Background A core evaluation framework that captures the health care and societal
benefits of value added medicines (VAMs, also often called repurposed medicines) was
proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes
across countries and to create incentives for manufacturers to invest into incremental
innovation. However, this can be impactful only if the framework can be adapted to
heterogeneous health care financing systems in different jurisdictions, and the cost
of evidence generation necessitated by the framework takes into account the anticipated
benefits for the health care system and rewards for the developers. Areas covered
The framework could potentially improve the pricing and reimbursement decisions of
VAMs by adapting it to different country specific decision-contexts such as deliberative
processes, augmented cost-effectiveness frameworks or formal multi-criteria decision
analysis (MCDA); alternatively, some of its domains may be added to current general
evaluation frameworks of medicines. The proposed evaluation framework may provide
a starting point for practices based on which VAMs can be exempted from generic pricing
mechanisms or can be integrated into the reimbursement and procurement system, allowing
for price differentiation according to their added value. Besides evidence from RCTs,
pricing and reimbursement decision processes of VAMs should allow for ex-ante non-RCT
evidence for certain domains. Alternatively, relying on ex-post evidence agreements-such
as outcome guarantee or coverage with evidence development-can also reduce decision
uncertainty. Conclusions The core evaluation framework for VAMs could trigger changes
in the existing pricing, reimbursement and procurement practices by improving the
appraisal of the added value created by incremental innovation.
