A New $16,000 Postpartum Depression Drug Is Here. How Will Insurers Handle It?
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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 of insurance policies.
The lack of guidance could limit use of the drug, which is both novel — it targets hormone function to relieve symptoms instead of the brain’s serotonin system, as typical antidepressants do — and expensive, at $15,900 for the 14-day pill regimen.
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 — known as the fail-first approach — before they could be approved for brexanolone, which was shown in early trials reviewed by the FDA to provide relief within days. Typical antidepressants take four to six weeks to take effect.
“We’ll have to see if insurers cover this drug and what fail-first requirements they put in” for zuranolone, said Meiram Bendat, a licensed psychotherapist and an attorney who represents patients.
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.
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.
Advocates are most worried about the lack of coverage guidance.
“If you don’t have a published policy, there is going to be more variation in decision-making that isn’t fair and is less efficient. Transparency is really important,” said Joy Burkhard, executive director of the nonprofit Policy Center for Maternal Mental Health, which commissioned the study.
With brexanolone, which was priced at $34,000 for the three-day infusion, California’s 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.
KP’s 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.
An analysis by NPR of a dozen other health plans at the time showed Kaiser Permanente’s 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.
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’t 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.
“No woman should suffer like I did after having a child,” McDonald said. “The policy was completely unfair. I was in purgatory.”
One month after NPR published its investigation, KP overhauled its criteria to recommend that women try just one medication before becoming eligible for brexanolone.
Then, in March 2023, after the federal Department of Labor launched an investigation into the insurer — citing NPR’s reporting — 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.
“Since brexanolone was first approved for use, more experience and research have added to information about its efficacy and safety,” the insurer said in a statement. “Kaiser Permanente is committed to ensuring brexanolone is available when physicians and patients determine it is an appropriate treatment.”
“Kaiser basically went from having the most restrictive policy to the most robust,” said Burkhard of the Policy Center for Maternal Mental Health. “It’s now a gold standard for the rest of the industry.”
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.
“This will prevent other women from having to go through a year of depression to find something that works,” she said.
Clinicians were excited when the FDA approved zuranolone last August, 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 in the baby, anxiety or depression in the father or partner, or the death of the mother to suicide, which accounts for up to 20% of maternal deaths.
So far, only one of the country’s six largest private insurers, Centene, has set a policy for zuranolone. It is unclear what criteria KP will set for the new pill. California’s Medicaid program, known as Medi-Cal, has not yet established coverage criteria.
Insurers’ 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 of 2008, which requires insurers to cover psychiatric treatments the same as physical treatments.
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.
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 for the rest of the country. Much-anticipated regulations for the law are expected to be released this spring and could offer further guidance for insurers in California setting policies for zuranolone.
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 their coverage criteria.
“Providers shouldn’t be deterred from prescribing zuranolone,” Burkhard said.
This article is from a partnership that includes KQED, NPR and KFF Health News.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
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Codependent No More – by Melody Beattie
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This is a book review, not a book summary, but first let’s quickly cover a common misconception, because the word “codependent” gets misused a lot in popular parlance:
- What codependence isn’t: “we depend on each other and must do everything together”
- What codependence is:“person 1 has a dependency on a substance (or perhaps a behavior, such as gambling); person 2 is trying to look after person 1, and so has developed a secondary relationship with the substance/behavior. Person 2 is now said to be codependent, because it becomes all-consuming for them too, even if they’re not using the substance/behavior directly”
Funny how often it happens that the reality is more complex than the perception, isn’t it?
Melody Beattie unravels all this for us. We get a compassionate and insightful look at how we can look after ourselves, while looking after another. Perhaps most importantly: how and where to draw a line of what we can and cannot do/change for them.
Because when we love someone, of course we want to fight their battles with them, if not for them. But if we want to be their rock of strength, we can’t get lost in it too, and of course that hurts.
Beatty takes us through these ideas and more, for example:
- How to examine our own feelings even when it’s scary
- How to practice self-love and regain self-worth, while still caring for them
- How to stop being reactionary, step back, and act with purpose
If the book has any weak point, it’s that it repeatedly recommends 12-step programs, when in reality that’s just one option. But for those who wish to take another approach, this book does not require involvement in a 12-step program, so it’s not a barrier to usefulness.
Click here to check out Codependent No More and take care of yourself, too
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Passion Fruit vs Pomegranate – Which is Healthier?
