SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES

Size: px
Start display at page:

Download "SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES"

Transcription

1 SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES WHO WE ARE In 1953, a small group of hemophiliacs, their families and physicians in Montreal founded the Canadian Hemophilia Society (CHS). Their dream at the time was to improve the quality of life and find a cure for hemophilia. The close collaboration among patients, health care providers and researchers was unique then and provides a model for the health care field today. Through their tireless efforts, the CHS quickly developed from a small, Montreal based support group to a national volunteer organization. Today, the Canadian Hemophilia Society is a national not for profit health charity, governed by a volunteer Board of Directors. Our national headquarters are in Montreal, and we have 10 provincial chapters. There are regional offices in three provinces: Quebec, Ontario and Manitoba. The CHS and its chapters have approximately 300 active volunteers and 20 staff across the country. The CHS is affiliated with the World Federation of Hemophilia, which is officially recognized by the World Health Organization. The CHS provides programs and services to people with hemophilia A and B, von Willebrand disease, rare factor deficiencies and inherited platelet disorders, and to the health care providers who care for them. OUR STRATEGIC PRIORITIES Care and Treatment We work in close collaboration with medical professionals physicians, nurses, physiotherapists, social workers, and other related specialists in the 26 bleeding disorder treatment centres across the country. Our common goal is to ensure optimal inter disciplinary care and treatment. We define this as comprehensive care. Research We provide clinical and research fellowships and we fund leading Canadian researchers working in the field of bleeding disorders in an effort to improve care and treatment and ultimately find a cure. The CHS invests $500,000 annually in peer reviewed research. Awareness, Support and Education We are the primary source of educational materials designed for people with bleeding disorders, their families, health care professionals and the general public. Our goal is to ensure access to up to date information adapted to each individual s needs. Safe, Secure Blood Supply In the 1990s we played key roles in the Royal Commission of Inquiry on the Blood System in Canada and in building a safer blood system for Canadians, leading to the creation of Canadian Blood Services and Héma Québec, and we continue to be the leading patient organization to independently monitor the safety and supply of blood, blood products and their recombinant alternatives within the Canadian Blood System. The CHS is committed to doing its part to make sure there is never another tainted blood tragedy. Its Blood Safety and Supply Committee is made up of physicians, CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 1

2 nurses, public health experts and regular recipients of blood products and their alternatives. Collectively, they have over 200 years of experience in blood safety and supply issues. International Development The Canadian Hemophilia Society and its dedicated teams of volunteers and health care professionals undertake leadership roles in supporting developing countries to improve care and treatment. Currently we have twinning partnerships in four developing countries. FUNDING The CHS receives program funding from all the companies in the Canadian clotting factor concentrate market. Our relationship with them is carefully regulated by our Policy on Relationships with Companies in the Pharmaceutical Industry, which is guided by best ethical practices. The CHS also receives significant donations and bequests from members of the general public and is one of 16 members of Healthpartners, a federal government workplace giving program. While the national organization receives no government funding, two of our chapters, Quebec and Ontario, receive provincial supporting grants. CARE AND TREATMENT Since the 1950s, treatment for hemophilia A and B has gone through four distinct phases: 1950s to 1965 Treatment with fresh frozen plasma, which required frequent and long hospitalization 1965 to 1985 Treatment with cryoprecipitate (for hemophilia A only), which permitted out patient and Emergency Department administration of factor replacement therapy, and reduced hospitalization significantly 1970 to 1988 Treatment with large pool preparations of plasma derived factor VIII and IX concentrates, which facilitated home infusion, but which were not virally inactivated and led to widespread infection with HIV and hepatitis B and C 1988 to today Treatment with virally safe plasma derived and recombinant factor concentrates, which led to the introduction of preventative treatment, called prophylaxis, for almost all children and many adults with the severe forms of hemophilia A and B. ON DEMAND THERAPY Since the inception of hemophilia care in the 1950s, the standard care has been to infuse factor FVIII or IX as soon as possible after the onset of bleeding. The interval before effective hemostasis, however, allowed accumulation of blood in joint spaces and inevitably led to serious joint damage. PROPHYLAXIS Prophylactic treatment for hemophilia was initiated in Sweden in the 1960s and became widespread in Canada in the 1990s after the introduction of virally attenuated factor concentrates. Research published in 2007 by Manco Johnson et al i showed that CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 2

3 prophylaxis with factor VIII prevents joint damage and decreases the frequency of joint and other hemorrhages in young boys with severe hemophilia A compared to on demand therapy. A second randomized controlled trial, the 2011 ESPRIT study, by Gringeri et al ii confirmed the efficacy of prophylaxis in preventing bleeds and arthropathy in children with hemophilia, particularly when it is initiated early in life. Similar RCTs have yet to be conducted in adults or with hemophilia B; however, observational studies clearly show that prophylaxis results in a reduction in the frequency of joint bleeding and, over time, a reduction in the severity of joint disease. A 2012 survey of the outcome of prophylaxis, on demand treatment or combined treatment in year old men with severe hemophilia in six countries iii, in which Canadians participated, found that people with severe hemophilia who have been on prophylaxis for their entire lives to date are reporting a quality of life much closer to their peers without hemophilia. This finding is supported by another Manco Johnson study iv in males aged years that concluded that the median number of total bleeding episodes and total bleeding episodes per year were significantly lower with prophylaxis than with on demand treatment (total, 0 vs. 54.5; total per year, 0 vs. 27.9; both P < ) Routine prophylaxis with rfviii FS leads to a significant reduction in bleeding as compared with on demand treatment. Prophylaxis is, nevertheless, a challenging therapy, especially in children, in whom it is ideally started before the age of two years or earlier. Factor VIII concentrates are infused intravenously two, three or more times a week and for some patients, daily. Factor IX concentrates, given the extended half life of the molecule, are usually infused every 3 or 4 days. Venous access can be difficult. Central venous access devices (e.g. port a caths) are sometimes needed in younger children. Traditionally, the goal of prophylaxis has been to raise the FVIII or IX level to 25 to 50% of normal and then re infuse when the level falls to 1%. While this has constituted a huge advance over on demand therapy, as demonstrated by Manco Johnson and Gringeri, factor levels as low as 1% do not prevent all bleeds. Even in young boys who report no episodes of bleeding, MRI, x ray and ultrasound examination of the joints often show radiological changes, likely due to subclinical bleeding. Manco Johnson s study suggests that 11% of normal factor VIII levels are required to completely prevent joint bleeding in hemophilia A patients. THE BENEFITS OF EXTENDED HALF LIFE FACTOR CONCENTRATES Excluding viral attenuation and recombinant preparation, the extended half life factor of concentrates constitutes the first significant change in factor replacement therapy since their introduction four decades ago. In the case of the first extended half life factor VIII concentrate to be approved, the half life is increased by half v ; in the case of the first factor IX, by two to three times vi. This advance has the potential to offer two different treatment improvements to patients with hemophilia A and B. 1. By virtue of their extended half life, prophylactic infusions can be less frequent. In factor VIII, instead of two or three infusions or more per week, the frequency can be reduced to one or two infusions. For those accessing veins peripherally with butterfly needles, this will mean less long term damage to veins. Some young children will be able to discard the central venous access device and its attendant infectious and CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 3

