Nordic Meeting for Primary Immunodeficiency Supply of Immunoglobulins Jose Drabwell IPOPI Board Member STOCKHOLM 25 MAY 2019
We are glad to be back! Previous IPOPI NMO Programmes Officer Saara Kiema speaking at the Nordic meeting in Helsinki, Finland in 2017.
What will I speak about today? 1) Global picture of plasma collection and IG supply 2) Impact on patient’s health and quality of life 3) The Nordic countries 4) The importance of working together
Some global figures of plasma collection & IG supply….
TH E G L O B A L IVIG & S C IG C O N S U M P TIO N B Y R E G IO N 2008 - 2017 (K ilo g ram s ) Source: MRB presentation, PLUS Conference, Estoril January 2019 88,678 C o m p o u n d edA n n u al G ro w th R ates o ver n in e years N o rthA m erica 9.7% 20 08 E u ro p e 8.5% 20 17 A s ia P acific 7.5% L atin A m erica 9.7% M id d le E as t 15.2% To tal W o rld 8.8% 50,470 To tal W o rld 188.4 M etric To n s (2017) 38,559 36,340 24,303 19,030 6,646 6,248 2,884 1,748 Middle East ( 2007-2016) Latin America (2007- Asia & Pacific (2009- Europe (2008-2017) Nort h America (2008- 2016) 2015) 2017)
IVIG & S U B C U TA N E O U S C O N S U M P TIO N P E R C A P ITA IN S E L E C TE D R E G IO N S A N D C O U N TR IE S - 2008 & 2017 (G ram s p er th o u s an d p o p u latio n ) United States (2008- 248.0 120.7 2017) 216.0 Canada (2008-2017) 116.2 167.3 France ( 2008-2017) 79.3 Australia (2006- 156.3 91.6 2015) Germany (2008- 109.2 36.4 2017) United Kingdom 106.8 46.1 (2008-2017) 93.1 Spain (2008-2017) 62.5 90.7 Italy (2008-2017) 52.5 55.5 Europe (2008-2017) 36.7 Middle East ( 2007- 16.5 6.0 2016) 15.0 China ( 2006-2017) 8.7 11.4 Latin America (2007- 5.2 2016) 9.4 Asia Pacific ( 2009- 5.8 2015) Source: MRB presentation, PLUS Conference, Estoril January 2019
Source: MRB presentation, PLUS Conference, Estoril January 2019
Source: MRB presentation, PLUS Conference, Estoril January 2019
Key considerations • Along with the continued demand for IgG therapy, the need for source plasma continues to go up and the calls for diversification of the origin of the plasma are becoming more pressing because of economic and political reasons: Economic: Collecting plasma is becoming increasingly difficult and expensive: The new centers are smaller, and less efficient, increasing the production costs, including rising donor compensation, Political: the dependency on the United States for the supply of plasma is increasingly debated • The controversies that separate the non-profit and commercial sectors with respect to blood and plasma continues to slow the progress at the expense of patients in need of plasma therapies Source: MRB presentation, PLUS Conference, Estoril January 2019
IPOPI advocating for more regional plasma collection • IPOPI founding member of PLUS – manages secretariat & event coordination • PLUS Stakeholders conference, Estoril, January 2019 • Production of Position Statements • Active participation in Council of Europe Symposium on Plasma Supply Management • Presentation on PLUS strategies to encourage blood & plasma donation in Europe • IPOPI active within APEC (Asia Pacific Economic Cooperation) • Blood Policy Forums (Taiwan, Vietnam…) • Bruce Lim presentation on patient needs and importance of plasma collection
Key statements from PLUS & IPOPI
Availability of Ig products: Globally and in the Nordic Countries Patients’ Perspective • Impact on patients’ health and QoL. • Differences between the Nordic Countries and other countries. • Importance of working together to secure availability.
Impact on patient’s health and quality of life Patients’ perspective • Concerns about future supplies. • Availability and continuation of same infusion product. • Changes in access to products due to a variety of reasons such: • Companies merging, acquisitions, economic pressures from governments, shortages etc • Psychological pressures due to anxiety. • Enforced switching of infusion product. • IVIG to SCIG and vice versa.
Impact on patient’s health and quality of life Patients’ Perspective • Switching from 10% to a 5% product • Longer infusion time. • More volume – detrimental to elderly and those with specific problems. • Changing to a new product all together – further problems. • Anxiety regarding sustainability of plasma supplies and therefore PDMPs. • Political pressures beyond our control.
Impact on patient’s health and quality of life. Patients’ Perspective • Differences between the Nordic Countries and globally with regard to access and supply. • Differences between Nordic countries regarding plasma collection, fractionation and some information about regulatory contacts.
