Regional and National Expert Centers as a Guarantor for Structural Quality in the Management of Rare Diseases

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1 Regional and National Expert Centers as a Guarantor for Structural Quality in the Management of Rare Diseases Renza Galluppi Barbon Presedent of UNIAMO Renza Barbon Galluppi October, 2nd

2 g1 Patient Organisations in UNIAMO FIMR onlus / / / / / /

3 Folie 2 g1 galluppi;

4 Is the national federation for Rare Disease Patient Organisation in Italy. A privileged partner for EURORDIS - the European Organisation for Rare Diseases Many national alliances belong to the Council of National Alliances (CNA) founded by Eurordis. In EURORDIS there are 16 National Alliances on Rare Diseases National rare disease alliances serve to bring together all the many rare disease groups in a particular country. Alliance members include large and small patient organisations as well as professional organisations, and liaise with government bodies, scientific and medical organisations on the subject of rare diseases.

5 Council of National Alliances (CNA), to work together on a European scale BELGIUM DANMARK FRANCE GERMANY GREECE RaDiOrg Belgium 2001 Rare Disorders DenmarkSjaeld ne Diagnoser 1995 Alliance Maladies Rares 2000 ACHSE 1999 PESPA ITALY UNIAMO HUNGARY HUFERDIS IRELAND GRDO NEDERLAND VSOP LUXEMBOURG ALAN asbl 1999 ROMANIA SPAIN SWEDEN RONARD FEDER 1999 Sallsynta diagnoser 1995

6 Policies on rare diseases FOCUSED ON Orphan drugs incentives Networks of centers of expertise

7 Policies on rare diseases TARGETED ON Patients Patients management rights protection

8 Complex health and welfare systems

9 1. Referral system 2. Vertical networks of expertise centers 3. Horizontal networks of local health services 4. Availability and accessibility of the treatment 5. Planning of resources and services 6. Palliative care 7. Monitoring system 8. Spreading knowledge and information

10 2001 The Italian Law on Rare Disorders STATED To plan a network of centres each dealing with a specific group of rare disorders To give specific benefits to the affected people To create ad hoc diagnostic and therapeutic guide-lines defining the limit of benefits To constitute area-based Registers focused on monitoring all patients

11 RD list Bound the benefit supplying to the patient together with the confirmation of diagnosis performed by few selected centres of reference THE ITALIAN LAW crucial points Oblige the Authority to define through a formal procedure Centres of Reference the for specified groups of rare diseases Institute Rare Diseases Registers

12 main mechanism CITIZENS AUTHORITY (government) Duty to define the network of Centres of Reference and to start up the system Advantage to obtain the exemption, that is to say entitlement to obtain the benefit of an health care completely free of charge ONLY if diagnosed and followed by the Centres of Reference

13 The Constitution was modified The Authority in charge of health planning REGIONS in charge to define the Centres of Reference and activate the whole System

14 VENETO 4.5 m inhab THE WIDE AREA 7 m inhab WIDE AREA & EMILIA &LIGURIA 13 m inhab 2008 WIDE AREA & EMILIA 11,5 m inhab 2006

15 All the Centers of Reference All the Hospitals All the Local Health Units A SINGLE COMPUTERIZED PLATFORM connecting All the pharmaceutical services

16 Diagnosis&Certification patient s identification Exemption benefits entitlement Benefits Allocation drugs, diet-therapy, prise en charge Registration case registration A UNIQUE SYSTEM UNIFICATION OF FOLLOWING PROCESSES

17 Unique Shared among all the Health System professionals involved in patient care Built and collected to serve the patient Supported by a single information technology platform BASED ON INFORMATION

18 MAIN STEPS TAKEN

19

20 The Italian Law on Rare Disorders-2001 NAMES or/& GROUPS 581 SPECIFIC DISEASES 2138 Nosological categories 131

21 Distribution 2138 of diseases Congenital malformations blood CNS immune sys. circulation infectious tumors muscoloskelata & connective genitourinary ocular 9 metabolic PNS endocrine digestive skin perinatal 9

22 PATIENTS 0-99 Ocular Congenital malformations Tumors 5 Immune sys. 4 Blood 14 Osteomuscular Connective ts 8 Metabolism 9 CNS 5 Circulation 3 PNS 6 Endocrine 5 Genitourinary 0 N=15134 Gastrointestinal 8 Skin 3 RD Register

