The Italian blood system: an overview with special focus on plasma production and plasma-derived medicinal products Giuliano Grazzini National Blood Centre Istituto Superiore di Sanità Rome, Italy
The Italian National Health Service basics In Italy, health-care service delivery is delegated to 21 regional health authorities funded by the national healthcare fund (~109 billion in 2013), mainly derived from general fiscal revenues. The governance of the NHS is entirely public (accredited private health-care providers can integrate the public services, according to regional plans). The Ministry of Health is responsible for national coordination, legislation/regulation and control of the appropriate delivery of the health-care services that must be guaranteed homogeneously and equitably nationwide by the regional health authorities.
THE ITALIAN BLOOD SYSTEM According to 21 st October 2005 Law New discipline for blood transfusion activities and national production of plasma-derived medicinal products
The Italian Blood System: strategic goals I Law 21 October 2005, n. 219 Self-sufficiency of blood and blood products, including plasma-derived medicinal products, as a supra-local and supra-regional goal of the NHS. Promotion and continuous development of voluntary non-remunerated (VNR), regular / repeat blood donation, and VNR donor retention. High quality and safety of blood components, transfusion medicine activities and plasma-derived medicinal products.
The Italian Blood System: strategic goals II Law 21 October 2005, n. 219 Achievement of full compliance with European regulatory provisions on blood and blood products Appropriate management and clinical utilization of blood resources (including patient blood management - PBM) Continuous development of transfusion medicine, aligned with scientific progress System s accountability, effectiveness, sustainability
The Italian Blood System: essential figures (2013) - I Donors: 1,734,669 / 1,000 pop: 29.1 Male: 69.4% Female: 30.6% Repeat: 1,442,715 (83%) First-time: 291,954 (17%) Frequent *: 682,512 (47,3% of repeat donors) Donations: 3,144,724 / 1,000 pop: 52.9 Whole blood (84%): 2,633,175 / 1,000 pop: 44,3 Apheresis (16%): 511,549 [Plasmapheresis: 409,363] / 1,000 pop: 8.6 Donations / donor / year : 1.81 Apheresis donors: 237,774 (13.7% of total) Apheresis-only donors: 134,371 (56.5% of apheresis donors) * National definition: donating at least once a year, every year, in the last 5 years
The Italian Blood System: essential figures (2013) - II Blood components produced Red blood cells (units): 2,625,608 Units / 1,000 pop: 44.0 (30% leukodepleted) Platelets (units*): 271,468 Units / 1,000 pop: 4.5 (30% apheresis) Plasma (units**): 3,107,848 Units / 1,000 pop: 52.1 [plasma for fractionation: 784,000 kg] Others (including by-products): 1,206,148 Total: 7,211,072 * Adult therapeutic dose ** Recovered and apheresis Blood components transfused Red blood cells (units): 2,482,473 Units / 1,000 pop: 41.6 (32,4% leukodepleted) Platelets (units*): 213,689 Units / 1,000 pop: 3.6 (33.4% apheresis) 2,625,608 FFP (units**): 375,268 Units / 1,000 pop: 6.3 (94,313 pharmaceutical pathogen-inactivated ) Total: 3,117,342 Units / 1,000 pop: 52.5 8,541 blood components transfused / day * Adult therapeutic dose ** Recovered and apheresis Transfused patients 643,616 / year 1,763 patients / day 11 persons / 1,000 pop / year Average number blood components transfused per patient: 4.8
Blood & blood product self-sufficiency in Italy - 1 According to the New discipline of blood transfusion activities and national production of plasma-derived medicines (Law of 21 October 2005, n. 219, article 14), every year a national self-sufficiency program must be issued by a decree of the Minister of Health. Annual technical proposals for this program must be provided for by the National Blood Centre after consultation with the relevant stakeholders (Regional Blood Centres and Blood Donor Associations). The annual self-sufficiency program includes prescriptions, recommendations and objectives both on blood and blood product demand and use and on blood and blood component collection and plasma for fractionation production. Since 2008, six annual self-sufficiency programs have been issued.
