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European & National Medicines Regulatory Systems:
challenges for an equitable, timely and suitable access
to innovation
Brussels, 10.5.2017
The payers’ perspective on access to
innovation
HVB AUSTRIA
Dr. Gottfried Endel
Payers perspective on innovation
Content
Dr Gottfried Endel
• COI
• Innovation – definition
• Perspectives of stakeholders
• Evidence based Medicine and Health Technology
assessment
• Pricing and Transparency
• Discussion
1
© HVB-EBM
METHODS
BIOETHICS
AUTONOMY
NON MALEFIZIENZ
BENEFIZIENCE
JUSTICE
AS FOUR DIMENSIONS TO KEEP IN BALANCE
ALSO TO BALANCE PREFERENCES OF INDIVIDUALS WITH
ENGAGEMENT OF INDIVIDUALS
17.1.2011 Dr. Gottfried Endel
2
Bernward Gesang „Eine Verteidigung des Utilitarismus“; Reclam
Dieter Birnbacher; „Bioethik zZwischen Natur und Interesse“
Payers perspective on innovation
COI
Dr Gottfried Endel
I WORK IN THE AUSTRIAN SOCIAL INSURANCE. SO MY POINT OF VIEW IS THE
RESPONSIBILITY OF A
• SUSTAINABLE
• APPROPRIATE
• SAFE
• EFFICIENT/EFFECTIV
• ACCESIBLE AND
• ACCEPTABLE
HEALTH CARE SYSTEM FOR ALL CITICENS/INSURED PEOPLE.
THATS THE PERSPECTIVE OF A PAYER WITH RESPONSIBILITY AND POLITICAL
ACCOUNTABILITY
USUALLY I REFERE TO THE AUSTRIAN SYSTEM
AS I AM NOT A NATIVE ENGLISH SPEAKER, PLEASE FORGIVE ERRORS IN GRAMMAR,
SPELLING OR UNUSUAL WORDING
ALSO I DID NOT TRANSLATE ALL OLD SLIDES
3
Payers perspective on innovation
Messwerte
Dr. Gottfried Endel 4
Austria a Welfare State based on
solidarity
5Joint HTA 4.5.2017
Payers perspective on innovation
Innovation - definition
Dr Gottfried Endel 6
COST
LYG
QALYs
DOMINANT
© HVB-EBM
WILLINGNESS TO PAY
Payers perspective on innovation
Dr. Gottfried Endel
7
WNP
-50.000,00 €
450.000,00 €
950.000,00 €
1.450.000,00 €
1.950.000,00 €
AR
WNP
WNP -30.000,00 -15.000,00 -7.500,00 € -3.800,00 € -1.900,00 € - € 3.800,00 € 7.600,00 € 15.200,00 30.400,00 60.800,00 121.600,00 243.200,00 486.400,00 972.800,00 1.945.600, 2.000.000,
AR
Low absulut risc
Cut off for sicknessfunds
High absolut risc
High willingness to
pay
Traditional health insurance
Prevention
Roles and responsibilities
Dr. Gottfried Endel
Role Respronsibility
Patients Health literacy, self awarness, coping, self control…
Provider/Professionals Professional skills, CME, communication, scientific
excellence, transparency (prices)…
Politicians Framework of the health care system, societys
perspective…
Regulators Market access, infrastructur decisions…
Payers Reimbursement decisions, quality, sustainability…
Citicens Providing sustainable financial basis, societys
perspective…
Differents stakeholders Different objectives
Other political fields Other political interests
International organizations International comparisons
…. ….
8Payers perspective on innovation
© HVB-EBM Dr. Gottfried Endel Payers perspective on innovation 9
VERSICHERTER
insured person
VERTRAGSPARTNER
contracting party
SOZIALVERSICHERUNG
social insurance
Abrechnung,
Antragstellung
accounting, applikation
Zahlung, Kontroll
payment, controle
VERTRAG Contract
BENEFIT IN KIND
HTA
• Scientific evidence
• Political/societal priorities
• Health system research
EBM
• Scientific evidence
• Patient preferences
• Experience of the provider
Payers perspective on innovation
Pricing and Transparency
Dr Gottfried Endel
• Price as „non disclosure“ clause
• Melphalan for multiple myeloma – essential!
– „old“ substance
– no competitor
– Pricing after GSK sold patents to Aspen Holding + 4.000% (https://www.thetimes.co.uk/article/drug-giant-s-secret-
plan-to-destroy-cancer-medicine-75rg6wt2n download 9.5.2017)
• adenosine-deaminase-deficient severe combined
immunodeficiency (ADA-SCID)
– Gene therapy : one treatment for the child  promise: cured (no other treatment available; real innovation)
– Value based pricing discussion: Value of the total life of the child for society (life expectancy in years X yearly
contribution of a person to the GDP) : quoted from a coffe discussion at a rare diseases conference
10
Payers perspective on innovation
Discussion
Dr Gottfried Endel
• We want / need innovation
• We deal with uncertainty
– HTA
• Balance of pricing for services - especially innovations,
research and development costs and sustainability of
the health care system is a priority.
