Novartis applied for the Class 1 reimbursement of a novel therapy, erenumab, for the prophylactic treatment of episodic and chronic migraine. They asked Hict for support in the pharmaco-economic section of this reimbursement submission.
Main Goal: Complete the pharmaco-economic section of the reimbursement dossier (data collection, CEA model population, BIA model development, and corresponding reports)
Main Result: Reimbursement of the first CGRP inhibitor in the prophylactic treatment of migraine in Belgium (since June 2021)
The support included:
Hict’s approach consisted of six phases:
Phase 1 – Intake phase
The context, strategy and key parameters of the submission were discussed and analysed. An in-depth analysis of the provided CEA model, data inputs and sources of this model was performed. Based on the model requirements and the knowledge of BIA model requirements a complementary 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 CEA and BIA model were collected. In collaboration with Novartis the option yielding the most reliable and credible data was selected: expert opinion via a survey followed by a consensus meeting. This phase thus consisted of two major subsections:
Phase 3 – CEA model support
The data collected during the intake and data collection phase was transformed to a set of CEA model inputs according to Belgian health economic guidelines. To ensure the model was correctly adapted, populated and results were correctly interpreted, a teleconference call with the model developers was set up. The type of results to be generated (e.g. decisions on base case and scenario analyses) were decided on in close collaboration with Novartis.
Phase 4 – CEA report support
A CEA report was created based on the technical report from Novartis HQ to be included as addenda in the submission. The report, clearly describing the model, its methodology, the inputs (general and Belgian specific inputs) and the results, was written in line with the Belgian reimbursement submission guidelines.
Phase 5 – BIA model support
Due to the very country specific nature of the existing BIA model, the preference was given to the development of a new, transparent, BIA model for Belgium. The added benefit of creating the model from scratch was that the model would be more in line with RIZIV/INAMI expectations (eg. budget lines, OWSA), and that it could be tailored to Belgian clinical practice (eg. specific requirements with regards to the target population and the effect of reimbursement on the population size). As well as the possibility to include multiple settings, which could be easily adjusted to by Novartis and support them during negotiations with the payer. The robustness of the model results was validated by including a one-way sensitivity analysis (OWSA). 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 Novartis BE.
Phase 6 – 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.