A year after her son, Nico, was born and she still felt like an empty shell of herself despite multiple attempts to find treatment, Miriam McDonald “came out” as suffering from debilitating postpartum depression, a decision she now says was totally worth it.

For months, McDonald battled her health provider and insurer, Kaiser Permanente, which denied her the one and only FDA-approved medication for postpartum depression, brexanolone. [pullquote size="medium" align="right" citation="Miriam McDonald, mother"]‘No woman should suffer like I did after having a child. The policy was completely unfair. I was in purgatory.’[/pullquote]But since she shared the details of her struggle in a 2021 KQED investigation, Kaiser has revamped its coverage guidelines twice, according to internal documents recently obtained by KQED, and federal regulators — citing KQED’s reporting — have launched an investigation into the insurer that is still ongoing.

“This will prevent other women from having to go through a year of depression to find something that works,” McDonald said after learning of Kaiser’s policy changes. “No woman should suffer like I did after having a child. The policy was completely unfair. I was in purgatory.”

When McDonald experienced her first symptoms of postpartum depression in 2019, including suicidal thoughts, Kaiser’s written guidelines required patients to try and fail four medications and electroconvulsive therapy before they would be eligible for brexanolone. But, because the drug was only approved for use up to six months postpartum, experts said this amounted to a blanket denial for all Kaiser patients, a potential violation of state and federal law.

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One month after KQED published its investigation, Kaiser overhauled its guidelines, instead recommending women try just one medication before becoming eligible for brexanolone, and if that trial could not be completed before the six-month window expired, women could bypass it and go straight to brexanolone.

“Kaiser basically went from having the most restrictive policy to the most robust,” said Joy Burkhard, executive director of the nonprofit Policy Center for Maternal Mental Health. “It’s now a gold standard for the rest of the industry.”

Next, a federal investigation

But the scrutiny over Kaiser didn’t stop there. By late 2022, the federal Department of Labor had launched an investigation into the insurer, according to emails reviewed by KQED. Investigators called McDonald and contacted other patients to discuss the difficulty they had accessing postpartum mental health care, including brexanolone.

A few months later, in March 2023, Kaiser revised its brexanolone guidelines again, removing all fail-first recommendations. Patients need only decline a trial of another medication. [pullquote size="medium" align="right" citation="Kaiser Permanente statement"]‘Kaiser Permanente is committed to ensuring brexanolone is available when physicians and patients determine it is an appropriate treatment.’[/pullquote]“Since brexanolone was first approved for use, more experience and research have added to information about its efficacy and safety,” Kaiser said in a statement. “Kaiser Permanente is committed to ensuring brexanolone is available when physicians and patients determine it is an appropriate treatment.”

The Department of Labor said in an email to KQED that it “will not confirm or deny the existence of an ongoing investigation” as a matter of policy but added the agency could sue a private insurer and force it to change its policies if they violate federal law. It can also force insurers to provide treatment or reimburse patients who paid out of pocket for treatments the department found improperly denied.

A new era for postpartum therapies

Brexanolone came on the market in 2019 with the hope of revolutionizing the treatment of postpartum depression by targeting hormone function instead of the brain’s serotonin system, as typical antidepressants do. In early trials, women with moderate to severe depression reported relief immediately after the three-day treatment. But brexanolone is expensive, $34,000 per treatment, and must be delivered intravenously during an inpatient hospital stay where patients can be closely monitored for side effects like fainting.

Both the price and finding a hospital certified to administer the drug proved to be prohibitive barriers for new mothers pursuing the treatment. Until recently, Kaiser did not have its own certification and had to refer women to one of only three other approved hospitals in California. [aside label='More Stories on health' tag='health']A new, more accessible pill form of the medication, zuranolone, taken once a day at home over 14 days, was approved by the FDA in August. In November, Sage Therapeutics, the company that makes both drugs, set the price for zuranolone at $15,900.

Since then, less than 1% of health plans have established criteria for when they will cover it, according to an analysis using data from Policy Reporter, a website that tracks insurance policies. Regulators, lawyers, and advocates are watching closely to see how insurance companies will shape policies for the new drug.

“We’ll have to see if insurers cover this drug and what fail-first requirements they put in,” said Meiram Bendat, an attorney and licensed psychotherapist who represents patients.

These new policies will be written at a time when the regulatory environment around mental health treatment is shifting. The federal Department of Labor is now cracking down more on potential violations of the 2008 Mental Health Parity and Addiction Equity Act, which requires insurers to cover psychiatric treatments on par with physical treatments.

As of this summer, insurers must comply with new, stricter reporting and auditing requirements that are intended to increase patient access to mental health care and, advocates say, could compel them to be more careful about the policies they write in the first place. [pullquote size="medium" align="right" citation="Meiram Bendat, attorney and licensed psychotherapist, who represents patients"]‘We’ll have to see if insurers cover this drug and what fail-first requirements they put in.’[/pullquote]In California, insurers must also comply with an even broader state mental health parity law from 2021, making sure their coverage policies are aligned with generally accepted standards of care. Highly awaited regulations for the law are expected to be released this spring.

Many perinatal psychiatrists told KQED it is imperative to treat postpartum depression as quickly as possible to avoid negative impacts, including cognitive and social problems in the baby, anxiety or depression in the husband or partner, or the death of the mother to suicide, which accounts for up to 20% of maternal deaths.

It’s possible this reasoning is why Kaiser was quick to revise its guidelines for brexanolone for the first time in 2021, Burkhard said, who worked at an insurance company before becoming an advocate. But it is unclear what criteria Kaiser will set for the new pill zuranolone.

“We will apply the same evidence-based, expert review process to zuranolone as we do with all medications,” Kaiser said.

McDonald is hopeful that women will now have more choices for care in policy and practice, including treatments that work faster and they can access immediately. She doesn’t want them to be forced on a trial-and-error medication merry-go-round like she was and can choose the treatment that’s right for them.

“There has to be more options for women,” she said.

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