Therapeutics for Emerging Infections with Pandemic Potential: Pipeline Portfolio Review and Cost Model

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2019

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Background: Since December 2015, the World Health Organization (WHO) Research and Development (R&D) Blueprint for Action to Prevent Epidemics1 has maintained a list of 10 priority pathogens that have a high epidemic and pandemic potential and no or few medical countermeasures (MCMs, i.e., vaccines, diagnostics, and therapeutics). Barriers to facilitating R&D for these MCMs include lack of information on what candidate MCMs are currently in the pipeline, the estimated costs to advance this portfolio of candidates through the pipeline and the anticipated product launches. This study aimed to help close these information gaps, focusing specifically on the pipeline of therapeutics for the 10 “Blueprint diseases”. Methods: We conducted a pipeline portfolio review to summarize which candidate therapeutics against the 10 priority diseases are currently in the pipeline, and at what development phase. Based on this pipeline, we then estimated the costs of moving these candidates through the pipeline, using a modified version of a financial modeling tool called the Portfolio to Impact (P2I) model. The model also estimates likely product launches. Based on the current pipeline, there would be no launches of therapeutics for several of the 10 diseases; we used the model to estimate the additional costs to launch these “missing” products. Results: The pipeline portfolio review identified 78 candidate therapeutics for the 10 Blueprint diseases as of December 3rd, 2018. The pipeline is dominated by Zika and Ebola, whereas the other Blueprint pathogens have very few candidates. The P2I model estimates that it would cost $1.76 billion to move these current candidates through the pipeline from 2019 to 2030, which would lead to an estimated 8.78 cumulative product launches. These launches would be dominated by simple biologics (n=2.30) and simple repurposed drugs (n=4.92). The three diseases that are likely to have the most product launches are Ebola (n=3.21), Zika (n=2.91), and Rift Valley Fever [RVF] (n=1.42). For the other seven Blueprint diseases, the model suggested there would be no launches of therapeutics. We estimated that it would cost an additional $0.64 billion to $1.46 billion dollars to launch these “missing“ therapeutics (i.e., one therapeutic for each of these seven diseases), depending on the complexity of the product type. Conclusions: Our study found that while the current pipeline is likely to lead to launches of therapeutics for three of the Blueprint diseases—Ebola, Zika, and RVF—it is unlikely that there would be launches for the other diseases. We hope our results will help to mobilize additional financing and to inform new funding mechanisms, which are urgently needed for emergency response and preparedness against the highest threat diseases. We also hope that the study results will help identify where the pipeline has gaps, so that funding can be better directed to areas of greatest need.

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Ma, Jiyan (2019). Therapeutics for Emerging Infections with Pandemic Potential: Pipeline Portfolio Review and Cost Model. Master's thesis, Duke University. Retrieved from https://hdl.handle.net/10161/18846.

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