Preglem, Gedeon Richter - A health economic analysis of a new drug for treatment of symptomatic leiomyoma in Belgium.

PregLem is a Swiss-based specialty biopharmaceutical company dedicated to the development and commercialisation of innovative drugs for women’s reproductive medicine. PregLem’s product pipeline focuses on women’s reproductive medicine with significant unmet medical needs that severely impact a patient’s quality of life and fertility like uterine fibroids (myoma), endometriosis, infertility and post-surgical abdominal adhesions.

On 7th October 2010, Gedeon Richter Plc. announced the acquisition of PregLem SA and PregLem became a member of the Richter Group. Gedeon Richter Plc. is a Hungarian-controlled Central-Eastern European multinational pharmaceutical company.

Project description

The objective of the project was to support Gedeon Richter in the reimbursement submission for Esmya®, a new innovative drug for the pre-operative treatment of uterine fibroids in women of reproductive age.

In a preliminary phase hict was responsible to support Gedeon Richter 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

  •  The development of a cost-minimization analysis model (CEA model) and a budget impact analysis (BIA model) model;
  • Collection of the necessary data of these models;
  • Population of the models;
  • Development of a report describing the CMA and BIA models and results.


Based on desk research, literature search and preliminary interviews with key opinion leaders, the most appropriate approach and strategy for the health economics section of the reimbursement dossier of Esmya® was defined in cooperation with Gedeon Richter.

Based on interviews with selected key opinion leaders, a survey was drafted to ascertain the current treatment pathway for treatment of symptomatic leiomyoma in Belgium, the disease prevalence and resources used for its treatment. This survey was used as the basis of a consensus meeting, moderate by hict, establishing the clinical practice of leiomyoma in Belgium. All consensus positions achieved during this meeting were described in a formal consensus statement report, approved by participating experts.

For the health economics analysis a model for a cost-minimization analysis and a model for a budget impact analysis was developed, based on literature review and inputs obtained from the expert consensus panel.

This model was populated with data from the consensus statement of literature search. Finally, the models and corresponding results were detailed in an extensive report.


  • Survey on the current clinical practice of leiomyoma in Belgium;
  • Consensus meeting moderated by hict on the clinical practice of leiomyoma in Belgium, including formal and validated consensus statement;
  • CMA and BIA model, populated with collected data;
  • Detailed report on the CMA and BIA models and their final results.


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Ann Tanghe
Senior Manager
Ann Tanghe
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