Novartis applied for the Class 1 reimbursement of a novel therapy, CAR-T, to treat patients with paediatric acute lymphoblastic leukaemia (pALL). They asked Hict for support in the pharmaco-economic section of this reimbursement submission.
This support includes:
Hict’s approach consists of six phases:
Phase 1 – Intake phase
In the intake phase, the context, strategy and key parameters of the submission are discussed and analysed. An in-depth analysis of the provided CEA and BIA model, data inputs and sources of these models are performed. Based on the requirements of the models a complementary high-level desk research was performed, resulting in a gap analysis matching the available data with the required data. This gap analysis aids in the identification of the optimal data collection approach, and possible adaptations to the proposed approach.
Phase 2 – Data collection
Based on the gap-analysis and data collection approach discussed and validated during the intake phase, the data collection protocol was executed during the data collection phase. In this phase relevant Belgian inputs for the CEA and BIA model are collected. This phase consists of two major subsections:
Desk research and unit cost collection
Phase 3 – CEA model support
The data collected during the intake and data collection phase is transformed to a set of CEA model inputs according to Belgian health economic guidelines. To ensure the model is correctly populated and results are correctly interpreted, close communication with the model developers is facilitated. The model is populated and results are generated. The type of results to be generated (e.g. decisions on base case and scenario analyses) was decided in close collaboration with Novartis.
Model adaptations to the CEA model were performed, to allow the model to correspond maximally to the Belgian clinical practice and context. These adaptations were performed by Hict and validated by the model developers.
Phase 4 – CEA report support
During this phase a Dutch summary report on the CEA was generated, which describes the model, its inputs and results. This summary report is enclosed in the reimbursement submission dossier.
Phase 5 – BIA model
The data collected during the intake and data collection phase is transformed to a set of BIA model inputs according to Belgian health economic guidelines. The model inputs and types of results to be generated (e.g. decisions on base case and scenario analyses) were decided on in close collaboration with Novartis.
The BIA model was populated with Belgian data, and where needed model adaptations are performed. Results were generated and discussed in detail with Novartis.
Phase 6 – BIA model report
The BIA report development phase is designed to create a summary report in Dutch to accompany the reimbursement submission. The report describes the BIA model, its methodology, the inputs, and the results.