By: David Ostrowsky

As you’re reading this blog, millions worldwide are suffering from the horrors of schizophrenia, one of the most complex, debilitating, and stigmatized mental disorders inflicted on humanity, the symptoms of which typically manifest themselves in early adulthood, though they are not always so easy to detect. Those afflicted by this condition are desperately trying to manage an array of frightening symptoms (hearing voices, delusions, memory lapses to name a few) while carrying on with their lives. In this country alone there are approximately 2.8 million Americans living with schizophrenia; tragically, many of those 2.8 million Americans won’t be living much longer as there is a particularly acute rate of suicide among people battling schizophrenia. Meanwhile, so many others suffering often experience prolonged bouts of homelessness and/or run afoul of the law. And for decades, pharmacological innovation has moved at such a glacial pace that treatment has largely yielded inadequate improvement in symptoms and/or intolerable side effects during therapy that many have felt inclined to discontinue usage.

Starting this month, however, game-changing relief may be forthcoming. After 70 years of incremental progress, the FDA has greenlighted Bristol Myers Squibb’s new drug to treat schizophrenia, Cobenfy, which promises to alleviate said conditions while averting debilitating side effects previously associated with schizophrenia medications such as incontrollable weight gain, involuntary muscle jerking, and heightened risk for diabetes. In contrast to earlier iterations of antipsychotic medications that targeted dopamine receptors, the twice-a-day pill Cobenfy, the active ingredients of which are xanomeline and trospium chloride, works on cholinergic receptors. It’s a scientific breakthrough that could very well have a life-changing impact on this vastly overlooked, vulnerable population that, according to some estimates, exceeds 24 million people around the world. 

“There is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” Chris Boerner, Ph.D., board chair and CEO at Bristol Myers Squibb, remarked following the FDA’s landmark approval. “As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval in schizophrenia.”

While Bristol Myers Squibb may be trumpeting the efficacy of Cobenfy, the soon-to-be released medication is not without its own considerable side effects, namely heightened risk for nausea, vomiting, and constipation, as evidenced by clinical trial results. Still, considering that many patients deem medications currently available for schizophrenia to be grossly ineffective, the emergence of Cobenfy as a viable alternative to existing treatments may be grounds for cautious optimism.

Of course, the larger, no-pun-intended million-dollar question is whether or not Cobenfy will be prohibitively expensive for the masses in dire need of relief. Indeed, Cobenfy carries a list price of $22,500 for a year’s supply before accounting for insurer rebates or discounts, which according to a Bristol Myers spokesperson, is priced “in line with the landscape of branded oral antipsychotics.” Apparently, the majority of schizophrenia patients are on Medicare or Medicaid and won’t pay the list price anyways, but what about those who are not on government-sponsored programs and don’t have the wherewithal to pay such imposing out-of-pocket costs? Will private insurers provide coverage for Cobenfy considering that the FDA has already approved over a dozen antipsychotic medications for schizophrenia that are on the market? Will these companies require patients to try their cheaper generic versions first before approving coverage of the far more expensive Cobenfy? (The FDA approved Cobenfy as a monotherapy—meaning it is meant to be taken alone, without other medications.)

“If it's like a lot of the other new medications, insurance is generally going to mandate that people try at least two generic medicines first … before they will pay for it [Cobenfy],” Dr. Jacob Ballon, an associate professor of psychiatry at Stanford University, told the Associated Press.

If such barriers are in place for an antipsychotic prescription, one has to wonder if is it within the realm of possibility that mental health parity violations surface.  

But for the time being, there is understandably a groundswell of hopefulness in the scientific and medical communities that the FDA’s recent approval of Cobenfy represents a watershed moment in psychiatric research. Should Cobenfy have the desired salubrious effects, it is quite possible, perhaps even likely that Bristol Myers Squibb will seriously explore other avenues for administering the medication, such as for treating Alzheimer’s-related psychosis, bipolar mania, Alzheimer’s-associated agitation, and Alzheimer’s-associated cognitive impairment.

Of course, though, first there needs to be a large enough sample size of the population to try Cobenfy for treating schizophrenia . . . which, in turn, means there needs to be reasonably priced coverage of the drug.