By April Dembosky, KQED, Kaiser Health News
When Miriam McDonald decided she wanted to have another baby at age 44, her doctor told her she had a better chance of winning the lottery. So when she got pregnant right away, she and her husband were thrilled. But within three days of giving birth to their son, in September 2019, everything shifted.
“I was thinking, 'Oh my God, what did I do?' I just brought this baby into this world and I can barely take care of myself right now," she recalled. “I feel exhausted. I haven't slept in three days. I haven't really eaten in three days."
As the weeks went by, her depression got worse. She felt sad, but also indifferent. She didn't want to hold her baby, she didn't want to change him. She says she felt no connection with him.
This confused her — she never felt anything like this after her first two kids — and she worried her mood might hurt her son. Untreated postpartum depression can affect babies' cognitive and social development. For the mother, it can be life or death. Suicide accounts for up to 20% of maternal deaths.
“Every day, I was crying. Every day, I felt like I just wanted to die. Every day, I thought about ending my life," said McDonald, who lives in Vacaville, California, and works as an IT professional at the University of California-Davis.
She went to Kaiser Permanente, her health care provider, for help. (KHN is not affiliated with Kaiser Permanente.) She said doctors there put her on a merry-go-round of medication trial and error. The first drug her doctor prescribed made her anxious. Upping the dose of a second drug gave her horrific nightmares. A third drug gave her auditory and visual hallucinations that took seven weeks to go away after she stopped taking it.
Then, her psychiatrist retired. And when McDonald complained to her new psychiatrist that she was still depressed, four months after giving birth, the physician suggested more medications.
“I was desperate," McDonald said. “I was like, 'I'm trying to help myself, but things are just getting worse. So what am I left with?'"
She did her own research and learned about a new treatment, brexanolone. It's the first and only drug approved by the Food and Drug Administration specifically to treat postpartum depression, which affects 1 in 8 new mothers in the United States. Instead of targeting the serotonin system in the brain, like many antidepressants, brexanolone replenishes a hormone metabolite that gets depleted after childbirth: allopregnanolone. Some doctors call allopregnanolone, which is produced by progesterone, “nature's Valium" because it helps regulate neurotransmitters that affect mood. After giving birth, natural levels of estrogen, progesterone and allopregnanolone all plummet rapidly, making some women vulnerable to postpartum depression. Brexanolone is a synthetic version of allopregnanolone, delivered through an IV infusion over the course of 60 hours. It costs $34,000 per treatment.
In clinical trials, 75% of women who got brexanolone started to feel better immediately after the three-day treatment. Half the women went into remission. In the placebo group, 56% of women responded and a quarter went into remission. In practice, doctors are seeing that the effectiveness of the drug in the field mirrors the trial results.
“People walk out of the hospital, wanting to be with their child, wanting to return home," said Dr. Riah Patterson, who has been treating women with brexanolone at the University of North Carolina-Chapel Hill since it became available in summer 2019. “There is a hopefulness, a brightness. You can really see that transformation in the hospital room over those 60 hours. It's pretty miraculous."
McDonald wanted to try it.
But when she asked her doctor for brexanolone, she was told no. In an email, the doctor wrote that the existing studies were “not very impressive." She added that McDonald did not meet Kaiser Permanente's criteria for the drug: She would first have to try — and fail to improve with — four medications and electroconvulsive therapy (ECT) before she could try brexanolone. And she had to be six months or less postpartum to try it at all. For Miriam, the clock had run out. She wondered, How could anyone qualify?
‘Unacceptable Burden’ on New Moms
For the first year of her son's life, Miriam McDonald says, all her smiles were fake or strained. She struggled to find effective treatment for severe postpartum depression.(KEITH MCDONALD)
Kaiser Permanente's guidance is an outlier. An analysis of guidelines from a dozen health plans revealed that three of them require women to fail treatment with at least one other medication before trying brexanolone. One plan, California's Medicaid program for low-income women, requires two fails. But KP is the only system analyzed that recommends women first fail four drugs, as well as ECT.
“That's absurd. So I'm assuming no woman will ever have the opportunity to try brexanolone?" said UNC's Patterson, one of several experts on postpartum depression who questioned KP's guidance.
“Asking someone to fail four oral antidepressants is an unacceptable burden that will undoubtedly create more harm than good," said Bethany Sasaki, who runs the Midtown Birth Center in Sacramento, California, and is licensed to administer brexanolone.
Psychiatrist Dr. Shannon Clark, who's been administering brexanolone at UC Davis Medical Center for the past two years, seeing positive results, said there are a lot of reasons new moms may not be candidates for one medication, let alone four: taking pills while breastfeeding could be too anxiety-provoking; some women may not be able to adhere to a daily pill regimen; or they may have a liver condition that contraindicates those medications. Clark called Kaiser Permanente's guidance “terrible."
It could also be illegal, according to some California lawmakers and mental health advocates. Under a California state law that took effect this January, health plans must conform to generally accepted standards of care, including scientific literature and expert consensus, when making decisions about mental health treatment.
