Complementary and Alternative Therapies
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211855Orig1s000
&(17(5)25'58*(9$/8$7,21$1' 5(6($5&+ APPLICATION NUMBER: 2ULJV 6800$5<5(9,(: Summary Memorandum for Regulato1y Action Summary Memorandum for Regulatory Action Date October 11, 2019 Paul Lee, MD, PhD From Nick Kozauer, MD Subject Summary Memorandum for Regulatory Action NDA/BLA # and Supplement# NDA 211855 under 505(b)(2)1 Applicant Alkermes Date of Submission December 13, 2018 PDUFA Goal Date October 13, 2019 Proprietary Name Vun1erity Established or Proper Name Diroximel fumarate Dosage Form(s) 231 mg delayed release capsules Applicant Proposed VUMERITY is indicated for the treatment of adult patients Indication(s)/Population(s) with relapsing forms of multiple sclerosis The starting dose for VUMERITY is 231 mg twice a day Applicant Proposed Dosing orally. After 7 days, the dose should be increased to 462 Regimen(s) mg (two 231 mg capsules) twice daily orally. Recommendation on Tentative Approval Regulatory Action VUMERITY is indicated for the treatment of adult patients Recommended with relapsing forms of multiple sclerosis (MS), to include Indication(s)/Population(s) (if clinically isolated syndrome, relapsing-remitting disease, applicable) and active secondary progressive d isease, in adults Recommended Dosing Same as proposed Recimen(s) (if applicable) 1The referenced dmg for this 505(b)(2) application is Tecfidera (NDA 204063) Reference ID: 4504909 Summary Memorandum for Regulatory Action 1. Benefit-Risk Assessment The application provides an adequate bridge to Tecfidera, the referenced product for this 505(b)(2) application. Therefore, the previous findings of safety and effectiveness for Tecfidera also apply to Vumerity. 2. Background The applicant seeks approval of Vumerity (diroximel fumarate) using the 505(b)(2) regulatory pathway for monomethyl fumarate (MMF), relying on the previous findings of safety and effectiveness for Tecfidera (dimethyl fumarate [DMF]). -
Oral MS Disease-Modifying Therapies C21142-A
Drug and Biologic Coverage Criteria Effective Date: 05/01/2019 Last P&T Approval/Version: 07/28/2021 Next Review Due By: 08/2022 Policy Number: C21142-A Oral MS Disease-Modifying Therapies PRODUCTS AFFECTED Mayzent (siponimod), Aubagio (teriflunomide), Gilenya (fingolimod), Mavenclad (cladribine), Tecfidera (dimethyl fumarate), Vumerity (diroximel fumarate), Bafiertam (monomethyl fumarate),dimethyl fumarate, Zeposia (ozanimod), Ponvory (ponesimod) COVERAGE POLICY Coverage for services, procedures, medical devices, and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide Molina Healthcare complete medical rationale when requesting any exceptions to these guidelines Documentation Requirements: Molina Healthcare reserves the right to require that additional documentation be made available as part of its coverage determination; quality improvement; and fraud; waste and abuse prevention processes. Documentation required may include, but is not limited to, patient records, test results and credentials of the provider ordering or performing a drug or service. Molina Healthcare may deny reimbursement or take additional appropriate action if the documentation provided does not support the initial determination that the drugs or services were medically necessary, not investigational or experimental, and otherwise within the scope of benefits afforded to the member, and/or the documentation demonstrates a pattern of billing or other practice that is inappropriate or excessive DIAGNOSIS: Multiple Sclerosis REQUIRED MEDICAL INFORMATION: A. -
Multiple Sclerosis
bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Pharmacy Policy Multiple Sclerosis Policy Number: 9.212 Version Number: 2.0 Version Effective Date: 6/1/2021 Product Applicability All Plan+ Products Well Sense Health Plan Boston Medical Center HealthNet Plan New Hampshire Medicaid MassHealth ACO NH Health Protection Program MassHealth MCO 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: Aubagio (teriflunomide) Kesimpta (ofatumumab) Avonex pen (interferon beta-1a) Mayzent (siponimod) Betaseron (interferon beta-1b) Plegridy (peginterferon beta-1a) Dalfampridine ER Rebif (interferon beta-1a) Dimethyl fumarate Tecfidera (dimethyl fumarate) (NF) Gilenya (fingolimod) Vumerity (diroximel fumarate) Glatiramer Zeposia (ozanimod) The Plan may authorize coverage of the above product(s) for members meeting the following criteria: Avonex, Betaseron, glatiramer, Plegridy, Rebif Initial Criteria 1. Member is 18 years of age and older; AND NF = non-formulary + 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. Multiple Scerlosis 2. Diagnosis of relapsing multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; AND 3. Prescribed by or in consultation with a neurologist; AND 4. Will not be used in combination with another MS disease modifying agent; AND 5. Will not be given concurrently with live vaccines; AND 6. -
Shands Confidentiality Agreement
University of Florida College of Medicine – Jacksonville Visiting Student Application Checklist NAME: ROTATION: DATES: HOME SCHOOL: Do you need housing while rotating in Jacksonville? ______ YES ______ NO ***Housing is not guaranteed to visiting students, but we will make every effort to accommodate your request*** EMERGENCY CONTACT INFORMATION Name Phone Address ****Do NOT submit your application until all items have been completed**** Incomplete applications will not be considered – Submission Instructions on page 2 Students: Initial in each blank to certify each document has been completed and included in your application ________ Application for Extramural Course ________ Shands Confidentiality Agreement ________ Required Health Record ________ Parking Application* ________ Liability Confirmation Form ________ Copy of vehicle registration* ________ Background and Drug Screen Affidavit ________ CV/Resume ________ HIPAA Training Certificate ________ USMLE Step 1 Scores (MD/DO only) ________ UF Confidentiality Statement * If you plan to rent a vehicle, you may submit this document at check-in FOR OEA USE ONLY – STUDENTS: DO NOT WRITE BELOW THIS LINE Application Received Sent to Department Contract Obligations Insurance: SIP EX AI Dorm: No Yes / Invoice ________ Enter Applicant in NI ________ Application uploaded to NI ________ Computer access sent to student & coordinator NOTES UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE –JACKSONVILLE APPLICATION FOR EXTRAMURAL COURSE Mail Application to: Medical Student Administrator Office of Educational Affairs Kelsey Kyne (904) 244-5128 [email protected] c/o Student Administrator Medical Student Coordinator 653-1 W. 8th Street, Box L-15 Karen Sisco (904) 244-8233 [email protected] Jacksonville, FL 32209 Fax Numbers (904) 244-8997 OR (904) 244-4771 This form must be filled out completely – no substitute will be accepted – and must include the completed Required Health Record Section (page 2) before any rotation request will be considered. -
On-Demand CME/CE Activities Available International Stroke
7:00 AM 8:00 AM 9:00 AM 10:00 AM 11:00 AM 12:00 PM 1:00 PM 2:00 PM 3:00 PM 4:00 PM 5:00 PM 6:00 PM SCHEDULE-AT-A-GLANCE State-of-the-Science Stroke Nursing Symposium Pre-Conference Symposium I: Stroke in the Real World: Working Man Blues: Challenges in Inpatient Stroke Care Pre-Conference Symposium II (Student/Trainee/ TUES • FEB. 10 Early Career): Emerging Trends for Stroke Trials International Stroke Conference 2015 Symposia Symposia Targeting Spreading Door-to-needle or Depolarizations in Injured Call-to-needle Challenges Brain: Triggers, Modulators across Health Care Symposia Symposia and Causation Systems Problems with STAIRing Down the Barrel Interventions in Acute of a Loaded Research Gun: Cerebral Small Vessel Contralesional Stroke: 7 Little Things Disease in the Community: Hemisphere in Stroke How Useful Are the STAIR PLENARY SESSION I Criteria 15 Years Later? Prevalence, Causes and Recovery: Vascular and