DOCSLIB.ORG

Benlysta® (Belimumab) Prior Authorization With

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Benlysta® (Belimumab) Prior Authorization With Benlysta® (belimumab) Prior Authorization with Quantity Limit Program Summary Benlysta® (belimumab) Prior Authorization with Quantity Limit TARGET AGENT Benlysta® (belimumab) Brand (generic) GPI Multisource Quantity Limit Code Benlysta (belimumab) 120 mg vial 99422015002120 M, N, O, or Y N/A 400 mg vial 99422015002140 M, N, O, or Y N/A 200 mg/mL autoinjector 9942201500D520 M, N, O, or Y 4 prefilled autoinjectors/ 28 days 200 mg/mL prefilled 9942201500E520 M, N, O, or Y 4 prefilled syringes/ 28 days syringe PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Initial Evaluation Target Agent will be approved when ALL of the following are met: 1. ONE of the following: A. Information has been provided indicating that the patient is currently being treated with the requested agent within the past 90 days OR B. The prescriber states that the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR C. The patient has a diagnosis of active systemic lupus erythematosus (SLE) disease AND ALL of the following: i. The patient has a history of positive antinuclear antibody (ANA) results AND ii. The patient has a SLE additive diagnostic criteria score >10 AND iii. ONE of the following: a. BOTH of the following: a. The patient has tried and had an inadequate response to TWO of the following: corticosteroids, hydroxychloroquine, and/or immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) AND b. The patient is currently being treated with at least ONE of the following: corticosteroids, hydroxychloroquine, and/or immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) OR b. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following: corticosteroids, Boeing_PS_Benlysta_PAQL_ProgSum_0121 Page 1 of 4 © Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective: 01/01/2021 hydroxychloroquine, and immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) AND ii. ONE of the following: a. The patient is 18 years of age and over OR b. The patient is 5 to 17 years of age AND the request is for IV administration OR 2. The patient has another FDA labeled indication for the requested agent AND 2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND 3. The patient does NOT have severe active lupus nephritis AND 4. The patient does NOT have severe active central nervous system lupus AND 5. The patient will NOT be using the requested agent in combination with another biologic agent OR intravenous cyclophosphamide AND 6. The patient does NOT have any FDA labeled contraindications to the requested agent AND 7. ONE of the following: a. The requested dosage form is intravenous administration AND the requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR b. The requested dosage form is subcutaneous administration AND ONE of the following: i. The requested quantity (dose) does NOT exceed the program quantity limit OR ii. ALL of the following: 1. The requested quantity (dose) is greater than the program quantity limit AND 2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND 3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit Length of Approval: 12 months Renewal Evaluation Target Agent will be approved when ALL of the following are met: 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND 2. ONE of the following: A. The patient has a diagnosis of active systemic lupus erythematosus (SLE) disease AND ALL of the following: Boeing_PS_Benlysta_PAQL_ProgSum_0121 Page 2 of 4 © Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective: 01/01/2021 i. ONE of the following: 1. The patient is currently being treated with at least ONE of the following: corticosteroids, hydroxychloroquine, and/or immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) OR 2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following: corticosteroids, hydroxychloroquine, and immunosuppressives (i.e., azathioprine, methotrexate, oral cyclophosphamide, mycophenolate) AND ii. The patient has had clinical benefit with the requested agent AND iii. ONE of the following: 1. The patient is 18 years of age and over OR 2. The patient is 5 to 17 years of age AND the request is for IV administration OR B. The patient has another FDA labeled indication for the requested agent AND has had clinical benefit with the requested agent AND 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND 4. The patient does NOT have severe active lupus nephritis AND 5. The patient does NOT have severe active central nervous system lupus AND 6. The patient will NOT be using the requested agent in combination with another biologic agent OR intravenous cyclophosphamide AND 7. The patient does NOT have any FDA labeled contraindications to the requested agent AND 8. ONE of the following: A. The requested dosage form is for intravenous administration AND the requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR B. The requested dosage form is for subcutaneous administration AND ONE of the following: i. The requested quantity (dose) does NOT exceed the program quantity limit OR ii. ALL of the following: a. The requested quantity (dose) is greater than the program quantity limit AND b. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND c. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit Boeing_PS_Benlysta_PAQL_ProgSum_0121 Page 3 of 4 © Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective: 01/01/2021 Length of Approval: 12 months Agent Contraindication(s) Benlysta (belimumab) Previous anaphylaxis to Benlysta (belimumab) Biologic Agents not allowed as Concomitant Therapy Actemra (tocilizumab) Arcalyst (rilonacept) Cimzia (certolizumab) Cosentyx (secukinumab) Enbrel (etanercept) Entyvio (vedolizumab) Humira (adalimumab) Ilaris (canakinumab) Ilumya (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Kevzara (sarilumab) Kineret (anakinra) Olumiant (baricitinib) Orencia (abatacept) Otezla (apremilast) Remicade (infliximab) Renflexis (infliximab-abda) Rituxan (rituximab) Rituxan Hycela (rituximab/hyaluronidase human) Siliq (brodalumab) Simponi (golimumab) Simponi ARIA (golimumab) Skyrizi (risankizumab-rzaa) Stelara (ustekinumab) Taltz (ixekizumab) Tremfya (guselkumab) Truxima (rituximab-abbs) Tysabri (natalizumab) Xeljanz (tofacitinib) Xeljanz XR (tofacitinib extended release) Boeing_PS_Benlysta_PAQL_ProgSum_0121 Page 4 of 4 © Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective: 01/01/2021 .