4 thrombotic risks. Compliance with prescribed treatment protocols will be less hindered by the burden of frequent venous access. 2. For many patients, the chief drawback of hemophilia care is not the frequency of infusions or the difficulty in venous access, it is the breakthrough bleeding, both observable and sub clinical, that still occurs with prophylactic protocols that target a trough level of 1% of normal. The stated goal of gene therapy trials is to maintain a constant factor level in excess of 5% in order to transform severe hemophilia into a mild form of the disease. The advent of extended half life factor concentrates offers the possibility of maintaining current prophylactic frequency and significantly increasing trough levels, thereby achieving greater protection from bleeding. There are good reasons why individuals would choose different options. The benefits of fewer infusions are: - easier venous access (the best veins cannot be used too often) - less pain and suffering - better compliance on the part of very young children - less recourse to central venous access devices with their risks of infection and thrombosis - less burden on families if infusions do not have to be scheduled as often - the possibility of weekly infusions scheduled at a fixed time of the week when families have fewer vocational and educational obligations. The benefits of higher factor trough levels are: - better protection from bleeds - fewer sub clinical bleeds - less long term joint damage - the ability to be more active and maintain better fitness without causing bleeding - the ability to lead a more normal lifestyle - the ability to change severe disease into mild disease. It is not, of course, an either/or decision between higher troughs and less frequent infusions. The extended half life products offer not only the possibility of choosing which benefit is most important based on personalized medicine, but also offer the option of combining the benefits. For example, patients with factor VIII deficiency, by infusing the same dose as previously, could reduce the frequency of infusions from three times a week to twice a week and increase the trough level to close to 3%. Others could infuse a larger dose once a week. This would be a significant advance for children with difficult venous access. Moreover, a once weekly dosing schedule is considered ideal for adherence. For some patients, the combined benefits of less frequent infusions and better protection from hemorrhages will also be accompanied by lower doses, thus decreasing the overall annual consumption in IUs. CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 4

5 PATIENT AND CAREGIVER ATTITUDES In 2012, the CHS conducted an online survey of adults with severe and moderate hemophilia A and B and the caregivers of children with severe and moderate hemophilia A and B. Close to 100 people responded. The objective was to discover which of the potential benefits patients and their caregivers thought most important. The options were presented in different ways. I would rather reduce the frequency of my infusions than get greater protection against bleeds. Strongly agree Agree Neutral Disagree Strongly disagree 5% 12% 14% 30% 38% Only 17% of respondents agreed or strongly agreed with the option of reducing frequency of infusions compared with a higher factor level and greater protection from bleeds. Almost 70% disagreed. This was somewhat surprising given that all the discussion by physicians over the last five years as these products moved from animal studies to the clinic, as well as public communications by the companies studying the products in human trials, focused solely on the benefit of fewer infusions. I would rather have higher factor levels than reduce my frequency of infusions. Strongly agree Agree Neutral Disagree Strongly disagree 20% 38% 32% 11% 0% Attitudes were similar even when the question was posed differently. Almost 60% agreed or strongly agreed that they would prefer higher factor levels to less frequent infusions. Only 11% disagreed. PATIENT AND CAREGIVER COMMENTS Our son is 6 years old and sometimes likes to argue with us or try to negotiate why he doesn't need to get his needle yet again. This can emotionally wear us all down (although we do not give in). His veins are still small and sometimes hard to get. Fewer needles, but still able to keep trough levels up would be an ideal situation! Mother of a boy with severe hemophilia If longer half life factor were available, it would make work and travel and other activities easier for our family. Yes, the ease of factor these days is wonderful, however, I worry about the vein damage to our son's only vein he lets us access. Longer half life factor would avoid the scar tissue building up and the risk of losing that vein. - Mother of a boy with severe hemophilia I have target joints that frequently bleed spontaneously without trauma. The low CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 5

6 level of protection with today s concentrates has caused me bleeds that have damaged my joints, needed the use of additional factor product and required hospitalization and surgery. An extended half life product would save on product use and health care consumption. A young man with severe hemophilia As a late convert to prophylaxis I am so relieved to be bleeding only a couple of times a year now instead of a couple of times a month. A significant barrier to my ability to follow my doctor s recommendation of every other day infusions is the great increase in the number of needles. This is no small barrier. If I were able to go from 3 infusions a week to 1 or even 2 that would be a great help in maintaining what has become a great improvement of health and quality of life. A middle aged man with severe hemophilia CONCLUSIONS AND RECOMMENDATIONS ON THE INTRODUCTION OF ELOCTATE Eloctate received its Notice of Compliance from Health Canada in August 2014 following one of the most extensive clinical trials ever conducted in hemophilia, including research sites in Canada. 1. Eloctate s 1.5 fold extended half life (19.0 hours vs hours for Advate ) represents the first advance in efficacy in clotting factor concentrates in four decades. It has the potential to - reduce the frequency of infusions - increase the protection against hemorrhages by raising the trough level - procure both of these benefits at the same time. The extended half life is of special benefit to certain categories of patients, including those who - demonstrate short half lives and high clearance rates with current FVIII products - have difficulty accessing peripheral veins, especially young children - have advanced joint damage and, as a result, bleed more easily - bleed more frequently, for reasons unknown, despite their current prophylactic protocol. Given its potential to improve patient outcomes over current products, Eloctate should be listed for reimbursement through the CBS budget immediately. 2. It is not yet clear how physicians and patients will best take advantage of this innovative therapy. Given the quality and efficacy of the standard half life concentrates, uptake is expected to be gradual. Based on individual pharmacokinetics, bleeding susceptibility, the condition of joints, lifestyle and treatment challenges, treatment protocols will vary, some favouring less frequent infusions, some favouring higher trough levels, some both at the same time. It will be critical to closely monitor utilization and patient outcomes. In addition, rare adverse reactions, including the development of inhibitors, less likely to be detected during pre marketing clinical trials, must be monitored. CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 6

