title: USING CLAIMS DATA FOR EVIDENCE GENERATION IN MANAGED ENTRY AGREEMENTS.
abstract: OBJECTIVE
  This study assesses the use of routinely collected claims data for managed entry agreements (MEA) in the illustrative context of German statutory health insurance (SHI) funds.
  
  
  METHODS
  Based on a nonsystematic literature review, the data needs of different MEA were identified. A value-based typology to classify MEA on the basis of these data needs was developed. The typology is oriented toward health outcomes and utilization and costs, key components of a new technology's value. For each MEA type, the suitability of claims data in establishing evidence of the novel technology's value in routine care was systematically assessed. Assessment criteria were data availability, completeness, timeliness, confidentiality, reliability, and validity.
  
  
  RESULTS
  Claims data are better suited to MEA addressing uncertainty regarding the utilization and costs of a novel technology in routine care. In schemes where safety aspects or clinical effectiveness are assessed, the role of claims data is limited because clinical information is not included in sufficient detail.
  
  
  CONCLUSIONS
  The suitability of claims data depends on the source of uncertainty and, in consequence, the outcome measures chosen in the agreements. In all schemes, the validity of claims data should be judged with caution as data are collected for billing purposes. This framework may support manufacturers and payers in selecting the most suitable contract type and agreeing on contract conditions. More research is necessary to validate these results and to address remaining medical, economic, legal, and ethical questions of using claims data for MEA.
authors.affiliation: Helmholtz Zentrum München; German Research Center for Environmental Health (GmbH),Institute of Health Economics and Health Care Management.
authors.forename: Alina
authors.initials: A
authors.lastname: Brandes
authors.affiliation: Helmholtz Zentrum München; German Research Center for Environmental Health (GmbH),Institute of Health Economics and Health Care Management.
authors.forename: Larissa
authors.initials: L
authors.lastname: Schwarzkopf
authors.affiliation: Department of Health Care Management,Institute of Public Health and Nursing Research,Health Sciences,University of Bremen,Germany;Helmholtz Zentrum München;German Research Center for Environmental Health (GmbH),Institute of Health Economics and Health Care Managementrogowski@uni-bremen.de.
authors.forename: Wolf H
authors.initials: WH
authors.lastname: Rogowski
mesh_terms: D003657:Decision Making; D005858:Germany; D006801:Humans; D007345:Insurance Claim Review / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D020414:Risk Sharing, Financial / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical / Q000458:organization & administration*; D035501:Uncertainty
keywords: Data collection/methods; Decision making; Insurance; Risk sharing; Technological innovation; financial/economics; health; reimbursement