Antigen -Antibody Interactions Principles and Applications

Pathology

1. Autoimmune Disease Awareness Month News Briefing: The Status of Autoimmune Disease March 18, 2014 National Coalition of Autoimmune Patient Groups (NCAPG) 1

2. Agenda Bob Goldberg NCAPG, The National Coalition of Autoimmune Patient Groups ADAM, Autoimmune Disease Awareness Month Virginia Ladd What are Autoimmune Diseases? Stephanie Hales The NCAPG Accountable Care Act Survey Results Stanley Finger The need for Physician Education Aaron Abend The Autoimmune Disease Registry 2

3. National Coalition of Autoimmune Patient Groups (NCAPG) 3

4. National Coalition of Autoimmune Patient Groups (NCAPG)   Mission Statement To consolidate the voice of autoimmune disease patients and to promote increased education, awareness, and research into all aspects of autoimmune diseases through a collaborative approach. 4

5. NCAPG Members American Autoimmune Related Diseases Association American Behçet's Disease Association American Vitiligo Research Foundation APS Foundation of America Arthritis Foundation Celiac Disease Foundation Celiac Sprue Association Coalition for Pulmonary Fibrosis Crohn's and Colitis Foundation of America Dysatonomia International Endometriosis Association Gluten Intolerance Group Graves’ Disease Foundation International Foundation for Autoimmune Arthritis International Pemphigus & Pemphigoid Foundation Lupus Foundation of America 5

6. NCAPG Members Lupus Foundation of Mid and Northern New York Myasthenia Gravis Foundation of America National Adrenal Diseases Foundation National Alopecia Areata Foundation National Kidney Foundation National Multiple Sclerosis Society National Psoriasis Foundation National Sleep Foundation P.A.N.D.A.S. Network.org Platelet Disorder Support Association Scleroderma Foundation Sjögren's Syndrome Foundation The Myositis Association Transverse Myelitis Association U.S. Pain Foundation Vasculitis Foundation Vitiligo Support International 6

7. March is Autoimmune Disease Awareness Month Unmet needs impacting on autoimmune patients Affordable Care Act (ACA) Delayed diagnosis Physician education Awareness No multiple specialty center of excellence No autoimmune disease registry 7

8. Thank you! 8

9. What are Autoimmune Diseases? 9

10. Autoimmune diseases are the result of a misdirected immune system that causes one’s own immune system to attack the self 10

11. Autoimmunity at a Glance Over 100 diseases Affecting 50 million Americans Costing over $120 billion annually 250,000 new diagnoses each year A major cause of death in women 11

12. Autoimmune disease can affect any part of the body 12

13. 13

14. Thank you! 14

15. ACA Survey National Coalition of Autoimmune Patient Groups (NCAPG) 15

16. Framing Thoughts Overview of this survey and why NCAPG conducted it The power and importance of advocacy 16

17. Age & Sex of Survey Respondents Reflects the disproportionate impact of autoimmunity on women 17

18. What conditions were you diagnosed with? Disease # Respondents Addison's Disease 97 Hashimoto's disease 32 Rheumatoid arthritis 23 Crohn's disease 22 Fibromyalgia 19 Sjogren's Disease 19 Lupus (SLE) 18 Graves' disease 12 Ulcerative Colitis 11 Autoimmune thyroid disease 9 Other AD 95 No Response 81 Non AD 43 18

19. Were you insured prior to the ACA? 19

20. If you were uninsured prior to the ACA, was it due to having a preexisting condition or being unable to afford a premium? 20

21. If you were previously uninsured, were you able to enroll in the ACA? 21

22. When the ACA became effective, did you have to select a new plan? 22

23. Has your premium increased? 23

24. Has your deductible increased, decreased or remained about the same after enrolling in the ACA? 24

25. Has your coverage increased, decreased or remained the same in the services important to you? 25

26. Has the price of your prescriptions increased, decreased or remained the same? 26

27. Were you able to keep the same prescriptions that you had prior to the ACA? 27

28. Have you suffered adverse reactions due to drug changes? 28

29. Were you able to keep the same specialists through the ACA? 29

30. Do you have concerns about the accessibility of specialists under the ACA? 30

31. Were you better off before or after the ACA? 31

32. Responses Reflect Some Improvements, but a Strong Need for Continued Advocacy “I believe the ACA is a step in the right direction. Improvements are necessary, for instance out of network options.” “I love ACA. I am now getting the help and medications I needed, plus test confirms ... not [rheumatoid arthritis] as first suspected ... [mixed connective tissue disease].” “[M]y employer had to change or insurance provider. Now I pay higher premiums, higher copays, and three of my specialists are no longer on our new plan.” “I was adversely affected when my former employer switched to a high deductible [health plan] when anticipating the premium jump ACA would cause.” 32