7 Rigourous and systematic Phase IV post marketing surveillance and research should be conducted to measure patient outcomes, determine how best to utilize these products and to detect rare adverse reactions. 3. Other extended half life factor VIII products are expected to be approved and marketed in Canada within the next one to three years. The factor VIII marketplace will become increasingly competitive. Physicians and patients will have more options and the cost of therapies is likely to decrease. Contracts with the manufacturer of Eloctate should be short in duration to allow purchasing flexibility as more factor VIII products are approved for use in Canada. Prepared by the Canadian Hemophilia Society Blood Safety and Supply Committee Michael King, MD, chair (Alberta) Martin Kulczyk, vice chair (Quebec) Tom Alloway, PhD (Ontario) Sarah Crymble (Ontario) Bill Featherstone (Manitoba) Julia Hews Girard, RN (Alberta) Mohammad Qadura, MD (Ontario) Bruce Ritchie, MD (Alberta) Craig Upshaw (Alberta) Rick Waines (British Columbia) Paul Wilton (Ontario) David Page (Staff support, CHS national office) September 30, 2014 i ii iii iv v vi Prophylaxis versus Episodic Treatment to Prevent Joint Disease in Boys with Severe Hemophilia; Marilyn J. Manco Johnson et al; N Engl J Med 2007;357: Gringeri A, Lundin B, von Mackensen S, Mantovani L, Mannucci PM and The ESPRIT Study Group. A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study). J Thromb Haemost 2011; 9: A survey of the outcome of prophylaxis, on demand treatment or combined treatment in year old men with severe haemophilia in six countries, D. Noone et al, Haemophilia (2012). DOI: /j x Randomized, controlled, parallel group trial of routine prophylaxis vs. on demand treatment with sucrose formulated recombinant factor VIII in adults with severe hemophilia A (SPINART), M.J. Manco Johnson et al, Journal of Thrombosis and Haemostasis, 11: , DOI: /jth Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Johnny Mahlangu et al. Pre published online November 13, 2013; Haemophilia doi: /blood Phase 3 Study of Recombinant Factor IX Fc Fusion Protein in Hemophilia B, Jerry S. Powell et al, N Engl J Med. DOI: /NEJMoa CHS SUBMISSION ON THE FUNDING OF EXTENDED HALF LIFE FACTOR VIII CONCENTRATES page 7

Irish Haemophilia Society. Introduction to Haemophilia. Brian O Mahony November 2009

Irish Haemophilia Society. Introduction to Haemophilia. Brian O Mahony November 2009 Irish Haemophilia Society Introduction to Haemophilia Brian O Mahony November 2009 1 Content Introduction to Haemophilia Introduction to Von Willebrand's Disease Inheritance Bleeding patterns Introduction

More information

PASSP RT. to well-being CHARTING YOUR COURSE. empowering people with bleeding disorders to maximize their quality of life

PASSP RT. to well-being CHARTING YOUR COURSE. empowering people with bleeding disorders to maximize their quality of life PASSP RT to well-being empowering people with bleeding disorders to maximize their quality of life CHARTING YOUR COURSE The Canadian Hemophilia Society (CHS) exists to improve the quality of life of persons

More information

ATHN Assets for the Community: ATHNdataset Michael Recht, MD PhD 10/30/2014 1

ATHN Assets for the Community: ATHNdataset Michael Recht, MD PhD 10/30/2014 1 ATHN Assets for the Community: ATHNdataset Michael Recht, MD PhD 10/30/2014 1 Sept. 2010 Dec. 2011 Mar. 2011 Jun. 2011 Sept. 2011 Dec. 2011 Mar. 2012 Jun. 2012 Sept. 2012 Dec. 2012 Mar. 2013 Jun. 2013

More information

Canadian Blood Services Therapeutic Blood Product Review Process. Corifact

Canadian Blood Services Therapeutic Blood Product Review Process. Corifact Canadian Blood Services Therapeutic Blood Product Review Process Corifact The National Advisory Committee on Blood and Blood Products (NAC) was asked and agreed to participate in the Canadian Blood Services

More information

SOCIAL WORKERS IN HEMOPHILIA CARE STANDARDS OF PRACTICE May, 2009

SOCIAL WORKERS IN HEMOPHILIA CARE STANDARDS OF PRACTICE May, 2009 SOCIAL WORKERS IN HEMOPHILIA CARE STANDARDS OF PRACTICE May, 2009 These standards are based on an original document prepared by Leonarda Szeweczyk, MSW CSW, Linda Prentice, MSW CSW Alison Oxalade, MSW,

More information

FREQUENTLY ASKED QUESTIONS (FAQ)

FREQUENTLY ASKED QUESTIONS (FAQ) FREQUENTLY ASKED QUESTIONS (FAQ) Questions What is the ABDR? How does the National Blood Authority (NBA) know that I ve ordered clotting factor product? Which bleeding disorders are within the scope of

More information

INTRODUCTION TO HAEMOPHILIA

INTRODUCTION TO HAEMOPHILIA INTRODUCTION TO HAEMOPHILIA Dr Clodagh Ryan, Consultant Paediatric Haematologist, CUH Ms Norma Collins, CNS Bleeding Disorders, CUH 5 th September 2009 2 How does bleeding start and stop? Blood vessel

More information

Hemophilia Care. Will there always be new people in the world with hemophilia? Will hemophilia be treated more effectively and safely in the future?

Hemophilia Care. Will there always be new people in the world with hemophilia? Will hemophilia be treated more effectively and safely in the future? Future of This chapter provides answers to these questions: Will there always be new people in the world with hemophilia? Will hemophilia be treated more effectively and safely in the future? Will the

More information

Rational for secondary prophylaxis in VWD

Rational for secondary prophylaxis in VWD Rational for secondary prophylaxis in VWD Susan Halimeh Medical Thrombosis and Haemophilia treatment Center, Duisburg, Germany Dr. med. Susan Halimeh When is prophylaxis in patients with VWD recommended?

