Balancing Value and Access to Innovative Medicines The HSE Experience
HSE Role: What We Do Reimbursement approval - innovative treatments - streamlined process - value for money - governance - transparency and fairness Framework for the future
Reimbursement: How We Do it Criteria Supply agreements - administrative process - pricing Decision-making
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
What We Face (i) Community scheme costs : €494 m : €1,270 m : €2,490 m %
What We Face (ii) Drug cost v distribution cost : 2 to 1
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
Per Item Cost: Long Term Illness Scheme
Per Item Cost: Drugs Payment Scheme
Per Item Cost: Medical Card Scheme
Making Room for Innovation: Absent Friends (i) Wholesale distribution - meaningful reform - formal relationship with State - transparency and costs: current model - vertical integration - competition law
Making Room for Innovation: Absent Friends (ii) Retail pharmacy - mark-up barrier - retail prices - substitution - retention of benefit/windfall profits - sector proposals
GMS Trends
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
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)
Making Room for Innovation: The Strategic View Medium to long term - sustainable - affordable - accessible - fair
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?
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