Cerebrovascular Vessel PROFESSOR-LED Clinical Relevance Neuronal Perspectives AHA’s CEO Welcome Wall Imaging: State of Improving Stroke Care for the Art Women POSTER TOUR Neuroinflammation and Childhood Stroke: AHA Presidential Cognitive Dysfunction in The Heart of the Matter Address Genetics and Stroke Moyamoaya Disease: SESSIONS Aneurysmal Subarachnoid Outcome Present and Future (60 MINS) Hemorrhage Oral Abstracts Thomas Willis Diagnosis of Stroke Lecture Oral Abstracts Reperfusion: The Latest, Emergency Care/Systems The Present, The Future REGULAR WED • FEB 11 Oral Abstracts Etiology Oral Abstracts I Late-Breaking Oral Abstracts -
Prior Authorization Multiple Sclerosis – Ponvory™ (Ponesimod Tablets)
Cigna National Formulary Coverage Policy Prior Authorization Multiple Sclerosis – Ponvory™ (ponesimod tablets) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 79750 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 2 Revision History ................................................... 2 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. -
Together for a Safe Campus
ANNUAL SECURITY AND FIRE SAFETY REPORT • 2019 TOGETHER FOR A SAFE CAMPUS UF HEALTH JACKSONVILLE CAMPUS • WWW.HSCJ.UFL.EDU Together for a Safe Campus: UF Health Jacksonville he University of Florida Police Department, a State of Florida and Nationally and Internationally accredited T law enforcement agency, was established to provide protection and service to the university community. We are committed to the prevention of crime and the protection of life and property; the preservation of peace, order, and safety; the enforcement of all laws and ordinances; and the safeguarding of your constitutional guarantees. The University of Florida Police Department is staffed by highly trained officers and Police Service Technicians (PSTs) who utilize only the very latest tools in the fight against crime to be better prepared to keep the campus community as safe as possible. The University of Florida has an array of services in place to promote an environment that is as crime-free as possible. We encourage you to familiarize yourself with these services and take advantage of them to help make your educational and living experience at the University of Florida as enjoyable and crime-free as possible. I encourage you to contact our Community Services Division at (352) 392-1409 and visit the department’s web site on-line at http://www.police.ufl.edu for additional information on available programs and services. — Chief Linda J. Stump-Kurnick Contents he UF Health Jacksonville Security Department is the main security provider for the University of Florida 2 Safety and Security a Shared T Health Jacksonville Campus. -
Grants Detail Schedule
THE COMMUNITY FOUNDATION FOR NORTHEAST FLORIDA, INC. EIN: 59-6150746 Tax Year 2019 Form 990, Schedule I, Part II, Line 1, GRANTS AND OTHER ASSISTANCE IN EXCESS OF $5,000 TO GOVERNMENTS AND ORGANIZATIONS IN THE UNITED STATES 1(a) Name and Address of Grantee 1(b) EIN 1 ( C ) IRS Section Amount 1(h) Purpose of Grant 1 100 Black Men of Jacksonville, Inc. P.O. Box 2065 Jacksonville FL 32203 59-3190565 501(c)(3) / 509(a)(2) $9,742.00 for student scholarships support 50 students to attend the "Alabama: Education & History" Spring 2 100 Black Men of Jacksonville, Inc. P.O. Box 2065 Jacksonville FL 32203 59-3190565 501(c)(3) / 509(a)(2) $5,000.00 College tour. 3 100 Black Men of Jacksonville, Inc. P.O. Box 2065 Jacksonville FL 32203 59-3190565 501(c)(3) / 509(a)(2) $2,500.00 support the 2019 Urban Educarion Symposium 4 Adventures in God's Creation Inc. 115 1st Avenue N Jacksonville Beach FL 32250 80-0946172 Church $8,010.53 for general operating support 5 Adventures in God's Creation Inc. 115 1st Avenue N Jacksonville Beach FL 32250 80-0946172 Church $1,000.00 for general operating support 6 African American Mental Health Initiative 4210 Emerald Bay Drive Jacksonville FL 32277 47-4353349 501(c)(3) / 509(a)(1) $5,000.00 for general operating support to