Reimbursement dossier / HTA dossier

Number of countries in the reimbursement process require submission of reimbursement/health technology assessment (HTA) dossier for medical technology by manufacturer. In some countries, it is a direct process of submission by manufacturer, in another dossier can be provided to clinical society of leading experts to save time/effort in development of such extensive documentation.

Reimbursement dossier typically covers number of topics:

  • Epidemiology and burden of disease
  • Current standard of care and its limitations
  • Overview of technology in scope
  • Systematic literature review for technology
  • Health economic analysis for technology
  • Recommendations in clinical guidelines and health technology assessments
  • Ethical considerations
  • Integration of novel technology into existing patient’s pathway
  • Current reimbursement for technology

Synergus can provide support with development of reimbursement dossier for submission in European countries.

In the beginning of the process we will evaluate feasibility of submission, whether available clinical and economic evidence for technology are sufficient or not to undergo review by authorities. Negative recommendation may seriously impact market access not only in the country of interest, but in other European countries as well.

Having international team on board and affiliated office in France enable us to deliver dossiers specifically tailored to the local requirements and language.

Our experience includes development of documents in following geographies:

  • Belgium – implant reimbursement dossier to INAMI/RIZIV
  • England – sponsor evidence submission dossier to the National Institute for Clinical and Care Excellence, business cases for negotiation with Clinical Commissioning Groups
  • France – implant reimbursement dossier (LPPR) to High Health Authority (HAS)
  • Norway – mini-HTA dossier for Regional Health Authorities
  • Poland – HTA dossier for support of submission to AHTAPol
  • Russia – implant reimbursement dossier for Ministry of Health
  • Sweden – mini-HTA for regional authorities

Our experience in value documentation, reimbursement and health technology assessment submission dossiers will ensure the best possible outcome for submission to secure market access for your technology.

Contact us for more information