Load more

Recommended publications
  • BAFF-Neutralizing Interaction of Belimumab Related to Its Therapeutic Efficacy for Treating Systemic Lupus Erythematosus
    ARTICLE DOI: 10.1038/s41467-018-03620-2 OPEN BAFF-neutralizing interaction of belimumab related to its therapeutic efficacy for treating systemic lupus erythematosus Woori Shin1, Hyun Tae Lee1, Heejin Lim1, Sang Hyung Lee1, Ji Young Son1, Jee Un Lee1, Ki-Young Yoo1, Seong Eon Ryu2, Jaejun Rhie1, Ju Yeon Lee1 & Yong-Seok Heo1 1234567890():,; BAFF, a member of the TNF superfamily, has been recognized as a good target for auto- immune diseases. Belimumab, an anti-BAFF monoclonal antibody, was approved by the FDA for use in treating systemic lupus erythematosus. However, the molecular basis of BAFF neutralization by belimumab remains unclear. Here our crystal structure of the BAFF–belimumab Fab complex shows the precise epitope and the BAFF-neutralizing mechanism of belimumab, and demonstrates that the therapeutic activity of belimumab involves not only antagonizing the BAFF–receptor interaction, but also disrupting the for- mation of the more active BAFF 60-mer to favor the induction of the less active BAFF trimer through interaction with the flap region of BAFF. In addition, the belimumab HCDR3 loop mimics the DxL(V/L) motif of BAFF receptors, thereby binding to BAFF in a similar manner as endogenous BAFF receptors. Our data thus provides insights for the design of new drugs targeting BAFF for the treatment of autoimmune diseases. 1 Department of Chemistry, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Republic of Korea. 2 Department of Bio Engineering, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. These authors contributed equally: Woori Shin, Hyun Tae Lee, Heejin Lim, Sang Hyung Lee.
    [Show full text]
  • Positioning Biologics in the Management of Moderate to Severe Crohn's Disease
    REVIEW CURRENT OPINION Positioning biologics in the management of moderate to severe Crohn’s disease Jana G. Hashash and Fadi H. Mourad Purpose of review Since there is a lack of head-to-head randomized controlled trials, little direction is provided from guidelines on the positioning of biologics for the treatment of Crohn’s disease (CD). This review utilizes comparative effectiveness and safety results from real-world data and network meta-analyses to inform clinical practice for positioning of biological therapies in the treatment of moderate-to-severe CD. Recent findings We summarize the results of studies pertaining to the identification of predictors for response to biologics in CD. Recently published studies about the management of moderate-to-severe CD are discussed and a positioning algorithm is proposed for the therapeutic approach of these patients. Summary Different classes of biologics are comparable with regards to safety and almost similar in effectiveness in the management of CD. There are certain clinical scenarios in which one biologic is more effective than another. For instance, patients with a more aggressive disease phenotype such as fistulizing disease would benefit from infliximab over other biologics, whereas in older patients at a higher risk for infectious complications, it may be more appropriate to use ustekinumab or vedolizumab over the anti-tumor necrosis factor (TNF) agents. More data pertaining to identifying predictors of response to the different available therapies and head-to-head comparison trials are needed to personalize our therapeutic approach of CD patients. Keywords biologics, Crohn’s disease, moderate-to-severe, positioning INTRODUCTION The medical management of patients with CD To guide the choice of treatment in patients with has changed over recent years.
