Just after New Year’s, in an announcement that was easy to overlook in the post-holiday haze, Johnson & Johnson’s Janssen Pharmaceutical celebrated an historic FDA approval. The agency cleared new label language for the company’s 9-year-old schizophrenia treatment, Invega Sustenna, stating that the drug can delay the arrest or incarceration of patients taking it.
Now, some mental health experts are questioning whether allowing J&J to market a drug as a stay-out-of-jail card is really a good idea. Jail time is a significant risk for patients with schizophrenia, said John Snook, executive director of the Treatment Advocacy Center in an interview with the Marshall Project, a nonprofit organization covering criminal justice. Still, Snook said, a pharma company using reduced jail time as selling point is a “depressing commentary” on mental health treatment, he said.
J&J declined to outline the company’s marketing plans for the Marshall Project, but a spokeswoman told Fierce in an email that people with serious mental illnesses are three times more likely to end up in jail than in a hospital because of uncontrolled symptoms. "The unfortunate reality is people living with schizophrenia face many challenges, among them hospitalization and incarceration," she said. "Today, the criminal justice system is the largest provider of mental healthcare in the U.S. At Janssen, we are committed to advancing effective therapies and addressing these challenging, real-life circumstances to offer hope to those impacted by schizophrenia."
The FDA green-lighted the expanded label for Invega Sustenna based on a study involving 444 adults with schizophrenia. All of the participants had been arrested at least twice in the two years leading up to the trial, with at least one of those leading to incarceration. The participants received either J&J’s monthly injectable drug or one of seven commonly prescribed antipsychotic pills dosed at least once daily.
The trial, published in 2015, showed that Invega Sustenna delayed relapse rates by 416 days on average, versus 226 days in patients taking the other drugs, and that time to arrest was “significantly longer” for the people taking J&J’s product, according to the company. "The trial was uniquely designed to mirror the population of adults living with schizophrenia that healthcare professionals commonly see in clinical practice," the spokeswoman said.
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J&J hasn’t outlined its full plans for taking advantage of the new FDA approval in its marketing materials, but a 17-minute video it released online last fall provides a good preview of how it is incorporating the concept of jail time in its advertising materials.
The video features a patient named Tanara, who was prescribed Invega after she was jailed for getting into a fight with a neighbor. She explains that she initially took antipsychotic pills to control her schizophrenia, but her struggles with time management made it difficult for her to adhere to those treatments. Invega Sustenna is a once-monthly injection. The company also markets a three-month version of the product.
Sales of Invega Sustenna and related products were $2.6 billion last year—up 16% from the previous year—making it one of J&J’s richest franchises. Nurturing the antipsychotic portfolio will be important for the company, which could be facing generic competition on other drugs sooner than expected. In January, the U.S. Patent Trial and Appeal Board invalidated a key patent on Zytiga, J&J’s billion-dollar-a year prostate cancer drug. That raised the threat of generics entering the market this year.
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Neurology remains a priority for J&J as it looks to boost its portfolio of innovative drugs. During its post-earnings conference call in January, CFO Dominic Caruso told investors the company plans to bring back about $12 billion of the $16 billion in cash it’s holding overseas and invest the cash in its pipeline. It had already formed one neuroscience pact, teaming up with the University of Pennsylvania to develop a gene therapy treatment for Alzheimer’s.
As for Invega Sustenna, the new FDA-approved indication could make marketing the drug a bit easier. At a cost of at least $400 per injection, Invega is pricier than most pills. Sometimes doctors have to jump through hoops to get insurers to pay for it, writing letters saying patients tried less expensive drugs and failed, for example. That said, the potential to avoid jail time could prove to be a good selling point, Snook conceded. Schizophrenia, he told the Marshall Project, “is really the only illness in United States that one of the major side effects...is jail time.”
Editor's note: This story has been updated with comments from J&J.