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Our Verdict
When comparing passion fruit to pomegranate, we picked the passion fruit.
Why?
Both of these fruits have beaten a lot of other contenders, so it’s time to pit them against each other:
In terms of macros, passion fruit has more protein, carbs, and fiber, the ratio of which meaning also that passion fruit has the lower glycemic index. So, we say passion fruit wins on macros.
In the category of vitamins, things are more even; passion fruit has more of vitamins A, B2, B3, B6, and C, while pomegranate has more of vitamins B1, B5, B9, E, and K. In light of this 5:5 tie, and since passion fruit’s overall vitamin coverage is better (in terms of meeting RDA needs) but pomegranate’s vitamins are often in shorter supply in diet, we’re calling it a tie on vitamins.
When it comes to minerals, passion fruit has more calcium, iron, magnesium, phosphorus, potassium, and selenium, while pomegranate has more copper, manganese, and zinc. That’s already an easy 6:3 win for passion fruit, before we even consider the fact that passion fruit’s minerals’ margin of difference is greater too.
Adding it up makes for a clear win for passion fruit. As ever when it comes to plants, enjoy both if you can, though!
Want to learn more?
You might like to read:
What’s Your Plant Diversity Score?
Take care!
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Metabolic Health Roadmap – by Brenda Wollenberg
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The term “roadmap” is often used in informative books, but in this case, Wollenberg (a nutritionist with decades of experience) really does deliver what can very reasonably be described as a roadmap:
She provides chapters in the form of legs of a journey [to better metabolic health], and those legs are broadly divided into an “information center” to deliver new information, a “rest stop” for reflection, “roadwork” to guide the reader through implementing the information we just learned, in a practical fashion, and finally “traveller assistance” to give additional support / resources, as well as any potential troubleshooting, etc.
The information and guidance within are all based on very good science; a lot is what you will have read already about blood sugar management (generally the lynchpin of metabolic health in general), but there’s also a lot about leveraging epigenetics for our benefit, rather than being sabotaged by such.
There’s a little guidance that falls outside of nutrition (sleep, exercise, etc), but for the most part, Wollenberg stays within her own field of expertise, nutrition.
The style is idiosyncratic; it’s very clear that her goal is providing the promised roadmap, and not living up to any editor’s wish or publisher’s hope of living up to industry standard norms of book formatting. However, this pays off, because her delivery is clear and helpful while remaining personable and yet still bringing just as much actual science, and this makes for a very pleasant and informative read.
Bottom line: if you’d like to improve your metabolic health, as well as get held-by-the-hand through your health-improvement journey by a charming guide, this is very much the book for you!
Click here to check out the Metabolic Health Roadmap, and start taking steps!
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Cooking for Longevity – by Nisha Melvani
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Before it gets to the recipes, this book kicks off with a lot of science (much more than is usual for even healthy-eating recipe books), demystifying more nutrients than most people think of on a daily basis, what they do and where to get them, and even how to enhance nutrient absorption.
As well as an up-front ingredients list, we additionally get not just meal planning advice in the usual sense of the word, but also advice on timing various aspects of nutrition in order to enjoy the best metabolic benefits.
The recipes themselves are varied and good. It’s rare to find a recipe book that doesn’t include some redundant recipes, and this one’s no exception, but it’s better to have too much information than too little, so it’s perhaps no bad thing that all potentially necessary bases are covered.
In terms of how well it delivers on the title’s promised “cooking for longevity” and the subtitle’s promised “boosting healthspan”, the science is good; very consistent with what we write here at 10almonds, and well-referenced too.
Bottom line: if you’d like recipes to help you live longer and more healthily, then this book has exactly that.
Click here to check out Cooking For Longevity, and cook for longevity!
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A new government inquiry will examine women’s pain and treatment. How and why is it different?
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The Victorian government has announced an inquiry into women’s pain. Given women are disproportionately affected by pain, such a thorough investigation is long overdue.
The inquiry, the first of its kind in Australia and the first we’re aware of internationally, is expected to take a year. It aims to improve care and services for Victorian girls and women experiencing pain in the future.
The gender pain gap
Globally, more women report chronic pain than men do. A survey of over 1,750 Victorian women found 40% are living with chronic pain.
Approximately half of chronic pain conditions have a higher prevalence in women compared to men, including low back pain and osteoarthritis. And female-specific pain conditions, such as endometriosis, are much more common than male-specific pain conditions such as chronic prostatitis/chronic pelvic pain syndrome.
