title: EVIDENCE REQUIREMENTS FOR REIMBURSEMENT OF PHARMACEUTICALS ACROSS EUROPE.
abstract: OBJECTIVE
  The objective of this study was to compare evidence requirements for health technology assessment of pharmaceuticals by national agencies across Europe responsible for reimbursement decisions focusing specifically on relative effectiveness assessment.
  
  
  METHODS
  Evidence requirements from thirty-three European countries were requested and twenty-nine national agencies provided documents to review. Data were extracted from national documents (manufacturer's submission templates and associated guidance) into a purpose-made framework with categories covering information about the health condition, the technology, clinical effectiveness and safety.
  
  
  RESULTS
  The level of detail in the required evidence varies considerably across countries. Some countries include specific questions while others request information under general headings. Some countries include all information in a single document, which may or may not include guidance on how to complete the template. Others have specific guidance documents or methods and process manuals that help with the completion of the submission templates. Despite differences in quantity and detail, the content of the evidence requirements is broadly similar. All countries ask for information on the health technology, target disease, and clinical effectiveness and safety. However, one country only requests clinical effectiveness information as part of cost-effectiveness analyses. We found twenty-six evidence requirements for which generic answers may apply across borders and nineteen in which countries requested nationally specific information.
  
  
  CONCLUSIONS
  This work suggests that it would be possible to put together a minimum set of evidence requirements for HTA to support reimbursement decisions across Europe which could facilitate collaboration between jurisdictions.
authors.affiliation: National Institute for Health and Care Excellenceo.r.o.oyebode@warwick.ac.uk.
authors.forename: Oyinlola
authors.identifier: http://orcid.org/0000-0003-0925-9839
authors.initials: O
authors.lastname: Oyebode
authors.affiliation: National Institute for Health and Care Excellence.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Garrett
authors.affiliation: National Institute for Health and Care Excellence.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: George
authors.affiliation: Italian Medicines Agency (AIFA).
authors.forename: Agnese
authors.initials: A
authors.lastname: Cangini
authors.affiliation: Italian Medicines Agency (AIFA).
authors.forename: Luisa Anna Adele
authors.initials: LA
authors.lastname: Muscolo
authors.affiliation: Clinical and Health Psychology,ZorgInstituut Nederland.
authors.forename: Simone
authors.initials: S
authors.lastname: Warren
authors.affiliation: National Institute for Quality and Organizational Development in HealthCare and Medicine (Hungary).
authors.forename: Bertalan
authors.initials: B
authors.lastname: Nemeth
authors.affiliation: National Institute for Quality and Organizational Development in HealthCare and Medicine (Hungary).
authors.forename: Csenge
authors.initials: C
authors.lastname: Földesi
authors.affiliation: State Institute for Drug Control.
authors.forename: Marcela
authors.initials: M
authors.lastname: Heislerová
authors.affiliation: Ministry of Health of the Czech Republic.
authors.forename: Eva
authors.initials: E
authors.lastname: Gajdošová
mesh_terms: D003362:Cost-Benefit Analysis; D005060:Europe; D006801:Humans; D055553:Prescription Drugs; D013673:Technology Assessment, Biomedical / Q000379:methods* / Q000592:standards*
chemical_list: D055553:Prescription Drugs
keywords: Biomedical technology; Delivery of health care; Health policy; Reimbursement mechanisms; Technology assessment; biomedical