Supply of Immunoglobulins Jose Drabwell IPOPI Board Member - - PowerPoint PPT Presentation

Jose Drabwell IPOPI Board Member

STOCKHOLM 25 MAY 2019

Nordic Meeting for Primary Immunodeficiency

Supply of Immunoglobulins

Previous IPOPI NMO Programmes Officer Saara Kiema speaking at the Nordic meeting in Helsinki, Finland in 2017.

We are glad to be back!

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

What will I speak about today?

Some global figures of plasma collection & IG supply….

1,748 2,884 19,030 24,303 38,559 6,248 6,646 36,340 50,470 88,678 Middle East ( 2007-2016) Latin America (2007- 2016) Asia & Pacific (2009- 2015) Europe (2008-2017) Nort h America (2008- 2017)

20 08 20 17

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 ) C

• m

p

• u

n d edA n n u al G ro w th R ates

• ver n

in e years N

• rthA

m erica 9.7% E u ro p e 8.5% 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

• rld

8.8% To tal W

• rld

188.4 M etric To n s (2017)

Source: MRB presentation, PLUS Conference, Estoril January 2019

Asia Pacific ( 2009- 2015) Latin America (2007- 2016) China ( 2006-2017) Middle East ( 2007- 2016) Europe (2008-2017) Italy (2008-2017) Spain (2008-2017) United Kingdom (2008-2017) Germany (2008- 2017) Australia (2006- 2015) France ( 2008-2017) Canada (2008-2017) United States (2008- 2017) 5.8 5.2 8.7 6.0 36.7 52.5 62.5 46.1 36.4 91.6 79.3 116.2 120.7 9.4 11.4 15.0 16.5 55.5 90.7 93.1 106.8 109.2 156.3 167.3 216.0 248.0

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

• u

s an d p

• p

u latio n ) Source: MRB presentation, PLUS Conference, Estoril January 2019

Source: MRB presentation, PLUS Conference, Estoril January 2019

Source: MRB presentation, PLUS Conference, Estoril January 2019

• 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

Key considerations

• 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

IPOPI advocating for more regional 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.

• 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.

Impact on patient’s health and quality of life. Patients’ Perspective

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

• 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.

Plasma collection and fractionation

The importance of working together to secure availability.

Availability of Ig products: Globally and in the Nordic Countries Patients’ Perspective

The importance of working together

• Nordic countries – similar

characteristics.

• If and when necessary use the other

countries to support your goal.

• Look what has been achieved by one
• f the Nordic countries such as

Norway and NBS for SCID.

• Support each other – stronger

together.

• Align your campaigns.
• Compare and learn.

• Early warnings should be shared.
• Get close to your NCA – National Competent Ageny.
• Teach them all about PIDs and the need for PDMPs.
• HTA agencies – try to ensure that there is an

understanding for PIDs and the complexities of this condition.

• Work closely together with the nurses and the

doctors.

• Contact IPOPI if you need help or specific

information.

• We are here to help you!

The importance of working together

• PIDs are a priority indication for IG therapies.
• UK Demand Management Plan example.
• In times of shortages, PID patients should be prioritized
• IGs are not generic products.
• Council of Europe Resolution CM/Res(2015)2 on principles

concerning human normal IG therapies for immunodeficiency and other diseases:

• “make available to patients all recognised routes of human normal

immunoglobulin administration”

• “take into account that human normal immunoglobulin therapeutic

products differ from one another in terms of production processes, which might have an impact on specifications and clinical performance”

The importance of working together: take home messages.

SEE YOU AT IPIC2019 IN MADRID!

facebook.com/IPOPIPID @IPOPI_info YouTube.com/IPOPIPID

Thank you for your attention!