These statistics are seen across the lifespan, with higher rates of chronic pain being reported in females as young as two years old. This discrepancy increases with age, with 28% of Australian women aged over 85 experiencing chronic pain compared to 18% of men.
It feels worse
Women also experience pain differently to men. There is some evidence to suggest that when diagnosed with the same condition, women are more likely to report higher pain scores than men.
Similarly, there is some evidence to suggest women are also more likely to report higher pain scores during experimental trials where the same painful pressure stimulus is applied to both women and men.
Pain is also more burdensome for women. Depression is twice as prevalent in women with chronic pain than men with chronic pain. Women are also more likely to report more health care use and be hospitalised due to their pain than men.
Women seem to feel pain more acutely and often feel ignored by doctors.
ShutterstockMedical misogyny
Women in pain are viewed and treated differently to men. Women are more likely to be told their pain is psychological and dismissed as not being real or “all in their head”.
Hollywood actor Selma Blair recently shared her experience of having her symptoms repeatedly dismissed by doctors and put down to “menstrual issues”, before being diagnosed with multiple sclerosis in 2018.
It’s an experience familiar to many women in Australia, where medical misogyny still runs deep. Our research has repeatedly shown Australian women with pelvic pain are similarly dismissed, leading to lengthy diagnostic delays and serious impacts on their quality of life.
Misogyny exists in research too
Historically, misogyny has also run deep in medical research, including pain research. Women have been viewed as smaller bodied men with different reproductive functions. As a result, most pre-clinical pain research has used male rodents as the default research subject. Some researchers say the menstrual cycle in female rodents adds additional variability and therefore uncertainty to experiments. And while variability due to the menstrual cycle may be true, it may be no greater than male-specific sources of variability (such as within-cage aggression and dominance) that can also influence research findings.
The exclusion of female subjects in pre-clinical studies has hindered our understanding of sex differences in pain and of response to treatment. Only recently have we begun to understand various genetic, neurochemical, and neuroimmune factors contribute to sex differences in pain prevalence and sensitivity. And sex differences exist in pain processing itself. For instance, in the spinal cord, male and female rodents process potentially painful stimuli through entirely different immune cells.
These differences have relevance for how pain should be treated in women, yet many of the existing pharmacological treatments for pain, including opioids, are largely or solely based upon research completed on male rodents.
When women seek care, their pain is also treated differently. Studies show women receive less pain medication after surgery compared to men. In fact, one study found while men were prescribed opioids after joint surgery, women were more likely to be prescribed antidepressants. In another study, women were more likely to receive sedatives for pain relief following surgery, while men were more likely to receive pain medication.
So, women are disproportionately affected by pain in terms of how common it is and sensitivity, but also in how their pain is viewed, treated, and even researched. Women continue to be excluded, dismissed, and receive sub-optimal care, and the recently announced inquiry aims to improve this.
What will the inquiry involve?
Consumers, health-care professionals and health-care organisations will be invited to share their experiences of treatment services for women’s pain in Victoria as part of the year-long inquiry. These experiences will be used to describe the current service delivery system available to Victorian women with pain, and to plan more appropriate services to be delivered in the future.
Inquiry submissions are now open until March 12 2024. If you are a Victorian woman living with pain, or provide care to Victorian women with pain, we encourage you to submit.
The state has an excellent track record of improving women’s health in many areas, including heart, sexual, and reproductive health, but clearly, we have a way to go with women’s pain. We wait with bated breath to see the results of this much-needed investigation, and encourage other states and territories to take note of the findings.
Jane Chalmers, Senior Lecturer in Pain Sciences, University of South Australia and Amelia Mardon, PhD Candidate, University of South Australia
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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Long-acting contraceptives seem to be as safe as the pill when it comes to cancer risk
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Many women worry hormonal contraceptives have dangerous side-effects including increased cancer risk. But this perception is often out of proportion with the actual risks.
So, what does the research actually say about cancer risk for contraceptive users?
And is your cancer risk different if, instead of the pill, you use long-acting reversible contraceptives? These include intrauterine devices or IUDs (such as Mirena), implants under the skin (such as Implanon), and injections (such as Depo Provera).
Our new study, conducted by the University of Queensland and QIMR Berghofer Medical Research Institute and published by the Journal of the National Cancer Institute, looked at this question.
We found long-acting contraceptives seem to be as safe as the pill when it comes to cancer risk (which is good news) but not necessarily any safer than the pill.
