Miriam MacDonald spends time with her 4-year-old son Nico. McDonald struggled to receive treatment for postpartum depression at Kaiser Permanente, but her experience ultimately led to significant policy changes by her health care provider.
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Miriam MacDonald spends time with her 4-year-old son Nico. McDonald struggled to receive treatment for postpartum depression at Kaiser Permanente, but her experience ultimately led to significant policy changes by her health care provider.
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The long-awaited postpartum depression treatment Zuranolone will hit the market in December, with hopes of becoming an accessible and fast-acting drug for the debilitating disease.
But a new analysis of insurance policies shows that most private health insurers have yet to publish criteria for when to cover.
Lack of guidance can limit drug use.
Zuranolone represents a new approach, targeting hormonal function to relieve symptoms rather than the brain's serotonin system like typical antidepressants. It's also expensive, costing $15,900 for a 14-day pill regimen.
Lawyers, advocates, and regulators are watching closely to see how insurance companies formulate coverage for zuranolone.
Part of their wariness stems from the way some insurance companies are treating Zuranolone's predecessor, an intravenous version of the same drug called Brexanolone, which launched in 2019.
At the time, many insurance companies required patients to first try other, less expensive drugs before receiving approval for brexanolone. This compensation approach is known as step therapy or “fail fast.” This is because before insurance companies will reimburse newer or more expensive treatments, patients (and their doctors) must first show that lower-cost treatments did not provide relief.
Early trials reviewed by the FDA showed that brexanolone relieved symptoms within a few days, whereas common antidepressants take four to six weeks to take effect.
Regarding Zuranolone, “You need to find out whether your insurance company will cover this drug and what fail-fast requirements they have in place,” says a licensed psychologist and attorney who represents patients. Mayram Bendat says:
Most health plans have not yet issued guidelines on zuranolone, and maternal health advocates are concerned that the few insurers that have issued guidelines are taking a restrictive approach. There is.
Some insurance policies require that patients first try and fail with standard antidepressants before the insurance company will pay for zuranolone treatment.
Guidelines may also specify that a psychiatrist rather than an obstetrician prescribe the drug. This can delay treatment for patients, as obstetricians and gynecologists are usually the first healthcare providers to notice signs of postpartum depression.
Advocates say the lack of insurance coverage guidance itself could be an obstacle.
“Without published policies, there is more variation in decision-making, which makes it unfair and inefficient. Transparency is really important,” says Joy Burkhard, executive director of the nonprofit Policy Center. . This study was commissioned by Maternal Mental Health.
A 2021 NPR investigation found that Brexanolone was priced at $34,000 for a three-day infusion, but Kaiser Permanente, California's largest insurer, had such strict prescribing standards that Experts said the policy amounted to blanket denial of all patients. .
Kaiser Permanente's guidelines required patients to try four failed drugs and try electroconvulsive therapy before being eligible to receive brexanolone.
Brexanolone is only approved for the first six months after childbirth, and trials for common antidepressants each take four to six weeks, so time could pass before patients try Brexanolone.
NPR's analysis of more than a dozen other health plans at the time showed that Kaiser Permanente's brexanolone policy was an outlier. Some required patients to disable one or two other drugs first, but only KP recommended four.
Miriam McDonald, who developed severe postpartum depression and suicidal thoughts after giving birth in late 2019, battled Kaiser Permanente for more than a year to find effective treatment.
Doctors put her on a barrage of ineffective drugs, often with excruciating side effects, but they refused to prescribe Brexanolone, the only FDA-approved drug specifically for postpartum depression at the time, she said. To tell.
“No woman should suffer as much as I did after having a child,” McDonald says. “The policy was completely unfair. I was in purgatory.”
Miriam McDonald and her 4-year-old son Nico. She hopes insurance coverage for the new drug Zuranolone will be less restrictive and frustrating than what she experienced trying to obtain IV medication after giving birth.
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Miriam McDonald and her 4-year-old son Nico. She hopes insurance coverage for the new drug Zuranolone will be less restrictive and frustrating than what she experienced trying to obtain IV medication after giving birth.
keith mcdonald
A month after NPR published its findings, KP overhauled its standards and recommended that women try only one drug before becoming eligible to receive brexanolone.
Then, in March 2023, after the federal Department of Labor launched an investigation into the insurer citing NPR's report, the insurer again revised its brexanolone guidelines and recommended a fail-fast recommendation, according to internal documents recently obtained by NPR. All items have been deleted. Patients can simply decline a trial of another drug.
“Since Brexanolone was first approved for use, more experience and research has added information regarding its effectiveness and safety,” the insurer said in a statement. “Kaiser Permanente is committed to ensuring that brexanolone is available to physicians and patients when they determine it is an appropriate treatment.”
“Kaiser basically went from the most restrictive policy to the most powerful policy,” says Burkhardt of the Center for Maternal Mental Health Policy. “This is now the gold standard for other industries.”
MacDonald hopes her positive comments and subsequent regulatory actions and policy changes for brexanolone will lead Kaiser Permanente and other health plans to set patient-friendly policies for the new drug zuranolone. are doing.
“This will save other women from having to go through a year of depression to find something that works,” she says.
When the FDA approved Zuranolone last August, clinicians concluded that a pill taken once daily for two weeks at home would be more accessible to women than the three-day hospital stay required for IV brexanolone. I was excited because I thought it would be easy.
Many perinatal psychiatrists tell NPR that postpartum depression should be diagnosed as early as possible to avoid negative consequences, such as cognitive and social problems in the baby, anxiety and depression in the father or partner, and death of the mother by suicide. He said treatment is essential. It accounts for up to 20% of maternal deaths.
So far, only one of the country's six largest private insurance companies, Centene, has a policy against zuranolone. It is unclear what standards KP will set for the new pill. California's Medicaid program, known as Medi-Cal, has not yet established eligibility criteria.
Insurer policies on zuranolone come at a time when the regulatory environment surrounding mental health treatment is changing. The U.S. Department of Labor is cracking down on violations of the Mental Health Parity Act of 2008 and the Addiction Fairness Act, which require insurance companies to cover psychiatric treatment the same as physical treatment.
Insurers will now have to follow stricter reporting and auditing requirements aimed at increasing patient access to mental health care, making them more cautious about the policies they write in the first place. The hope is that the medical plan will be enforced.
In California, insurers will also have to comply with the broader state Mental Health Parity Act starting in 2021, which requires them to use clinically-based, expert-accepted standards and guidelines when making medical decisions. required to use it.
California's law aims to limit arbitrary or cost-based denials of mental health treatment and has been hailed as a model for other parts of the country.
The law's long-awaited regulations are expected to be released this spring and could provide further guidance to California insurers when setting policies against zuranolone.
In the meantime, Dr. Burkhardt says patients suffering from postpartum depression shouldn't be afraid to ask their doctors about zuranolone. Insurers can grant access to medicines on a case-by-case basis before formalizing coverage criteria.
“Health care professionals should not be discouraged from prescribing zuranolone,” Burkhardt says.
This story comes from NPR's health reporting partnership with KQED and KFF Health News.
