Reducing Uncertainty in Value-Based Pricing Using Evidence Development Agreements

Abstract

Economic appraisal differs from clinical assessment, and decision makers benefit from analysis of naturalistic, actual practice data. Despite reviewing the initial trial-based, 'piggy-back' economic analysis, TLV was uncertain of the cost effectiveness in actual practice and deferred a final decision until observational data from the DAPHNE study became available. Second, acceptance of economic modelling and use of temporary reimbursement conditional on additional evidence development provide a mechanism for risk sharing between TLV and manufacturers, which enabled patient access to a drug with proven clinical benefit while necessary evidence to support claims of cost effectiveness could be generated.

Role of centralized review processes for making reimbursement decisions on new health technologies in Europe

“…Reimbursement price may be adjusted to reflect actual costs and benefits once such information becomes available (eg, continuous intraduodenal infusion of levodopa/carbidopa for advanced Parkinson’s disease)209…”

General Overview ofValue-Based Pricing

“…They also made sure that the industries that developed these drugs get the proper credit for investing in a company that does not have a great success ratio [8]. After the implementation of VBR, the government (NHS) was able to save approximately £ 1.2 billion in terms of drugs expenditure, which is a very important achievement for the pharmaceutical industry [9].…”

“…If appropriately structured, VBP holds the potential to motivate providers to improve clinical quality, reduce adverse events, coordinate care, avoid unnecessary costs, encourage patient-centered care, and invest in information technologies and other tools proven effective in improving quality [8]. To be a viable option in the UK, VBP must deliver efficiency (defined as the value for money) to the NHS and also provide adequate incentives for the pharmaceutical industry to invest in innovation.…”

The assessment of pharmacoeconomic studies quality of Levodopa’s use for the management of Parkinson’s diseases, 2010-2015

“…In total 19 articles were found [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41], of which 5 met the inclusion criteria and were submitted to the respective analysis (Figure 1). The list of excluded studies is provided in Annex (1).…”