By April Dembosky, KQED and KFF Health News
Zuranolone, a long-anticipated treatment for postpartum depression, became available in December. It offers a quick-acting solution for a serious illness. However, most private health insurers have not yet specified when they will cover it, according to a recent analysis of insurance policies. a new analysis of insurance policies.
The lack of clear guidelines could restrict the use of the drug, which is unique in that it targets hormone function to alleviate symptoms instead of focusing on the brain’s serotonin system like typical antidepressants. Additionally, it comes with a hefty price tag of $15,900 for a 14-day pill regimen.
Lawyers, advocates, and regulators are closely monitoring how insurance companies will establish policies for zuranolone, especially in light of their approach to its predecessor, an intravenous form of the same drug called brexanolone, which entered the market in 2019. Many insurers insisted that patients attempt other, less expensive medications first, known as the fail-first approach, before being eligible for brexanolone. This drug, as indicated in early trials reviewed by the FDA, provided relief within days, unlike typical antidepressants, which take four to six weeks to take effect. early trials reviewed by the FDA to provide relief within days. Typical antidepressants take four to six weeks to take effect.
Meiram Bendat, a licensed psychotherapist and attorney representing patients, commented, “We’ll have to see if insurers cover this drug and what fail-first requirements they put in” for zuranolone. Meiram Bendat, a licensed psychotherapist and an attorney who represents patients.
Most health plans have not yet issued any guidelines for zuranolone, and maternal health advocates are concerned that the few that have are taking a restrictive approach. Some policies mandate that patients first attempt and fail with a standard antidepressant before the insurer will cover zuranolone.
In other cases, guidelines require psychiatrists rather than obstetricians to prescribe it, potentially delaying treatment since OB-GYN practitioners are usually the first to identify signs of postpartum depression.
Advocates are primarily concerned about the absence of coverage guidance.
Joy Burkhard, executive director of the nonprofit Policy Center for Maternal Mental Health, which commissioned the study, stressed the importance of transparency. She stated, “If you don’t have a published policy, there is going to be more variation in decision-making that isn’t fair and is less efficient. Transparency is really important.” Policy Center for Maternal Mental Health, which commissioned the study.
When brexanolone, priced at $34,000 for the three-day infusion, was available, California’s largest insurer, Kaiser Permanente, had such strict criteria for its prescription that experts considered the policy to be a blanket denial for all patients, as highlighted in a 2021 NPR investigation. NPR investigation in 2021.
KP’s guidelines mandated that patients try and fail with four medications and electroconvulsive therapy before being eligible for brexanolone. Since the drug was only approved for up to six months postpartum, and trials of typical antidepressants take four to six weeks each, the time would run out before a patient had the chance to try brexanolone.
An analysis conducted by NPR of a dozen other health plans at the time showed that Kaiser Permanente’s policy on brexanolone was an exception. While some required patients to fail with one or two other drugs first, KP was the only one that insisted on four.
Miriam McDonald, who experienced severe postpartum depression and thoughts of wanting to end her life after giving birth in late 2019, struggled with Kaiser Permanente for more than a year to find effective treatment. Her doctors put her on a cycle of medications that didn’t work and often had unbearable side effects, she said. Her doctors refused to prescribe brexanolone, the only FDA-approved medication specifically for postpartum depression at the time.
“No woman should endure what I went through after having a child,” McDonald said. “The policy was completely unfair. I felt like I was stuck in a difficult situation.”
One month after NPR published its investigation, KP overhauled its criteria to suggest that women try just one medication before becoming eligible for brexanolone.
Then, in March 2023, after the federal Department of Labor launched an investigation into the insurer — citing NPR’s reporting — the insurer revised its brexanolone guidelines again, removing all fail-first recommendations, according to internal documents recently obtained by NPR. Patients need only decline a trial of another medication.
“Since brexanolone was first approved for use, more experience and research have added to information about its effectiveness and safety,” the insurer said in a statement. “Kaiser Permanente is committed to ensuring brexanolone is available when physicians and patients determine it is an appropriate treatment.”
“Kaiser basically went from having the most restrictive policy to the most effective,” said Burkhard of the Policy Center for Maternal Mental Health. “It’s now a model for the rest of the industry.”
McDonald is hopeful that her willingness to speak out and the subsequent regulatory actions and policy changes for brexanolone will lead Kaiser Permanente and other health plans to establish patient-friendly policies for zuranolone.
“This will prevent other women from having to go through a year of depression to find something that works,” she said.
Clinicians were excited when the FDA approved zuranolone last August, believing the pill form, taken once a day at home over two weeks, will be more accessible to women compared with the three-day hospital stay for the IV infusion. Many perinatal psychiatrists told NPR it is crucial to treat postpartum depression as quickly as possible to avoid negative effects, including cognitive and social problems in the baby, anxiety or depression in the father or partner, or the death of the mother to suicide, which accounts for up to 20% of maternal deaths.
So far, only one of the country’s six largest private insurers, Centene, has set a policy for zuranolone. It is unclear what criteria KP will set for the new pill. California’s Medicaid program, known as Medi-Cal, has not yet established coverage criteria.
Insurers’ policies for zuranolone will be written at a time when the regulatory environment around mental health treatment is changing. The U.S. Department of Labor is cracking down on violations of the Mental Health Parity and Addiction Equity Act of 2008, which requires insurers to cover psychiatric treatments the same as physical treatments.
Insurers must now follow stricter reporting and auditing requirements aimed at increasing patient access to mental health care, which advocates hope will prompt health plans to be more cautious about the policies they create in the first place.
In California, insurers must also adhere to a broader state mental health parity law from 2021, which requires them to use clinically based, expert-recognized criteria and guidelines in making medical decisions. The law was created to limit arbitrary or cost-driven denials for mental health treatments and has been praised as a model for the rest of the country. Much-anticipated regulations for the law are expected to be released this spring and could provide further guidance for insurers in California establishing policies for zuranolone.
In the meantime, Burkhard said, patients suffering from postpartum depression should not hesitate to ask their doctors about zuranolone. Insurers can still grant access to the drug on an individual basis before they formalize their coverage criteria.
“Providers shouldn’t be discouraged from prescribing zuranolone,” Burkhard said.
KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of KFF — the independent source for health policy research, polling and journalism.
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