Cost-utility analysis & budget impact analysis for reimbursement of a new alcohol dependence treatment drug in Belgium

06 août 2019

Lundbeck requested support with the pharmaco-economic section of the reimbursement submission for Selincro® (nalmefene), a new and innovative medicine to decrease the alcohol consumption of adult alcohol-dependent patients.

Expertise: Health Economics, Reimbursements

Project Highlights

  • Customer: Lundbeck
  • Main Goal: Strategic advice on the reimbursement submission, data collection of Belgian-specific data, population of a CEA model and development of a BIA model, including a CEA and BIA reports.
  • Main Result: : Reimbursement of Selincro® in alcohol-dependent patients in Belgium

The aim of the project was to support Lundbeck with the reimbursement submission for Selincro® (nalmefene), a new and innovative medicine to decrease the alcohol consumption of adult alcohol-dependent patients.

In a preliminary phase Hict was responsible to support Lundbeck to define the correct and most optimal strategy and approach in the reimbursement submission (correct comparator, most appropriate health economic analysis, etc.)

In a second phase Hict was responsible for:

  • Collection of the necessary Belgian cost data for the CEA and BIA model
  • Development and implementation of a data collection strategy for the required CEA and BIA inputs
  • CEA support
    • Critical review of the CEA model and (clinical) inputs
    • Population of the CEA model with the collected data, and generation of results
    • Adaptations of an existing CEA full report to the Belgian context
  • BIA support
    • Development of a BIA model tailored to the Belgian context
    • Population of the BIA model with the collected data, and generation of results
    • Development of a BIA report

Approach

Based on desk research, literature search (economic and clinical literature), in-depth analysis of existing cost-utility model and preliminary interviews with key opinion leaders, the most appropriate approach and strategy for the health economics section of the reimbursement dossier of Selincro® was defined in cooperation with Lundbeck.

In a subsequent phase, based on interviews with selected key opinion leaders, a survey was drafted to ascertain the current pathway for treatment of alcohol dependent patients in Belgium, the disease prevalence and resources used for its treatment. This survey was used as the basis of a consensus meeting, moderated by Hict, establishing the clinical practice in Belgium and estimating the prevalence of the specific patient population for Selincro®. All consensus statements achieved during this meeting were described in a formal consensus statement report, approved by participating experts.

Additionally, data was captured from existing literature and databases (e.g. ‘Minimale Klinische Gegevens’ database, MDB and DMDB databases of WHO).

For the health economics analysis an existing cost-utility model was populated with Belgian Data with inputs from literature and database searches and inputs obtained from the expert consensus panel. A new budget impact model was developed and populated with collected inputs.

Finally, the models and corresponding results were detailed in extensive reports.

Results

  • Survey on the current Belgian clinical practice and prevalence of the patient population for Selincro®
  • Consensus meeting moderated by Hict, including formal and validated consensus statement
  • Data analyses of MKG, MDB and DMDB databases
  • Cost-utility model populated with collected data (including one-way sensitivity analysis and probabilistic sensitivity analysis)
  • Budget impact model populated with collected data (including one-way sensitivity analysis)
  • Detailed report on the models and their final results