Post on 11-Jan-2017
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Plasma zur Fraktionierung(PzF) in Europa
Helmi Storch
Haemo- Consult D-98596 Brotterode-Trusetal
nach einem Vortrag ECA-Seminar 9.-10. April 2013, Vienna, Austria ARGE Plasmapherese, Magdeburg 23.November 2013
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Übersicht § Konzept Europäische Selbst Versorgung (SS) § „Driving“ Faktoren für Plasma Proteine (PP) § SS in Europe mit PzF und PP § Plasmapherese(PPH) der Schlüssel zur SS § Zusammenfassung § Ausblick
PzF in Europa
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Konzept der Europäischen SS EU Council entscheidet sich für ein Konzept „European Self Sufficiency Programme“ for blood
products * Gründe: Plasma Defizit seit Jahrzehnten,
Abhängigkeit von Importen von Source Plasma aus den USA. Die epidemiologische Situation kann einen kurzzeitigen Wechsel der Orte der Plasmagewinnung bedingen (HIV in den USA in den 80ern) * Council Directive 14.6.1989,Official Journal of the European Communities (89/381/EEC)
PzF in Europa
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„Driving“ Faktoren . Albumin war der „driver“ für PzF in den 70ern . Faktor VIII war der „driver“ bis zum Ende der 90er . Seit Ende der 90er sind Immunoglobuline (IVIG/SCIG) die „driver“
PzF in Europa
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„Driving“ Faktoren Globaler Verbrauch von IVIG/SCIG 1984 7,41 Tonnen 1994 27,74 Tonnen 2004 58,82 Tonnen 2010 94,89 Tonnen seit 2010 = 7% globales Wachstum /Jahr
PzF in Europa
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PfF in Europe
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„Driving“ Faktoren Verbrauch von IVIG/SCIG in Deutschland* 2010 2.690 Kg 2011 4.900 Kg 2012 5.321 Kg seit 2010 97% Wachstum *PEI- Berichte entsprechend § 21 TFG
PzF in Europa
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Selbstversorgung (SS) . Unzureichende Daten zur Bereitstellung und Verbrauch von PP in Europa (einige Länder haben nationale Daten) . Letzte Datenbasis: Council of Europe,2013 veröffentlicht
EDQM Reports 2009/2010 .The collection,Testing and Use Blood and Blood Components in Europe.*
. European Commission beauftragte Creativ Ceutical im Mai 2012 eine EU Übersicht des Markts von Blut, Blutkom- ponenten und Plasmaderivaten zur Verfügbarkeit für Patienten zu erstellen.(keine Daten derzeit verfügbar) • *Not yet published. Acknowledgment: I am grateful to M.P.Janssen,C.L.van der Poel and
M.-E.Behr-Gross,EDQM, who provided data for inclusion in my presentation.
PzF in Europa
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SS 1989 -2008(1)* nach 4 Jahren . There is still a significant deficit in the European plasma supply esp. in southern and eastern Europe . Health authorities believe that SS is an attainable goal within 5-10 years . Representatives of the plasma industry do not believe that SS can be attained without commercial plasmacenters and compensated donors * Piet J. Hagen, Blood transfusion in Europe: a „white paper“,Council of Europe Press, 1993
PzF in Europa
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SS 1989-2008(2)* in 2000(nach 11Jahren) § Belgium 200,000 L 19.63/1,000 inhabitants § France 524,172 L 8.87/1,000 inhabitants § Germany 1,555,000 L 18.94/1,000 inhabitants § Italy 456,000 L 8.04/1,000 inhabitants § Netherlands 233,000 L 14.67/1,000 inhabitants § Spain 250,000 L 6.37/1,000 inhabitants § Sweden 234,000 L 26.17/1,000 inhabitants § UK and Portugal zero 59,247,400/9,902,100 population * Patrick Robert (2002).Personal communication. Blood Collection and Transfusion in 13 European Countries.
The Marketing Research Bureau Inc.,284 Racebrook Road Orange,CT 06477,USA
PzF in Europa
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SS 1989-2008(3)* in 2008(nach 19 Jahren) § Belgium 163,089 L 15.53/1,000 inhabitants <as 2000 § France 769,931 L 12.04/1,000 inhabitants >as 2000 § Germany 2,526,637 L 30.81/1,000 inhabitants >as 2000 § Italy 648,000 L 10.80/1,000 inhabitants >as 2000 § Netherlands 225,557 L 13.67/1,000 inhabitants <as 2000 § Poland 46,582 L 1.22/1,000 inhabitants n.d.before § Sweden 113,419 L 12.25/1,000 inhabitants <as 2000 § Greece 15,402 L 1.47/1,000 inhabitants n.d.before * EDQM,2008 Report “The Collection,Testing an Use of Blood and Blood Components in Europe“.Table 4.
