ESC Prior Authorization Program Drug List
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Oregon Medicaid Pharmaceutical Services Prior Authorization Criteria
Oregon Medicaid Pharmaceutical Services Prior Authorization Criteria HEALTH SYSTEMS DIVISION Prior authorization (PA) criteria for fee-for-service prescriptions for Oregon Health Plan clients March 1, 2021 Contents Contents ................................................................................................................................................................ 2 Introduction........................................................................................................................................................... 7 About this guide ......................................................................................................................................... 7 How to use this guide ................................................................................................................................. 7 Administrative rules and supplemental information .................................................................................. 7 Update information............................................................................................................................................... 8 Effective March 1, 2021 ............................................................................................................................ 8 Substantive updates and new criteria ............................................................................................. 8 Clerical changes ............................................................................................................................ -
Medicines Not Reimbursed Through National Prices and Directly Commissioned by Nhs England V14 Changes to Version 13
MEDICINES NOT REIMBURSED THROUGH NATIONAL PRICES AND DIRECTLY COMMISSIONED BY NHS ENGLAND V14 CHANGES TO VERSION 13 PUBLISHED APRIL 2019 Changes to v13 Lines removed SUITABLE SPECIALIST FOR CENTRE SUITABLE FOR SHARED ONLY SHARED CARE CARE PRIOR (includng WITH PRIMARY BETWEEN STOPPING MONITORING/ AUDIT APPROVAL outreach CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA SPECIALIST COMMENT CRITERIA REQUIREMENTS PROFORMA when SUPPORTED AND REQUIRED delivered as BY LOCAL SECONDARY part of a PRESCRIBING CARE VIA provider COMMITTEE) NETWORK network) MODEL PAEDIATRIC INDICATIONS (IN LINE WITH NHS ENGLAND AS PER ADULT TA'S (TA195, TA373, ABATACEPT NHS ENGLAND CYTOKINE MODULATORS NICE NICE NICE √ MEDICINES FOR CHILDREN TA375) POLICY) Now covered by comment 8 PAEDIATRIC INDICATIONS (IN AS PER TA455 OR ADULT TA'S (TA130 LINE WITH NHS ENGLAND (replaced by TA375), TA143 (repalced by ADALIMUMAB NHS ENGLAND CYTOKINE MODULATORS NICE NICE NICE AUDIT √ √ MEDICINES FOR CHILDREN TA383), TA146, TA187, TA199, TA329, POLICY) TA392, TA460) Now covered by comment 8 ALBUTREPENONACOG ALFA HAEMOPHILIA B PRODUCTS ON CMU Blood factor products simplified NHS ENGLAND BLOOD-RELATED PRODUCTS SSC 1652 SSC 1652 SSC 1652 √ FRAMEWORK to blood factor product VIII etc PAEDIATRIC INDICATIONS (IN LINE WITH NHS ENGLAND AS PER IFR AS PER IFR ANAKINRA NHS ENGLAND CYTOKINE MODULATORS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL √ MEDICINES FOR CHILDREN APPROVAL APPROVAL POLICY) Now covered by comment 8 AS PER BCSH GUIDELINES ANTIHAEMOPHILIC FACTOR/VON -
CDER Breakthrough Therapy Designation Approvals Data As of December 31, 2020 Total of 190 Approvals
CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2020 Total of 190 Approvals Submission Application Type and Proprietary Approval Use Number Number Name Established Name Applicant Date Treatment of patients with previously BLA 125486 ORIGINAL-1 GAZYVA OBINUTUZUMAB GENENTECH INC 01-Nov-2013 untreated chronic lymphocytic leukemia in combination with chlorambucil Treatment of patients with mantle cell NDA 205552 ORIGINAL-1 IMBRUVICA IBRUTINIB PHARMACYCLICS LLC 13-Nov-2013 lymphoma (MCL) Treatment of chronic hepatitis C NDA 204671 ORIGINAL-1 SOVALDI SOFOSBUVIR GILEAD SCIENCES INC 06-Dec-2013 infection Treatment of cystic fibrosis patients age VERTEX PHARMACEUTICALS NDA 203188 SUPPLEMENT-4 KALYDECO IVACAFTOR 21-Feb-2014 6 years and older who have mutations INC in the CFTR gene Treatment of previously untreated NOVARTIS patients with chronic lymphocytic BLA 125326 SUPPLEMENT-60 ARZERRA OFATUMUMAB PHARMACEUTICALS 17-Apr-2014 leukemia (CLL) for whom fludarabine- CORPORATION based therapy is considered inappropriate Treatment of patients with anaplastic NOVARTIS lymphoma kinase (ALK)-positive NDA 205755 ORIGINAL-1 ZYKADIA CERITINIB 29-Apr-2014 PHARMACEUTICALS CORP metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Treatment of relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients NDA 206545 ORIGINAL-1 ZYDELIG IDELALISIB GILEAD SCIENCES INC 23-Jul-2014 for whom rituximab alone would be considered appropriate therapy due to other co-morbidities -