23 2. centers

24 Selection of Health Care Centres of Expertise for Rare Diseases for every group of rare diseases Creation of a Health Care Network on Rare Diseases 2

25 2 WA YS Several indicators 1 (experience, research activity, patients associations links, diagnostic and therapeutic facilities, etc ) Number of patients followed by the centre estimated through the 2 utilization of the Hospital Discharge Records 1. Selection of ICD diagnoses 2. 3 years surveying 3. reconstruction of individual histories of each patient

26 Mandatory from 1975 Inpatient (ordinary & day-hospital) Payer different from editor Basis for compensation HOSPITAL DATA DISCHARGE Personal Wards Interventions REGISTER Diagnosis (5)

27 HDRs RD ICD-cod HDRs RD ICD-cod patients RD Patients

28 overall crude prevalence of rare disease calculated for the specific codes 5 per 1000 inhabitants

29 Several indicators 260 applications Hospital Discharge Records 9 Hospitals & few Centres

30 3. register

31 HEALTh organization Network of Centres of Expertise (BASIC RESEARCH & ADVANCED HEALTH CARE) charchterized by a wide body of users LINKED WITH VERTICAL NETWORKS ALL HEALTH CARE SERVICES WORKING where patients live HORIZONTAL NETWORKS

32 How does it work?

33 Hospital Discharge Register Rehabilitation flow Birth Register Death Register Current data flows Patient Centre of Expertise Diagnosis & Certification Patient s history Exemption Health districts Drugs GP Health districts Pharmaceutical Services Diet therapy Health districts Pharm. Services Clinical Record Referral Centre Primary Care Network GP Pharm. Services

34 AGE N= a 85-89a 80-84a 75-79a 70-74a 65-69a 60-64a 55-59a 50-54a 45-49a 40-44a 35-39a 30-34a 25-29a 20-24a 15-19a 10-14a 05-09a 01-04a 00a

35 PATIENTS 0-99 Ocular Congenital malformations Tumors 5 Immune sys. 4 Blood 14 Osteomuscular Connective ts 8 Metabolism 9 CNS 5 Circulation 3 PNS 6 Endocrine 5 Genitourinary 0 N=15134 Gastrointestinal 8 Skin 3 RD Register

36 Patients under 18 years osteomusc. connective tissue 1% visual s. 2% immunitarian s. 2% perinatal pat. 1% genito-urinary 0% circulation 3% nervous system 5% cong. malform. 28% digestive s. 7% blood 12% endocrine s. 12% tumours 12% metabolism 15%

37 Patients years metabolism 4% tumours 4% endocrine s. 3% skin 2% circulation s. 1% infective dis. 0% genito-urinary 0% immunitarian s. 5% blood 26% cong. malform 5% digestive s. 8% osteomusc. connective tissue 8% nervous s. 15% visual s. 19%

38 Patients over 40 years circulation 2% endocrine s. 2% cong. malform 4% tumours 2% immunitarian s. 5% metabolism 4% infect. dis. 1% genito-urinary 1% nervous s. 19% digestive s. 7% skin 8% blood 16% osteomusc. connective tissue 15% visual s. 14%

39 Hospitalization periodo rate tasso Admission ricovero rate pazienti rare disorders Malattie patients Rare 1,003 tasso General ricovero admission popolazione rate 0,430 Pazienti Rare disorders Malattie Rare patients ricoveri Admissions specifici rate due to rare disorder 0,457 comorbidità Admissions rate due to comorbidity 0,394 0,546 intercorrenti Admission rate due to occasional pathologies 0,152 Popolazione Population Morbidità Admisison rate due to whole morbidity 0,343 intercorrenti Admission rate due to occasional pathologies 0,087 Osservato Observed-expected / Atteso Morbidità Admissionaggiuntiva rate due other causes (excl. RD) 1,148 1,6 intercorrenti Admission rate due to occasional pathologies 1,746 1,8

40 Rehabilitation rate: 48%

41 Rare diseases lead to: Medium-severe disabilities: 61% Chronicity: 90% A long terminally ill phase: 10%

42 Nearly never aetiologic Nearly never healing TREATMENT

43 Translating law to reality tailor-made on the patient and his-her family changing as years and situations roll by draw a health care plan assure continuity among centre, local hospital, local health services and place of life of the person Prise en charge

