The lack of incentives for investing in new treatments for serious mental illness is resulting in high unmet need, says a study from the Center for the Evaluation of Value and Risk in Health (CEVR) and Tufts Medical Center.
By the numbers: In 2020, 6% of adults in the U.S. (1 in 20) and 10% of young adults aged 18-25 had serious mental illness, such as schizophrenia, bipolar disorder, and major depressive disorder—and prevalence is increasing.
“While beneficial treatments exist…it is often a challenge for patients to find an effective and tolerable treatment regimen to manage their specific condition, in part due to the underlying heterogeneity and complex biology underpinning mental health conditions,” says the report. Patients may experience unwanted side effects, or may not respond to the treatment at all.
“Despite high unmet need, the development of novel pharmaceuticals in serious mental illness has lagged behind advancements in other disease areas over the last 30 years,” the report continues. “[N]ew treatments that are effective in treating symptoms and improving the wellbeing of patients living with serious mental illness are urgently needed.”
But, there are major barriers, including…
- Science: “The complexity of studying the brain and its basic mechanics is a fundamental challenge to identifying new molecular targets.”
- Lack of incentive for private investment: “Due to these knowledge gaps, clinical development timelines for drugs used to treat serious mental illness are some of the longest, clinical trial success rates are lower, and regulatory approval is slower than average. As a result, over time many large pharmaceutical companies have shifted investment away.”
- Lack of government funding, which is “disproportionately low” for serious mental illness.
- “Existing market protection periods are disadvantageous to pharmaceutical companies in serious mental illness, given the longer research times and ultimately higher costs of developing a drug in this disease area,” says the report—and the Accelerated Approval Pathway cannot be used.
- “High expected clinical development costs and the potential for low expected revenues, compared to other therapeutic areas, may discourage companies from investing in serious mental illness. In addition, there is a relatively low proportion of patients living with a serious mental illness who obtain treatment compared to other disease areas, and there is lower expected net revenue given the high proportion of treated patients who are insured through Medicaid.”
The report suggests a number of policy solutions—including increases in government funding, market exclusivity reform and the development of an FDA Neuroscience Center of Excellence to expedite approvals, Medicaid reform, and support for public-private partnerships to drive innovation.
Read the whole thing.
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