Congress must fix the IRA to help alleviate our mental illness crisis
More than 50 million Americans suffer from mental illness, ranging from anxiety and mild depression to more serious diseases like obsessive compulsive disorder, bipolar disorder, major depressive disorder, substance abuse disorder, schizophrenia, and suicidal ideation.
Mental Health America reports that one in ten youth are experiencing depression severe enough to impair their ability to function at school, work, at home, with family or in their social life. Some say it is one in five. From 2009 to 2019, the proportion of high school students reporting persistent feelings of sadness or hopelessness increased by 40 percent and the number considering suicide increased by 36 percent, says Rachel Werner, MD, PhD, Professor of Medicine at the Perelman School of Medicine.
To look at the crisis from another angle, 64 percent of local jail inmates have a mental illness, as well as about half of state and federal prisoners.
Challenges
The crisis is worsening, in part exacerbated by the effects of the COVID-19 pandemic, the growth of social media, the smaller size of family units and dwindling levels of community involvement.
Most individuals suffering from mental illnesses are not receiving treatment because they are uninsured, underinsured, fear the stigma, or even deny they have a mental illness, and because the resources for treatment are deplorably scarce. It is estimated that for every 350 individuals suffering from mental illness, there is one mental health provider.
Beyond the ability of affected individuals to access treatment and extant drugs, there is the problem of the product pipeline.
The price of our failure to identify and treat those affected by these disorders is profound and visible. It manifests in many ways: in unnecessary disability, unemployment, homelessness, addiction, and crime – including mass shootings, child and spousal abuse, suicide, and human misery. The price society pays in dollars and anguish is far greater than what it would cost to provide adequate mental health treatment.
Treatment of mental illness involves counselling, sometimes inpatient treatment, and frequently prescription drugs. The biopharmaceutical industry has developed a wide range of psychiatric medications to treat mental illnesses, including antidepressants, antipsychotics, mood stabilizers, anti-anxiety medications, and stimulants. These drugs, which are effective, and which have become so commonly recognized that their brands are household names, work by influencing the brain chemicals that regulate emotions and thought patterns.
And, beyond the ability of affected individuals to access and continue using these extant drugs, there is the problem of the product pipeline. Medications to treat psychiatric diseases have the lowest probability of success in clinical drug development compared to all other disease categories, reports Frontiers in Psychiatry. Measured by the number of drugs brought to market per billion dollars spent on research and development, the number of new mental health medicines has steadily declined. Regulatory requirements and reimbursement hurdles imposed by insurers contribute to this reduction in the pipeline of new psychiatric medications. The likelihood of these new drugs surviving clinical trials and gaining FDA approval is less than 10 percent.
Moreover, the science of identifying drug-able targets in the complex neural networks of the human brain is daunting. for instance, translating animal model outcomes to humans is complicated: animal models have limited observable behavioral variations, and animal symptoms may be highly subjective – only two of the issues scientists face when translating such study outcomes to humans.
The effect of the IRA
The Inflation Reduction Act of 2022 has added a fresh new set of obstacles for pharmaceutical companies’ drug development pipelines. Among its provisions is the requirement that the Department of Health and Human Services “negotiate” drug prices within the Medicare Program. These price controls could significantly impair our nation’s ability to innovate new medicines; such damage could fall disproportionately on biopharmaceutical companies trying to develop medicines to treat mental illness. This is because eligibility for price controls occurs 9 years after FDA approval for small molecules, but 13 years after approval for biologics. This matters because it is only small molecules with low molecular weight that can cross the blood-brain barrier and impact the brain at the cellular level and thus treat mental and neurodegenerative illnesses.
That is, this aspect of the IRA disincentivizes investors and pharmaceutical companies that otherwise would be inclined to tackle the challenging task of developing medicines to treat mental illness. The IRA’s requirements mean that even if such businesses succeed in developing a new, effective drug to treat a mental illness, they may never recover their R&D investment.
It’s up to Congress
This is why Congress must make a technical correction in the IRA equalizing the number of years after FDA approval so that both small molecule drugs and biologics become subject to Medicare price controls at 13 years. The cost of this amendment would be minuscule compared to the price we pay as a nation. And this change would also be a potential boon for the development of urgently needed drugs to treat neurodegenerative diseases like Alzheimer’s, Parkinson’s and ALS.
The human suffering arising from all these diseases is so vast, and a simple amendment could in the long run make such an enormous difference, to so many, now and into the future – not just in the United States but throughout the world.
To discuss this issue and find out more about the role of Congress, please contact any of the authors.
