the italian blood system: an overview with special focus on plasma

IL CONTROLLO STATISTICO DI PROCESSO

The Italian blood system: an overview with special focus on plasma production and plasma-derived medicinal products

Giuliano GrazziniNational Blood Centre

Istituto Superiore di SanitàRome, Italy

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The Italian National Health Servicebasics

In Italy, health-care service delivery is delegated to 21regional health authorities funded by the “national health-care fund” (~109 billion € in 2013), mainly derived fromgeneral fiscal revenues.

The governance of the NHS is entirely public (accreditedprivate health-care providers can integrate the publicservices, according to regional plans).

The Ministry of Health is responsible for nationalcoordination, legislation/regulation and control of theappropriate delivery of the health-care services that must beguaranteed homogeneously and equitably nationwide by theregional health authorities.



THE ITALIAN BLOOD SYSTEMAccording to 21st October 2005 Law

“New discipline for blood transfusion activities and national production of plasma-derived medicinal products”



The Italian Blood System: strategic goals – ILaw 21 October 2005, n. 219

Self-sufficiency of blood and blood products, includingplasma-derived medicinal products, as a supra-local andsupra-regional goal of the NHS.

Promotion and continuous development of voluntarynon-remunerated (VNR), regular / repeat blood donation,and VNR donor retention.

High quality and safety of blood components, transfusionmedicine activities and plasma-derived medicinal products.



Achievement of full compliance with European regulatoryprovisions on blood and blood products

Appropriate management and clinical utilization of bloodresources (including patient blood management - PBM)

Continuous development of transfusion medicine, alignedwith scientific progress

System’s accountability, effectiveness, sustainability


The Italian Blood System: strategic goals – IILaw 21 October 2005, n. 219


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)

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

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

The Italian Blood System: essential figures (2013) - I



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


The Italian Blood System: essential figures (2013) - II

IL CONTROLLO STATISTICO DI PROCESSOThe Italian blood system: an overview with special focus on plasma production and plasma-derived medicinal products

Blood & blood product self-sufficiency in Italy - 1

• According to the “New discipline of blood transfusion activities andnational production of plasma-derived medicines” (Law of 21 October2005, n. 219, article 14), every year a national self-sufficiency programmust be issued by a decree of the Minister of Health.

• Annual technical proposals for this program must be provided for by theNational 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 productdemand and use and on blood and blood component collection andplasma for fractionation production.

• Since 2008, six annual self-sufficiency programs have been issued.



• Driving products for self-sufficiency: red blood cells andplasma 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 components for transfusion

• Nineteen out of 21 regions are fully self-sufficient in RedBlood Cells (RBC) for transfusion

• The two non self-sufficient regions (11 million pop) aresupported by additional RBC production (80,000 units/year)annually planned by self-sufficient regions

• All regions are self-sufficient for all other blood componentsfor transfusion


Blood & blood product self-sufficiency in Italy - 4Plasma form fractionation (PfF) and PDMPs

• PDMP production from domestic plasma is by law a nationalessential health-care service; exchange of products amongregions is performed, supported by specific plans and non-profit/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 haveachieved, or are close to achieving, substantial PDMP self-sufficiency, while most south-central and southern regionsand the greater islands furthest from self-sufficiency


POPULATION/TOT: 56%

Plasma for fractionation: 73%

Plasma for fractionation: 27%

POPULATION/TOT: 44%

Italy 2013 - Plasma for fractionation: north vs. south gap

L / 1,000 pop: 16 L / 1,000 pop: 9

Italy 13.1‰




Production of PfF since 2000

462805 457651

492598505028

532728

565280

587729

608698

648945

682863

721108

742800

768435

784657790000

400000

450000

500000

550000

600000

650000

700000

750000

800000

850000

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Italy - Plasma for fractionation (Kg) - 2000 - 2014

Kg plasma

Forecast


Plasma derived products market (M€) in Europe - 20111

1DRAFT – European Commission “An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients”

Top 5 (DE + FR + IT + ES + UK) = 76%




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 !



CNS elaboration based on “Traccia farmaco” (“drug tracking”) data provided by Ministry of Health’s Directorate General for IT systems and statistics

2013

Percentage of total NHS demand covered bycontract fractionation: 54% (16,690 kg)

Estimated economic equivalent of contractfractionation albumin (based on average tendercosts of commercial products): € 49,485,844.

Perspectives of plasma manufacturing in Italy

Albumin: national demand (Kg) 2011-2013


IGIV: national demand (Kg) 2011-2013

2013

Percentage of total NHS demand covered bycontract fractionation: 71% (2,518 kg)

Estimated economic equivalent of contractfractionation IVIG (based on average tendercosts of commercial products): € 133,380,499.

Italy - IVIG and albumin demand, 2011-2013

IL CONTROLLO STATISTICO DI PROCESSOPerspectives of plasma manufacturing in ItalyThe Italian blood system: an overview with special focus on plasma production and plasma-derived medicinal products

Albumin demand - 2011

Calizzani G, et Al. Analisi della domanda dei principali medicinali plasmaderivati in Italia. 2007-2011. RapportiISTISAN, 12/53. www.iss.it.


Plasma-derived medicinal products:

demand and clinical use

Guest editors

Giuliano Grazzini&

Pier Mannuccio Mannucci

September 2013

http://www.bloodtransfusion.it

Achievements in the field of plasma & PDMPs



• What is the (approximate) economic value of the PDMPsproduced in Italy from national plasma?

€ 248,000,000

2013 estimate(based on average tender costs of commercial products)

Perspectives of plasma manufacturing in Italy

The estimated economic value of PDMPs produced from national plasma


IL CONTROLLO STATISTICO DI PROCESSOPerspectives of plasma manufacturing in Italy


• Provided standardized costs are achieved, Italy couldcompete with the international commercial market only forrecovered plasma

• Current standardized costs of apheresis plasma are > 2.5times higher than international commercial prices

• In spite of the high costs of apheresis plasma, the overallPDMP production from national plasma (with 25% ofapheresis plasma) would allow a cost saving around 4-10%compared to current commercial costs of equivalentproducts.


Thanks for your attention ! Giuliano Grazzini

National Blood CentreIstituto Superiore di Sanità

Rome, Italy



the italian blood system: an overview with special focus on plasma

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