Risk Sharing SchemesDr Rafiq HasanDirector of Market AccessNovartis Pharmaceuticals UK Ltd

This presentation reflects my personal views and not those of Novartis Pharmaceuticals UK Ltd

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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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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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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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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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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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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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Experience to date and future direction

Experience to date

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