Kaiser Permanente Bernard J. Tyson School of Medicine, Inc. Exclusive Provider Organization (EPO) Student Blanket Health Plan Drug Formulary
Kaiser Permanente Bernard J. Tyson School of Medicine, Inc. Exclusive Provider Organization (EPO) Student Blanket Health Plan Drug Formulary Effective September 1, 2021 Health Plan Products: Kaiser Permanente Bernard J. Tyson School of Medicine, EPO Student Blanket Health Plan offered by Kaiser Permanente Insurance Company For the most current list of covered medications or for help understanding your KPIC insurance plan benefits, including cost sharing for drugs under the prescription drug benefit and under the medical benefit: Call 1-800-533-1833, TTY 711, Monday through Friday, 7 a.m. to 9 p.m. ET Visit kaiserpermanente.org to: • Find a participating retail pharmacy by ZIP code. • Look up possible lower-cost medication alternatives. • Compare medication pricing and options. • Find an electronic copy of the formulary here. • Get plan coverage information. For cost sharing information for the outpatient prescription drug benefits in your specific plan, please visit kp.org/kpic-websiteTBD The formulary is subject to change and all previous versions of the formulary are no longer in effect. Kaiser Permanente Last updated: September 1, 2021 Table of Contents Informational Section...........................................................................................................................................3 ANTIHISTAMINE DRUGS - Drugs for Allergy.....................................................................................................9 ANTI-INFECTIVE AGENTS - Drugs for Infections........................................................................................... -
Recent Advances in Oligonucleotide Therapeutics in Oncology
International Journal of Molecular Sciences Review Recent Advances in Oligonucleotide Therapeutics in Oncology Haoyu Xiong 1, Rakesh N. Veedu 2,3 and Sarah D. Diermeier 1,* 1 Department of Biochemistry, University of Otago, Dunedin 9016, New Zealand; [email protected] 2 Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Perth 6150, Australia; [email protected] 3 Perron Institute for Neurological and Translational Science, Perth 6009, Australia * Correspondence: [email protected] Abstract: Cancer is one of the leading causes of death worldwide. Conventional therapies, including surgery, radiation, and chemotherapy have achieved increased survival rates for many types of cancer over the past decades. However, cancer recurrence and/or metastasis to distant organs remain major challenges, resulting in a large, unmet clinical need. Oligonucleotide therapeutics, which include antisense oligonucleotides, small interfering RNAs, and aptamers, show promising clinical outcomes for disease indications such as Duchenne muscular dystrophy, familial amyloid neuropathies, and macular degeneration. While no approved oligonucleotide drug currently exists for any type of cancer, results obtained in preclinical studies and clinical trials are encouraging. Here, we provide an overview of recent developments in the field of oligonucleotide therapeutics in oncology, review current clinical trials, and discuss associated challenges. Keywords: antisense oligonucleotides; siRNA; aptamers; DNAzymes; cancers Citation: Xiong, H.; Veedu, R.N.; 1. Introduction Diermeier, S.D. Recent Advances in Oligonucleotide Therapeutics in According to the Global Cancer Statistics 2018, there were more than 18 million new Oncology. Int. J. Mol. Sci. 2021, 22, cancer cases and 9.6 million deaths caused by cancer in 2018 [1]. -
2020 Medicaid Preapproval Criteria
2020 Medicaid Preapproval Criteria ABILIFY MAINTENA ................................................................................................................................................................ 10 ACTHAR HP ............................................................................................................................................................................ 11 ACTIMMUNE ......................................................................................................................................................................... 13 ADCIRCA ................................................................................................................................................................................ 14 ADEMPAS .............................................................................................................................................................................. 15 ADENOSINE DEAMINASE (ADA) REPLACEMENT ................................................................................................................... 17 AFINITOR ............................................................................................................................................................................... 18 AFINITOR DISPERZ ................................................................................................................................................................. 19 ALDURAZYME ....................................................................................................................................................................... -