    [Show full text]
  • Ocrevus (Ocrelizumab) Policy Number: C11250-A
    Prior Authorization Criteria Ocrevus (ocrelizumab) Policy Number: C11250-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 8/1/2017 2/17/2021 4/26/2022 LAST P&T J CODE TYPE OF CRITERIA APPROVAL/VERSION J2350-injection,ocrelizumab, Q2 2021 RxPA 1mg 20200428C11250-A PRODUCTS AFFECTED: Ocrevus (ocrelizumab) DRUG CLASS: Multiple Sclerosis Agents - Monoclonal Antibodies ROUTE OF ADMINISTRATION: Intravenous PLACE OF SERVICE: Specialty Pharmacy or Buy and Bill The recommendation is that medications in this policy will be for pharmacy benefit coverage and the IV infusion products administered in a place of service that is a non-hospital facility-based location (i.e., home infusion provider, provider’s office, free-standing ambulatory infusion center) AVAILABLE DOSAGE FORMS: Ocrevus SOLN 300MG/10ML FDA-APPROVED USES: 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 • Primary progressive MS, in adults COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Multiple Sclerosis REQUIRED MEDICAL INFORMATION: A. RELAPSING FORMS OF MULTIPLE SCLEROSIS: 1. Documentation of a definitive diagnosis of a relapsing form of multiple sclerosis as defined by the McDonald criteria (see Appendix), including: Relapsing- remitting multiple sclerosis [RRMS], secondary-progressive multiple sclerosis [SPMS] with relapses, and progressive- relapsing multiple sclerosis [PRMS] or First clinical episode with MRI features consistent with multiple sclerosis Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare.
    [Show full text]
  • Clinical Policy: Baricitinib (Olumiant) Reference Number: ERX.SPA.291 Effective Date: 07.24.18 Last Review Date: 11.18 Revision Log
    Clinical Policy: Baricitinib (Olumiant) Reference Number: ERX.SPA.291 Effective Date: 07.24.18 Last Review Date: 11.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Baricitinib (Olumiant®) is Janus kinase (JAK) inhibitor. FDA Approved Indication(s) Olumiant is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation(s) of use: Use of Olumiant in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 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. It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Olumiant is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Rheumatoid Arthritis (must meet all): 1. Diagnosis of RA; 2. Prescribed by or in consultation with a rheumatologist; 3. Age ≥ 18 years; 4. Member meets one of the following (a or b): a. Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; b. If intolerance or contraindication to MTX (see Appendix D), failure of a ≥ 3 consecutive month trial of at least ONE conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 5.
    [Show full text]
  • Immunosuppressant Drugs Therapy with COVID-19
    Immunosuppressant Drugs Therapy with COVID-19: Associated Risks, Drug-Drug Interactions & Contraindications Debjyoti Talukdar1, Diane Ignacio2, and Madan Mohan Gupta2 1Teerthanker Mahaveer University 2The University of the West Indies at St Augustine September 24, 2020 Abstract Immunosuppressant drugs like Etanercept, Mycophenolate mofetil, Sirolimus, Cyclosporine and Rituximab can weaken the immune system and make patients susceptible to SARS nCoV-2 virus. These drugs make immunocompromised persons more vulnerable to complications associated with COVID-19. Moreover, it can also increase the mortality and morbidity, as a weakened immune system can lead to longer duration of infection. This study discusses the guidelines on immunosuppressant drugs and its associated risk factors with COVID-19, issued by the U.S CDC (Centers for Disease Control and Prevention), WHO (World Health Organisation), U.S FDA (Food and Drug Administration) and other accredited global health organisa- tions. Moreover, it also includes information about pharmaceutical properties, mechanism of action, COVID-19 associated risk factors, adverse drug reactions, contraindications and drug-drug interactions. Our study will help government partners and international health organisations to better understand COVID-19 health risks associated with immunosuppressants. Increased public awareness about effective drug therapy for autoimmune diseases, cancer treatment, immunocompromised and organ transplant patients will help lower the mortality and morbidity associated with the disease amid COVID-19 pandemic. 1. INTRODUCTION As per the U.S Department of Health and Human Services and U.S FDA, immunosuppressant drugs can cause susceptibility to viruses leading to infection with increase in morbidity of the disease. It can cause severe risk of illness from COVID-19 due to a weakened immune system.
