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.
“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. This story comes from NPR’s health reporting partnership with KQED and Kaiser Health News ( KHN ). This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.)©2021 Kaiser Health News. Visit khn.org. Distributed by Tribune Content Agency, LLC.