Development of a core evaluation framework of value-added medicines: report 2 on pharmaceutical policy perspectives

Abstract

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.

The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

“…Simple and efficient policies are required to achieve financial efficiency due to price competition among generics ( Kwon and Godman, 2017 ). Policy tools that can increase price competition among off-patent medicines by generic substitution, along with internal and external price referencing, are evident in many countries ( Kaló et al, 2021 ). The key target for public healthcare payers is to reinforce the allocative efficiency of healthcare costs ( Inotai et al, 2017 ; Petykó et al, 2021 ).…”

Performance-based risk-sharing arrangements for devices and procedures in cardiac electrophysiology: an innovative perspective

“…-Coordinate the assessment of the clinical evidence supporting clinical implementation of new devices after regulatory approval and appropriately define the specific clinical outcome that may be the reference for value-based assessments; -Help in promoting educational initiatives to help assess the determinants of the learning curve for innovative treatment, an important factor conditioning the speed and extent of implementation of innovative technologies; -Promote the institution, validation and verification of large-scale registries for a precise assessment of patient outcomes. These prospective registries could be the reference for objectively assessing patient outcome, but this would require the guarantee on data reliability, with possibility of verification and audits by stakeholders 38 ;…”