Conditional Access Ed Godber Head of EU Access to Medicines GSK

1. Conditional Access Ed GodberHead of EU Access to MedicinesGSK

2. Outline of Talk A pragmatic framework for conditional access 1 Emergent best practice in conditional contracts 2 Which value gaps can we address? 3 Implications for field of conditional access research 4

3. Focal points for Consortium A pragmatic framework for conditional access 1 Emergent best practice in conditional contracts 2 Which value gaps can we address? 3 Implications for field of conditional access research 4

4. Theoretical model through Pharma lens Innovative Pricing 1. Known low benefit vsSoC 2. Uncertain benefit over SoC 4. Known high benefit vs SoC 3. Uncertain Usage risk High or significant No chance to address Un-resolvable No need to address Low unmet need High Unmet need High Unmet need High unmet need Macro Level Affordability Price Premium Pricing Trad Fixed price, Discount versus SoC Non-outcome based Conditional or Outcome based P&R * Un-resolvable uncertainties = those which pharma could not have realistically addressed in development due to ethics, lack of patients, no comparator etc.

5. Pragmatic model through value lens Value with imperfect HTA dossier 4. Clarity of evidence and/or strategic value 1. Unclear value proposition 2. Curate’s egg: Good in parts 3. Evidence gaps “believable” Don’t fund/ major restrictions Controlled access Partial access Full access AND OR WITH WITH Price competition Discounts via CED Price/Volume near WTP Real CED Value to Patients, payers and investors Full value Salvage value Phased value Restricted value

6. Focal points for Consortium A pragmatic framework for conditional access 1 Emergent best practice in conditional contracts 2 Which value gaps can we address? 3 Implications for field of conditional access research 4

7. Proportionality NETH UK Collaborative Special situations, Joint Working PragmaticHTA AUS/ITALY GER/SWE Budget control and safety Value based contracts Transactional Simple, Standardised Complex, Tailored

8. Focal points for Consortium A pragmatic framework for conditional access 1 Emergent best practice in conditional contracts 2 Which value gaps can we address? 3 Implications for field of conditional access research 4

9. Value certainty: Right Focus? Value Certainty Max Value Robustness Adoption infrastructure, COGS and price/volume Focus of conditional access schemes: Saturated market? Value misalignment Sub-optimal application Real world data Wrong data Real world solutions for Developing mkts/LDCs Value issues “designed-in” from start Infrastructure for relative/cost effectiveness Biotech stability and sequencing, dose optimisation, phase III design insight, stopping rules… Drug Discovery Early Development Pivotal studies Life cycle Phase

10. Focal points for Consortium A pragmatic framework for conditional access 1 Emergent best practice in conditional contracts 2 Which value gaps can we address? 3 Implications for field of conditional access research 4

11. Shifting the balance