More information

DVT/PE Management with Rivaroxaban (Xarelto)

DVT/PE Management with Rivaroxaban (Xarelto) DVT/PE Management with Rivaroxaban (Xarelto) Rivaroxaban is FDA approved for the acute treatment of DVT and PE and reduction in risk of recurrence of DVT and PE. FDA approved indications: Non valvular

More information

Canadian Hemophilia Society Policy on Blood, Blood Products and their Alternatives 2016

Canadian Hemophilia Society Policy on Blood, Blood Products and their Alternatives 2016 Canadian Hemophilia Society Policy on Blood, Blood Products and their Alternatives 2016 Table of Contents 1. INTRODUCTION 2. COAGULATION THERAPY 2.1 Introduction 2.2 Optimal Quality 2.2.1 Safety 2.2.2

More information

2006 Provider Coding/Billing Information. www.novoseven-us.com

2006 Provider Coding/Billing Information. www.novoseven-us.com 2006 Provider Coding/Billing Information 2 3 Contents About NovoSeven...2 Coverage...4 Coding...4 Reimbursement...8 Establishing Medical Necessity and Appealing Denied Claims...10 Claims Materials...12

More information

Dec. 9, 2013, 11:00 a.m. EST

Dec. 9, 2013, 11:00 a.m. EST Dec. 9, 2013, 11:00 a.m. EST Portola Pharmaceuticals Announces New Phase 2 Results Confirming Immediate, Dose-Dependent and Well-Tolerated Reversal of Anticoagulation Activity of XARELTO(R) (rivaroxaban)

More information

Facts about Inhibitors

Facts about Inhibitors Facts about Inhibitors NHF is grateful to Dr. Marion A. Koerper, pediatric hematologist at the University of California, San Francisco Medical Center for reviewing this brochure. The editors would also

More information

The National Centre for Hereditary Coagulation Disorders (NCHCD), St. James s Hospital, Dublin 8. Ph:

The National Centre for Hereditary Coagulation Disorders (NCHCD), St. James s Hospital, Dublin 8. Ph: Adults with Haemophilia and Related Bleeding Disorders Acute Treatment Guidelines Adult Comprehensive Care Centres (CCC) Ireland The National Centre for Hereditary Coagulation Disorders (NCHCD), St. James

More information

Products for the Treatment of Factor VIII Deficiency

Products for the Treatment of Factor VIII Deficiency Products for the Treatment of Factor VIII Deficiency Conference Call August 24, 2004 7pm-8pm Presenters: Marcus E. Carr, MD, PhD & Gita V. Massey, MD I. Overview of Factor VIII products currently on the

More information

BREAST CANCER AWARENESS FOR WOMEN AND MEN by Samar Ali A. Kader. Two years ago, I was working as a bedside nurse. One of my colleagues felt

BREAST CANCER AWARENESS FOR WOMEN AND MEN by Samar Ali A. Kader. Two years ago, I was working as a bedside nurse. One of my colleagues felt Ali A. Kader, S. (2010). Breast cancer awareness for women and men. UCQ Nursing Journal of Academic Writing, Winter 2010, 70 76. BREAST CANCER AWARENESS FOR WOMEN AND MEN by Samar Ali A. Kader Two years

More information

Treatment of Hemophilia A and B Marianne McDaniel, RN FACTOR REPLACEMENT CONCENTRATES AND VIRAL INACTIVATION

Treatment of Hemophilia A and B Marianne McDaniel, RN FACTOR REPLACEMENT CONCENTRATES AND VIRAL INACTIVATION Treatment of Hemophilia A and B Marianne McDaniel, RN INTRODUCTION Treatment for patients with hemophilia and other bleeding disorders has evolved over the past several decades. Replacement of the specific

More information

Addressing the Needs of Members with Hemophilia in Medicaid Managed Care: Issues and Implications for Health Plans

Addressing the Needs of Members with Hemophilia in Medicaid Managed Care: Issues and Implications for Health Plans Addressing the Needs of Members with Hemophilia in Medicaid Managed Care: Issues and Implications for Health Plans Clinical Brief Medicaid Health Plans of America Center for Best Practices July 22, 2013

More information

Welcome from the Chair

Welcome from the Chair October 2015 Issue 1 Get in touch 01256 461303 Welcome from the Chair Dear Colleagues, The purpose of this newsletter is to keep you up to date with the studies we have so far established and the staff

More information

Introduction to Bleeding Disorders Dawn Banks RN (Original author Regina B. Butler, RN)

Introduction to Bleeding Disorders Dawn Banks RN (Original author Regina B. Butler, RN) Introduction to Bleeding Disorders Dawn Banks RN (Original author Regina B. Butler, RN) Bleeding disorders are relatively rare genetic disorders characterized by increased or prolonged bleeding due to

More information

Dabigatran (Pradaxa) Guidelines

Dabigatran (Pradaxa) Guidelines Dabigatran (Pradaxa) Guidelines Dabigatran is a new anticoagulant for reducing the risk of stroke in patients with atrial fibrillation. Dabigatran is a direct thrombin inhibitor, similar to warfarin, without

More information

Low Molecular Weight Heparin. All Wales Medicines Strategy Group (AWMSG) Recommendations and advice

Low Molecular Weight Heparin. All Wales Medicines Strategy Group (AWMSG) Recommendations and advice Low Molecular Weight Heparin All Wales Medicines Strategy Group (AWMSG) Recommendations and advice Starting Point Low Molecular Weight Heparin (LMWH): Inhibits factor Xa and factor IIa (thrombin) Small

More information

STANDARD BLOOD PRODUCTS AND SERVICES

STANDARD BLOOD PRODUCTS AND SERVICES STANDARD BLOOD PRODUCTS AND SERVICES Policy NHP reimburses contracted providers for the medically necessary administration (transfusion) of blood and standard blood products. Prerequisites Authorization,

More information

Carla Duff, CPNP MSN CCRP Clinical Advanced Registered Nurse Practitioner University of South Florida Division of Allergy, Immunology, and

Carla Duff, CPNP MSN CCRP Clinical Advanced Registered Nurse Practitioner University of South Florida Division of Allergy, Immunology, and Carla Duff, CPNP MSN CCRP Clinical Advanced Registered Nurse Practitioner University of South Florida Division of Allergy, Immunology, and Rheumatology Intravenous Subcutaneous IVIg SCIg What should you

