Cost watchdogs scold J&J for 'overpricing' its new ketamine-like antidepressant

Johnson & Johnson's brand-new depression spray Spravato already faces a few challenges. It's restricted to use in a doctor's office, for one, and its efficacy data aren't uniformly positive. And now, a U.S. cost watchdog says it's overpriced, too.

Spravato, a reformulation of the tranquilizer-turned-street drug ketamine, won FDA approval to treat resistant depression, and the agency hailed it at the time as a much-needed option for patients who don't get relief from other drugs. 

But it costs too much, according to the Institute for Clinical and Economic Review, which released its assessment Thursday—and threw down a gauntlet about the clinical need. It's “concerning to have an overpriced therapy where there is such need for treatment,” ICER Chief Medical Officer David Rind said in a statement.

A Janssen spokesperson said the company disagrees with the assessment. ICER's report "underestimates the proven short- and long-term benefits that this treatment, which was granted FDA Breakthrough Therapy designation, brings to [treatment resistant depression] patients in need.

"Furthermore, the inaccurate assumptions in the draft report on the established positive benefit risk profile of Spravato are misguided," she added.

Before rebates and discounts, Spravato ranges from $4,720 to $6,785 for the first month of treatment and $2,360 to $3,540 after that, ICER said. Quoting a typical benchmark for cost-effectiveness, the body said Spravato treatment would cost $198,000 per quality-adjusted life year gained. An acceptable number would fall in the $50,000 to $150,000 range, ICER said. 

The drug is approved as an add-on to oral antidepressants in patients who have tried at least two antidepressants without success. It’s chemically similar to ketamine, which is used legally in anesthesia, but also illegally as a street drug.

J&J's Spravato rollout is going well so far, executives said last month. The company has already certified 800 sites for Spravato treatment, which must be supervised by a healthcare provider, and the first patients have received treatment, J&J pharma chairman Jennifer Taubert said during the company's first-quarter conference call.

"[W]e believe that we're off to a very, very strong start with Spravato, and that it is going to be an important growth driver for us," Taubert said.

RELATED: J&J depression spray Spravato, carrying big expectations and restrictions, scores FDA nod 

The med succeeded in two clinical trials—one short-term and one longer-term—but it flunked two other short-term trials. Still, independent experts convened by the FDA endorsed it in February based on its ability to help patients who haven't benefited from other meds.

For its part, ICER said Spravato’s evidence to date “provides moderate certainty” that the drug can achieve a “comparable, small, or substantial net health benefit” for patients with treatment-resistant depression. The data to date don't fully demonstrate that benefits outweigh the potential harms, though, ICER argued. And because J&J didn't run any head-to-head trials comparing Spravato with existing drugs, the ICER team couldn’t draw conclusions on whether it outperforms other treatments. 

The drug carries a boxed warning for risk of sedation and difficulty with attention or thinking, risk of abuse, and suicidal thoughts and behaviors. In clinical testing, side effects included disassociation, dizziness, anxiety, vomiting and feeling drunk.

Potential side effects are one reason J&J is forced to launch Spravato in that closed distribution system, where patients travel to a doctor’s office for treatment and must be monitored for two hours after it's administered. Patients can't go home until their doctors agree, and they aren’t allowed to drive or operate heavy machinery until the next day.   

Still, the med has the potential to help patients who haven’t seen benefits from other drugs. One patient in the drug’s clinical testing program, Robin P., said in a statement shared by J&J that her “symptoms started to lift” on esketamine and that she could “see very clearly just how depressed" she had been. 

“I’m now able to appreciate a wider range of emotions than when I was depressed,” she added. “My long-term goals have taken shape and actually seem attainable.”

Editor's note: This story was updated with a statement from Johnson & Johnson's Janssen unit.