Novartis, a large international pharmaceutical company had applied for Class 1 reimbursement of Jakavi for adult patients with myelofibrosis. The company asked Hict for support in the pharmaco-economic section of this reimbursement submission.
This support includes:
Hict’s approach consisted of the following four phases:
Phase 1 – Intake phase
During the intake phase, the context, strategy and key parameters of the submission and CEA model 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 a complementary high-level desk research was performed and a gap analysis outlining the missing data and potential data sources was provided. This gap analysis served to identify the optimal data collection approach to be used during the data collection phase.
Phase 2 – Data collection
The data collection phase is designed to capture relevant Belgian inputs for the CEA model and was comprised of 3 sub phases:
3. Collection of unit costs out of national databases.
Phase 3 – CEA model support
During the CEA model support phase, the data collected during the intake and data collection phase was used to adapt the model to the Belgian context and populate the model with Belgian data. Results were generated (conform strategy on base case and scenario analyses) and discussed extensively with the pharmaceutical company.
Phase 4 – CEA report support
During this phase a CEA report was developed that is in line with the overall reimbursement strategy, meets KCE guidelines and is comprehensible for all readers.
Extra phase – Support answering questions in report D60
During this additional phase, answers to the pharmacoeconomic questions present by RIZIV/INAMI in the report D60 were formulated. This was done in close collaboration with Novartis and in collaboration with the model developers (for the respective questions). After which a comprehensible report, drafting the answers to all pharmacoeconomic questions, was written by Hict to be used/included in the response to RIZIV/INAMI. In addition, additional analyses (scenario’s) were performed and new model settings were used to generate results to comply with the questions/comments made by RIZIV/INAMI.
