Budget impact analysis of filgotinib for treatment of rheumatoid arthritis in Belgium

28 octobre 2021

Galapagos applied for the Class 2 reimbursement of a novel therapy, filgotinib, for the treatment of rheumatoid arthritis. They asked Hict for support in the pharmaco-economic section of this reimbursement submission, including the preparation and moderation of a consensus discussion on defining the target population and clinical practice.

Project Highlights

  • Customer: Galapagos
  • Main Goal: Complete the pharmaco-economic section of the reimbursement dossier (data collection and BIA model development with corresponding reports)
  • Timing: Reimbursement of filgotinib, the first product of Galapagos, in Belgium

The support included:

  • Development and implementation of a data collection strategy for the required BIA inputs
    • Desk research
  • Expert input via a survey and consensus meeting
  • BIA support
    • Development of a budget impact model tailored to the Belgian context
  • Population of the budget impact model with the collected Belgian data and generation and discussion of the results
  • Development of a BIA report in Dutch (to be integrated inherently into the submission file)

Approach

Hict’s approach consisted of four phases:

Phase 1 – Intake phase

The current context of rheumatoid arthritis treatment in Belgium, including reimbursement conditions of already reimbursed products and expected future products, and the strategy for the reimbursement submission of filgotinib were analyzed and discussed. Based on the information gathered on the treatment of rheumatoid arthritis and the BIA model requirements specified by the client, a high-level desk research was performed. A gap analysis matching the available data with the required data was performed.

Phase 2 – Data collection

Based on the gap-analysis the data collection protocol was validated and executed. In this phase, relevant Belgian inputs for the BIA model were collected via an expert survey followed by a consensus meeting. This phase consisted of two major subsections:

  • Desk research and unit cost collection (including costs for drugs, tests, imaging, hospitalisation, etc., as well as life tables and epidemiological data). This data was collected from IQVIA data, literature, RIZIV/INAMI national database, etc.
  • Expert opinion via a survey and consensus meeting. A survey on epidemiology and clinical practice of rheumatoid arthritis (RA) in Belgium was developed, reviewed and sent out to eight rheumatologists. All data collected via the survey was processed by Hict and presented during a consensus discussion moderated by Hict. The consensus statement report on the epidemiology and clinical practice, developed by Hict, was sent to all participating experts for validation.
Filgotinib bia

Phase 3 – BIA model support

A new, transparent, BIA model tailored to the Belgian RA clinical practice and requirements and expectations of RIZIV/INAMI was developed. After developing the BIA model, the model was populated with the data collected in previous phases, in line with the Belgian health economic guidelines, and results were generated. The model inputs and types of results to be generated were decided on in close collaboration with Galapagos.

Phase 4 – BIA model report support

A BIA report meeting the Belgian reimbursement submission guidelines and clearly describing the model, its methodology, the inputs, and the results was developed in Dutch and validated by Galapagos for finalization.

Results

  • Kick-off meeting in which the strategy of the reimbursement submission was determined in cooperation with Galapagos
  • Data collection of all key Belgian information to populate the BIA model
  • Survey on the current Belgian clinical practice and epidemiology
  • Consensus statement report on the clinical practice: a report describing the applied methodology, questions asked, results obtained, and conclusions made
  • Validated and populated dynamic BIA model for Belgium
  • Clear and validated BIA report conform KCE guidelines and RIZIV/INAMI expectations, describing the model, methodology, inputs and results
  • Reimbursement of the first Galapagos product in Belgium as of August 2021