33. Thank you! 33

34. AARDA Autoimmune Disease Diagnosis Surveys 34

35. AD Diagnosis Takes an Inordinate Amount of Time and Perseverance Survey Issues 1996 2001 2006 2013 Years to Diagnosis 5 4 4 4 No. Physicians Seen 6 4 4 5 Labeled Chronic Complainer 64% 45% 45% 51% 35

36. Years to Diagnosis 36

37. Number of Doctors Seen to get a Diagnosis 37

38. Percent told their disease was imagined or they were overly concerned … 38

39. Why so Long and Difficult to Get a Correct Diagnosis? Physician Education was identified as a contributing factor. 39

40. AARDA Conducted a Survey of Physicians AARDA participated in an educational workshop attended by 130 family physicians. Participants were asked to participate in a survey on the extent of their knowledge of autoimmune diseases. The survey results prompted a larger ongoing study. 40

41. In medical school, how much training in autoimmune diseases did you receive? 41

42. Would you agree that you received enough training to diagnose and treat autoimmune disease? 42

43. What is your level of comfort in diagnosing autoimmune disease? 43

44. Strategic Goal AARDA is conducting a larger study to determine: Level of physician education Physicians’ preferred way of continuing education With the goal of developing A syllabus for medical school A Continuing Medical Education program for autoimmune diseases 44

45. Public Awareness also contributes to the problem Awareness Study GFK randomly surveyed 1000 Americans Study is conducted every five to seven Years to measure progress 45

46. Public Awareness of Autoimmune Diseases 1992 2001 2008 2013 Correctly name an autoimmune disease 5% 6% 13% 15% Thought AIDS was an autoimmune disease 93% 38% 32% 21% 46

47. Need for a Multiple Specialist Center of Excellence for Diagnosing and Treating Autoimmune Diseases A patient Survey Would you travel to a center to get diagnosed ? Yes - 75% No - 25% 47

48. Travel to a Center for: (may select more than one) Second opinion 69.7% Specialized treatment 86.5% Coordinated care 76.9% 48

49. Improved Autoimmune Disease Diagnosis Requires Increased Physician education Increased Public Awareness Autoimmune Disease Multi-Specialist Center 49

50. Return on Investment Fewer chronic disabilities Less human suffering Dramatic reduction in AD healthcare costs 50

51. Thank you! 51

52. The Autoimmune Disease Registry 52

53. In the US today, there are 13,027,914 individuals with cancer How many have autoimmune disease? 9 million? 23 million? 50 million? 53

54. What is goal of the Autoimmune Disease Registry? A system that can count every patient suffering from an autoimmune disease. It will encompass data already collected by individual disease registries, but it will not supplant those registries It will be used for: Research - for cohort discovery and some population research Public health reporting It will not be used for: Fundraising Patient treatment It will be the SEER system for Autoimmune Disease 54

55. What do SEER & NAACCR do for Cancer? Surveillance , Epidemiology, and End Results Program (SEER) The premier source for cancer statistics in the United States; Provides information on cancer statistics in an effort to reduce the burden of cancer among the U.S. population. The North American Association of Central Cancer Registries A professional organization that develops and promotes uniform data standards for cancer registration Provides education and training; Certifies population-based registries; Aggregates and publishes data from central cancer registries; Promotes the use of cancer surveillance data and systems for cancer control and epidemiologic research, public health programs, and patient care to reduce the burden of cancer in North America. 55

56. 56

57. 57

58. 58

59. 59

60. 60

61. 61

62. 62

63. 63

64. 64

65. 65

66. The ADR can accomplish the following Provide a central resource for recruitment of patients for clinical trials; Provide statistics on the burden of AD on public health; Provide statistics on multiple-disease sufferers; Provide consolidated statistics that can transform the image of AD as a large number of unrelated and mostly rare diseases to something similar to Cancer – a single disease with a variety of sometimes common, sometimes rare manifestations . 66

67. Proposed Milestones Short Term Take results from the current survey and put them into a database for ad hoc query by NCAPG members; Establish data standards for AD similar to those established by NAACCR for Cancer; Provide support to NCAPG members to make their own data accessible to researchers and prepare it for participation in a national network (including addressing the patient consent necessary to accomplish this goal); Long Term Establish protocols for research using the ADR, including an IRB and an Honest Broker (an individual tasked with distributing data pursuant to IRB authorization); Develop a reporting website like SEER for AD (see http://seer.cancer.gov/data/ ) Identify sources of ongoing funding for the ADR and submit proposals to promising sources . 67

68. Next Steps Establish a governing process for NCAPG oversight and control of the registry Establish protocols for data handling and use Begin to aggregate de-identified NCAPG data Create a central query resource for de-identified AD Data Engage with NIH and others to bring all AD under a single umbrella, like Cancer 68

69. Thank you! 69

70. Autoimmune Disease Awareness Month News Briefing: The Status of Autoimmune Disease March 18, 2014 National Coalition of Autoimmune Patient Groups (NCAPG) 70