“If Kaiser is making it effectively impossible to get a particular, important mental health treatment, that could definitely be a violation of our parity law," said state Sen. Scott Wiener (D-San Francisco), the bill's author.
KP officials responded by saying they always follow the law. They also say its integrated structure — as both the health insurer and the health provider — makes it different from traditional insurers. At KP, a patient's doctor determines whether a medication is appropriate, not the health plan, and the criteria doctors use are recommendations, not requirements or prerequisites that patients need to “exhaust," said Dr. Maria Koshy, KP's chair of psychiatry for Northern California.
“At the end of the day, this is an individual clinical decision by both the provider — the physician — and the patient," she said.
But inside KP, the workplace culture is such that doctors are expected to follow these recommendations, according to former KP clinicians who spoke on background — as well as legislative experts familiar with KP's model. They say that when KP doctors deviate from the recommendations, they can get questioned or face other consequences.
“These physicians know that if they start routinely ignoring these bad recommendations, that that could have impacts on them professionally," said Wiener, who has worked on several bills aimed at regulating KP and other insurers in California. “Whether it's couched as a recommendation or a requirement is almost irrelevant. It has the same effect."
To McDonald, her physician seemed to follow the recommended criteria as if they were requirements when she declined to prescribe brexanolone. Another patient, Yesenia Muñoz, got a similar response when she sought brexanolone treatment. KP's grievance department sent her a letter denying the request because she had not failed enough medications.
After Yesenia Muñoz appealed to state regulators and received brexanolone, she says she felt calm and "happy enough to want to live."(RAFAEL MUNOZ)
“When I talked to the caseworker at Kaiser that had denied the medication, he said that Zulresso was very expensive," said Muñoz, referring to brexanolone's brand name.
In addition to the $34,000 cost for brexanolone, the three-day hospital stay can tack on another $30,000 to a patient's bill. Another complicating factor is the FDA requirement that health centers obtain special certification to infuse brexanolone, because of the risks of excessive sedation or fainting from the drug. KP doesn't have the certifications yet to administer the treatment at its own hospitals, so it must pay outside hospitals to provide it for its patients. KP officials say they have plans to eventually open three of their own certified centers in Northern California.
Muñoz, 35, was devastated by the denial. She was overwhelmed by postpartum depression and anxiety shortly after her daughter was born in August 2020. But none of the medications or therapies KP offered her worked. Four months after giving birth, she still felt suicidal.
“I could get out the door sometimes and take the stroller and go walk, and my mind kept on saying, 'If you just step in front of the car, it's all going to go away," she remembered.
Muñoz got help from family members and co-workers to appeal KP's decision to the state, and after reviewing her medical records, regulators ordered KP to pay for the brexanolone treatment.
Muñoz received the treatment at UC Davis Medical Center, and she started feeling better within the first day.
“The nurse came in and she said something funny and I laughed," Muñoz said. “It was the first time I had laughed in so long."
She started looking through photos and videos of her daughter on her phone and she said it was like she was experiencing those moments for the first time. She started making plans for the future.
“It was like a switch flicked and it made me happy enough to want to live," she said. “It saved my life."
Sage Therapeutics, the maker of brexanolone, said KP's approach to the new drug reflects “a lack of a sense of urgency for treating mental health." Dr. Steve Kanes, Sage's chief medical officer, said the company is working on making the treatment more accessible. Its biggest challenge has been getting enough health centers certified, across a wide enough geography, to reach women who need it. The company is studying a pill form of allopregnanolone that could eliminate the need for a hospital stay, but Kanes said that is still not close to being commercially available.
Stitching Up Legal Loopholes
In 2008, Congress passed a landmark federal law aimed at correcting disparities between how insurers pay for mental health treatments compared with care for physical health. The Mental Health Parity and Addiction Equity Act was later reinforced by provisions in the Affordable Care Act in 2010. But insurers found loopholes, creating overly restrictive or self-serving criteria that made it easy to deny services for mental health care and, as a result, save money.
California's new law, SB 855, aimed to tighten those loopholes and has been hailed by advocates as a national model for mental health reform. It requires health plans to use clinically based, expert-recognized criteria and guidelines in making medical decisions, with the goal of limiting arbitrary or cost-driven denials for treatments of mental health or substance use disorders.
KP operates in eight states and Washington, D.C. In California, it is the largest insurer, and in 2011 held a 40% share of the market, covering 9.2 million patients. KP officials have questioned how the new state law applies to the Kaiser system, given its unique integrated structure as both health insurer and medical provider. For example, Koshy, the KP psychiatrist, said that SB 855's requirement to comply with generally accepted standards of care “does not apply" to its brexanolone recommendations because they were developed and are used by the doctors, not the health plan administrators. When a reporter asked KP to provide the brexanolone policy its health plan uses for grievances or appeals, it said it didn't have one.
“We 100% intended this law to apply to the care people get at Kaiser," said Julie Snyder, government affairs director at the Steinberg Institute, which co-sponsored the law. “There is no place where we say Kaiser is exempt" because of its integrated structure.
