Economics of Influenza Vaccine Development

In this thesis we are particularly concerned about the development of new and improved influenza vaccines with in the changing external economic environment. The thesis covers two major objectives: 1) Developing methods to estimate the costs of influenza vaccine development The ability to calculate the development costs for specific medicines and vaccines are important to inform investments in innovation. Unfortunately, the literature is predominated by non-reproducible studies only measuring aggregate level drug research and development (R&D) costs. Further, the literature appears very scant on the development costs of new vaccines. In the first objective we therefore describe methodology that improves the transparency and reproducibility of primary indication expected R&D expenditures of influenza vaccines. 2) Developing methods to focus influenza vaccine R&D towards meeting cost-effectiveness targets The second objective is focused on how to forecast evidence requirements for cost effectiveness analysis (CEA) of influenza vaccines. The guidance to manufacturers on what evidence would optimally support acceptable CEA is scant. The absence of such guidance and the increased emphasis on CEA can add significant risk to the vaccine development process. Thus we perform a Value of Information (VOI) analysis on the parameters of a cost effectiveness model designed to evaluate new influenza vaccines designed for use in elderly adults. The results of this study highlight what type of endpoints that should be studied in influenza vaccine R&D programs. From our work on these objectives we are able to shed light on economics that should be considered while developing a new influenza vaccine. Though our contribution is mainly methodological, we conclude the thesis suggesting changes in the way the vaccine industry and HTA agencies work. These changes are in our view necessary to meet society’s demand for new vaccines that deliver high value for money.Ph