11
Payers perspective on innovationDr Gottfried Endel
Thank you for your attention
12

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Gottfried Endel, Main Association of Austrian Social Insurance Institutions, Austria

  • 1. European & National Medicines Regulatory Systems: challenges for an equitable, timely and suitable access to innovation Brussels, 10.5.2017 The payers’ perspective on access to innovation HVB AUSTRIA Dr. Gottfried Endel
  • 2. Payers perspective on innovation Content Dr Gottfried Endel • COI • Innovation – definition • Perspectives of stakeholders • Evidence based Medicine and Health Technology assessment • Pricing and Transparency • Discussion 1
  • 3. © HVB-EBM METHODS BIOETHICS AUTONOMY NON MALEFIZIENZ BENEFIZIENCE JUSTICE AS FOUR DIMENSIONS TO KEEP IN BALANCE ALSO TO BALANCE PREFERENCES OF INDIVIDUALS WITH ENGAGEMENT OF INDIVIDUALS 17.1.2011 Dr. Gottfried Endel 2 Bernward Gesang „Eine Verteidigung des Utilitarismus“; Reclam Dieter Birnbacher; „Bioethik zZwischen Natur und Interesse“
  • 4. Payers perspective on innovation COI Dr Gottfried Endel I WORK IN THE AUSTRIAN SOCIAL INSURANCE. SO MY POINT OF VIEW IS THE RESPONSIBILITY OF A • SUSTAINABLE • APPROPRIATE • SAFE • EFFICIENT/EFFECTIV • ACCESIBLE AND • ACCEPTABLE HEALTH CARE SYSTEM FOR ALL CITICENS/INSURED PEOPLE. THATS THE PERSPECTIVE OF A PAYER WITH RESPONSIBILITY AND POLITICAL ACCOUNTABILITY USUALLY I REFERE TO THE AUSTRIAN SYSTEM AS I AM NOT A NATIVE ENGLISH SPEAKER, PLEASE FORGIVE ERRORS IN GRAMMAR, SPELLING OR UNUSUAL WORDING ALSO I DID NOT TRANSLATE ALL OLD SLIDES 3
  • 5. Payers perspective on innovation Messwerte Dr. Gottfried Endel 4
  • 6. Austria a Welfare State based on solidarity 5Joint HTA 4.5.2017
  • 7. Payers perspective on innovation Innovation - definition Dr Gottfried Endel 6 COST LYG QALYs DOMINANT
  • 8. © HVB-EBM WILLINGNESS TO PAY Payers perspective on innovation Dr. Gottfried Endel 7 WNP -50.000,00 € 450.000,00 € 950.000,00 € 1.450.000,00 € 1.950.000,00 € AR WNP WNP -30.000,00 -15.000,00 -7.500,00 € -3.800,00 € -1.900,00 € - € 3.800,00 € 7.600,00 € 15.200,00 30.400,00 60.800,00 121.600,00 243.200,00 486.400,00 972.800,00 1.945.600, 2.000.000, AR Low absulut risc Cut off for sicknessfunds High absolut risc High willingness to pay Traditional health insurance Prevention
  • 9. Roles and responsibilities Dr. Gottfried Endel Role Respronsibility Patients Health literacy, self awarness, coping, self control… Provider/Professionals Professional skills, CME, communication, scientific excellence, transparency (prices)… Politicians Framework of the health care system, societys perspective… Regulators Market access, infrastructur decisions… Payers Reimbursement decisions, quality, sustainability… Citicens Providing sustainable financial basis, societys perspective… Differents stakeholders Different objectives Other political fields Other political interests International organizations International comparisons …. …. 8Payers perspective on innovation
  • 10. © HVB-EBM Dr. Gottfried Endel Payers perspective on innovation 9 VERSICHERTER insured person VERTRAGSPARTNER contracting party SOZIALVERSICHERUNG social insurance Abrechnung, Antragstellung accounting, applikation Zahlung, Kontroll payment, controle VERTRAG Contract BENEFIT IN KIND HTA • Scientific evidence • Political/societal priorities • Health system research EBM • Scientific evidence • Patient preferences • Experience of the provider
  • 11. Payers perspective on innovation Pricing and Transparency Dr Gottfried Endel • Price as „non disclosure“ clause • Melphalan for multiple myeloma – essential! – „old“ substance – no competitor – Pricing after GSK sold patents to Aspen Holding + 4.000% (https://www.thetimes.co.uk/article/drug-giant-s-secret- plan-to-destroy-cancer-medicine-75rg6wt2n download 9.5.2017) • adenosine-deaminase-deficient severe combined immunodeficiency (ADA-SCID) – Gene therapy : one treatment for the child  promise: cured (no other treatment available; real innovation) – Value based pricing discussion: Value of the total life of the child for society (life expectancy in years X yearly contribution of a person to the GDP) : quoted from a coffe discussion at a rare diseases conference 10
  • 12. Payers perspective on innovation Discussion Dr Gottfried Endel • We want / need innovation • We deal with uncertainty – HTA • Balance of pricing for services - especially innovations, research and development costs and sustainability of the health care system is a priority. 11
  • 13. Payers perspective on innovationDr Gottfried Endel Thank you for your attention 12