Amgen 2010 Annual Report and Financial Summary
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Specialty Drug List 10-22-12 Final
Iowa Medicaid Specialty Drug List Effective 10/22/2012 “Specialty” drugs include biological drugs, blood-derived products, complex molecules, and select oral, injectable, and infused medications identified by the Department and reimbursed at AWP-17% plus the dispensing fee. Specialty pricing will be applied to both the brand and generic drug products. NOTE: See the PDL at www.iowamedicaidpdl.com for specific PA criteria for the following drugs. BRAND NAME GENERIC NAME AGENTS FOR GAUCHER DISEASE ELELYSO taliglucerase alfa VPRIV velaglucerase alfa ALS RILUTEK riluzole ALCOHOL DEPENDENCE VIVITROL naltrexone AMINOGLYCOSIDES TOBI tobramycin ANTI-ASTHMATICS ALPHA PROTEINASE INHIBITORS ARALAST proteinase inhibitor ARALAST NP proteinase inhibitor PROLASTIN, C proteinase inhibitor ZEMAIRA alpha-1 proteinase inhibitor ANTIASTHMATIC - BETA - ADRENERGICS BRETHINE INJECTION turbutaline sulfate ANTIASTHMATIC - HYDRO-LYTIC ENZYMES KALYDECO ivacaftor ANTIBIOTICS - MISC. CAYSTON aztreonam lysine for inhal soln ANTI-CATAPLECTIC AGENTS XYREM sodium oxybate oral solution ANTICOAGULANTS ARIXTRA fondaparinux sodium FRAGMIN dalteparin sodium INNOHEP tinzaparin sodium LOVENOX enoxaparin sodium ANTICONVULSANTS SABRIL vigabatrin ANTIDOTES FERRIPROX deferiprone ANTIDOTES - CHELATING AGENTS CHEMET succimer EXJADE deferasirox tab for oral susp Page 1 of 10 ANTIEMETIC - TETRAHYDROCANNABINOL (THC) DERIVATIVES MARINOL dronabinol ANTIFUNGALS - ASSORTED AMBISOME amphotericin B Liposome IV for suspension ANCOBON flucytosine CANCIDAS caspofungin acetate for IV solution -
September 11, 2018 DUR Minutes
Maine Department of Health and Human Services PAUL R. LEPAGE MaineCare Services BETHANY L. HAMM GOVERNOR Pharmacy Unit ACTING COMMISSIONER 11 State House Station Augusta, Maine 04333-0011 TO: Maine Drug Utilization Review Board DATE: 9/14/2018 RE: Maine DUR Board Meeting minutes from September 11, 2018 ATTENDANCE PRESENT ABSENT EXCUSED Linda Glass, MD X Lisa Wendler, Pharm. D., Clinical Pharmacy Specialist, X Maine Medical CTR Mike Antoniello, MD X Kathleen Polonchek, MD X Kenneth McCall, PharmD X Steve Diaz, MD X Erin Ackley, PharmD. X Corinn Martineau, PharmD. X Non –Voting Mike Ouellette, R.Ph., Change Healthcare X Jeffery Barkin, MD, Change Healthcare X Christopher Pezzullo, State Health Officer DHHS, DO X Jill Kingsbury, MaineCare Pharmacy Director X Guests of the Board: Ed Bosshart, PharmD, Jeff Caulfield, Lead Epidemiologist for Viral Infections from CDC: Discussed HCV treatment. CALL TO ORDER: 5:30PM Jill Kingsbury called the meeting to order at 5:30 PM. PUBLIC COMMENTS Robert Mead from Pfizer: Highlighted the attributes of Retacrit. Jane Guo from Otsuka: Highlighted the attributes of Jynarque. OLD BUSINESS DUR MINUTES The June DUR meeting minutes were accepted as written. MAINECARE UPDATE No update at this time. NEW BUSINESS INTRODUCTION: USE OF CHRONIC TRIPTANS The use of triptans has become standard of care for the treatment of acute migraine headaches, given their effectiveness, safety and tolerability. However, like many medications used to treat migraine, overuse renders them less effective. Additionally, rebound headaches from triptan overuse is common. For patients who experience frequent headaches, or whose headaches are long lasting or chronic, use of headache prophylactic medications are recommended by several medical associations, including the American Headache Society and the American Academy of Neurology. -
Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
The Role of Biological Therapy in Metastatic Colorectal Cancer After First-Line Treatment: a Meta-Analysis of Randomised Trials
