Table 2.

Key issues for health authorities and health insurance companies to consider when appraising risk sharing arrangements proposed by pharmaceutical companies for new drugs.

Key issues regarding risk sharing arrangements

• Validity of the appropriateness of the arrangement(s) for the situation/circumstances in the country/region incorporating current or proposed service delivery arrangements and involving the use of experts • Specificity and transparency of the objectives and scope of the proposed scheme(s) • Novelty of the new drug – including its envisaged health gain, assessment of the effectiveness of current treatments, priority of the disease area, and the translational evidence base • Proportion health authorities will end up funding of a new drug’s development costs through registries post-launch • Data ownership – ideally, all key stakeholders should be involved in the development of any subsequent patient registries. In principal, these should be funded by the manufacturer • Feasibility of IT infrastructure already in place to collect data to monitor the agreement(s) in practice. Alternatively, if new structures are needed, their development costs need to be considered alongside the financial benefits of any proposed risk sharing scheme • Beneficial impact on service delivery and/or safety of the new drug. This should be substantial but has been difficult to prove in Phase III trials • Administrative burden of any proposed risk sharing scheme in relation to the potential overall savings • Likely patient concordance in practice, especially if this has not been fully considered in the proposed scheme(s)