More information

Management of Haemophilia and Related Bleeding Disorders

Management of Haemophilia and Related Bleeding Disorders Policy Directive Ministry of Health, NSW 73 Miller Street North Sydney NSW 2060 Locked Mail Bag 961 North Sydney NSW 2059 Telephone (02) 9391 9000 Fax (02) 9391 9101 http://www.health.nsw.gov.au/policies/

More information

Canadian Blood Services National Public Cord Blood Bank Give Life Twice Transfusion Medicine Residents

Canadian Blood Services National Public Cord Blood Bank Give Life Twice Transfusion Medicine Residents Canadian Blood Services National Public Cord Blood Bank Give Life Twice Transfusion Medicine Residents Eileen Quinlan Collection Supervisor, Brampton (GTA) 2015-11-10 History One Match Stem Cell and Marrow

More information

JUST 5 EASY STEPS FOR CORD BLOOD DONATION...

JUST 5 EASY STEPS FOR CORD BLOOD DONATION... JUST 5 EASY STEPS FOR CORD BLOOD DONATION... STEP 1 Read this Information Kit. STEP 2 Print and fill in the forms. STEP 3 Give completed forms to your healthcare provider or to your hospital RN on day

More information

Clinical trials in haemophilia

Clinical trials in haemophilia Clinical trials in haemophilia Dr. Paul Giangrande Oxford Haemophilia and Thrombosis Centre & Nuffield Department of Clinical Medicine University of Oxford paul.giangrande@ndm.ox.ac.uk Why do clinical

More information

NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl

NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl Mikele Wissing, RN June 2014 Introduction until recently, was the unrivaled medication for treatment

More information

Blood Transfusion. Red Blood Cells White Blood Cells Platelets

Blood Transfusion. Red Blood Cells White Blood Cells Platelets Blood Transfusion Introduction Blood transfusions are very common. Each year, almost 5 million Americans need a blood transfusion. Blood transfusions are given to replace blood lost during surgery or serious

More information

Bayer HealthCare, LLC Sharps Disposal Submission to CalRecycle July 1, 2014

Bayer HealthCare, LLC Sharps Disposal Submission to CalRecycle July 1, 2014 Bayer HealthCare, LLC Sharps Disposal Submission to CalRecycle July 1, 2014 1. A pharmaceutical manufacturer that sells or distributes a medication in California that is usually intended to be self-injected

More information

HAEMOPHILIA & UMBILICAL CORD BLOOD TRANSPLANT

HAEMOPHILIA & UMBILICAL CORD BLOOD TRANSPLANT HAEMOPHILIA & UMBILICAL CORD BLOOD TRANSPLANT Haemostatic System in Body Blood vessels Platelets Plasma coagulation system Proteolytic or Fibrinolytic system How Bleeding Stops Vasoconstriction Platelet

More information

Clinical Trials. Clinical trials the basics

Clinical Trials. Clinical trials the basics Clinical Trials Clinical Trials This brochure is for people making decisions about cancer treatment. You may be thinking about a clinical trial for you or your child but need to know more before you decide.

More information

Acquired hemophilia A form of hemophilia in which the body starts producing antibodies that fight its own blood clotting proteins.

Acquired hemophilia A form of hemophilia in which the body starts producing antibodies that fight its own blood clotting proteins. Glossary of Terms A Acquired hemophilia A form of hemophilia in which the body starts producing antibodies that fight its own blood clotting proteins. Activated partial thromboplastin time (aptt) Measures

More information

Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012

Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012 Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012 CANADIAN PERSPECTIVE Common Drug review: A *pan-canadian process CANADA: 33 M people; area 10 M km 2 DIVERSITY!

More information

A Career in Pediatric Hematology-Oncology? Think About It...

A Career in Pediatric Hematology-Oncology? Think About It... A Career in Pediatric Hematology-Oncology? Think About It... What does a pediatric hematologist-oncologist do? What kind of training is necessary? Is there a future need for specialists in this area? T

More information

National Patient Safety Goals Effective January 1, 2015

National Patient Safety Goals Effective January 1, 2015 National Patient Safety Goals Goal 1 Nursing are enter ccreditation Program Improve the accuracy of patient and resident identification. NPSG.01.01.01 Use at least two patient or resident identifiers when

More information

Summary of the risk management plan (RMP) for Cerdelga (eliglustat)

Summary of the risk management plan (RMP) for Cerdelga (eliglustat) EMA/743948/2014 Summary of the risk management plan (RMP) for Cerdelga (eliglustat) This is a summary of the risk management plan (RMP) for Cerdelga, which details the measures to be taken in order to

More information

S1. Which of the following age categories do you fall into? Please select one answer only. 18-44 years of age. 45-64 years of age. 65-74 years of age

S1. Which of the following age categories do you fall into? Please select one answer only. 18-44 years of age. 45-64 years of age. 65-74 years of age Supplemental Materials Supplemental Methods Patient Survey We are presently conducting a market research study to help us better understand some of the challenges experienced by patients taking anticoagulants

More information

SAVE A LIFE... BY GIVING LIFE!

SAVE A LIFE... BY GIVING LIFE! SAVE A LIFE... BY GIVING LIFE! FOLLOW US ON: HÉMA-QUÉBEC PUBLIC CORD BLOOD BANK www.hema-quebec.qc.ca Scan this code with your smart phone to access the page Register to the Public Cord Blood Bank on the

More information

Inpatient Anticoagulation Safety. To provide safe and effective anticoagulation therapy through a collaborative approach.