REVIEW British Journal of Cancer (2014) 111, 1122–1131 | doi: 10.1038/bjc.2014.404 Keywords: colorectal; biological; meta-analysis The role of biological therapy in metastatic colorectal cancer after first-line treatment: a meta-analysis of randomised trials E Segelov1, D Chan*,2, J Shapiro3, T J Price4, C S Karapetis5, N C Tebbutt6 and N Pavlakis2 1St Vincent’s Clinical School, University of New South Wales, Sydney, NSW 2052, Australia; 2Royal North Shore Hospital, St Leonards, Sydney, NSW 2065, Australia; 3Monash University and Cabrini Hospital, Melbourne, VIC 3800, Australia; 4The Queen Elizabeth Hospital and University of Adelaide, Woodville South, SA 5011, Australia; 5Flinders University and Flinders Medical Centre, Flinders Centre for Innovation in Cancer, Bedford Park, SA, 5042, Australia and 6Austin Health, VIC 3084, Australia Purpose: Biologic agents have achieved variable results in relapsed metastatic colorectal cancer (mCRC). Systematic meta-analysis was undertaken to determine the efficacy of biological therapy. Methods: Major databases were searched for randomised studies of mCRC after first-line treatment comparing (1) standard treatment plus biologic agent with standard treatment or (2) standard treatment with biologic agent with the same treatment with different biologic agent(s). Data were extracted on study design, participants, interventions and outcomes. Study quality was assessed using the MERGE criteria. Comparable data were pooled for meta-analysis. Results: Twenty eligible studies with 8225 patients were identified. The use of any biologic therapy improved overall survival with hazard ratio (HR) 0.87 (95% confidence interval (CI) 0.82–0.91, Po0.00001), progression-free survival (PFS) with HR 0.71 (95% CI 0.67–0.74, Po0.0001) and overall response rate (ORR) with odds ratio (OR) 2.38 (95% CI 2.03–2.78, Po0.00001). -
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Activating Death Receptor DR5 As a Therapeutic Strategy for Rhabdomyosarcoma
International Scholarly Research Network ISRN Oncology Volume 2012, Article ID 395952, 10 pages doi:10.5402/2012/395952 Review Article Activating Death Receptor DR5 as a Therapeutic Strategy for Rhabdomyosarcoma Zhigang Kang,1, 2 Shi-Yong Sun,3 and Liang Cao1 1 Genetics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA 2 Laboratory of Proteomics and Analytical Technologies, SAIC-Frederick, Inc., NCI Frederick, Frederick, MD 21702, USA 3 Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA 30322, USA Correspondence should be addressed to Liang Cao, [email protected] Received 4 January 2012; Accepted 24 January 2012 Academic Editors: E. Boven and S. Mandruzzato Copyright © 2012 Zhigang Kang et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in children. It is believed to arise from skeletal muscle progenitors, preserving the expression of genes critical for embryonic myogenic development such as MYOD1 and myogenin. RMS is classified as embryonal, which is more common in younger children, or alveolar, which is more prevalent in elder children and adults. Despite aggressive management including surgery, radiation, and chemotherapy, the outcome for children with metastatic RMS is dismal, and the prognosis has remained unchanged for decades. Apoptosis is a highly regulated process critical for embryonic development and tissue and organ homeostasis. Like other types of cancers, RMS develops by evading intrinsic apoptosis via mutations in the p53 tumor suppressor gene. -
TEXAS MEDICAID Clinical Edit Prior Authorization Epoetin Alfa (PROCRIT)
