Using a Pharmacology to Payer Framework to Support Product Development

Using a Pharmacology to Payer Framework to Support Product Development

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, pharmacometricians, specialist physicians, virologists, epidemiologists, mathematicians, and health economists to plan and implement a P2P framework for the antiviral, oseltamivir, to inform pandemic influenza planning. In this blog post, we’ll discuss how quantitative frameworks like P2P can drive pharmaceutical ecosystem innovation.

Towards multidisciplinary use of P2P and M&S

One of the challenges of developing the P2P proof of concept was not going deep too quickly into any particular scientific domain. We needed to think modularly and then focus on the links between scientific domains. By getting those links right and having everyone agree on them, we were able to propagate the depth in each individual module—pharmacology, epidemiology, or health economics.

The true innovation of the P2P approach will be its ability to inform other disease areas. This approach to modeling and simulation facilitates effective communication and knowledge transfer to link domain specific expertise. Applied multidisciplinary approaches which address multiple stakeholders’ perspectives offers an opportunity to expand and enhance the impact of modeling and simulation within the healthcare system.

Applications in product development

We believe that profiling of new molecular entities (NMEs) early in drug development to estimate their market value and business case can be a future application of P2P. The insights gained from this quantitative framework will support stage-gating investments and facilitate earlier discussions with financial stakeholders.

In particular, multiscale models support medical interventions beyond therapeutics. P2P can examine the impact on the healthcare system of diagnostics and other healthcare solutions—adherence support, nursing home aids, or other ancillary offerings that can be bundled with a therapeutic or a diagnostic.

The application of pharmacology to the payer has applications in other patient journeys—for infectious diseases, cardiology, diabetes, neurology (Alzheimer’s disease, multiple sclerosis), oncology, medical countermeasures, and more. For example, moxidectin is being developed to help manage and eradicate onchocerciasis (river blindness). Along with the Medicines Development for Global Health (MDGH), Imperial College London, and the World Health Organization’s Special Program for Research and Training in Tropical Diseases (WHO/TDR), we linked moxidectin’s PK/PD variability to other disease models. This linkage allowed us to address pharmacoeconomic questions regarding the investment required to provide global access to moxidectin to accelerate onchocerciasis eradication in Africa. P2P supports linking drug development and the projected financial ask when designing various intervention programs.

Developing new therapeutics for dementia is an example of how P2P multiscale models could be used to describe patient journeys for non-infectious diseases. A new therapeutic to treat dementia may improve patients’ quality of life. This could mean that they don’t require a caregiver to look after them as much and that they’re able to continue their daily activities. A P2P framework could capture the direct economic benefits attained from patients having a greater level of autonomy as well as the indirect economic benefits to caregivers.

Moreover, the advent of new technologies—smart phone apps that can track patient mobility and artificial intelligence apps that can assess cognitive function—will enable more information to feed back into these multiscale models. This information can then be used to further refine models to support more robust predictions. The P2P approach allows clear and transparent discussions on which patients get a drug, at what dose, and whether this intervention has societal and/or payer benefits.


References

Kamal MA, et al. (2013). Population pharmacokinetics of oseltamivir: Pediatrics through geriatrics. Antimicrobial Agents and Chemotherapy, 57(8), 3470–3477. doi:10.1128/AAC.02438-12.

Kamal MA, et al. (2017). Interdisciplinary pharmacometrics linking oseltamivir pharmacology, influenza epidemiology and health economics to inform antiviral use in pandemics. British Journal of Clinical Pharmacology, 83(7), 1580–1594. doi:10.11 11/b cp. 13229

Milton P, et al. (2017). Modeling alternative treatment strategies for onchocerciasis: Moxidectin for control and elimination. Presented at the American Society of Tropical Medicine & Hygiene Annual Meeting, Baltimore, MD.

Milton P, et al. (2017). The potential for six-monthly mass administration of moxidectin to accelerate onchocerciasis elimination. Presented at the American Society of Tropical Medicine & Hygiene Annual Meeting, Baltimore, MD.

Wu DBC, et al. (2018). Cost-utility analysis of antiviral use under pandemic influenza using a novel approach—linking pharmacology, epidemiology and heath economics. Epidemiology and Infection, Epub ahead of print. doi:10.1017/S0950268818000158


Should you be interested in learning more, please watch the webinar we presented on this topic.

C. Kirkpatrick, C. Rayner

About the Author

C. Kirkpatrick, C. Rayner

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Carl Kirkpatrick is the Director of the Centre for Medicines Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. Since receiving his Doctor of Philosophy (Medicine) from the University of Otago (NZ) in 2002, Carl has worked at the University of Queensland and more recently Monash University. Carl has extensive knowledge in the area of PK/PD modeling and the factors that alter these processes, pre-clinical and clinical drug development, and clinical applications to optimization of therapy. He has worked on projects and produced publications across a number of therapeutic areas including diabetes, cardiovascular disease, cancer, aged/frailty, and infectious diseases (bacteria, viruses, and fungi). — Craig Rayner has more than 15 years of drug development experience. His past appointments include leadership roles in Clinical Pharmacology and Early development (Roche), Clinical development (CSL-Behring), in Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research (Monash University). Dr. Rayner has extensive experience in early and late development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings and accountability for numerous due diligences, active support of negotiations, deal making and integration activities. He holds an Adjunct Associate Professorship in Pharmaceutical Science (Monash University), and is broadly published in clinical pharmacology and also infectious diseases.