Therapeutic Apheresis in South America

Transcription

1 Therapeutic Apheresis in South America Alfredo Mendrone Jr, MD, PhD Fundação Pró-Sangue Hemocentro de SP / University of São Paulo São Paulo - Brazil

2 Therapeutic Apheresis in Brazil The beginning... Late 80 s No more than five public Hospitals Equipment types Vivacell DIDECO V30 - HAEMONETICS University of São Paulo Vivacell DIDECO LDL apheresis device (KANEKA) A few procedures monthly

3 Therapeutic Apheresis in Brazil The Beginning... In the 90 s, other apheresis units were created in blood banks along the country It was due time to overspread the benefits of the therapeutic apheresis procedures to other centers and among physicians. How? Inserting topics in the field of apheresis at the Annual National Congress of Hematology Organizing symposia about apheresis medicine in different parts of the country Training professionals involved with the apheresis procedures Presenting lectures and contributing in programs of hematology residents in the field of apheresis medicine

4 Therapeutic Apheresis in Brazil The Beginning... Participating in annual meetings of other specialties and participating in discussions with many other medical specialists about apheresis applications and complications, in order to share our experience. Stimulating all medical centers to develop standardized operatinational procedures in apheresis field Taking part in discussions about increment in the reimbursement of the procedures to make it more and more accessible Participating and contributing with the elaboration of federal regulations related to transfusion procedures, including apheresis

5 Therapeutic Apheresis in Brazil Current Situation... We have a specific regulation for apheresis (therapeutic and non therapeutic procedures) The indication of the procedures as well as the planning of therapeutic program for the patient must be discussed with the hematologist of the blood bank The hematologist will be the responsible for the procedures The blood bank must have standardized operational procedures related to apheresis, defined and written The blood bank must register every significant data about the procedure Reimbursement of each therapeutic apheresis procedures = US$ 75,00 disposables, equipment, staff, etc (without the replacement fluid)

6 BRAZIL = 26 States and 01 Federal District 05 Regions (N, NE, SE, S, MW) Public 72% Private 28%

7 Therapeutic Apheresis in Brazil and South America Current Situation... In order to obtain a general overview of apheresis activity in Brazil and South America, we developed two different surveys Brazil = A questionnaire was sent to every public regional coordinator blood bank in Brazil, asking about their apheresis activities and difficulties. 32 questionnaires were sent out : 21 out of 32 (65%) were responded accordingly South America = Other questionnaire was developed and sent out to Societies of Hematology in South America 09 questionnaires were sent out to Argentina, Chile, Colombia, Equator, Peru, Venezuela, Bolivia, Uruguay and Paraguay We got some feedback from Argentina, Chile, Colombia, Equator, Uruguay and Venezuela (66%) We have consulted companies that sell apheresis kits in Brazil and South America: TERUMO BCT, FRESENIUS AND CEI (HAEMONETICS).

8 Therapeutic Apheresis in Brazil and South America Current Situation... The questionnaires were sent out in December/2013 and the responses were received by February/2014 The forms were similar and basically requested information about the procedures and devices The answers were sent by either fax or The data that will be presented here are the results of these two surveys The participation was completely voluntary

9 Therapeutic Apheresis in Brazil Current Situation... In 2013, a total of 5,224 therapeutic apheresis procedures were performed in public blood banks in Brazil 4,162 Plasma Exchanges 877 Extracorporeal Photoapheresis 122 RBC Exchanges 46 Leukapheresis 17 Platelet Apheresis

10 Therapeutic Apheresis in Brazil Current Situation... 4,6% 16,8% 79,6%

11 Regional Distribution 5,0% From a total of 4,162 plasma exchanges performed 2,435 in Southeast 911 in South 593 in Northeast 221 in North Only 2 in Midwest 0% 59% 22% 14%

12 Therapeutic Apheresis in Brasil Current Situation... The top 6 diagnoses treated by plasma exchange DISEASE Thrombotic Thrombocytopenic Purpura Neuromyelitis optica of Devic Myasthenia gravis Guillain-Barré Syndrome (before IgG) Severe Cryoglobulinemia Antibody-mediated rejection - renal transplantation ASFA CATEGORY I II I I I I

13 Therapeutic Apheresis in Brazil Current Situation... On average, 3 4 liters of plasma were removed during each plasma exchange procedures Replaced by equal volume of replacement fluid (1 x 1) Albumin solution 4-5% in the most of diseases FFP for TTP or HUS Electrolyte solution Cryosupernatant plasma was rarely used, only in some cases of thrombotic microangiopathy that had not responded to FFP

14 Therapeutic Apheresis in Brasil Current Situation... Red Blood Cell Exchanges were performed 122 times 100% in patients with Sickle Cell Disease Treatment of acute complications Prophylaxis for stroke prevention Preoperative management Therapeutic apheresis for cytoreduction was performed 63 times 46 leukocytapheresis in hyperleukocytosis 17 plateletpheresis in thrombocytosis

