Reimbursement Dossier

Within our reimbursement dossier service, we prepare  HTA reports that are compliant with all local legal requirements.

Arcana Institute offers preparation of Reimbursement Dossiers for:

  • Medical devices
  • Pharmaceuticals and dietary foods for special medical purposes
  • Generic productsReimbursement Dossier

In order to determine the full extent of the HTA report, a preliminary analysis is performed that provides a review of the basic information in the clinical context. The aim of the preliminary analysis is to formulate a clinical question following the PICOS scheme:

  • P – population
  • I – intervention
  • C – comparison (comparator)
  • O – outcomes
  • S – study design

During this stage of the report, the following information is compiled:

  • Description of the health problem with identification and estimation of potential target population;
  • Statement of epidemiological data related to the proposed target population;
  • Review of the current clinical practice guidelines (local and foreign countries);
  • Review of recommendations & reimbursement decisions in selected country(ies) for intervention;
  • Description & selection of a comparator(s) with a full description of methods and level of financing.

At the clinical effectiveness analysis stage, we perform an assessment of health outcomes (clinical efficacy and safety profile) for the intervention vs. optional technology(ies) in the target population. This analysis is carried out as a systematic review of evidence, in accordance with the following scheme:

  • Systematic identification of evidence (primary and secondary studies);
  • Critical appraisal of the evidence: assessment of quality and reliability of the included studies;
  • Extraction of data from included trials and related publications, converted to matching units;
  • Assessment of methodological, clinical, and statistical heterogeneity among studies;
  • Qualitative description of studies;
  • Quantitative synthesis;
  • Reporting study results in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines;
  • Discussion of the results and limitations of the analysis;
  • Comprehensive safety analysis;
  • Conclusions and summary of the analysis.

As a part of clinical effectiveness analysis, we also take into account advanced methods of data analysis, such as network analysis (e.g. Mix Treatment Comparison).


The cost-effectiveness analysis compares the evaluated technology with optional technologies in terms of cost and health consequences. This analysis is based on the decision-making model for a fixed time horizontal analysis de novo, constructed in TreeAge Pro, MS Excel, or by adjusting our client’s own model to local conditions.

The assessment of cost-effectiveness is conducted according to the following scheme:

  • Defining the Decision Problem according to PICOS;
  • Defining the perspective and time horizon;
  • Defining of the appropriate analytical technique (e. g. cost-effectiveness, cost-utility, cost minimization analysis);
  • Costs identification (for intervention and comparators groups);
  • Resource utilisation estimate on basis of information available in literature & expert opinion;
  • Development of economic model or adaptation of core cost-effectiveness model to local settings;
  • Conducting a cost-consequence analysis;
  • Presentation and interpretation of the economic analysis results (e.g. cost-effectiveness/cost-utility/cost-minimisation analysis);
  • Inclusion of a risk sharing scheme;
  • Sensitivity analysis and threshold analysis;
  • Systematic review of pharmacoeconomic studies for the intervention in the defined health problem;
  • Systematic search of the studies relating to the health state utilities which will be incorporated into a model and presenting them in the form of a review;
  • Discussion of the results and limitations of the analysis;
  • Conclusions and summary of the analysis.

The budget impact analysis is a simulation of financial consequences on a healthcare system resulting from a health technology reimbursement. This analysis is conducted in accordance with the following scheme:

  • Estimation of costs relevant to the defined perspective (e.g. the payer, payer and patient, the Ministry of Health, patient, societal);
  • Analysis of the target population;
  • Identification of the ‘current practice’ in the defined health problem;
  • Sensitivity analysis with the use of alternative input values;
  • Construction of the best- and worst-case scenarios;
  • Assessment comparing the financial consequences for health technology reimbursement to the public payer and without refund of the product;
  • Inclusion of Risk Sharing Scheme;
  • Development of the budget impact calculator (within the economic model) in MS Excel.