support the 2019 Mental Health and Village Talk promoting access to mental 7 African American Mental Health Initiative 4210 Emerald Bay Drive Jacksonville FL 32277 47-4353349 501(c)(3) / 509(a)(1) $3,500.00 health services in the African American community to provide goods and services to elderly person or for their direct benefit in 8 Aging True 4250 Lakeside Drive, Suite 116 Jacksonville FL 32210 59-6161532 501(c)(3) / 509(a)(2) $10,788.00 Duval County 9 Aging True 4250 Lakeside Drive, Suite 116 Jacksonville FL 32210 59-6161532 501(c)(3) / 509(a)(2) $912.75 to support Meals on Wheels 10 All Beaches Experimental Theatre 1015 Atlantic Blvd., #175 Atlantic Beach FL 32233 59-3212409 501(c)(3) / 509(a)(2) $5,200.00 to support the 2020 production of Souvenir 11 All Saints Church of Winter Park 338 E. -
American Association of Critical-Care Nurses Recognizes 208 Hospital Units with Beacon Award for Excellence in 2020
Editorial Contact: Kristie Aylett AACN Communications 228-229-9472 [email protected] American Association of Critical-Care Nurses recognizes 208 hospital units with Beacon Award for Excellence in 2020 State Hospital, Unit, City (Award Level) StateAlabama Mobile Infirmary Medical Center, Neurology Step Down Unit, Mobile (Bronze) Mobile Infirmary Medical Center, Neurology Intensive Care Unit (ICU), Mobile (Bronze) North Baldwin Infirmary, The Birth Center, Bay Minette (Bronze) Arizona HonorHealth John C. Lincoln Medical Center, Specialty Surgical Care Unit, Phoenix (Gold) HonorHealth John C. Lincoln Medical Center, ICU, Phoenix (Silver) California Huntington Memorial Hospital, Critical Care Unit, Pasadena (Silver) Kaiser Permanente, Intermediate Cardiac Surgical Unit, Los Angeles (Gold) Little Company of Mary Hospital, Progressive Care Unit / Step Down Unit, Torrance (Silver) Pomona Valley Hospital Medical Center, Cardiovascular Intensive Care Unit, Pomona (Silver) Sharp Grossmont Hospital, Medical ICU, La Mesa (Gold) Sharp Memorial Hospital, Surgical ICU (2W), San Diego (Gold) St. Jude Medical Center, Critical Care Unit, Fullerton (Silver) UCLA Medical Center, 6ICU - Neuroscience / Trauma ICU, Los Angeles (Silver) UCLA Santa Monica Medical Center, 4MN, Santa Monica (Silver) Colorado Denver Health Medical Center, Surgical ICU, Denver (Silver) Connecticut Hospital of St. Raphael, Medical ICU-SRC, New Haven (Silver) Delaware Christiana Care Health System, Transitional Medical Unit, Newark (Silver) District of Medstar Georgetown University Hospital, C61 Neurosciences and Stroke IMC, Columbia Washington (Gold) Medstar Georgetown University Hospital, C41, Washington (Silver) Florida Baptist Health South Florida, Baptist Health Telehealth Center, Coral Gables (Gold) Baptist Hospital of Miami, Critical Care Center, Miami (Gold) Baptist Hospital of Miami, Neonatal ICU, Miami (Silver) Baptist Medical Center, T4A MSICU, Jacksonville (Silver) Dr. -
5948 6 March 2020 Freedom of Information Request I Am Writing In
Trust Headquarters East Surrey Hospital Canada Avenue Redhill RH1 5RH Tel: 01737 768511 www.surreyandsussex.nhs.uk Our ref: 5948 6 March 2020 Freedom of information request I am writing in response to your request for information which has been handled under the Freedom of Information Act 2000 (FOIA). Could you please provide us with the numbers of patients in relation to the questions mentioned below, for a period of last 12 months: We do not record the number of patients who have attended the trust who have a diagnosis on MS 1. In your trust how many patients have a diagnosis of Multiple Sclerosis (MS), regardless of whether they are currently on treatment? We only record the number of patients who have attended the trust who have a diagnosis but we are unable to tell if they were diagnosed for the first time within this admission. 