Inpatient Anticoagulation Safety. To provide safe and effective anticoagulation therapy through a collaborative approach. Inpatient Anticoagulation Safety Purpose: Policy: To provide safe and effective anticoagulation therapy through a collaborative approach. Upon the written order of a physician, Heparin, Low Molecular Weight

More information

LABORATORY DIAGNOSIS OF BLEEDING DISORDERS

LABORATORY DIAGNOSIS OF BLEEDING DISORDERS LABORATORY DIAGNOSIS OF BLEEDING DISORDERS Secondary Hemostasis CIRCULATORY SYSTEM Low volume, high pressure system Efficient for nutrient delivery to tissues Prone to leakage 2º 2 to endothelial surface

More information

Clinical Trials: Questions and Answers

Clinical Trials: Questions and Answers Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which

More information

National Patient Safety Goals Effective January 1, 2015

National Patient Safety Goals Effective January 1, 2015 National Patient Safety Goals Effective January 1, 2015 Goal 1 Improve the accuracy of resident identification. NPSG.01.01.01 Long Term are ccreditation Program Medicare/Medicaid ertification-based Option

More information

Antithrombin Reduction Improves Coagulation in Rare Bleeding Disorder Plasma

Antithrombin Reduction Improves Coagulation in Rare Bleeding Disorder Plasma Antithrombin Reduction Improves Coagulation in Rare Bleeding Disorder Plasma Alfica Sehgal, Kun Qian, Julia Hettinger, Benny Sorensen and Akin Akinc Alnylam Pharmaceuticals, Cambridge, MA, United States

More information

Patient Information Leaflet: Part 1 select-d

Patient Information Leaflet: Part 1 select-d Patient Information Leaflet: Part 1 select-d Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism Introduction This

More information

Blood Transfusion. There are three types of blood cells: Red blood cells. White blood cells. Platelets.

Blood Transfusion. There are three types of blood cells: Red blood cells. White blood cells. Platelets. Blood Transfusion Introduction Blood transfusions can save lives. Every second, someone in the world needs a blood transfusion. Blood transfusions can replace the blood lost from a serious injury or surgery.

More information

Blood Transfusions and Other Options for Pregnant Women

Blood Transfusions and Other Options for Pregnant Women Saint Mary s Hospital Information for Patients Blood Transfusions and Other Options for Pregnant Women Red cells in blood are necessary to carry oxygen around the body. If the number of red cells in your

More information

FACTOR XII DEFICIENCY AN INHERITED BLEEDING DISORDER AN INFORMATION BOOKLET

FACTOR XII DEFICIENCY AN INHERITED BLEEDING DISORDER AN INFORMATION BOOKLET FACTOR XII DEFICIENCY AN INHERITED BLEEDING DISORDER AN INFORMATION BOOKLET Acknowledgements This information booklet on Factor XII Deficiency was prepared by: Nathalie Aubin Nurse Coordinator, Hemophilia

More information

Helping you find the one match.. Guide for Unrelated Stem Cell Transplant Patients OneMatch Stem Cell and Marrow Network BLOOD.

Helping you find the one match.. Guide for Unrelated Stem Cell Transplant Patients OneMatch Stem Cell and Marrow Network BLOOD. Helping you find the one match.. Guide for Unrelated Stem Cell Transplant Patients OneMatch Stem Cell and Marrow Network BLOOD.CA WWW This guide is intended for patients in need of an unrelated volunteer

More information

Mesothelioma. Information for Patients and Families. identifying and evaluating experimental

Mesothelioma. Information for Patients and Families. identifying and evaluating experimental Mesothelioma CLINICAL TRIALS Information for Patients and Families identifying and evaluating experimental treatments table of contents Pg. 2... Phases of a Clinical Trial Pg. 3... Mesothelioma and Clinical

More information

ALBERTA IMMUNIZATION POLICY GUIDELINES

ALBERTA IMMUNIZATION POLICY GUIDELINES ALBERTA IMMUNIZATION POLICY GUIDELINES Hepatitis Vaccines. Hepatitis A Vaccines Refer to the vaccine product monograph and the Canadian Immunization Guide for further Product monographs are available on

More information

This reference summary explains platelet disorders. It covers symptoms of these disorders as well as treatment options.

This reference summary explains platelet disorders. It covers symptoms of these disorders as well as treatment options. Platelet Disorders Introduction Platelets are little pieces of blood cells that help wounds heal. They prevent severe bleeding by forming blood clots. Having too few platelets, too many platelets or platelets

More information

Multiple Sclerosis Society of Canada. CADA Presentation May 4, 2011

Multiple Sclerosis Society of Canada. CADA Presentation May 4, 2011 Multiple Sclerosis Society of Canada CADA Presentation May 4, 2011 1 MS Society s Mission To be a leader in finding a cure for multiple sclerosis and enabling people affected by MS to enhance their quality

More information

Position Paper on Access to Oral Health Care for Canadians

Position Paper on Access to Oral Health Care for Canadians Position Paper on Access to Oral Health Care for Canadians Approved CDA Board of Directors May 2010 Preamble A daily regimen of brushing and flossing is an important part of good oral health while equitable

More information

A patient guide to immunoglobulin replacement therapy

A patient guide to immunoglobulin replacement therapy A patient guide to immunoglobulin replacement therapy Delivering the best in care UHB is a no smoking Trust To see all of our current patient information leaflets please visit www.uhb.nhs.uk/patient-information-leaflets.htm

More information

A Real Time Lab for Pan Canadian Innovation Leveraging Canadian Blood Services Model for Better Value to Health care Systems

A Real Time Lab for Pan Canadian Innovation Leveraging Canadian Blood Services Model for Better Value to Health care Systems A Real Time Lab for Pan Canadian Innovation Leveraging Canadian Blood Services Model for Better Value to Health care Systems November 14, 2014 Submission to the Advisory Panel on Health Care Innovation

More information

Genetic Testing in Research & Healthcare

Genetic Testing in Research & Healthcare We Innovate Healthcare Genetic Testing in Research & Healthcare We Innovate Healthcare Genetic Testing in Research and Healthcare Human genetic testing is a growing science. It is used to study genes

More information

THE PREPARATION OF SINGLE DONOR CRYOPRECIPITATE

THE PREPARATION OF SINGLE DONOR CRYOPRECIPITATE FACTS AND FIGURES JUNE 2004 NO 2 THE PREPARATION OF SINGLE DONOR CRYOPRECIPITATE Revised Edition Shân Lloyd National Blood Transfusion Service Zimbabwe Published by the World Federation of Hemophilia (WFH);

More information

Introduction Hemophilia is a rare bleeding disorder in which the blood does not clot normally. About 1 in 10,000 people are born with hemophilia.

Introduction Hemophilia is a rare bleeding disorder in which the blood does not clot normally. About 1 in 10,000 people are born with hemophilia. Hemophilia Introduction Hemophilia is a rare bleeding disorder in which the blood does not clot normally. About 1 in 10,000 people are born with hemophilia. Hemophilia can be mild, moderate, or severe.