44 Health plan depends on Health care NeedS

45 Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Centred on the health-care problem Diagnostic assessment

46 Diagnostic assesment From disease To impairment profile From impairment To functioning From functioning To activities (what he can do, what he is expected to do, what he wants to do) From activity To life environment (family, school, work )

47 Diagnostic assessment supports the intervention plan

48 MULTIDISCIPLINARY MULTISECTORIAL Interventions comprehend medical treatment BUT Also: social, educational, emotional, cultural dimensions MULTIDIMESIONAL

49 Has to support Maximum development/dignity/social Inclusion/Non-discrimination/ Quality in survival Prise en charge

50 Health care plan is based on a health and social organization that links centres to local health and life places (vertical network) links several institutions and dimensions of local community (horizontal network) allows for each patient the immediate access to the available care (equity, effectiveness)

51 Family centred Bare in mind the patient s suffering Specific, unique and dynamic health care plans Each professional is a small part of a bigger system

52 REGIONAL REGISTER FOR RARE DISEASES pfacchin ITALY, VENETO REGION

53

54 Reference Centre

55 Personal Therapy Plan Reference Centre

56 Clinical record summary

57 web based information flow Internet (SSL) GLOBAL DATA BASE Mod.1.01 Immunodeficiencies Centro Operativo AIEOP Data Review Committee Internet (SSL) Centro di PID Responsibility for data collection and registry update: Centro Operativo AIEOP e Data Review Committee A.Pession R.Rondelli A.Soresina

58

59 - RD list WEARNESSES 279/2001- crucial points -To create ad hoc diagnostic and therapeutic guide-lines defining the limit of benefits -Oblige the Authority to define through a formal procedure Centres of Reference the for specified groups of rare diseases

60 Our Mission: Offer to all patient organizations the opportunity of being listened to, regardless of the frequency of the interested pathology Become an active subject in the decision making process within the scope of the Programma Sanitario Nazionale (National health programme) Improve and help the growth of international cooperation among patient organizations to ensure common aims and working methods Obtain equality of treatment for all different diseases and in all different countries

61 The International Rare Disease Day launched by Eurordis promotes a Rare Disease Culture Creating new synergies Pavia, Roma, ottobre settembre

62 UNIAMO FIMR onlus Advocacy through cooperation with other organisations Signed in Venice on 3rd July 2009 Memo of Understanding Between : UNIAMO FIMR onlus & SIP SIMGEPED- FIMP SIMG FMMG SIGU & FARMINDUSTRIA Objective: To provide professional training and refreshing courses in all Italian regions within 3 years Target Groups: General Practitioneers, pediatric doctors, social counsellors empowerment

