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Sunday, May 19, 2024
Health

There’s a new pill for postpartum depression, but who can access it?

The first pill for postpartum depression approved by the U.S. Food and Drug Administration is now available, but experts worry that minority and low-income people, who are disproportionately affected by the condition, won’t have easy access to the new medication.

About 1 in 8 people experience symptoms of postpartum depression after giving birth, federal data shows. Suicide and drug overdoses are among the leading causes of pregnancy-related death, defined as death during pregnancy, labor or within the first year of childbirth. Black, Indigenous, Hispanic and low-income people are more likely to be affected.

Most antidepressants take six to eight weeks to take full effect. The new drug zuranolone, which patients take daily for two weeks, acts much faster. But the medication, manufactured jointly by Biogen and Sage Therapeutics under the brand name Zurzuvae, comes with a hefty price tag of nearly $16,000 for the two-week course.

Postpartum depression can be treated with a combination of therapy and other antidepressants. But Zurzuvae is only the second medication, and the first pill, that the FDA has approved specifically for the condition.

The first approved drug, brexanolone, also made by Sage Therapeutics, under the brand name Zulresso, costs $34,000 before insurance and requires a 60-hour hospital stay for an IV treatment. Doctors typically must get approval from patients’ health plans before prescribing it, and hospitals must be certified to administer it.

Experts and advocates are urging state Medicaid agencies to make sure the low-income patients who are covered under the joint state-federal program have easy access to Zurzuvae. They want Medicaid managed care plans — and private insurers — to waive any prior authorization requirements and other restrictions, such as “fail-first” approaches that require patients to try other drugs first.

Zurzuvae became available by prescription last month. Several state Medicaid agencies contacted by Stateline said they haven’t yet adopted a policy and will handle prescriptions on a case-by-case basis. Others said they automatically add FDA-approved drugs to their preferred drug lists, though some require prior authorization.

Medicaid covers about 41 percent of births nationwide and more than two-thirds of Black and Indigenous births, according to health policy research organization KFF.

As of last month, only 17 insurers in at least 14 states — less than 1 percent of the nation’s 1,000 private insurance companies — had published coverage guidelines for Zurzuvae, according to an analysis by the Policy Center for Maternal Mental Health. Five of the 17 companies said they will require patients to try a different medication first. Three will mandate that psychiatrists prescribe Zurzuvae, though OB-GYNs can and do treat perinatal and postpartum depression, per the American College of Obstetricians and Gynecologists.

Experts say restricting prescription privileges to psychiatrists will limit access because many of them don’t accept insurance. While most states now offer Medicaid coverage for a full year postpartum, many psychiatrists don’t accept Medicaid due to low reimbursement rates.

States also are grappling with shortages of psychiatrists and OB-GYNs.

“A lot of people in the early postpartum period are going to still be served by their obstetric provider, and if their obstetric provider is very, very far away, it’s going to be more difficult for them to get diagnosed with postpartum depression and have the recommended follow-up care, whether that’s through an obstetric provider or referral to a mental health care provider,” said Maria Steenland, a researcher on maternal and reproductive health services and health policy at Brown University.

In a statement to Stateline, a spokesperson for the federal Centers for Medicare & Medicaid Services said Sage Therapeutics participates in the federal Medicaid drug rebate program, but that individual state Medicaid agencies will determine their own coverage policies.

Dr. Leena Mittall, a psychiatrist and chief of the Division of Women’s Mental Health at Brigham and Women’s Hospital in Boston, advocates a “no wrong door” approach to the new treatment and mental health coverage overall.

“I’m really hopeful that there will not be excessive restrictions in terms of especially burdensome authorization processes or availability,” she said. “If somebody’s seeking treatment or help, that we have multiple points of entry into care.”

In New Mexico, more than a third of residents are covered by Medicaid, the highest percentage in the nation, according to 2021 figures analyzed by KFF. New Mexico Medicaid said it automatically adds drugs approved by the FDA to its preferred drug list, meaning Zurzuvae is covered.

A spokesperson for the Medicaid agency in Louisiana, which has the nation’s second-highest proportion of Medicaid recipients at 32 percent, said it also will cover the drug.

In Illinois, where 20 percent of people are covered by Medicaid, officials told Stateline that for now, they will cover the cost of the medication on a case-by-case basis.

