A much-awaited treatment for postpartum depression, zuranolone, hit the market in December, promising an accessible and fast-acting medication for a debilitating illness. But most private health insurers have yet to publish criteria for when they will cover it, according to a new analysis<\/a> of insurance policies.<\/p>\n

The lack of guidance could limit use of the drug, which is both novel \u2014 it targets hormone function to relieve symptoms instead of the brain\u2019s serotonin system, as typical antidepressants do \u2014 and expensive, at $15,900 for the 14-day pill regimen.<\/p>\n

Lawyers, advocates, and regulators are watching closely to see how insurance companies will shape policies for zuranolone because of how some handled its predecessor, an intravenous form of the same drug called brexanolone, which came on the market in 2019. Many insurers required patients to try other, cheaper medications first \u2014 known as the fail-first approach \u2014 before they could be approved for brexanolone, which was shown in early trials<\/a> reviewed by the FDA to provide relief within days. Typical antidepressants take four to six weeks to take effect.<\/p>\n

\u201cWe\u2019ll have to see if insurers cover this drug and what fail-first requirements they put in\u201d for zuranolone, said Meiram Bendat<\/a>, a licensed psychotherapist and an attorney who represents patients.<\/p>\n

Most health plans have yet to issue any guidelines for zuranolone, and maternal health advocates worry that the few that have are taking a restrictive approach. Some policies require that patients first try and fail a standard antidepressant before the insurer will pay for zuranolone.<\/p>\n

In other cases, guidelines require psychiatrists to prescribe it, rather than obstetricians, potentially delaying treatment since OB-GYN practitioners are usually the first medical providers to see signs of postpartum depression.<\/p>\n

Advocates are most worried about the lack of coverage guidance.<\/p>\n

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\u201cIf you don\u2019t have a published policy, there is going to be more variation in decision-making that isn\u2019t fair and is less efficient. Transparency is really important,\u201d said Joy Burkhard, executive director of the nonprofit Policy Center for Maternal Mental Health<\/a>, which commissioned the study.<\/p>\n
With brexanolone, which was priced at $34,000 for the three-day infusion, California\u2019s largest insurer, Kaiser Permanente, had such rigorous criteria for prescribing it that experts said the policy amounted to a blanket denial for all patients, according to an NPR investigation in 2021<\/a>.<\/p>\n
KP\u2019s written guidelines required patients to try and fail four medications and electroconvulsive therapy before they would be eligible for brexanolone. Because the drug was approved only for up to six months postpartum, and trials of typical antidepressants take four to six weeks each, the clock would run out before a patient had time to try brexanolone.<\/p>\n
An analysis by NPR of a dozen other health plans at the time showed Kaiser Permanente\u2019s policy on brexanolone to be an outlier. Some did require that patients fail one or two other drugs first, but KP was the only one that recommended four.<\/p>\n
Miriam McDonald, who developed severe postpartum depression and suicidal ideation after giving birth in late 2019, battled Kaiser Permanente for more than a year to find effective treatment. Her doctors put her on a merry-go-round of medications that didn\u2019t work and often carried unbearable side effects, she said. Her doctors refused to prescribe brexanolone, the only FDA-approved medication specifically for postpartum depression at the time.<\/p>\n
\u201cNo woman should suffer like I did after having a child,\u201d McDonald said. \u201cThe policy was completely unfair. I was in purgatory.\u201d<\/p>\n
Miriam McDonald with her son, Nico.(Keith McDonald)<\/span><\/figcaption><\/figure>\n
One month after NPR published its investigation, KP overhauled its criteria to recommend that women try just one medication before becoming eligible for brexanolone.<\/p>\n
Then, in March 2023, after the federal Department of Labor launched an investigation into the insurer \u2014 citing NPR\u2019s reporting \u2014 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.<\/p>\n
\u201cSince brexanolone was first approved for use, more experience and research have added to information about its efficacy and safety,\u201d the insurer said in a statement. \u201cKaiser Permanente is committed to ensuring brexanolone is available when physicians and patients determine it is an appropriate treatment.\u201d<\/p>\n
\u201cKaiser basically went from having the most restrictive policy to the most robust,\u201d said Burkhard of the Policy Center for Maternal Mental Health. \u201cIt\u2019s now a gold standard for the rest of the industry.\u201d<\/p>\n
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 set patient-friendly policies for zuranolone.<\/p>\n
\u201cThis will prevent other women from having to go through a year of depression to find something that works,\u201d she said.<\/p>\n
Clinicians were excited when the FDA approved zuranolone last August<\/a>, 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 imperative to treat postpartum depression as quickly as possible to avoid negative effects, including cognitive and social problems<\/a> in the baby, anxiety or depression in the father or partner<\/a>, or the death of the mother to suicide, which accounts for up to 20% of maternal deaths<\/a>.<\/p>\n
So far, only one of the country\u2019s six largest private insurers, Centene, has set a policy for zuranolone. It is unclear what criteria KP will set for the new pill. California\u2019s Medicaid program, known as Medi-Cal, has not yet established coverage criteria. <\/p>\n
Insurers\u2019 policies for zuranolone will be written at a time when the regulatory environment around mental health treatment is shifting. The U.S. Department of Labor is cracking down on violations of the Mental Health Parity and Addiction Equity Act<\/a> of 2008, which requires insurers to cover psychiatric treatments the same as physical treatments.<\/p>\n
Insurers must now comply with stricter reporting and auditing requirements intended to increase patient access to mental health care, which advocates hope will compel health plans to be more careful about the policies they write in the first place.<\/p>\n
In California, insurers must also comply with an even 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 designed to limit arbitrary or cost-driven denials for mental health treatments and has been hailed as a model<\/a> for the rest of the country. Much-anticipated regulations for the law<\/a> are expected to be released this spring and could offer further guidance for insurers in California setting policies for zuranolone.<\/p>\n
In the meantime, Burkhard said, patients suffering from postpartum depression should not hold back from asking their doctors about zuranolone. Insurers can still grant access to the drug on a case-by-case basis before they formalize\u00a0their coverage criteria.<\/p>\n
\u201cProviders shouldn\u2019t\u00a0be deterred\u00a0from prescribing zuranolone,\u201d Burkhard said.\u00a0<\/p>\n
This article is from a partnership that includes\u00a0KQED<\/a>,\u00a0<\/em>NPR<\/em><\/a>\u00a0and KFF Health News.<\/em><\/p>\n
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