Blood & blood product self-sufficiency in Italy - 2 Driving products for self-sufficiency: red blood cells and plasma for fractionation Driving actions/goals: - recruitment of new donors to ensure donor base turn over - Achievement of full compliance with EU blood regulations and Plasma Master File in 100% BEs (deadline: 31 Dec 2014) - continuous promotion of optimal use of blood - Patient Blood Management national project just launched Monitoring (KPIs)
Blood & blood product self-sufficiency in Italy - 3 Blood components for transfusion Nineteen out of 21 regions are fully self-sufficient in Red Blood Cells (RBC) for transfusion The two non self-sufficient regions (11 million pop) are supported by additional RBC production (80,000 units/year) annually planned by self-sufficient regions All regions are self-sufficient for all other blood components for transfusion
Blood & blood product self-sufficiency in Italy - 4 Plasma form fractionation (PfF) and PDMPs PDMP production from domestic plasma is by law a national essential health-care service; exchange of products among regions is performed, supported by specific plans and nonprofit/cost-recovery national tariffs PDMPs produced by domestic plasma: polyvalent IVIG, albumin, FVIII, FIX, antithrombin, prothrombin complex, anti-hbv IG Driving products: IVIG, albumin Gaps: most of the central and northern regions have achieved, or are close to achieving, substantial PDMP selfsufficiency, while most south-central and southern regions and the greater islands furthest from self-sufficiency
Italy 2013 - Plasma for fractionation: north vs. south gap POPULATION/TOT: 44% Plasma for fractionation: 27% POPULATION/TOT: 56% Plasma for fractionation: 73% Italy 13.1 L / 1,000 pop: 16 L / 1,000 pop: 9
Blood & blood product self-sufficiency in Italy - 5 Plasma form fractionation (PfF) and PDMPs Production of PfF since 2000 Italy - Plasma for fractionation (Kg) - 2000-2014 850000 800000 768435 784657 790000 750000 721108 742800 700000 682863 650000 648945 600000 565280 587729 608698 Kg plasma 550000 532728 500000 462805 457651 492598 505028 450000 400000 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Forecast
Blood & blood product self-sufficiency in Italy - 6 Plasma form fractionation (PfF) and PDMPs Plasma derived products market (M ) in Europe - 2011 1 Top 5 (DE + FR + IT + ES + UK) = 76% 1 DRAFT European Commission An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients
Achievements in the field of plasma & PDMPs Analysis of the demand for the main plasma-derived medicinal products in Italy 2007-2011 Calizzani G, Lanzoni M, Candura F, Profili S, Catalano L, Vaglio S, Biffoli C, Grazzini G December 2012 http://www.iss.it/ 2011-2013 Report forthcoming!
Perspectives of plasma manufacturing in Italy The Italian blood system: an overview with special focus on plasma production and plasma-derived medicinal products Italy - IVIG and albumin demand, 2011-2013 IGIV: national demand (Kg) 2011-2013 Albumin: national demand (Kg) 2011-2013 2013 Percentage of total NHS demand covered by contract fractionation: 71% (2,518 kg) Estimated economic equivalent of contract fractionation IVIG (based on average tender costs of commercial products): 133,380,499. 2013 Percentage of total NHS demand covered by contract fractionation: 54% (16,690 kg) Estimated economic equivalent of contract fractionation albumin (based on average tender costs of commercial products): 49,485,844. CNS elaboration based on Traccia farmaco ( drug tracking ) data provided by Ministry of Health s Directorate General for IT systems and statistics
The Italian blood system: an overview Perspectives with special of plasma focus on manufacturing plasma production in Italy and plasma-derived medicinal products Albumin demand - 2011 Calizzani G, et Al. Analisi della domanda dei principali medicinali plasmaderivati in Italia. 2007-2011. Rapporti ISTISAN, 12/53. www.iss.it.
Achievements in the field of plasma & PDMPs Plasma-derived medicinal products: demand and clinical use Guest editors Giuliano Grazzini & Pier Mannuccio Mannucci September 2013 http://www.bloodtransfusion.it
Perspectives of plasma manufacturing in Italy The Italian blood system: an overview with special focus on plasma production and plasma-derived medicinal products The estimated economic value of PDMPs produced from national plasma What is the (approximate) economic value of the PDMPs produced in Italy from national plasma? 248,000,000 2013 estimate (based on average tender costs of commercial products)
Perspectives of plasma manufacturing in Italy
Perspectives of plasma manufacturing in Italy Provided standardized costs are achieved, Italy could compete with the international commercial market only for recovered plasma Current standardized costs of apheresis plasma are > 2.5 times higher than international commercial prices In spite of the high costs of apheresis plasma, the overall PDMP production from national plasma (with 25% of apheresis plasma) would allow a cost saving around 4-10% compared to current commercial costs of equivalent products.
Perspectives of plasma manufacturing in Italy
Thanks for your attention! Giuliano Grazzini National Blood Centre Istituto Superiore di Sanità Rome, Italy