    [Show full text]
  • Quality Report 2020/21 Royal Devon and Exeter NHS Foundation Trust
    Quality Report 2020/21 Royal Devon and Exeter NHS Foundation Trust HOME . COMMUNITY- .1 HOSPITAL - WE WORK TOGETHER Quality Report 2020/21 CONTENTS Page Chief Executive’s Introduction ......................................................................................................................1 Progress on our 2020/21 Priorities: Governor Priorities ..............................................................................3 Progress on our 2020/21 Priorities: Trust Priorities .....................................................................................6 Improvements to Quality and Safety 2020/21 .............................................................................................7 Our Priorities for 2021/22: Governor Priorities ..........................................................................................15 Our Priorities for 2021/22: Trust Priorities .................................................................................................16 Duty of Candour ..........................................................................................................................................18 Learning from Deaths ..................................................................................................................................18 Seven Day Services ......................................................................................................................................21 NHS Staff Survey Results for indicators KR19 and KF27 ...........................................................................21
    [Show full text]
  • Exploring the Association Between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: a Vigibase Study
    Drug Safety https://doi.org/10.1007/s40264-018-00789-9 ORIGINAL RESEARCH ARTICLE Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Lotte A. Minnema1,2 · Thijs J. Giezen2,3 · Patrick C. Souverein1 · Toine C. G. Egberts1,4 · Hubert G. M. Leufkens1 · Helga Gardarsdottir1,4,5 © The Author(s) 2019 Abstract Introduction Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, includ- ing depression and suicidal ideation and behavior. Objective The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mecha- nism of action. Methods We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer). Results Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0).
    [Show full text]
  • 2017 American College of Rheumatology/American Association
    Arthritis Care & Research Vol. 69, No. 8, August 2017, pp 1111–1124 DOI 10.1002/acr.23274 VC 2017, American College of Rheumatology SPECIAL ARTICLE 2017 American College of Rheumatology/ American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty SUSAN M. GOODMAN,1 BRYAN SPRINGER,2 GORDON GUYATT,3 MATTHEW P. ABDEL,4 VINOD DASA,5 MICHAEL GEORGE,6 ORA GEWURZ-SINGER,7 JON T. GILES,8 BEVERLY JOHNSON,9 STEVE LEE,10 LISA A. MANDL,1 MICHAEL A. MONT,11 PETER SCULCO,1 SCOTT SPORER,12 LOUIS STRYKER,13 MARAT TURGUNBAEV,14 BARRY BRAUSE,1 ANTONIA F. CHEN,15 JEREMY GILILLAND,16 MARK GOODMAN,17 ARLENE HURLEY-ROSENBLATT,18 KYRIAKOS KIROU,1 ELENA LOSINA,19 RONALD MacKENZIE,1 KALEB MICHAUD,20 TED MIKULS,21 LINDA RUSSELL,1 22 14 23 17 ALEXANDER SAH, AMY S. MILLER, JASVINDER A. SINGH, AND ADOLPH YATES Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to the recommendations within this guideline to be volun- tary, with the ultimate determination regarding their application to be made by the physician in light of each patient’s individual circumstances. Guidelines and recommendations are intended to promote benefi- cial or desirable outcomes but cannot guarantee any specific outcome. Guidelines and recommendations developed and endorsed by the ACR are subject to periodic revision as warranted by the evolution of medi- cal knowledge, technology, and practice.
    [Show full text]
  • Curriculum Vitae: Daniel J
    CURRICULUM VITAE: DANIEL J. WALLACE, M.D., F.A.C.P., M.A.C.R. Up to date as of January 1, 2019 Personal: Address: 8750 Wilshire Blvd, Suite 350 Beverly Hills, CA 90211 Phone: (310) 652-0010 FAX: (310) 360-6219 E mail: [email protected] Education: University of Southern California, 2/67-6/70, BA Medicine, 1971. University of Southern California, 9/70-6/74, M.D, 1974. Postgraduate Training: 7/74-6/75 Medical Intern, Rhode Island (Brown University) Hospital, Providence, RI. 7/75-6/77 Medical Resident, Cedars-Sinai Medical Center, Los Angeles, CA. 7/77-6/79 Rheumatology Fellow, UCLA School of Medicine, Los Angeles, CA. Medical Boards and Licensure: Diplomate, National Board of Medical Examiners, 1975. Board Certified, American Board of Internal Medicine, 1978. Board Certified, Rheumatology subspecialty, 1982. California License: #G-30533. Present Appointments: Medical Director, Wallace Rheumatic Study Center Attune Health Affiliate, Beverly Hills, CA 90211 Attending Physician, Cedars-Sinai Medical Center, Los Angeles, 1979- Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, 1995- Professor of Medicine, Cedars-Sinai Medical Center, 2012- Expert Reviewer, Medical Board of California, 2007- Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, 2010- Board of Governors, Cedars-Sinai Medical Center, 2016- Member, Medical Policy Committee, United Rheumatology, 2017- Honorary Appointments: Fellow, American College of Physicians (FACP) Fellow, American College of Rheumatology (FACR)
