Modelling the R&D Process for Global Diseases Driven By Public-Private Partnersips (PPPs)

Rational: The most significant initiative to address the innovation gap for neglected diseases affecting poor populations in poor countries has been the establishment of Public-Private Partnerships for product development (PD PPPs) which have been supported in conception and funding by a number of donors. This model is part of a study commissioned by the Rockefeller Foundation to estimate the cost of developing new products for global diseases via PD PPPs and to develop a framework for assessing the value for money offered by these initiatives to funders. Objective: To model the R&D process undertaken by PD PPPs in HIV AIDS, TB and malaria to estimate how much it will cost to obtain successful products. Methods: The R&D portfolios of PD PPPs were modelled using a Markov multi-state model. Data: The Markov model was populated with data on cost of clinical phases, transition probabilities, duration of phases and technical specifications of future products drawn from the published literature and information provided by the relevant PD PPPs. Results: For vaccines PD PPPs portfolios, the cost per successful product ranged from $1.4 billion and $2.2 billion (in 2006 US$) depending on the disease area whilst, for drugs, it ranged from $16 million to $1.2 billion depending on the disease area and on the stage of development at which the R&D process starts. The higher cost of vaccines is, among other factors, due to the significant degree of uncertainty about the underlying science associated with these health technologies as compared to drugs. Conclusions: This study provides preliminary indications of the cost of developing new products for the prevention and the treatment of global diseases when R&D portfolios are driven by PD PPPs. It enables comparisons to be made with the costs of developing new products for richer markets to assess the efficiency of different incentive mechanisms. It enables an analysis of the cost per DALY and therefore value for money of investing in R&D for neglected diseases to be assessed