2. Of these MS patients, how many have been diagnosed with relapsing (RRMS), primary progressive (PPMS) or secondary progressive (SPMS) MS; See above If you do not code your MS patients in this way, do you have plans to do this? RRMS PPMS SPMS Not known 3. How many patients with Multiple Sclerosis have been treated with disease modifying drugs in the past 6 months. Please include all patients whose treatment is ongoing, even those with infrequent dosing schedules (e.g. Lemtrada, Mavenclad, Ocrevus). Please provide the total number of patients by treatment for the following disease modifying drugs: See question 5 below. Aubagio (teriflunomide) Avonex (interferon beta-1a) Betaferon (interferon beta-1b) Brabio (glatiramer acetate) Copaxone (glatiramer acetate) Extavia (beta interferon-1b) Gilenya (fingolimod) Lemtrada (alemtuzumab) Mavenclad (cladribine) Mayzent (siponimod) Ocrevus (ocrelizumab) Plegridy (peginterferon beta-1a) Rebif (beta interferon-1a) Tecfidera (dimethyl fumarate) Tysabri (natalizumab) Vumerity (diroximel fumarate) Zinbryta (daclizumab) Ampyra (fampyra) Ozanimod 4. -
Timeline of Progress in MS Research
Timeline of Progress in MS Research This timeline highlights a selection of major landmarks in research into multiple sclerosis and the launch of programs to propel this research forward. These are only a few of thousands of advances in basic and clinical research that have laid the foundation for the rapid progress we’re seeing today. 1421 First documented case of MS; St. Lidwina of Schiedam 1860-70 First studies of myelin and glial cells in brain tissue 1868 First correlation of MS clinical symptoms with central nervous system pathology; disease named "Sclerose en plaques" by Jean Martin Charcot 1869 First attempts to treat MS with gold chloride, zinc, sulfate, silver nitrate, strychnine and electrical stimulation (by Charcot) 1928 Discovery that myelin is produced by oligodendrocyte glial cells 1933 Acute experimental allergic encephalomyelitis (EAE) developed as model for MS 1936 Discovery that lymphocytes are involved in immune function 1943 First detailed description of the composition of myelin 1946 National MS Society USA Launched 1947 First research grant to Elvin A. Kabat, MD 1950 National Institute of Neurological Diseases founded at National Institutes of Health through the work of the Society 1950 Society funds first major survey of MS in the U.S. and Canada 1954 First Fellowship programs to train MS Scientists offered 1965 Society-convened panel of experts develops precise criteria for diagnosing MS 1969 Society co-funds research of steroid ACTH, which becomes the first drug shown to speed recovery from MS relapses 1974 -
Ponesimod (Ponvory) Reference Number: ERX.SPA.437 Effective Date: 06.01.21 Last Review Date: 05.21 Line of Business: Commercial, Medicaid Revision Log
Clinical Policy: Ponesimod (Ponvory) Reference Number: ERX.SPA.437 Effective Date: 06.01.21 Last Review Date: 05.21 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Ponesimod (Ponvory™) is a sphingosine 1-phosphate receptor modulator. FDA Approved Indication(s) Ponvory is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. Health plan approved formularies should be reviewed for all coverage determinations. Requirements to use preferred alternative agents apply only when such requirements align with the health plan approved formulary. It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Ponvory is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Multiple Sclerosis (must meet all): 1. Diagnosis of one of the following (a, b, or c): a. Clinically isolated syndrome, and member is contraindicated to all, or has experienced clinically significant adverse effects to two, of the following: Aubagio®, glatiramer (Copaxone®, Glatopa®), an interferon-beta agent (Betaseron® or Rebif®); b. Relapsing-remitting MS, and failure of two of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Aubagio®, dimethyl fumarate, Gilenya®, glatiramer (Copaxone®, Glatopa®), an interferon-beta agent (Betaseron® or Rebif®), Kesimpta®, Mayzent®, Ocrevus®, Tysabri®, Vumerity®, Zeposia®;* *Prior authorization is required for all disease modifying therapies for MS.