15 Therapeutic Apheresis in Brasil Current Situation... DEVICES FOR PERFORMING THERAPEUTIC APHERESIS PROCEDURES NUMBER % HAEMONETICS MCS TERUMO SPECTRA FRESENIUS COM.TEC 8 15 TERUMO OPTIA 4 7 FRESENIUS AS TOTAL 55

16 Therapeutic Apheresis in Brazil Current Situation... Extracorporeal Photoapheresis was performed 877 times For chronic GVHD treatment Number of Equipment = 9 (97 procedures for each machine / year) Neither Immunoadsorption nor LDL apheresis was reported in Brazil during the last year

17 Therapeutic Apheresis in Brazil Current Situation... Stem cell collection 3,137 Procedures For both autologous and allogeneic progenitor hematopoietic cell transplantation Device most frequently utilized: Spectra TERUMO BCT

18 Therapeutic Apheresis in Brazil Conclusions We still don't have regular and formal reports of activities in apheresis medicine Voluntary reporting is the major impediment to data collecting This was the first nationwide survey performed in Brazil to gather information about apheresis activities We believe that the number of apheresis procedures were underreported due to: the short time we counted on between sending the questionnaires and getting them answered on due date; the private system and a few independent public blood banks were not included in the survey.

19 Therapeutic Apheresis in Brazil Conclusions Despite the number of underreported procedures, we believe that this survey is representative concerning the public apheresis scenario because we were able to obtain data from the biggest public regional coordinator blood banks in the country It became clear that there are big gaps among different geographic regions The main difficulties and challenges to conduct these procedures are related to the poor reimbursement taking.

20 ARGENTINA Therapeutic Apheresis in South America Current Situation... Where = Many centers (Buenos Aires, Chaco, Cordoba, Corrientes, Mendonza, Nuequén, Rio Negro, San Juan, Santa Fé, Tucuman) Therapeutic procedures = 2,318 PE = 2,059 RBC exchange = 172 Cytoreduction = 87 Stem Cell Collection = 576

21 COLOMBIA Therapeutic Apheresis in South America Current Situation... Where = Many centers around the country Plasma Exchange = 1,600 (TTP, GBS, Poisoning) Stem Cell Collection = 550 There is a specific legislation for blood banks in which is included apheresis Responsibility = Hematologist and Nefrologist (many apheresis procedures are performed with devices developed for dialysis) Challenge = Reimbursement

22 Therapeutic Apheresis in South America Current Situation... CHILE Where = Many centers along the country Therapeutic Apheresis = 1,300 PE = 1,171 PE (TTP, SGB, Renal Transplantation) RBC Exchange = 0 Cytoreduction = 63 Extracorporeal Photoapheresis = 66 Stem Cell Collection = 200 Equipment type Terumo Spectra = 18 Haemonetics MCS+ = 13 Terumo Optia = 4 Fresenius Com.Tec = 2 Amicus = 2

23 Therapeutic Apheresis in South America Current Situation... EQUATOR Where = Red Cross Ecuatoriana, Seguro Social, Hospital Oncologico Solca, Serhem, Omnihospital, Idytes Plasma Exchange = 400 (Guillain-Barré Syndrome, TTP, Renal transplantation) Stem Cell Collection = 60 Reimbursement = US$ 315,00 / procedures There is no specific legislation for apheresis Responsibility = Hematologist, Neurologist, Surgeons Challenge = Educational programs in apheresis

24 VENEZUELA Therapeutic Apheresis in South America Current Situation... Where = Many centers around the country Plasma Exchange =? Stem Cell Collection = 80 There is no a specific legislation for apheresis Responsibility = Hematologist Challenge = Reimbursement

25 URUGUAY Therapeutic Apheresis in South America Current Situation... Where = 14 centers Therapeutic apheresis = 82 procedures PE = 48 Cytapheresis = 34 Stem Cell Collection = 45 There is no a specific legislation for apheresis Responsibility = Hematologist

26 Therapeutic Apheresis in South America Current Situation... Country Therapeutic Apheresis Stem Cell Collection Brazil 5,224 3,137 Argentina 2, Colômbia 1, Chile 1, Peru Equador Venezuela? 80 Uruguay Total 11,524 4,748

27 Therapeutic Apheresis in South America Conclusions We received 06 responses from South America (66%) Probably the short time we counted on between sending the questionnaires and getting them answered on due date contributed for the low number of responses No data from Paraguay and Bolivia The results of the survey lead to the conclusion that not only Brazil but also all the countries we collected data from don't have systematic and continuous registration of activities in apheresis medicine Main difficulties and challenges reported were lack of educational programs and appropriate reimbursement

28 ACKOWLEDGMENTS Brazilian Public Blood Banks: São Paulo, Campinas, Ribeirão Preto, São José do Rio Preto, Botucatú, Marilia, Rio de Janeiro, Paraná, Santa Catarina, Rio Grande do Sul, Ceará, Pernambuco, Sergipe, Alagoas, Amazonas, Bahia, Mato Grosso, Mato Grosso do Sul, Pará e Piauí Argentina, Colombia, Chile, Equator, Venezuela and Uruguay CEI Fresenius Terumo BCT

29 São Paulo THANK YOU