Providing support with the resubmission of a radiopharmaceutical product by developing a cost model, updating the budget impact model and the reimbursement file.
Support for a cost analysis study, budget impact model, price and reimbursement dossier, and post-submission follow-up within the context of a reimbursement submission for a radiopharmaceutical product in Belgium.
June 2021 - February 2022
The reimbursement of a radiopharmaceutical product for the treatment of adult GEP-NET patients in Belgium.
Hict was asked to support the resubmission of a radiopharmaceutial product after a previously negative evaluation by TRRI (“Technische Raad voor Radioisotopen”). This negative evaluation was based on a simplified cost comparison of the radiopharmaceutical product with the magistral preparation of the compound in hospitals.
Hict assisted in the development of a cost model to correctly estimate the total cost of magistral preparation of the product, and updating the budget impact (BIA) model and reimbursement file.
Phase 1 - Intake
In the intake phase, the context, strategy and key parameters of the previous submission were discussed and analysed. Based on this analysis, the new strategy was discussed to determine the optimal approach for resubmission.
Next to the strategy discussion, the approach for the cost study was discussed.
To update the BIA model in the most efficient way, we first analysed in depth the available BIA model, data inputs and sources of this model and performed a gap-analysis between the available data and the required data.
Phase 2 - Cost analysis
We executed a cost analysis to get transparant and correct insights on the total cost of the magistral preparation of the radiopharmaceutical compound in Belgian hospitals (Figure 1). For this cost analysis, Hict prepared a cost model in which both the indirect and direct costs related to the production process have been taken into account.
We collected information on the Belgian clinical practice through interviews with a Belgian radiopharmacist experienced with the magistral preparation of this radiopharmaceutical compound. Additional information was obtained from a financial expert with knowledge on cost calculations in hospitals and a head pharmacist.
To calculate the total cost of the magistral preparation of the radiopharmaceutical compound, a flow of the production process was established and the unit costs and respective volumes were collected.
Next to a base case analysis, several scenarios were developed to test different parameters and assumptions, and give the payer insights in potential clinical practices.
Phase 3 - BIA model
Based on the gap-analysis, the missing data to update the BIA model was collected through desk research (i.e. unit costs, epidemiology data) and validation interviews (i.e. market shares, comparators and current clinical practice) with clinical experts in the field.
The BIA model was adapted conforming to the KCE guidelines and RIZIV/INAMI expectations (e.g. 3 budget lines) and updated with the collected data inputs. Sensitivity analyses and scenario analyses were also added to the model.
A report was developed describing the model, methodology, inputs and results to incorporate in the reimbursement file.
Phase 4 - Reimbursement dossier
We updated the previous reimbursement dossier for Belgium with the new strategy, cost study and budget impact model. This was an iterative process with the customer.