Nordic countries • Denmark • Finland • Iceland • Norway • Sweden
Denmark • Population5.5 million • Male life expectancy 79.3 • Female life expectancy 83.2 • Current health expenditure (CHE) of GDP – 10.3% • PID estimated patients – 3600 • PID patient group – Immun Defekt Foreningen • Other PDMP groups: Danish Haemophilia, Alpha -1 Denmark and HAE Scandinavia
Finland • Population5.5 million • Male life expectancy 78.7 • Female life expectancy 84.2 • Current health expenditure (CHE) of GDP – 9.4% • PID estimated patients – 750 • PID patient group – Immunipuuto-spotilaiden Yhdistys RY • Other PDMP groups: Finnish Haemophilia Society, Alpha -1 Finland and HAE Finland
Iceland • Population320,000 • Male life expectancy 82.4 • Female life expectancy 82.4 • Current health expenditure (CHE) of GDP – 8.9% • PID diagnosed or estimated patients – ???? • PID patient group – LIND • Other PDMP groups: Icelandic Haemophilia Society, Alpha -1 ??? and HAE Iceland
Norway • Population5.3 million • Male life expectancy 80.6 • Female life expectancy 84.3 • Current health expenditure (CHE) of GDP – 10.5% • PID diagnosed or estimated patients – ??? • PID patient group – Norsk Immunsviktforening • Other PDMP groups: Norwegian Haemophilia Society, Alpha -1Norge
Sweden • Population9.6 million • Male life expectancy 80.6 • Female life expectancy 84.1 • Current health expenditure (CHE) of GDP – 11% • PID estimated patients – 3000 • PID patient group – PIO Primär Immunbrist Organisationen • Other PDMP groups: Swedish Haemophilia Society, Alpha -1 Sverige and HAE Scandinavia
Available products by company • Denmark – BIOTEST, CSL, GRIFOLS, LFB, OCTAPHARMA,SANQUIN TAKEDA. IVIG and SCIG • Finland – BIOTEST, CSL, LFB, GRIFOLS, OCTAPHARMA, TAKEDA. IVIG and SCIG • Iceland - CSL, OCTAPHARMA. IVIG and SCIG • Norway – BIOTEST, CSL, OCTAPHARMA, TAKEDA. IVIG and SCIG • Sweden – BIOTEST, CSL, LFB, GRIFOLS, OCTAPHARMA, TAKEDA. IVIG and SCIG
Plasma collection and fractionation • DENMARK • No domestic plasma fractionation. • Collection of plasma for toll fractionation to supply albumin and IVIG. • Recovered plasma is collected for toll fractionation. • Government agencies : • Danish Health and Medicine Authority – http://sundhedsstyrelsen.dk • Danish National Bio-bank (Statens Serum Institut) – http://www.ssi.dk • Danish Healthcare Quality Program (DDKM) is operated by • Institute for Quality and Accreditation in Healthcare (IKAS) – www.ikas.dk • Danish National Institute of Public Health – www.si-folkesundhed.dk
Plasma collection and fractionation • FINLAND • No domestic plasma collection. • Finnish Red Cross Blood Service collects recovered plasma for toll fractionation. • Government agencies: • Ministry of Social Affairs and Health – http://stm.fi • Finnish Medicine Agency (FIMEA) - http://fimea.fi • Finnish Office for Health Technology Assessment – www.thl.fi/finohta • National Institute for Health and Welfare (THL) – https://thl.fi
Plasma collection and fractionation • ICELAND • Bloodbanking is the sole supplier of blood components in Iceland. 4000 plasma units per year. • Government agencies: • Icelandic Medicine Agency - http://www.ima.is
Plasma collection and fractionation • NORWAY • No domestic plasma fractionation. • Recovered and source plasma for fractionation (Baxter, Octapharma). Finished plasma products returned to Norway, except those that are surplus to domestic Norwegian requirements. Hospitals can demand PDMPs and no additional Ministry funding is needed for this purchase. • Government agencies: • Norwegian Medicine Agency - http://www.regjeringen.no • Norwegian Institute of Public Health (INAHTA) – www. Inahta.org
Plasma collection and fractionation • SWEDEN • Plasma collected mostly by hospital centres. • Swedish centres sold about 132,000 liters of plasma for toll fractionation • Government agencies: • Medical Products Agency - https://www.lakemedelsverket.se • Swedish Council for Health Technologies – http://sbu.se • National Board of Health and Welfare – https://www.socialstyrelsen.se • Medical Responsibility Board – http://kammarkollegiet.se • Various Ministries of Sweden: Social Security, Children, the Elderly and Gender Equality, Health Care, Public Health and Sport.
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