Health economic analysis of erenumab for treatment of migraine in Belgium

06 september 2021

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.

Project highlights

Customer: Novartis

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:

  • Development and implementation of a data collection strategy for the required CEA and BIA inputs
    • Desk research
    • Expert input via a survey and consensus meeting
  • CEA support
    • Critical review of an existing CEA model and (clinical) inputs
  • Population of the CEA model with the collected Belgian data and generation and discussion of the results
  • Development of a CEA report
  • BIA support
    • Development of a budget impact model tailored to the Belgian context and chronic disease pathway. Including modelling of different options which allowed to simulate different reimbursement options/criteria to support negotiations with the payer.
  • Population of the budget impact model with the collected Belgian data and generation and discussion of the results
  • Development of a BIA report

Approach

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:

  • Desk research and unit cost collection (including costs for drugs, tests, imaging, hospitalisation, terminal care, etc as well as life tables and epidemiological data). This data was collected from MZG-MKG national data, IMS data, literature, RIZIV/INAMI national database, etc.
  • Expert opinion via a survey and consensus meeting. A survey on epidemiology and clinical practice of episodic and chronic migraine in Belgium was developed, reviewed in collaboration with a pilot expert and sent out to eight experts. All data collected via the survey was processed by Hict and presented during a consensus meeting (organised and moderated by Hict). After which a consensus statement report on the epidemiology and clinical practice was developed by Hict and validated by all experts who participated.

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.

Novartis erenumab CE model

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.

Results

  • Kick-off meeting in which strategy of the reimbursement submission (CEA and BIA) was determined in cooperation with Novartis
  • Data collection of all key information to populate the CEA and 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 CEA model adapted for Belgium, with results
  • Clear and validated CEA report conform KCE guidelines and RIZIV/INAMI expectations, describing the model, methodology, inputs and results
  • Validated and populated dynamic BIA model for Belgium, with results, including an OWSA
  • Clear and validated BIA report conform KCE guidelines and RIZIV/INAMI expectations, describing the model, methodology, inputs and results
  • Reimbursement of the first CGRP inhibitor for the prophylactic treatment of migraine in Belgium