A newly approved drug to treat postpartum depression will cost $15,900 per 14-day course before insurance when it hits the market later this year, with some patients paying for the drug. There is growing concern among doctors and researchers that they may have a hard time with the disease.
The drug Zurzvae is approved It was approved by the U.S. Food and Drug Administration in August, making it the first drug approved to treat postpartum depression taken as a pill.Pharmaceutical company Sage Therapeutics Said On Tuesday, the drug is expected to be released in December, and the company and its partner Biogen announced that they are talking with insurance companies about coverage plans.
Sage CEO Barry Greene said in a news release that the companies’ goal is to “ensure broad and equitable access to women with PPD who are prescribed this drug.” It is expected to make drugs available to patients “regardless of their financial means and, if possible, with little or no out-of-pocket payment,” and companies will offer financial assistance to cover costs. The plan is to provide the drug free of charge to certain patients.
Postpartum depression affects one in eight women who have a baby. according to Collaborate with research from the Centers for Disease Control and Prevention. Although it usually occurs after childbirth, it can also develop later in pregnancy and can cause sadness, loss of energy, and thoughts of self-harm.
Mental health experts said they welcomed the approval of Zurzvae this summer, not only because it offers a new way to treat postpartum depression, but also because it “appears to have immediate effects.” Ta. Dr. Catherine MonkDirector of Women’s Mental Health, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons.
The medicine is It is shown Sage and Biogen say that in one clinical trial, the drug improved symptoms of depression in just three days. It was approved based on two trials that showed significant improvement after two weeks on a 17-item scale for depression compared to a placebo.
Zurzuvae mimics the function of natural brain steroids that act on the GABA signaling pathway, helping to regulate brain function. Because of the potential for depressant effects on the central nervous system, the drug’s label states that patients should not drive or engage in other “potentially hazardous activities” for at least 12 hours after taking the drug. There is a prominent warning that this should not be done.
“Early recovery is clearly a huge plus for people with PPD to get back to themselves,” Monk wrote in an email. That could be the key to a baby’s early bonding, she says.
Current options for orally treating postpartum depression are selective serotonin reuptake inhibitors, or SSRIs, antidepressants that “take several weeks to take effect and are continued to be taken daily for at least 6 to 12 months.” “There is a need,” he said. Dr. Katrina Furya practicing psychiatrist specializing in women’s mental health and reproductive psychiatry and clinical instructor at Yale University.
Furey said the price of the virus appears to be particularly high compared to those drugs. SSRIs include generic drugs like Prozac and Zoloft and typically cost less than $20 per month, according to GoodRx data.
“It remains to be seen how much insurance companies will cover, or if they will require women to ‘fail’ treatment with cheaper SSRIs before paying for this new treatment,” Furey said. “I hope that is not the case and that the price is not a deterrent to receiving this treatment.”
But she pointed out that the $15,900 price tag is less than half the price of Sage’s earlier postpartum depression drug Zuresso. It costs about $35,000 and is administered through an intravenous drip over a 60-hour period at the hospital.
Some of the financial analysts who follow Mr. Sage are predicted After FDA, Zurzvae price could approach Zuresso price I refused Giving Zurzuvae broader recognition for major depressive disorder. If broader approval were granted, companies were expected to price their drugs below $10,000, a key threshold for the specialty drug tier covered by Medicare. Analysts at financial firm Mizuho expect prices to rise further because of the small number of patients. One such analyst, Ui Ear, acknowledged Tuesday that the quota does not apply to Medicaid.
A Sage spokesperson said in an email Tuesday that the company “recognizes that Black and brown women are disproportionately impacted, and we prioritize equitable access and support women who are underrepresented. “We’re advocating for policies that better support our communities,” he said, “and people who live in rural areas.” Additionally, people on Medicaid may be more likely to receive inadequate postpartum care than those who live in urban areas and have private health insurance. ”
“That’s why Sage and Biogen aim to ensure broad and equitable access to all women with PPD who are prescribed Zurzva,” he continued.
The $15,900 price tag “raises major concerns about accessibility, especially in a situation where we don’t yet know how insurance will cover it,” he said. Dr. Lindsay Allenassistant professor of emergency medicine, health economist and health services researcher at Northwestern University Feinberg School of Medicine.
“Ensuring access to such treatments is essential, as they can potentially save the lives of new mothers at a vulnerable time,” Allen said. “Suicide is the leading cause of death in the first year postpartum.”
She and Columbia’s Monk expressed concern that even with insurance coverage, there are disparities in access to medicines, “exacerbating inequities in who gets what treatment.”
She noted that the drug had been tested in people with severe and rarer forms of depression, and said the “extensive media attention and publicity” surrounding Zurzvae meant the drug was being overused. He said he was concerned that patients would not be able to receive the other treatments they need. Care that feels like therapy. ”
“The gold standard in mental health care is a combination of psychotherapy and pharmacotherapy, where medication is required,” Monk said. “Treatment alone is often sufficient.”
It’s important to keep in mind the “hidden costs” of not treating or under-treating postpartum depression and anxiety, said Furey, who is also a co-organizer of .Analyze the script” A podcast about the portrayal of mental health in the media.
“We know that PPD and other postpartum mental health issues can negatively impact mother-infant bonding and the overall family relationship, and increase the risk of physical health problems. [and] It makes it difficult to return to work,” she said.
The costs of these impacts are “not easy to quantify in monetary terms,” she says.
For more CNN news and newsletters, create an account at: CNN.com