Appraisal of NICE's Cost-Effectiveness Thresholds for Assessing Orphan
Master's Degree Dissertation Appraisal of NICE’s cost-effectiveness thresholds for assessing orphan drugs Author: Ruodan Nan Master's Degree in Health Economics and Pharmacoeconomics UPF Barcelona School of Management Academic Year 2018 – 2021 Mentor: Laura Vallejo 1 Project performed within the framework of the Health Economics and Pharmacoeconomics program taught by Barcelona School of Management, a centre associated with Pompeu Fabra University 2 Abstract A rare disease is one that affects less than 1 in 2,000 in general population, and they are often chronic and life-threatening [1]. Due to the high cost to develop and small market for orphan drugs, historically manufacturers are reluctantly to explore the rare disease therapeutic areas. There is highly unmet need from patients with rare diseases. As the pharmaceutical expenditure rises, governments around the world are increasingly under pressure to contain the costs on drug reimbursement. Meanwhile patients with rare diseases need to be ensured for access to orphan drugs, and the industry needs to be incentivized to innovate. Health technology assessment and reimbursement bodies set out measures and policies for orphan drugs to be given market access. In this literature review, the landscape of health technology appraisals for orphan drugs in England UK is studied. The process for an orphan drug to gain marketing authorisation in the European Union (EU), the methods and criteria that used by National Institute for Health and Care Excellence (NICE) are reviewed. All orphan drugs with marketing authorisations from European Medicine Agency (EMA) are searched from the agency’s online database, whereas each of the authorised orphan drug is searched in NICE’s database for any technology appraisals and recommendations made for the orphan drug. -
Lists of Medicinal Products for Rare Diseases in Europe*
March 2021 Lists of medicinal products for rare diseases in Europe* the www.orpha.net www.orphadata.org General Table of contents PART 1: List of orphan medicinal products in Europe with European orphan designation and European marketing authorization 3 Table of contents 3 Methodology 3 Classification by tradename 5 Annex 1: Orphan medicinal products withdrawn from the European Community Register of orphan medicinal products 22 Annex 2: Orphan medicinal products withdrawn from use in the European Union 31 Classification by date of MA in descending order 33 Classification by ATC category 34 Classification by MA holder 35 PART 2 : 37 List of medicinal products intended for rare diseases in Europe with European marketing authorization without an orphan designation in Europe 37 Table of contents 37 Methodology 37 Classification by tradename 38 Classification by date of MA in descending order 104 Classification by ATC category 106 Classification by MA holder 108 For any questions or comments, please contact us: [email protected] Orphanet Report Series - Lists of medicinal products for rare diseases in Europe. March 2021 http://www.orpha.net/orphacom/cahiers/docs/GB/list_of_orphan_drugs_in_europe.pdf 2 PART 1: List of orphan medicinal products in Europe with European orphan designation and European marketing authorization* Table of contents List of orphan medicinal products in Europe with European orphan designation and European marketing authorisation* 3 Methodology 3 Classification by tradename 5 Annex 1: Orphan medicinal products removed or withdrawn from the European Community Register of orphan medicinal products 22 Annex 2: Orphan medicinal products withdrawn from use in the European Union 31 Classification by date of MA in descending order 33 Classification by ATC category 34 Classification by MA holder 35 Methodology This part of the document provides the list of all orphan with the list of medicinal products that have been granted a medicinal products that have received a European Marketing marketing authorization (http://ec.europa. -
November 2019
PCORI Health Care Horizon Scanning System High Potential Disruption Report November 2019 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, PA-C Kariann Hudson, MEd Marcus Lynch, PhD Misha Mehta, MS Angela Motter, PhD Brian Wilkinson, MA Donna Beales, MLIS Jennifer De Lurio, MS Eloise DeHaan, BS Eileen Erinoff, MSLIS Maria Middleton, MPH Diane Robertson, BA Amy Stone, MLS Kelley Tipton, MPH Rosemary Walker, MLIS Karen Schoelles, MD, SM Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI Institute under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG- 2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the horizon scanning system has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. -