    [Show full text]
  • [Product Monograph Template
    PRODUCT MONOGRAPH PrXELJANZ® tofacitinib, tablets, oral 5 mg tofacitinib (as tofacitinib citrate) 10 mg tofacitinib (as tofacitinib citrate) PrXELJANZ® XR tofacitinib extended-release, tablets, oral 11 mg tofacitinib (as tofacitinib citrate) ATC Code: L04AA29 Selective Immunosuppressant Pfizer Canada ULC Date of Preparation: 17,300 Trans-Canada Highway October 24, 2019 Kirkland, Quebec H9J 2M5 TMPF PRISM C.V. c/o Pfizer Manufacturing Holdings LLC Pfizer Canada ULC, Licensee © Pfizer Canada ULC 2019 Submission Control No: 230976 XELJANZ/XELJANZ XR Page 1 of 80 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 ADVERSE REACTIONS..................................................................................................15 DRUG INTERACTIONS ..................................................................................................29 DOSAGE AND ADMINISTRATION..............................................................................34 OVERDOSAGE ................................................................................................................38 ACTION AND CLINICAL PHARMACOLOGY ............................................................38
    [Show full text]
  • R&D Briefing 76
    The Impact of Recent Regulatory Developments on the Mexican Therapeutic Landscape Access to innovative medicines is key to El acceso a medicamentos innovadores es clave para improving overall population health, reducing mejorar la salud de toda la población, para reducir los hospitalisation time and decreasing morbidity and tiempos de hospitalización, la morbilidad y la mortalidad mortality. An efficient regulatory process can be de un país. Un proceso regulatorio eficiente tiene un reflected in measurable positive health impacts; impacto positivo medible en la salud, y por el contrario, conversely, activities that slow or impede acciones que retrasan o impiden la eficiencia regulatoria y regulatory efficiency and predictability can be su predictibilidad pueden ser perjudiciales. La parálisis detrimental. Recent developments in the Mexican reciente del Sistema regulatorio mexicano respecto a la regulatory system for the assessments of evaluación de nuevos medicamentos innovadores innovative new products have had a negative conlleva un impacto negativo en la salud de la población impact on Mexican public health. mexicana. This Briefing addresses the impact of suspending Este informe analiza el impacto de la suspensión de las the activities of the New Molecules Committee actividades del Comité de Moléculas Nuevas (NMC, por (NMC) on the Mexican therapeutic landscape. sus siglas en inglés) sobre el horizonte terapéutico de First, we compared the way that “new medicines” México. En primer lugar, comparamos la definición de are defined within the context of the Mexican nuevos medicamentos según el contexto regulatorio regulatory system, with definitions used by mexicano con las definiciones adoptadas por otras comparable regulators and health organisations. agencias reguladoras u organizaciones de salud del We have also investigated the extent to which mundo.
    [Show full text]
  • B.C. Pharmacare Drug Information Sheet for Vedolizumab (Entyvio)
    The drug below is being considered for possible coverage under the B.C. PharmaCare program. PharmaCare is a government-funded drug plan that helps British Columbians with the cost of eligible prescription drugs and specific medical supplies. For more information on PharmaCare, visit Ministry of Health - PharmaCare. PharmaCare reviews each drug for treating a specific illness or medical condition (known as an “indication”). If a decision is made to cover the drug, it will be only for that illness or condition. In some cases, PharmaCare may cover a drug only for people who have the illness or condition and have not responded to other drugs used to treat that illness or condition. For more information on PharmaCare’s drug coverage review process, see the last page of this information sheet. Information about the drug Generic name (scientific name) vedolizumab Brand name Entyvio® Manufacturer Takeda Canada Inc. Indication Entyvio is indicated for the treatment of moderately to severely active Crohn’s disease in adult patients. Has the drug been reviewed by Yes the Common Drug For more information about the CDR’s review of vedolizumab (Entyvio®), you can Review (CDR)? Search the CDR Reports. (see the note below this table.) Public input start date Friday, November 13, 2020 Public input closing date Friday, December 11, 2020 AT MIDNIGHT How is the drug taken? Entyvio is administered by subcutaneous injection (into the skin). How often is the drug taken? Entyvio is administered every two weeks, following at least two intravenous infusions (into the vein). Ministry of Health Pharmaceutical Services Division Page 1 of 4 BC PharmaCare Drug Information — vedolizumab (Entyvio®) continued… Information about the drug General drug and/or drug Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract, which study information most commonly affects the small intestine, beginning of large intestine, and rectum.
    [Show full text]