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Reporting from the frontiers
of health and medicine
This antidepressant may be no better than cheaper alternatives. But demand could soon soar
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The drug makers behind a brand-name antidepressant are betting that they can win the first-ever regulatory approval for the treatment of cloudy thinking in people with depression.
By REBECCA ROBBINS @rebeccadrobbins
FEBRUARY 2, 2016
Their antidepressant is expensive, and it isn’t selling well.
But the drug makers behind the medication are betting they can give it a boost by marketing it to treat a whole new category of depression symptoms — namely, cloudy thinking.
The catch: The Food and Drug Administration must first be persuaded that such symptoms can be treated as a separate category — and that the drug, sold as Brintellix, can treat it.
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An FDA advisory committee meets Wednesday morning to debate whether cognitive dysfunction can be pulled out and treated as “a distinct entity,” separate from symptoms like pervasive sadness and apathy. That will set the stage for an afternoon vote on whether the FDA should approve Brintellix as the first treatment for the muddled thinking that often comes along with depression.
Drug makers Takeda Pharmaceuticals and Lundbeck are counting on approvals to create new demand for the drug and new justification to convince insurance companies to pay for it.
But experts say it’s not clear that Brintellix is any more effective than its competitors in making a difference for reversing depression’s cognitive complications.
“Clinically, in talking to my colleagues, we don’t really see any major differences in terms of cognitive effects between Brintellix and other drugs,” said Dr. Norman Sussman, a psychiatrist at New York University’s Langone Medical Center. “We don’t know that Prozac doesn’t do it as well. Or Zoloft. Or any of the other drugs.”
Illustration of the thought processes in the brain
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Brintellix, known generically as vortioxetine, was approved in 2013 for treating depression. And in a field dominated by generics, Brintellix stands out mostly for the hefty price tag it carries.
A 30-tablet regimen of the drug went for $290 late last year. Compare that with equivalent dosages of the many off-patent alternatives on the market: a generic version of Prozac sold by Vensun Pharmaceuticals has a $3 price tag, and a generic version of Zoloft sold by Northstar Rx goes for $5. (Those numbers, compiled by the research firm Truven Health Analytics, refer to the price that a manufacturer listed for a drug when it was sold to a wholesaler.)
That price gap has prompted health plans to balk when physicians try to prescribe Brintellix.
Clinicians often face a headache of paperwork demands from insurance companies when seeking justification for a Brintellix prescription, and many plans have formal policies in place to limit them. For example, the Michigan insurer HealthPlus will only cover Brintellix for patients who’ve struggled with dosage levels and have already tried at least three generic antidepressants.
That’s made many psychiatrists reluctant to prescribe Brintellix, or prompted them to only turn to it as a late resort for patients for whom other cheaper drugs have failed.
“I don’t want to start someone on something and know that they’re not going to be able to afford more than a week of it,” said Dr. Christopher Marano, a psychiatrist at Johns Hopkins University School of Medicine who specializes in treating depression in the elderly. “From my perspective, I don’t see any reason to jump right to Brintellix as a first-line agent right now.”
Takeda and Lundbeck’s investment in research to show that Brintellix can effectively treat the cognitive symptoms of depression — including problems with concentration, memory, and processing speed — is an effort to change that attitude among doctors.
Reporting from the frontiers
of health and medicine
This antidepressant may be no better than cheaper alternatives. But demand could soon soar
FOLLOW
NEWSLETTERS
JOB BOARD
SEARCH
The drug makers behind a brand-name antidepressant are betting that they can win the first-ever regulatory approval for the treatment of cloudy thinking in people with depression.
By REBECCA ROBBINS @rebeccadrobbins
FEBRUARY 2, 2016
Their antidepressant is expensive, and it isn’t selling well.
But the drug makers behind the medication are betting they can give it a boost by marketing it to treat a whole new category of depression symptoms — namely, cloudy thinking.
The catch: The Food and Drug Administration must first be persuaded that such symptoms can be treated as a separate category — and that the drug, sold as Brintellix, can treat it.
ARTICLE CONTINUES AFTER ADVERTISEMENT
An FDA advisory committee meets Wednesday morning to debate whether cognitive dysfunction can be pulled out and treated as “a distinct entity,” separate from symptoms like pervasive sadness and apathy. That will set the stage for an afternoon vote on whether the FDA should approve Brintellix as the first treatment for the muddled thinking that often comes along with depression.
Drug makers Takeda Pharmaceuticals and Lundbeck are counting on approvals to create new demand for the drug and new justification to convince insurance companies to pay for it.
But experts say it’s not clear that Brintellix is any more effective than its competitors in making a difference for reversing depression’s cognitive complications.
“Clinically, in talking to my colleagues, we don’t really see any major differences in terms of cognitive effects between Brintellix and other drugs,” said Dr. Norman Sussman, a psychiatrist at New York University’s Langone Medical Center. “We don’t know that Prozac doesn’t do it as well. Or Zoloft. Or any of the other drugs.”
Illustration of the thought processes in the brain
READ MORE
Could a drug that tamps down inflammation lift the fog of depression?
Brintellix, known generically as vortioxetine, was approved in 2013 for treating depression. And in a field dominated by generics, Brintellix stands out mostly for the hefty price tag it carries.
A 30-tablet regimen of the drug went for $290 late last year. Compare that with equivalent dosages of the many off-patent alternatives on the market: a generic version of Prozac sold by Vensun Pharmaceuticals has a $3 price tag, and a generic version of Zoloft sold by Northstar Rx goes for $5. (Those numbers, compiled by the research firm Truven Health Analytics, refer to the price that a manufacturer listed for a drug when it was sold to a wholesaler.)
That price gap has prompted health plans to balk when physicians try to prescribe Brintellix.
Clinicians often face a headache of paperwork demands from insurance companies when seeking justification for a Brintellix prescription, and many plans have formal policies in place to limit them. For example, the Michigan insurer HealthPlus will only cover Brintellix for patients who’ve struggled with dosage levels and have already tried at least three generic antidepressants.
That’s made many psychiatrists reluctant to prescribe Brintellix, or prompted them to only turn to it as a late resort for patients for whom other cheaper drugs have failed.
“I don’t want to start someone on something and know that they’re not going to be able to afford more than a week of it,” said Dr. Christopher Marano, a psychiatrist at Johns Hopkins University School of Medicine who specializes in treating depression in the elderly. “From my perspective, I don’t see any reason to jump right to Brintellix as a first-line agent right now.”
Takeda and Lundbeck’s investment in research to show that Brintellix can effectively treat the cognitive symptoms of depression — including problems with concentration, memory, and processing speed — is an effort to change that attitude among doctors.
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