substances imipenem, cilastatin and relebactam. How is Recarbrio used? Recarbrio can only be obtained with a prescription and it should be used only after consulting a doctor with experience of managing infectious diseases. Recarbrio is given by infusion (drip) into a vein over 30 minutes. It is given every 6 hours for 5 to 14 days, depending on the nature of the infection. For more information about using Recarbrio, see the package leaflet or contact your doctor or pharmacist. How does Recarbrio work? One of the active substances in Recarbrio, imipenem, kills bacteria and the other two, cilastatin and relebactam, increase imipenem’s effectiveness in different ways. Imipenem interferes with bacterial proteins that are important for building the bacterial cell wall. This results in defective cell walls that collapse and cause the bacteria to die.
    [Show full text]
  • Neuromyelitis Optica News
    Neuromyelitis Optica News Gloria von Geldern, MD Assistant Professor of Neurology University of Washington Multiple Sclerosis Center Multiple Sclerosis Regional Summit June 13, 2020 Disclosures ▪ No conflict of interest ▪ Off-label treatments will be mentioned Current research funding Patient-Centered Outcomes Research Institute (PCORI) What is New in NMO? Natalia Rost, MD Chair scientific committee AAN Neuromyelitis Optica (NMO) Neuromyelitis Optica Spectrum Disease (NMOSD) ▪ Inflammatory disorder of the central nervous system ▪ Predominantly involving optic nerves and spinal cord ▪ Severe demyelination and axonal damage ▪ Rare disease: 0.5-10/100,000, ~8,000 patients in the US ▪ Black > Asian > White ▪ Female > Male Flanagan et al., 2016 Bukhari et al. 2017 Hor et al. 2018 (Guthy-Jackson Charitable Foundation) Multiple Sclerosis vs NMO Pittock and Lucchinetti 2016 History 1894: Clinical case descriptions 2004: AQP4 antibody identified by Devic and Gault by Lennon, Weinshenker et al. Eugene Devic (1858–1930) Lancet2004; 364: 2106–12; Journal of Neuroinflammation 2013, 10:8 Diagnostic Criteria Wingerchuk et al. 2015 Myelin Oligodendrocyte (MOG) Antibody ▪ More common in men and whites ▪ Bilateral optic neuritis, caudal myelitis ▪ Better recovery compared to AQP4-Ab pos NMO ▪ MRI brain without NMO findings ▪ Assay now commercially available at Mayo Sato et al. 2014; van Pelt et al. 2016 Auto-Antibody to Aquaporin 4 Water channel protein in ▪ Astrocytic foot processes at the blood-brain barrier ▪ Spinal cord grey matter ▪ Periaqueductal and periventricular regions ▪ Mueller cells in the retina Amiry-Moghaddam and Otterson 2003 Bystander Oligodendrocyte Injury Tradtrantip et al 2017 Pathology Extensive demyelination Perivascular & parenchymal Complement activation Axonal injury, necrosis eosinophils & granulocytes rosette and rim pattern Jacob et al.
    [Show full text]
  • New Β-Lactamase Inhibitor Combinations: Options for Treatment; Challenges for Testing
    MEDICAL/SCIENTIFIC AffAIRS BULLETIN New β-lactamase Inhibitor Combinations: Options for Treatment; Challenges for Testing Background The β-lactam class of antimicrobial agents has played a crucial role in the treatment of infectious diseases since the discovery of penicillin, but β–lactamases (enzymes produced by the bacteria that can hydrolyze the β-lactam core of the antibiotic) have provided an ever expanding threat to their successful use. Over a thousand β-lactamases have been described. They can be divided into classes based on their molecular structure (Classes A, B, C and D) or their function (e.g., penicillinase, oxacillinase, extended-spectrum activity, or carbapenemase activity).1 While the first approach to addressing the problem ofβ -lactamases was to develop β-lactamase stable β-lactam antibiotics, such as extended-spectrum cephalosporins, another strategy that has emerged is to combine existing β-lactam antibiotics with β-lactamase inhibitors. Key β-lactam/β-lactamase inhibitor combinations that have been used widely for over a decade include amoxicillin/clavulanic acid, ampicillin/sulbactam, and pipercillin/tazobactam. The continued use of β-lactams has been threatened by the emergence and spread of extended-spectrum β-lactamases (ESBLs) and more recently by carbapenemases. The global spread of carbapenemase-producing organisms (CPOs) including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii, limits the use of all β-lactam agents, including extended-spectrum cephalosporins (e.g., cefotaxime, ceftriaxone, and ceftazidime) and the carbapenems (doripenem, ertapenem, imipenem, and meropenem). This has led to international concern and calls to action, including encouraging the development of new antimicrobial agents, enhancing infection prevention, and strengthening surveillance systems.
    [Show full text]
  • AMEG Categorisation of Antibiotics
    12 December 2019 EMA/CVMP/CHMP/682198/2017 Committee for Medicinal Products for Veterinary use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Categorisation of antibiotics in the European Union Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 29 October 2018 Adopted by the CVMP for release for consultation 24 January 2019 Adopted by the CHMP for release for consultation 31 January 2019 Start of public consultation 5 February 2019 End of consultation (deadline for comments) 30 April 2019 Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 19 November 2019 Adopted by the CVMP 5 December 2019 Adopted by the CHMP 12 December 2019 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Categorisation of antibiotics in the European Union Table of Contents 1. Summary assessment and recommendations .......................................... 3 2. Introduction ............................................................................................ 7 2.1. Background ........................................................................................................
    [Show full text]
  • HY 2021 Results
    Roche HY 2021 results Basel, 22 July 2021 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected.
    [Show full text]
  • Biologic Immunomodulators Pa Summary
    GEORGIA MEDICAID FEE-FOR-SERVICE BIOLOGIC IMMUNOMODULATORS PA SUMMARY Preferred Non-Preferred Arcalyst (rilonacept) Actemra Subcutaneous (tocilizumab) Benlysta subcutaneous (belimumab) Cimzia (certolizumab) Enbrel (etanercept) Cosentyx (secukinumab) Humira (adalimumab) Dupixent (dupilumab) Ilaris (canakinumab) Enspryng (satralizumab-mwge) Xeljanz (tofacitinib) Fasenra Pen (benralizumab autoinjector) Xeljanz XR (tofacitinib extended-release) Kevzara (sarilumab) Kineret (anakinra) Nucala Pen (mepolizumab autoinjector) Olumiant (baricitinib) Orencia Subcutaneous (abatacept) Otezla (apremilast) Rinvoq (upadacitinib) Siliq (brodalumab) Simponi (golimumab) Stelara (ustekinumab) Skyrizi (risankizumab) Taltz (ixekizumab) Tremfya (guselkumab) The drug names above include all available oral or subcutaneous formulations under the same primary name. LENGTH OF AUTHORIZATION: Varies NOTES: ▪ All preferred and non-preferred products require prior authorization. Intravenous (IV) formulations of the biologic immunomodulators are not covered under Pharmacy Services. ▪ The criteria details below are for the outpatient pharmacy program. If a medication is being administered in a physician’s office or clinic, then the medication must be billed through the DCH physician services program and not the outpatient pharmacy program. Information regarding the physician services program is located at www.mmis.georgia.gov. PA CRITERIA: Actemra Subcutaneous ❖ Approvable for members 2 years of age or older with a diagnosis of moderately to severely active polyarticular
    [Show full text]