“We will not have them wait for our system to have it listed on that [preferred drug] roster,” said Dr. Arvind Goyal, chief medical officer of the Illinois Department of Healthcare and Family Services. “We will maybe talk to the prescriber and make sure that it’s the appropriate medication.”

The Massachusetts state health department told Stateline it will add Zurzuvae to its preferred drug list in March, but will require prescribers to get prior authorization. The Georgia Department of Community Health said it will consider coverage on a case-by-case basis until May 1, after the issue is discussed at an April drug board meeting.

“We recognize that Black and Brown women are reported to be disproportionally impacted by [postpartum depression]. In addition, those who live in rural areas and those who have Medicaid may be more likely to receive inadequate postpartum care, compared to those who live in urban areas,” Biogen spokesperson Allison Murphy wrote in the statement.

“We are also working with key stakeholders across states to help raise awareness of the importance of treating [postpartum depression] rapidly and helping remove potential barriers to treatment.”

In a 2022 report, the federal Centers for Disease Control and Prevention detailed causes of pregnancy-related deaths between 2017 and 2019, finding that pregnant and newly postpartum people were more likely to die from mental health-related issues, including suicides and drug overdoses, than any other cause. In total, mental health conditions were responsible for 23 percent of more than 1,000 maternal deaths, the CDC study found.

The CDC report also found that about 31 percent of parental-related deaths among Indigenous people were due to mental health conditions. Black people, whose national maternal death rate is three times higher than White people’s, are twice as likely as White birthing parents to suffer from a maternal mental health condition but half as likely to get treatment, according to the Maternal Mental Health Leadership Alliance.

Similarly, a review published in 2021 in The American Journal of Maternal/Child Nursing found a higher prevalence of postpartum depression among American Indian and Alaska Native women.

Previous analyses also have shown disparities in postpartum depression prevalence and its risk factors among Latinas.

Sage Therapeutics and Biogen tapped Kay Matthews, founder of Houston-based Shades of Blue, a national Black maternal mental health advocacy and support group, to help craft culturally sensitive advertising campaigns.

Matthews, who struggled with postpartum depression after giving birth to her stillborn daughter, said she was glad to see financial assistance programs offered but hopes they will continue beyond the rollout. Matthews said more pharmaceutical companies should focus on developing postpartum mental health drugs.

“We know that all drugs don’t work the same for everybody, right? There’s no one-size-fits-all approach,” she said. “The more we uplift these things in a way, then we start to really reach towards equitable care within a system that we know wasn’t designed to care for us, but we have the ability to change that.”

Catherine Monk, a clinical psychologist and director of the Perinatal Pathways Lab at Columbia University Irving Medical Center, said while the medication “isn’t a panacea,” access to it as a treatment option is an opportunity for insurers to improve mental health coverage parity.

“We’re stuck in our unfairness, and I’m deeply concerned about that,” Monk told Stateline. “Please cover it so we don’t have the situation of greater inequities in terms of access to frontline treatments. … [There’s] really strong evidence that these untreated mental health conditions contribute to maternal mortality.”

In Washington state, Uniform Medical, which covers state government employees, requires a diagnosis of severe postpartum depression, though Zurzuvae is approved for use by the FDA regardless of severity, according to the Policy Center for Maternal Mental Health’s report.

University of Washington professor Dr. Ian Bennett, a family medicine physician, specializes in perinatal mental health. Bennett said he hopes that state Medicaid agencies won’t use the introduction of Zurzuvae as an excuse to cut back on other types of mental health care for new mothers. UnitedHealthcare Community Plan under Washington’s Apple Health, the state’s Medicaid program, added Zurzuvae to its preferred drug list but requires prior authorization.

“The issue is not just that we should be covering these medications, but that there needs to be an attention to the increasing costs of these medications and the need to increase overall coverage and funding of the cost for serving these communities,” he said.

In a recent MedPage Today piece, Monk and psychiatrist Dr. Andrew Drysdale criticized the new drug’s high cost, which they fear will limit access to the patients who need it most.

“We’ve already seen this play out with infused brexanolone: Barriers to treatment, such as cost, insurance coverage, availability, and logistical difficulties, have hampered uptake,” she and Drysdale wrote.

Stateline is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public charity. Stateline maintains editorial independence. Contact Editor Scott S. Greenberger for questions: [email protected]. Follow Stateline on Facebook and Twitter.

Excerpts or more from an article that was originally published on 19th news is included in this post.

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