More information

National Poll: Clinical Research

National Poll: Clinical Research National Poll: Clinical Research June 2013 Results of a New Public Opinion Poll National Poll on Clinical Research The National Poll on Clinical Research was conducted online in May 2013 by Zogby Analytics

More information

Insurance and compensation in the event of injury in Phase I clinical trials

Insurance and compensation in the event of injury in Phase I clinical trials Insurance and compensation in the event of injury in Phase I clinical trials Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical

More information

WORKSHOP GUIDELINES. People with hemophilia or another bleeding disorder Parents or caregivers of a person with a bleeding disorder

WORKSHOP GUIDELINES. People with hemophilia or another bleeding disorder Parents or caregivers of a person with a bleeding disorder WORKSHOP GUIDELINES GOAL OF WORKSHOP The workshop, Navigating the emergency department, will provide guidance and direction to people with bleeding disorders on how to prepare and make things go more smoothly

More information

Living Donor Paired Exchange Registry I M NOT A MATCH FOR MY KIDNEY RECIPIENT. CAN I STILL HELP? Answers for Potential Kidney Donors

Living Donor Paired Exchange Registry I M NOT A MATCH FOR MY KIDNEY RECIPIENT. CAN I STILL HELP? Answers for Potential Kidney Donors Living Donor Paired Exchange Registry I M NOT A MATCH FOR MY KIDNEY RECIPIENT. CAN I STILL HELP? Answers for Potential Kidney Donors You have a lot of big questions. The Living Donor Paired Exchange Registry

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Pulmonary Embolism Note: The Canadian Drug Expert Committee (CDEC) previously reviewed rivaroxaban for the treatment of deep vein

More information

Illinois Bleeding and Clotting Disorders Institute 1 Glossary

Illinois Bleeding and Clotting Disorders Institute 1 Glossary Illinois Bleeding and Clotting Disorders Institute 1 AIDS (Acquired Immunodeficiency Syndrome) a disease caused by the human immunodeficiency virus (HIV), which attacks the body s immune system, making

More information

Your Guide to. Mild Hemophilia

Your Guide to. Mild Hemophilia Your Guide to Mild Hemophilia MILD HEMOPHILIA What is Hemophilia? Hemophilia is a bleeding disorder that prevents blood from clotting normally. Hemophilia is caused by a shortage or deficiency of one of

More information

The New Oral Anticoagulants: When and When Not to Use Them Philip C. Comp, M.D., Ph.D. Professor of Medicine, University of Oklahoma Health Sciences

The New Oral Anticoagulants: When and When Not to Use Them Philip C. Comp, M.D., Ph.D. Professor of Medicine, University of Oklahoma Health Sciences The New Oral Anticoagulants: When and When Not to Use Them Philip C. Comp, M.D., Ph.D. Professor of Medicine, University of Oklahoma Health Sciences Center September 25, 2015 Question: With which of the

More information

Breast Cancer. CSC Cancer Experience Registry Member, breast cancer

Breast Cancer. CSC Cancer Experience Registry Member, breast cancer ESSENTIALS Breast Cancer Take things one step at a time. Try not to be overwhelmed by the tidal wave of technical information coming your way. Finally you know your body best; you have to be your own advocate.

More information

National Physician Survey 2013

National Physician Survey 2013 National Physician Survey 2013 Backgrounder (October 23, 2013, Ottawa, ON) The National Physician Survey (NPS) is a major ongoing research project that gathers the opinions of physicians, medical residents

More information

WHAT ARE RARE CLOTTING FACTOR DEFICIENCIES?

WHAT ARE RARE CLOTTING FACTOR DEFICIENCIES? WHAT ARE RARE CLOTTING FACTOR DEFICIENCIES? Published by the World Federation of Hemophilia (WFH) World Federation of Hemophilia, 2009 The WFH encourages redistribution of its publications for educational

More information

The rare coagulation disorders. Dr. Klara Vezendi Szeged University Transfusiology Department

The rare coagulation disorders. Dr. Klara Vezendi Szeged University Transfusiology Department The rare coagulation disorders Dr. Klara Vezendi Szeged University Transfusiology Department The rare coagulation disorders are inherited abnormalities of hemostasis. Inheritance: autosomal recessive.

More information

Disability Living Allowance (DLA) for children with bleeding disorders

Disability Living Allowance (DLA) for children with bleeding disorders Disability Living Allowance (DLA) for children with bleeding disorders This factsheet gives an overview of DLA for children, together with guidance on completing the claim form and appealing a decision.

More information

Drug development for children: how adequate is the current European ethical guidance?

Drug development for children: how adequate is the current European ethical guidance? Chapter 7 Drug development for children: how adequate is the current European ethical guidance? ABSTRACT It is unacceptable that many drugs prescribed to children have not been proven safe and effective

More information

Stop the Bleeding: Management of Drug-induced Coagulopathy. Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery

Stop the Bleeding: Management of Drug-induced Coagulopathy. Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery Stop the Bleeding: Management of Drug-induced Coagulopathy Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery Objectives Discuss contemporary management of warfarin reversal in patients

More information

Patient Assistance Program Primer

Patient Assistance Program Primer Patient Assistance Program Primer Suzanne Lepage Private Health Plan Strategist Suzanne Lepage Consulting Inc. Kitchener, Ontario The opinions expressed in this presentation are those of the speaker. The

More information

GAO MEDICARE. Payment for Blood Clotting Factor Exceeds Providers Acquisition Cost

GAO MEDICARE. Payment for Blood Clotting Factor Exceeds Providers Acquisition Cost GAO United States General Accounting Office Report to the Ranking Minority Member, Subcommittee on Health, Committee on Ways and Means, House of Representatives January 2003 MEDICARE Payment for Blood

More information

Biologic Treatments for Rheumatoid Arthritis

Biologic Treatments for Rheumatoid Arthritis Biologic Treatments Rheumatoid Arthritis (also known as cytokine inhibitors, TNF inhibitors, IL 1 inhibitor, or Biologic Response Modifiers) Description Biologics are new class of drugs that have been

More information

Clinical Trials. I didn t know anything about clinical trials. I d never been in one before and just never thought of it. ~ Albert

Clinical Trials. I didn t know anything about clinical trials. I d never been in one before and just never thought of it. ~ Albert Clinical Trials Clinical Trials This brochure is for people making decisions about cancer treatment. You may be thinking about a clinical trial for you or your child but need to know more before you decide.