Issued 2011
PzF in Europa
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SS 2001, 2008* and 2010(4)** L/ /1,000 Inhabitants § Belgium 23.54 > 15.53* <16.16** 65% RP** § France 7.78 < 12.04* <13.14** 74% RP** § Finland 14.42 > 12.87*<14.58** 91% RP** § Italy 7.95 < 10.80*<12.04** 65% RP** § Netherlands 16.67 > 13.67*<20.34** 44% RP** § Spain 5.56 < 7.29*< 8.29** n.d.available § Sweden 23.04 > 12.25*> 11.42** n.d.available § Germany 20.41 < 30.81*< 35.30** 37% RP** § Czech Republic 6.17 < 24.01*< 52.38** 10% RP**
* EDQM,2008 Report “The Collection,Testing and Use of Blood and Blood Components in Europe“Table4 issued 2011 ** EDQM,2010 Report. Table 4.1.Not yet published. See acknowledgment slide 8
PzF in Europa
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SS IVIG 1989-2008(5)* in 2008 § Belgium 97.1g/1,000 inhabitants SS=47% § France 79.3g/1,000 inhabitants SS=45% § Finland 70.4g/1,000 inhabitants SS=54% § Italy 52.5g/1,000 inhabitants SS=61% § Netherlands 57.8g/1,000 inhabitants SS=71% § Spain 52.7g/1,000 inhabitants no data available § Sweden 93.8g/1,000 inhabitants SS=39% § UK 46,1g/1,000 inhabitants SS= zero * Patrick Robert.The Marketing Research Bureau Inc.,284 Racebrook Road Orange,CT 06477,USA
PzF in Europa
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SS mit IVIG/SCIG (6)in 2010*/2012** Population PfF IVIG/SCIG) PfF required Degree of SS Million Litres (000) kg Litres (000)
§ Austria 8.344 470 630 210 224% § Czech Rep. 10.429 350 220 73 447% § France 59.400 1,020 4,323 1,441 71% § Germany 82.360 2,600 2,690 897 290% § Italy 58.100 690 3,015 1,005 69% § Switzerland 7.600 90 370 123 73% § Spain 39.300 340 2,445 815 42% § Sweden 9.221 150 505 210 89% § Germany 80.498 3,075 5,321 1,773 173%**
* Patrick Robert. MRB. Dublin, January 13-14 2011 . ** PEI, Bericht § 21 TFG für 2012 vom 31.3.2013
PzF in Europa
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SS in Italien in 2011 * Albumin 601 kg/1 Mio Inhabitants SS=55% highest albumin consumption among the mostly industrialized countries
IVIG 3,570,542 g= need of 892,635 L PfF SCIG 112,749 g= need of 28,187 L PfF SS=81% Need of PfF for Immunoglobulins= 920,822 L Kedrion with the monopoly as contract
fractionator processed 747,982 L Deficit of 172,840 L *Report on the demand for the major blood-derived medicinal products in Italy 2007-2011, Instituto Superiore de Sanita
PzF in Europa
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Rolle der Plasmapherese (Österreich) Plasmapherese startete 1966 1.Land in Europa April, 1975 Plasmapherese Gesetz 1.Land in Europa
1993 wurde die IG Plasma gegründet 2012 erzeugten IG Plasma Mitglieder 522.432 L SP in18 PZ von 664.997 Spenden = 786 ml/Spende A distinguished national contribution of PfF in Europe
PzF in Europa
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Rolle der Plasmapherese (Tschech. Republik)* Vor 2007:Plasmapherese BTS 70.000 Spenden/Jahr 2007 erstes kommerzielles PZ in Zlín 2011 kommerzielle PZ produzieren 344.658 L SP = 33,14 L/ 1.000 EW 2011 BTS produzieren 114.638 L SP 2011 Tschech. Republik produziert 560.365 L PzF (18,8 % RP, 81,2 % SP) An engaged national contribution of PfF in Europe * UZIS. Statistical Bureau for Health Care of the Czech Republic. Activity of health care institutions in the section of transfusion
service in the Czech Republic in 2011
PzF in Europa
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Rolle der Plasmapherese (Deutschland) Plasmapherese startete in den 70ern,Mannheim 1972 1994 staatlich initiiertes Plasmapherese Programm 1997 Gründung ARGE Plasmapherese zu dieser Zeit wurden 520.196 L SP produziert 2012 produzierten 21 Mitglieder 1.833.838 L PzF in 93 PZ An engaged national contribution of PfF in Europe
PzF in Europa
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PzF durch Plasmapherese in Europa 2010* § Germany 54 % § Czech Republic 14 % § Austria 11 % § Rest of Europe 21 %
* Source: Patrick Robert, MRB
PzF in Europa
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Plasma zur Fraktionierung in Deutschland
Gewinnung von Plasma zur Fraktionierung
0,892 0,947 0,986 0,916 0,964 0,9161,090 0,973 1,015
1,2081,055 1,178 1,214
0,5850,738
0,979
1,493
0,9680,838
1,053 1,2591,483
1,6911,833
1,820 1,861
0,0
0,5
1,0
1,5
2,0
2,5
3,0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Lite
r in
Mio
.