Partnerre Trigger Pharmaceuticals (At 9.3.20) Code Brand Name Generic Name Code Brand Name Generic Name J0800 Acthar®
PartnerRe Trigger Pharmaceuticals (at 9.3.20) Code Brand Name Generic Name Code Brand Name Generic Name J0800 Acthar® ...................... repository corticotropin injection J9176 Empliciti® ..................................................... elotuzumab J9216 Actimmune® .................................interferon gamma-1B J3590 Enspryng® .........................................satralizumab-mwge J9042 Adcetris® ....................................... brentuximab vedotin J9055 Erbitux® ......................................................... cetuximab J7192 Advate® ............................... factor viii recombinant nos J7192 Esperoct® ............................. factor viii recombinant nos J7207 Adynovate® ........... antihemophilia factor viii, pegylated J3590 Evrysdi® ........................................................... risdiplam J7210 Afstyla® ........................... recombinant human factor viii J1428 Exondys 51® .................................................... eteplirsen J1931 Aldurazyme® .................................................. laronidase J0180 Fabrazyme® ............................................ agalsidase beta J8999 Alecensa® .......................................................... alectinib J7198 Feiba NF® .................. anti-inhibitor coagulant complex* J7186 Alphanate®......von willibrand factor complex/antihemophilic J1744 Firazyr® ............................................................. icatibant J7201 Alprolix® ....................................... factor ix recombinant -
Appendix B - Product Name Sorted by Applicant
JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 1 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** 3 ** 3D IMAGING DRUG * 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 3M * 3M CO PERIDEX, CHLORHEXIDINE GLUCONATE * 3M HEALTH CARE INC AVAGARD, ALCOHOL (OTC) DURAPREP, IODINE POVACRYLEX (OTC) 3M HEALTH CARE * 3M HEALTH CARE INFECTION PREVENTION DIV SOLUPREP, CHLORHEXIDINE GLUCONATE (OTC) ** 6 ** 60 DEGREES PHARMS * 60 DEGREES PHARMACEUTICALS LLC ARAKODA, TAFENOQUINE SUCCINATE ** A ** AAA USA INC * ADVANCED ACCELERATOR APPLICATIONS USA INC LUTATHERA, LUTETIUM DOTATATE LU-177 NETSPOT, GALLIUM DOTATATE GA-68 AAIPHARMA LLC * AAIPHARMA LLC AZASAN, AZATHIOPRINE ABBVIE * ABBVIE INC ANDROGEL, TESTOSTERONE CYCLOSPORINE, CYCLOSPORINE DEPAKOTE ER, DIVALPROEX SODIUM DEPAKOTE, DIVALPROEX SODIUM GENGRAF, CYCLOSPORINE K-TAB, POTASSIUM CHLORIDE KALETRA, LOPINAVIR NIASPAN, NIACIN NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE NIMBEX, CISATRACURIUM BESYLATE NORVIR, RITONAVIR SYNTHROID, LEVOTHYROXINE SODIUM ** TARKA, TRANDOLAPRIL TRICOR, FENOFIBRATE TRILIPIX, CHOLINE FENOFIBRATE ULTANE, SEVOFLURANE ZEMPLAR, PARICALCITOL ABBVIE ENDOCRINE * ABBVIE ENDOCRINE INC LUPANETA PACK, LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC * ABBVIE ENDOCRINE INC LUPRON DEPOT, LEUPROLIDE ACETATE LUPRON DEPOT-PED KIT, LEUPROLIDE ACETATE ABBVIE INC * ABBVIE INC DUOPA, CARBIDOPA MAVYRET, GLECAPREVIR NORVIR, RITONAVIR ORIAHNN (COPACKAGED), ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE -
Perioperative Medication Management - Adult/Pediatric - Inpatient/Ambulatory Clinical Practice Guideline
Effective 6/11/2020. Contact [email protected] for previous versions. Perioperative Medication Management - Adult/Pediatric - Inpatient/Ambulatory Clinical Practice Guideline Note: Active Table of Contents – Click to follow link INTRODUCTION........................................................................................................................... 3 SCOPE....................................................................................................................................... 3 DEFINITIONS .............................................................................................................................. 3 RECOMMENDATIONS ................................................................................................................... 4 METHODOLOGY .........................................................................................................................28 COLLATERAL TOOLS & RESOURCES..................................................................................................31 APPENDIX A: PERIOPERATIVE MEDICATION MANAGEMENT .................................................................32 APPENDIX B: TREATMENT ALGORITHM FOR THE TIMING OF ELECTIVE NONCARDIAC SURGERY IN PATIENTS WITH CORONARY STENTS .....................................................................................................................58 APPENDIX C: METHYLENE BLUE AND SEROTONIN SYNDROME ...............................................................59 APPENDIX D: AMINOLEVULINIC ACID AND PHOTOTOXICITY