title: Health economic value of an innovation: delimiting the scope and framework of future market entry agreements.
abstract: OBJECTIVE
  The objective of our paper is to offer a new, payer-friendly taxonomy of market entry agreements (MEAs) that aims to twin contracts with their methodological designs in an effort to clarify the distinction between contracts that are based on performance and those that are based on demonstrated effect.
  
  
  METHODS
  Our analysis proceeds in two stages: First, we delimit the scope and framework of pay for performance (P4P) and pay for demonstrated effect (P4E) agreements. Second, we distinguish the methodological designs supporting the implementation of each of these contracts.
  
  
  RESULTS
  We elucidate why P4P contracts prevent the payer from funding the true effectiveness of an innovation by expanding on their limitations. These include: 1) the normative nature of comparisons, 2) the impossibility of true effect imputability for each individual, and 3) the use of intermediary outcome measures. We then explore three main criticisms that payers must take into account when reasoning in terms of performance rather than in terms of the product effectiveness.
  
  
  CONCLUSIONS
  The potential effect that performance-based reimbursements may have on dissociating the components of the cost-effectiveness ratio constitutes an obstacle to a true health economic reasoning.
authors.affiliation: French Network for Evaluation in Health Economics, Paris, France.
authors.forename: Robert
authors.initials: R
authors.lastname: Launois
authors.affiliation: French Network for Evaluation in Health Economics, Paris, France.
authors.forename: Lucia Fiestas
authors.initials: LF
authors.lastname: Navarrete
authors.affiliation: Research Unit for the Economic Evaluation of Medical Innovation, University of Liege, Liege, Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Ethgen
authors.affiliation: French Network for Evaluation in Health Economics, Paris, France.
authors.forename: Jean-Gabriel
authors.initials: JG
authors.lastname: Le Moine
authors.affiliation: French Network for Evaluation in Health Economics, Paris, France.
authors.forename: René
authors.initials: R
authors.lastname: Gatsinga
keywords: comparative effectiveness research; cost-effectiveness studies; pay for performance contract; risk sharing