1. Risk Sharing Schemes Dr Rafiq Hasan Director of Market Access
Novartis Pharmaceuticals UK Ltd
This presentation reflects my personal views and not those of Novartis Pharmaceuticals UK Ltd

2. Summary - risk share schemes facilitate access to innovative therapies
Risk share schemes are many and varied in design and structure. Examples include outcome based guarantees, price adjustments based on outcome and dose capping schemes to name but a few.
Schemes are likely to differ depending on the nature of the medicine and the condition to be treated
Schemes should only be used in exceptional circumstances and in consultation with the manufacturer
Schemes should provide clear benefit to patients
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3. Context - risk share schemes provide a method to reduce uncertainty and enable patient access
Risk share schemes usually arise in the context of a Health Technology Appraisal (HTA)
HTA is based upon complex mathematical modelling incorporating data and critically assumptions from varied sources
Economic modelling is an evolving science and often results in wide-ranging estimates of cost-effectiveness – based on methodology and assumptions
At time of launch clinical data set tends to be limited resulting in greater uncertainty in economic modelling
More difficult to accurately estimate the cost effectiveness of the intervention and therefore likely to result in negative HTA decision with little or no patient access
Risk share schemes can reduce this uncertainty whilst allowing appropriate patient access and importantly the ongoing collection of relevant naturalistic data for future HTA
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4. Principles underlying such schemes – industry perspective
Benefit to patients
Not mandatory – initiated by manufacturer
Consideration of administrative burden of implementing the scheme – simplicity is essential
Scheme should be based on objective, transparent and workable criteria such as measures of response
Pragmatic approach required from all stakeholders to allow different models to be applied flexibly
Predetermined duration usually linked to HTA re-review and/or when new data is available
Maintain patient confidentiality
Must comply with relevant local regulations including PMCPA Code of Practice
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5. Early engagement with key stakeholders critical for success
Manufacturer
Department of Health
HTA agency – NICE, SMC
Professional bodies – Royal Colleges
Patient Support Groups
Local NHS stakeholders
Local clinicians
Hospital Pharmacy/Medicines Management Team
PCT Commissioners/Pas
Agreement between commissioners and providers
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6. Benefits of such schemes
Patient access and consequent health benefits
Support commitment to demonstrating value of the technology and reducing uncertainty to budget holders
Ensure appropriate use of technology – eligible patients and objective assessment of benefit
Encourage compliance
Transparent assessment of outcomes
Ongoing data collection assessing use of technology in ‘real life’ circumstances – useful for future HTA
Partnership working between NHS and industry
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7. Challenges Administrative burden Complexity of multiple NHS systems
Alignment with NHS financial flows
Agreement on objective measures that underpin a particular scheme
Mechanisms for conflict resolution required
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8. Experience to date and future direction
Still early days – mixed opinions
Initial teething problems overcome in most instances
Enable patient access
Future Direction
A useful option in specific circumstances to facilitate early market access
Improved operational efficiency as experience with current schemes matures
Further consideration and quantification of resources required to administer such schemes
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