aus Vollblut aus Apherese
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Struktur u. Leistung der ARGE
21 Mitglieder erzeugten 2012 in 93 PZ mittels Plasmapherese
1.833.838 Liter PzF und 48.863 Liter z. direkten therapeutischen
Anwendung (FFP) das sind 20.244L/PZ
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Plasmaaufkommen in Deutschland
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Plasmaaufkommen in Deutschland
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Wissenschaftliche Aktivität ARGE
§ 1998 Stellungnahme(S3) AK-Blut pro SIPLA § 2004 Publikation:45 L/Jahr, IgG- Messung, keine
Immundefekte, kardiovaskuläres o.Fe- Defizitrisiko* § 2005 Publikation: Drop outs hpts. sozioökonomisch** § 2006 Publikation :850 ml/Spende KG> 70kg und 60 Spenden/Jahr bei sorgfältigem Monitoring*** § 2013 SIPLA II: Sichere, intensive Plasmapherese auch bei Neuspendern**** § Tagungsteile PP DGTI 2005 Erfurt,2012 Graz,2014 Dresden *P.Hellstern et al. Vox Sanguinis (2004)86,189-197 **P.Hellstern et al.Vox Sanguinis (2005)88m189-195 ***P.Hellstern et al. Vox Sanguinis(2006)91,162-173 ****S.T.Kiessig et al. ISBT,Amsterdam 2.-5.6.2013
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Zusammenfassung
§ In D wurden zwischen 2009-2012 35,4-38,2 L PzF pro 1.000 EW gespendet
§ In EU A und CZ vergleichbar- Mehrzahl der Mitglieder defizitär zur SS § ARGE PPH erzeugte 2012 mit 1.833.838 L 98,5% des PPH- Plasma u.
59,6% des gesamten PzF in D § PPH ist unverzichtbar bei weltweit steigendem Bedarf an PzF für
Plasmaprodukte (Ig driving Faktor) § Die Aufwandsentschädigung ist eine adäquate Kompensation f. Spender,
die einen wertvollen Beitrag z. Gesundheit von Patienten mit seltenen Erkrankungen leisten
§ Die EU sollte erhebliche Anstrengungen zur Steigerung des PzF durch PPH unternehmen und die Akzeptanz des in einem kontrolliertem, regulatorischen Umfeld in der EU erzeugten PzF als globalen Standard,
gleichwertig mit US-Plasma erreichen
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Problems with plasmapheresis in Europa § Compensated donors § Not enough hyperimmune plasma § Efficiency compared to US-Plasma § Need of scientific data* about yield, frequency and hemovigilance * T.Schulzki et al. A prospective multicentre study on the safety of long-term intensive plasmapheresis in donors(SIPLA) Vox Sanguinis(2006),91:162-173 ** St.Kießig et al. First results from the study on intensive plasmapheresis (SIPLA II) submitted and accepted 23.Regional Congress of ISBT,Amsterdam ,June 2-5,2013
Outlook PfF in Europe
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The role of plasmapheresis in Europe Assumption: Plasmapheresis is the solution to get enough starting material (PfF)in order to meet the clinical need of PP for patients In European countries with a controlled, regulatory environment and EMA accepted epidemiological data national contributions are needed for SP obtained by plasmapheresis
Outlook PfF in Europe
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Plasma for Fractionation IVIG IS NOT APPROVED FOR ALZHEIMER'S DISEASE TREATMEN
Volume of Plasma collected - Apheresis + RecoveredLiters x 1,000
Region 2007 2010 2012 2015
Asia & Oceania 4,585 4,736 4,993 5,371
Latin America 515 536 558 581
North America 14,825 18,018 18,714 20,087
Middle East/Africa 240 250 260 271
Europe 6,382 6,938 7,172 7,521
World 26,547 30,477 31,697 33,831
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Is European Self Sufficiency of PfF achievable?* § If plasmapheresis will be extended in countries with a
regulatory environment based on EU-directives and EMA accepted epidemiological conditions § If UK will accept PfF sourced in Europe § If the compensated donation will not be restricted § If the effciency of plasmapheresis will be increased in order to be competitive with SP procured from US *excluded hyperimmune plasma
Outlook PfF in Europe
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Is European Self Sufficiency of PfF achievable also for hyperimmune plasma? YES
If diagnostic measures and immunization programmes will be established in EU countries with developed
plasmapheresis NO If the compensated donation will be restricted If the problems of immunization e. g. Anti-D can not be solved
Outlook PfF in Europe
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Is European Self Sufficiency of PP and PfF a reasonable goal in a gobalized world ? Yes we can - if we take the necessary steps!
Outlook PfF in Europe
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Welcome in Trusetal
Welcome to Trusetal in Thuringia
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