Doctors at Kaiser have historically been “gatekeepers" for services in the system, more so than doctors who work with traditional insurers, said Meiram Bendat, an attorney and licensed psychotherapist who also advised legislators as the law was being drafted. It doesn't matter if practice recommendations for brexanolone were written by doctors or administrators, or whether the recommendations are mandatory or optional, Bendat said, they must be in compliance with the law.
“If it's inconsistent with generally accepted standards of care, then it has no place in California," he said.
Some of KP's recommended criteria for brexanolone are aligned with generally accepted standards of care; for example, reserving the drug for women who are six months or less postpartum, which was a criterion used in the clinical trials the FDA relied on when approving the drug.
But the recommendation that patients first try four or five alternative depression treatments before considering brexanolone conflicts with the judgment of half a dozen women's health experts interviewed for this story. They say there just isn't enough time to do that in the postpartum period — and too much is at stake.
Not only are babies at risk of developmental and emotional problems if their mother is depressed, husbands and partners are also at higher risk for depression and anxiety. And because new moms are learning to breastfeed, and figuring out what's part of the new normal and what's not, it can take months just to realize there's a problem, said UNC's Patterson.
“It takes so long for this illness to come to recognition and for someone to actually get into an appointment and actually be seen by a provider," she said.
Despite Run-Around, a Quick Turnaround
Indeed, the FDA fast-tracked the approval of brexanolone, in part, because of how well and how quickly it worked, allowing women to feel better and get back to their families in three days.
“It's new, it's promising," said KP's Koshy, adding that “it's not a benign medication." Six women in the clinical trials felt faint or fainted, which is why the FDA requires women to be continuously monitored in certified health centers when getting the medication.
Also, the safety and efficacy data is limited, Koshy said. The clinical trials compared brexanolone only to placebo, not to alternative treatments. So while the data shows brexanolone works better than nothing, there's no data on whether it works better than drugs like Zoloft, or better than electroconvulsive therapy.
Women who received the placebo in the trials also showed improvement in depressive symptoms — which is common in studies of depression treatments — but more women who received brexanolone showed improvement, and their improvement was more substantial and lasted longer, especially if their depression was more severe before treatment. Women with moderate depression who received the placebo did just as well, 30 days after treatment, as those who received brexanolone, which could be because they felt better on their own, or because other antidepressants they were allowed to take during the trial finally kicked in.
Koshy said KP is always reviewing practice recommendations as new evidence becomes available, but also acknowledged that KP's recommendations for brexanolone have not been updated since they were developed two years ago, in July 2019.
Two weeks after this story first aired in Northern California, Koshy said KP is now reviewing the recommendations.
It is unclear what role California's Department of Managed Health Care, the state agency that regulates KP, might play in resolving issues of access to the infusion. In a statement, department officials said they will review any criteria or guidelines the KP health plan uses for brexanolone, but the department does not have jurisdiction over physician decisions.
The department also monitors patient complaints when new medications or treatments begin to be used, in order to identify problems with access to care. So far, the department has received two complaints about brexanolone — both filed by KP patients.
One was Yesenia Muñoz. The other was Miriam McDonald.
Before going to the state, McDonald called KP's grievance department to complain about her treatment and the denial of brexanolone. KP responded by sending the cops to her house for a welfare check.
The officers were calm and nice, McDonald said, but when she closed the door, she cried her eyes out.
“It just brought me to a whole new low," she said. “Why didn't my doctor call me and talk to me first? I mean, this is how you treat postpartum mental health? How dare you!"
KP declined to comment on any individual cases, but said that, generally, “we feel deep compassion for any patient experiencing the difficult and serious effects of postpartum depression, and our goal is always to support every patient's safe return to a healthy mental state."
McDonald never got brexanolone; by the time her appeals were heard, she was past the six-month postpartum window.
Still, she continued to fight for relief and eventually got KP to cover a different treatment for severe depression, transcranial magnetic stimulation, which uses an electromagnetic coil to stimulate nerve cells in the brain that control mood. That typically costs about $300 per session, and McDonald went in for the treatment five days a week, for three months. Now she is finally feeling like herself again.
After her efforts to get treated with brexanolone failed, Miriam McDonald received transcranial magnetic stimulation at Kaiser Permanente to treat her postpartum depression. Eventually she started to feel like herself again, she says.(MIRIAM MCDONALD)
“I can remember I woke up one day and I was excited. I had actual joy," she said. “I got up and I walked into his room and I was like, 'Hey, Nico! Hi! Hey, baby!' And he jumped up from his crib and giggled and put his arms out. And I just swooped him up in my arms and cried. Because I was like, 'I am so proud to be your mom.'"
Now when her son smiles at her, she genuinely smiles back. But it took more than 18 months to feel better. She can't help but grieve all the smiles she didn't return in that time, and how she felt like she was barely present at crucial times, like when her son took his first steps.
“I felt like I've been robbed of all those moments," she said, “of those little milestones, that I'm never going to get back."
This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
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