Peakstock/Shutterstock Some hormonal contraceptives take the form of implants under the skin. WiP-Studio/Shutterstock How does the contraceptive pill affect cancer risk?
The International Agency for Research on Cancer, which compiles evidence on cancer causes, has concluded that oral contraceptives have mixed effects on cancer risk.
Using the oral contraceptive pill:
- slightly increases your risk of breast and cervical cancer in the short term, but
- substantially reduces your risk of cancers of the uterus and ovaries in the longer term.
Our earlier work showed the pill was responsible for preventing far more cancers overall than it contributed to.
In previous research we estimated that in 2010, oral contraceptive pill use prevented over 1,300 cases of endometrial and ovarian cancers in Australian women.
It also prevented almost 500 deaths from these cancers in 2013. This is a reduction of around 25% in the deaths that could have occurred that year if women hadn’t taken the pill.
In contrast, we calculated the pill may have contributed to around 15 deaths from breast cancer in 2013, which is less than 0.5% of all breast cancer deaths in that year.
Previous work showed the pill was responsible for preventing far more cancers overall than it contributed to. Image Point Fr What about long-acting reversible contraceptives and cancer risk?
Long-acting reversible contraceptives – which include intrauterine devices or IUDs, implants under the skin, and injections – release progesterone-like hormones.
These are very effective contraceptives that can last from a few months (injections) up to seven years (intrauterine devices).
Notably, they don’t contain the hormone oestrogen, which may be responsible for some of the side-effects of the pill (including perhaps contributing to a higher risk of breast cancer).
Use of these long-acting contraceptives has doubled over the past decade, while the use of the pill has declined. So it’s important to know whether this change could affect cancer risk for Australian women.
Our new study of more than 1 million Australian women investigated whether long-acting, reversible contraceptives affect risk of invasive cancers. We compared the results to the oral contraceptive pill.
We used de-identified health records for Australian women aged 55 and under in 2002.
Among this group, about 176,000 were diagnosed with cancer between 2004 and 2013 when the oldest women were aged 67. We compared hormonal contraceptive use among these women who got cancer to women without cancer.
We found that long-term users of all types of hormonal contraception had around a 70% lower risk of developing endometrial cancer in the years after use. In other words, the risk of developing endometrial cancer is substantially lower among women who took hormonal contraception compared to those who didn’t.
For ovarian cancer, we saw a 50% reduced risk (compared to those who took no hormonal contraception) for women who were long-term users of the hormone-containing IUD.
The risk reduction was not as marked for the implants or injections, however few long-term users of these products developed these cancers in our study.
As the risk of endometrial and ovarian cancers increases with age, it will be important to look at cancer risk in these women as they get older.
What about breast cancer risk?
Our findings suggest that the risk of breast cancer for current users of long-acting contraceptives is similar to users of the pill.
However, the contraceptive injection was only associated with an increase in breast cancer risk after five years of use and there was no longer a higher risk once women stopped using them.
Our results suggested that the risk of breast cancer also reduces after stopping use of the contraceptive implants.
We will need to follow-up the women for longer to determine whether this is also the case for the IUD.
It is worth emphasising that the breast cancer risk associated with all hormonal contraceptives is very small.
About 30 in every 100,000 women aged 20 to 39 years develop breast cancer each year, and any hormonal contraceptive use would only increase this to around 36 cases per 100,000.
What about other cancers?
Our study did not show any consistent relationships between contraceptive use and other cancers types. However, we only at looked at invasive cancers (meaning those that start at a primary site but have the potential to spread to other parts of the body).
A recent French study found that prolonged use of the contraceptive injection increased the risk of meningioma (a type of benign brain tumour).
However, meningiomas are rare, especially in young women. There are around two cases in every 100,000 in women aged 20–39, so the extra number of cases linked to contraceptive injection use was small.
The French study found the hormonal IUD did not increase meningioma risk (and they did not investigate contraceptive implants).
Benefits and side-effects
There are benefits and side-effects for all medicines, including contraceptives, but it is important to know most very serious side-effects are rare.
A conversation with your doctor about the balance of benefits and side-effects for you is always a good place to start.
Susan Jordan, Professor of Epidemiology, The University of Queensland; Karen Tuesley, Postdoctoral Research Fellow, School of Public Health, The University of Queensland, and Penny Webb, Distinguished Scientist, Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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