63 A Patient centered Model Rare diseases A Public Health Issue Roma, 7 ottobre 2009

64 Iscrizione n. 102 Del Registro nazionale A.P.S. Associazioni di Promozione Sociale Fondata a Roma il 3 luglio 1999 La FEDERAZIONE ITALIANA delle associazioni di pazienti affetti da patologie rare da sempre impegnata nella tutela dei diritti e nel miglioramento della qualità della vita del paziente e della sua famiglia Associazioni federate: G R A Z I E A.L.T. Ass. Lotta alla Talassemia di Ferrara - A.T.D.L. Ass. Talassemici Lombardi - A.MA.PO. Onlus Ass. Malati di Porfiria - Ass.VISUS Retinite pigmentosa e ipovisione - AISAC Ass. per l'informazione e lo Studio dell'acondroplasia. - A.F.A.D.O.C. Ass. Famiglie di soggetti con Deficit dell'ormone della Crescita e altre patologie - A.I.C.I. Ass. Italiana Cistite Interstiziale - A.P.M.M.C. Ass. Prevenzione Malattie Metaboliche Congenite - PXE ITALIA Ass. PseudoXantoma Elastico - A.I.P. Ass. Immunodeficienze Primitive - LES Gruppo lotta al Lupus Erimatoso Sistemico - A.I.L.U. Ass. It. Leucodistrofie Unite - A.S.T. Ass. Sclerosi Tuberosa - AIMEN Ass. Neoplasie Endocrine Multiple Tipo 1 e 2 - A.M.R.I. Ass. per le Malattie Reumatiche Infantili - Ass. Naz. ALFA 1 AT - I.A.G.S.A. International Aicardi-Goutières Syndrome Association - I.A.L.C.A. Italian Association Leber Congenital Amaurosis - A.R.D. Toscana Ass. per la Ricerca sulla DISTONIA - ANIDI Ass. Naz. Diabete Insipido - UNITI Unione Italiana ITTIOSI Ass. It. Sindrome di WILLIAMS - UNITASK Unione Italiana Sindrome di Klinefelter - A.I.LAM Ass. It. Linfangioleiomiomatosi - G.I.L.S. Gruppo Italiano Lotta alla Sclerodermia - AS.IT.O.I. Ass. It. Osteogenesi Imperfetta A.I.M. Ass. It. Miopatie Rare - AT Ass. Nazionale Davide De Marini - A.N.A.N.A.S. Ass. Nazionale Aiuto per la Neurofibromatosi, amicizia e solidarietà - I.R.I.S. Ass. Siciliana Malattie Ereditarie Metaboliche - A.I.S.M.E. Onlus Ass. It. Studio Malformazioni Epilessia - LAGEV Libera Ass. Genitori ed Emofilici del Veneto "Antonio Valiante" - AIdel 22 Ass. It. Delezione del Cromosoma 22 - A.I.M.A.R. Ass. It. per le Malformazioni Anorettali - Ass. It. Sindrome di Rett - Ass. It. FAVISMO - KOROS Ass. per la ricerca e la prevenzione delle malattie Oculari infantili - U.M.A.R. onlus Unione Malattie Rare - Ass. RETE MALATTIE RAREonlus - AIST Ass. It. Sindrome di Tourette - AISP Ass. It. Sindrome di Poland Ass. It. Malattia di Niemann Pick - Ass. FOP Italia Fibrodisplasia Ossificante progressiva - AISNAF Ass. It. Sindromi Neurodegenerative da Accumulo di Ferro - AIFP Ass. It. Febbri Periodiche - AISMME Ass. It. Studio Malattie Metaboliche Ereditarie - Fondazione Italiana HHT Onilde Carini - ASNIT Ass. Sindrome Nefrosica Idiopatica onlus - ACAR Ass. Conto Alla Rovescia onlus D.E.B.R.A. It. Ass. per la Ricerca sull'epidermolisi Bollosa onlus - Progetto Alice lotta alla Sindrome Emolitico Uremica Ass. Sindrome di Crisponi e Malattie Rare - A.S.C.E. Ass. Sarda Coagulopatici Emorragici - Angeli Noonan onlus Ass. It. Sindrome di Noonan - Ass. IL CIGNO Sindrome Craniostenosi - ANAA Ass. Nazionale Alopecia Areata - Ass. Estrofia Vescicale onlus - A.I.B.E.D. onlus Ass. It. Bambini con ernia Diaframmatica congenita - Ass. LA VITA E' UN DONO Acidemia Propionica - AMEI Ass. Malattie Epatiche Infantili ASIMAS Ass. It. Mastocitosi - AEL Ass. Emofilici del Lazio - SOD Italia Ass. Displasia Setto-ottica e Ipoplasia del nervo ottico - Ass. Amici dell'emofilia - ANFISC Ass. Nazionale Fibromialgia, - CFS, Encefalomielite Mialgica Ass. It. Sindrome X Fragile onlus - Ass. CISTINOSI - L'A.P.E. onlus Ass. PKU - Comitato It. Progetto Mielina - BA.CO.DI.RA.ME Ass. del Bambino con disordini rari del metabolismo - AISC Ass. It. Sindrome di Costello - LA GEMMA RARA onlus Malattie genetiche rare - A.Ma.HHD onlus Ass. Malattia di Hailey Hailey Disease - LA NUOVA SPERANZA Lotta alla Glomerulosclerosi Focale - AID onlus Kartagener Ass. It. Discinesia Ciliare Primaria ASMARA onlus Sclerodermia E. Giuffrè AIMW Ass.it. Wowat Wilson SOFT Italia Trisomie 13-18

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