1. Balancing Value and Access to Innovative Medicines The HSE Experience

2. HSE Role: What We Do Reimbursement approval - innovative treatments - streamlined process - value for money - governance - transparency and fairness Framework for the future

3. Reimbursement: How We Do it Criteria Supply agreements - administrative process - pricing Decision-making

4. Core Principles: Why We Do It Provide public access to innovative and other medicines through reimbursement based on: - continuity and security of supply - affordability - sustainability - value for money Strategic view/limited budget

5. What We Face (i) Community scheme costs - 1997: €494 m - 2002: €1,270 m - 2007: €2,490 m - 504 %

6. What We Face (ii) Drug cost v distribution cost - 2007: 2 to 1

7. Making Room for Innovation: Finding the Balance 2006 manufacturer agreements Pricing - new products: expanded basket - patent expiry: premium removal - reviews: early launch HTA - budget impact - clinical innovation, benefit Making room

8. Per Item Cost: Long Term Illness Scheme

9. Per Item Cost: Drugs Payment Scheme

10. Per Item Cost: Medical Card Scheme

11. Making Room for Innovation: Absent Friends (i) Wholesale distribution - meaningful reform - formal relationship with State - transparency and costs: current model - vertical integration - competition law

12. Making Room for Innovation: Absent Friends (ii) Retail pharmacy - mark-up barrier - retail prices - substitution - retention of benefit/windfall profits - sector proposals

13. GMS Trends 2000 - 2007

14. Making Room for Innovation: Where Next (i)? Agreement evolution - price: review, alignment, discussion - PEA: existing therapies, line extensions, post-launch effectiveness - conditional reimbursement: prescribing, patient groups, access - exit strategies Anticipation and forecasting

15. Making Room for Innovation: Where Next (ii)? Formularies Prescribing Procurement Distribution models - logistics v ownership - delivered v ex-factory price - clinic v pharmacy (esp commospital)

16. Making Room for Innovation: The Strategic View Medium to long term - sustainable - affordable - accessible - fair

17. Making Room for Innovation: The Outlook Sponsorship of innovation - core principle - patient benefit One bucket, many claims Making room: a burden shared - responses or imposed solutions?

18. Thank you