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Incentivizing Drug Development in Serious Mental Illness.

Hannah Geils¹, Abigail Riley¹, Tara A Lavelle¹

¹Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, Boston, Massachusetts.

Clinical Therapeutics

|September 2, 2022

Summary

Serious mental illness (SMI) presents significant challenges, with lagging pharmaceutical innovation hindering new treatment development. This report identifies barriers and proposes policies to incentivize investment in novel SMI drugs.

Keywords:

Healthcare policy Incentive Pharmaceutical innovation Pharmaceutical research Regulation Serious mental illness

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Area of Science:

Neuroscience and Psychiatry
Pharmacology
Health Policy

Background:

Serious mental illness (SMI) significantly impacts individuals and society, leading to poorer health, education, and career outcomes.
Existing treatments for SMI are insufficient, and pharmaceutical innovation has lagged compared to other disease areas.
There is a critical unmet need for novel therapeutic interventions for SMI.

Purpose of the Study:

To identify and describe the key barriers hindering pharmaceutical innovation and new drug development for SMI.
To propose policy recommendations aimed at incentivizing investment in the development of novel SMI treatments.

Main Methods:

Literature review and analysis of existing research on SMI drug development.
Examination of scientific, research, regulatory, and health system-related barriers.
Policy analysis and formulation based on identified challenges.

Main Results:

Identified significant barriers in scientific understanding, research methodologies, regulatory pathways, and health system integration.
Highlighted the need for a multi-faceted approach to overcome these obstacles.
Developed a set of policy recommendations to stimulate innovation.

Conclusions:

Addressing the barriers in science, regulation, and healthcare systems is crucial for advancing SMI drug development.
Implementing proposed policies can incentivize pharmaceutical investment and accelerate the creation of new treatments for serious mental illness.
Overcoming these challenges is essential to improve outcomes for individuals living with SMI.