title: Harmonization of HTA--based reimbursement and regulatory approval activities: a qualitative study.
abstract: BACKGROUND
  Regulatory approval and reimbursement are necessary to bring health technologies to market. As both are distinct processes, the lack of interaction between regulators and payers has been criticized for resulting in health system inefficiencies.
  
  
  OBJECTIVE
  This study describes the experiences of health system stakeholders on the development and implementation of initiatives to better harmonize HTA-reimbursement and regulatory activities, as well as Canadian perceptions on such initiatives.
  
  
  METHODS
  Thematic analysis of semi-structured interviews was conducted. Participants represented those whom have published or worked actively in this area or who held positions in HTA and/or reimbursement agencies that gave them insight into the Canadian healthcare system. Interviews were recorded, transcribed and analyzed to identify emerging themes and relationships.
  
  
  RESULTS
  Fourteen individuals from twelve organizations participated, including representatives from Canada, US, UK and Netherlands. Harmonization was identified as either a means to: (i) develop economies of scale in the generation of clinical data; and/or (ii) align the lifecycle of a health technology. For such initiatives to be successfully implemented, the following key issues emerged: (i) fostering healthy relationships; (ii) promoting well-intentions; (iii) defining governance and leadership clearly; and (iv) securing organizational infrastructure.
  
  
  CONCLUSIONS
  Attempts to harmonize reimbursement and regulatory activities is in its infancy; although, much can be learned from current Canadian and international experiences. Within Canada there is much interest, although concerns have been raised on the extent to which harmonization is possible. Successful policy implementation would require inter-agency collaborations, with particular attention towards capacity building and strong leadership.
authors.forename: Bernice
authors.initials: B
authors.lastname: Tsoi
authors.forename: Daria
authors.initials: D
authors.lastname: O'Reilly
authors.forename: Lisa
authors.initials: L
authors.lastname: Masucci
authors.forename: Michael
authors.initials: M
authors.lastname: Drummond
authors.forename: Ron
authors.initials: R
authors.lastname: Goeree
mesh_terms: D000288:Administrative Personnel / Q000523:psychology; D001290:Attitude; D002170:Canada; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017277:Drug Approval; D005060:Europe; D033161:Government Regulation; D017048:Health Care Costs / Q000331:legislation & jurisprudence; D019981:Health Care Sector / Q000191:economics / Q000331:legislation & jurisprudence; D006291:Health Policy / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics / Q000331:legislation & jurisprudence; D007407:Interviews as Topic; D010465:Perception; D011050:Policy Making; D036301:Qualitative Research; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000331:legislation & jurisprudence; D014481:United States