More information

Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs) Frequently Asked Questions (FAQs) Research Rationale 1. What does PrEP stand for? There is scientific evidence that antiretroviral (anti-hiv) medications may be able to play an important role in reducing

More information

Other treatments for chronic myeloid leukaemia

Other treatments for chronic myeloid leukaemia Other treatments for chronic myeloid leukaemia This information is an extract from the booklet Understanding chronic myeloid leukaemia. You may find the full booklet helpful. We can send you a copy free

More information

Global Database on Blood Safety

Global Database on Blood Safety Global Database on Blood Safety Summary Report 2011 1 Key facts Global Blood Collection: Around 92 million blood donations are collected annually from all types of blood donors (voluntary unpaid, family/replacement

More information

Emergency and out of hours care for patients with bleeding disorders Standards of care for assessment and treatment.

Emergency and out of hours care for patients with bleeding disorders Standards of care for assessment and treatment. Emergency and out of hours care for patients with bleeding disorders Standards of care for assessment and treatment. John Hanley 1, Mary Mathias 2, Emma Franklin 3, Chris Harrington 4, Oliver Chapman 5,

More information

Phase 1 Study of ALN-AT3 An Investigational RNAi Therapeutic for the Treatment of Hemophilia and Rare Bleeding Disorders.

Phase 1 Study of ALN-AT3 An Investigational RNAi Therapeutic for the Treatment of Hemophilia and Rare Bleeding Disorders. Phase 1 Study of ALN-AT3 An Investigational RNAi Therapeutic for the Treatment of Hemophilia and Rare Bleeding Disorders January 12, 2015 1 Agenda Welcome Cynthia Clayton Vice President, Investor Relations

More information

Alberta s chiropractors: Spine care experts Patient satisfaction and research synopsis

Alberta s chiropractors: Spine care experts Patient satisfaction and research synopsis www.albertachiro.com 11203 70 Street NW Edmonton, AB T5B 1T1 Telephone: 780.420.0932 Fax: 780.425.6583 Alberta s chiropractors: Spine care experts Patient satisfaction and research synopsis Chiropractic

More information

1/12/2016. What s in a name? What s in a name? NO.Anti-Coagulation. DOACs in clinical practice. Practical aspects of using

1/12/2016. What s in a name? What s in a name? NO.Anti-Coagulation. DOACs in clinical practice. Practical aspects of using What s in a name? Practical aspects of using DOACs (Direct Oral Anticoagulants) James L. Sebastian, MD, MACP Professor of Medicine (GIM) Medical College of Wisconsin February 5, 2016 DOAC NOAC NOAC ODI

More information

Reducing Overutilization of Orthopedic Surgeries: Knee Replacement and Arthroscopy

Reducing Overutilization of Orthopedic Surgeries: Knee Replacement and Arthroscopy Reducing Overutilization of Orthopedic Surgeries: Knee Replacement and Arthroscopy Kim W. Sloan, MD Orthopedic Surgeon Ann Correa, RN, OCN AllMed Healthcare Management Speaker Introductions Moderator Ann

More information

AUSTRALIAN BLEEDING DISORDERS REGISTRY

AUSTRALIAN BLEEDING DISORDERS REGISTRY AUSTRALIAN BLEEDING DISORDERS REGISTRY Annual Report 2011-12 With the exception of any logos and registered trademarks, and where otherwise noted, all material presented in this document is provided under

More information

Multiple Myeloma. This reference summary will help you understand multiple myeloma and its treatment options.

Multiple Myeloma. This reference summary will help you understand multiple myeloma and its treatment options. Multiple Myeloma Introduction Multiple myeloma is a type of cancer that affects white blood cells. Each year, thousands of people find out that they have multiple myeloma. This reference summary will help

More information

CANCER TREATMENT AND SUPPORT DRUGS

CANCER TREATMENT AND SUPPORT DRUGS POSITION PAPER: CANCER TREATMENT AND SUPPORT DRUGS November 2010 Executive Summary The Canadian Cancer Society, Manitoba Division is advocating for three changes that together would significantly improve

More information

Summary of the risk management plan (RMP) for Ofev (nintedanib)

Summary of the risk management plan (RMP) for Ofev (nintedanib) EMA/738120/2014 Summary of the risk management plan (RMP) for Ofev (nintedanib) This is a summary of the risk management plan (RMP) for Ofev, which details the measures to be taken in order to ensure that

More information

Delivering gene therapy to patients

Delivering gene therapy to patients Delivering gene therapy to patients FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements

More information

DRUG APPROVAL PROCESS FOR THE TREATMENT OF ALZHEIMER S DISEASE

DRUG APPROVAL PROCESS FOR THE TREATMENT OF ALZHEIMER S DISEASE Research DRUG APPROVAL PROCESS FOR THE TREATMENT OF ALZHEIMER S DISEASE There are certain principles that should be followed when involving people with Alzheimer s disease in research. For more information,

More information

Canadian Diabetes Association. 2015 Pre-Budget Submission. to the House of Common Standing Committee on Finance

Canadian Diabetes Association. 2015 Pre-Budget Submission. to the House of Common Standing Committee on Finance Canadian Diabetes Association 2015 Pre-Budget Submission to the House of Common Standing Committee on Finance August 2014 The Canadian Diabetes Association (the Association) is a registered charitable

More information

Investor News. Not intended for U.S. and UK media

Investor News. Not intended for U.S. and UK media Investor News Not intended for U.S. and UK media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer s Xarelto (Rivaroxaban) Approved for the Treatment of Pulmonary Embolism

More information

The one-stop prostate clinic: information for patients

The one-stop prostate clinic: information for patients The one-stop prostate clinic: information for patients What will happen in the clinic? Your doctor has referred you to the clinic because you have a raised PSA (prostate specific antigen), or an abnormal

More information

New Anticoagulants: When and Why Should I Use Them? Disclosures

New Anticoagulants: When and Why Should I Use Them? Disclosures Winship Cancer Institute of Emory University New Anticoagulants: When and Why Should I Use Them? Christine L. Kempton, MD, MSc Associate Professor of Pediatrics and Hematology and Medical Oncology Hemophilia

More information

Risk Management Plan (RMP) Guidance (Draft)

Risk Management Plan (RMP) Guidance (Draft) Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Pharmaceuticals and Medical Devices Agency Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour

More information