TEXAS MEDICAID Clinical Edit Prior Authorization epoetin alfa (PROCRIT) STEP 1: CLEARLY PRINT AND COMPLETE TO EXPEDITE PROCESSING Date: Prescriber First & Last Name: Patient First & Last Name: Prescriber NPI: Patient Address: Prescriber Address: Patient ID: Prescriber Phone: Patient Date of Birth: Prescriber Fax: STEP 2: MEDICATION INFORMATION Medication Requested (Name): Quantity Requested: Dose Requested: Dosing Instructions: Patient’s Primary Diagnosis: ____________________________________ ICD 10 Code: __________ Please indicate ONE (1) of the following: OR STAR / STAR KIDS client (Go to Step 3 - PDL PA Criteria Applies) OR CHIP / PERINATE client (Go to Step 4) STEP 3: PDL PRIOR AUTHORIZATION CRITERIA FOR NON-PREFERRED PRODUCT 1. Has the client failed a 30-day treatment trial with at least 1 preferred agent in the last 180 days? Yes (Go to Step 4 Question 1) No (Go to #2) 2. Is there a documented allergy or contraindication to preferred agents in this class? Yes (Go to Step 4 Question 1) No (Go to #3) 3. Is the drug necessary for treatment of stage-4 advanced metastatic cancer and associated conditions? Yes (Go to Step 4 Question 1) No (Deny) Rev. 11/18/2020 Page 1 of 3 Version 1.5 STEP 4: CLINICAL PRIOR AUTHORIZATION CRITERIA 1. Does the client have a diagnosis of chronic renal failure in the last 730 days? Yes (Go to #7) No (Go to #2) 2. Does the client have a diagnosis of cancer in the last 730 days? Yes (Go to #3) No (Go to #5) 3. Does the client have a history of an antineoplastic agent in the last 30 days? Examples of antineoplastic -
Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix
United States International Trade Commission Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix USITC Publication 4208 December 2010 U.S. International Trade Commission COMMISSIONERS Deanna Tanner Okun, Chairman Irving A. Williamson, Vice Chairman Charlotte R. Lane Daniel R. Pearson Shara L. Aranoff Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix Publication 4208 December 2010 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 15, 2010, set forth at the end of this publication, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the United States International Trade Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement changes to the Pharmaceutical Appendix, effective on January 1, 2011. Table 1 International Nonproprietary Name (INN) products proposed for addition to the Pharmaceutical Appendix to the Harmonized Tariff Schedule INN CAS Number Abagovomab 792921-10-9 Aclidinium Bromide 320345-99-1 Aderbasib 791828-58-5 Adipiplon 840486-93-3 Adoprazine 222551-17-9 Afimoxifene 68392-35-8 Aflibercept 862111-32-8 Agatolimod -
Myelodysplastic Syndromes
MYELODYSPLASTIC SYNDROMES TREATMENT REGIMENS (Part 1 of 3) Clinical Trials: The National Comprehensive Cancer Network recommends cancer patient participation in clinical trials as the gold standard for treatment. Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies. These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. First-Line Treatment1 Note: All recommendations are Category 2A unless otherwise indicated. Relatively Lower-Risk Patientsa,b Symptomatic Anemia With del(5q) ± One Other Cytogenetic Abnormality (except those involving chromosome 7) REGIMEN DOSING Lenalidomide2-5,c Days 1–21: Lenalidomide 10mg orally once daily. Repeat cycle every 28 days (or 28 days monthly). Assess response 2–4 months after initiation of treatment. -
UWHC Guidelines for the Use of Darbepoetin and Epoetin
Use of Darbepoetin and Epoetin in Non-Nephrology Patients – Adult/Pediatric – Inpatient/Ambulatory Clinical Practice Guideline Table of Contents Executive Summary ......................................................................................... 3 Scope ............................................................................................................. 7 Methodology ................................................................................................... 7 Definitions (optional): ...................................................................................... 8 Introduction.................................................................................................... 8 Recommendations........................................................................................... 9 UW Health Implementation............................................................................ 19 References ................................................................................................... 19 Note: Active Table of Contents Click to follow link CPG Contact for Changes: Name: Philip Trapskin, PharmD, BCPS, Manager, DPP Phone Number: 608-263-1328 Email address: [email protected] CPG Contact for Content: Name: Jason Bergsbaken, PharmD Phone Number: 608-265-0341 Email address: [email protected] Copyright © 2015 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 07/2015 Guideline Authors: Jason Bergsbaken, PharmD Coordinating -
Dr. Winegarden Presentation
Empowering Market Competition through Biosimilars Presentation to National Council of Insurance Legislators (NCOIL) 2019 Summer Meeting Newport Beach, California July 12, 2019 Total Savings (in millions) 25% 50% 75% Originator Total Annual Savings for Current, 25%, Drug Class Current Biosimilar Biosimilar Biosimilar Biologic 50%, and 75% Biosimilar Share Share Share Share Scenarios Compared to All-Originator Infliximab Remicade $79.4 $318.2 $636.5 $954.7 Biologic Baseline Pegfilgrastim Neulasta $21.8 $121.9 $243.8 $365.7 Filgrastim Neupogen $152.1 $152.1 $152.1 $206.8 Epoetin Alfa Epogen & Procrit $0.5 $8.4 $16.9 $25.3 Bevacizumab Avastin $0.0 $199.2 $398.5 $597.7 Trastuzumab Herceptin $0.0 $208.0 $415.9 $623.9 • Biosimilars price discounts expected 30% - Rituxumab Rituxan $0.0 $280.6 $561.2 $841.8 40% off originator biologic Etanercept Enbrel $0.0 $324.0 $648.0 $972.1 • Forthcoming study estimates possible Adalimunab Humira $0.0 $861.1 $1,722.1 $2,583.2 health care savings from wider adoption of biosimilars. GRAND TOTAL $253.8 $2,473.6 $4,795.0 $7,171.2 • Estimates are based on the average sales price (ASP) data that are effective from April 2019 through June 2019 and rolling 12-month volume data through February 2019. Biosimilars have no “clinically meaningful difference” in safety, purity, • Methodology: compare potential savings to hypothetical all-originator biologic scenario and effectiveness relative to its reference originator biologic. Just like • Over 10 years, potential savings of $24.7 generic medicines, the benefits of biosimilars are the substantial price billion, $48.0 billion, and $71.7 billion respectively. -
Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy
cancers Review Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy Laura Boyero 1 , Amparo Sánchez-Gastaldo 2, Miriam Alonso 2, 1 1,2,3, , 1,2, , José Francisco Noguera-Uclés , Sonia Molina-Pinelo * y and Reyes Bernabé-Caro * y 1 Institute of Biomedicine of Seville (IBiS) (HUVR, CSIC, Universidad de Sevilla), 41013 Seville, Spain; [email protected] (L.B.); [email protected] (J.F.N.-U.) 2 Medical Oncology Department, Hospital Universitario Virgen del Rocio, 41013 Seville, Spain; [email protected] (A.S.-G.); [email protected] (M.A.) 3 Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), 28029 Madrid, Spain * Correspondence: [email protected] (S.M.-P.); [email protected] (R.B.-C.) These authors contributed equally to this work. y Received: 16 November 2020; Accepted: 9 December 2020; Published: 11 December 2020 Simple Summary: Immuno-oncology has redefined the treatment of lung cancer, with the ultimate goal being the reactivation of the anti-tumor immune response. This has led to the development of several therapeutic strategies focused in this direction. However, a high percentage of lung cancer patients do not respond to these therapies or their responses are transient. Here, we summarized the impact of immunotherapy on lung cancer patients in the latest clinical trials conducted on this disease. As well as the mechanisms of primary and acquired resistance to immunotherapy in this disease. Abstract: After several decades without maintained responses or long-term survival of patients with lung cancer, novel therapies have emerged as a hopeful milestone in this research field.