This post was originally published on this site.
Puberty came for Jez Roberts early. The hormones, which often made her menstrual cycles incredibly painful, never let up.
Even at the age of 10, when she first got her period, she knew something wasn’t right.
With each passing year, her menstrual cycle worsened. So did the pain.
It would take 14 years for her to be diagnosed with polyendocrine metabolic ovarian syndrome, or PMOS, a hormonal disorder formerly known as PCOS, that affects 10% of reproductive-aged women worldwide.
Even after her diagnosis, Roberts, now 39, struggled to manage the condition. Every medication — from birth control to metformin, a diabetic medication that can help lower blood sugar — caused severe side effects, without improving her overall health.
Her doctor says there is one thing left to try: a GLP-1.
The problem? Her insurance won’t cover it, and she can’t afford the hundreds of dollars out-of- pocket.
“I don’t understand how if my doctor prescribes a medication, insurance can say, ‘actually, you don’t need it,’” Roberts told Straight Arrow. “‘Just get sicker. You’ve tried everything else, and we know you’ve tried everything else because you’ve submitted that to us. But we don’t care. We’re not going to cover this for you.’”
Despite some clinical guidelines and growing evidence that GLP-1s — like Ozempic, Mounjaro, Wegovy or Trulicity — are among the most effective drugs to manage PMOS, they remain financially out of reach for many. The medication can cost $25 to $50 with insurance. Without, it can range from $250 to over $1,000, even with coupons.
How do GLP-1 drugs actually help manage PMOS?
The barriers to obtaining a GLP-1 prescription are extremely low — it’s actually receiving the drug that can be difficult, health experts said. Insurers often deny coverage because it is considered an “off-label” treatment for most conditions, unless a patient has been diagnosed with either diabetes or obesity.
Dr. Mihail Zilbermint, director of endocrine hospitalists at the Johns Hopkins Community Physicians, described PMOS as a “complex” disorder because of how vastly different it can present in each person. Many people struggle with weight gain or experience difficulty losing weight, have irregular periods and increased facial and body hair due to higher androgen levels.
READ MORE: Could GLP-1 drugs become the first longevity medications? Scientists think it’s possible
Many with PMOS, Zilbermint said, can also have insulin resistance, which means that while their body produces the hormone, it doesn’t utilize it as well as other people. Roberts is in this camp.
For those with insulin resistance, a GLP-1 can be helpful as it assists with regulating blood sugar and restoring insulin sensitivity. The medication can also help with fertility, Zilbermint said, a known difficulty for women with PMOS.
Those with insulin resistance often have a difficult time losing weight because of the hormonal imbalance, Zilbermint said. A GLP-1 can change that. It can also help improve liver, kidney and cardiovascular health and lower inflammatory markers.
Emma Ranta, 32, from Portland, Oregon, was diagnosed with PMOS nearly a decade ago.
After years of steady weight gain and trying various remedies, she finally brought up the issue to her doctor again last spring. Ranta’s doctor didn’t hesitate to put her on a GLP-1.
Her insurance quickly approved the pre-authorization, and Ranta pays just $50 a month for the medication.
Since taking it, she has seen a decrease in food noise and an increase in her energy. After years of struggling at the scale, she has lost more than 70 pounds. It also helped make her cycles more regular and significantly less painful.
“The first month on a GLP-1 was more beneficial than a year on birth control and other medications meant to help with PMOS,” she told Straight Arrow.
Why won’t health insurance cover GLP-1 prescriptions for PMOS?
The lack of access to GLP-1s is the “poster child of everything wrong with our healthcare system,” said Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation.
“Whether or not people can get access to it, it’s just such a lottery and it’s just really unfair,” she told Straight Arrow. “There’s just an enormous amount of unmet demand for GLP-1s and the way in which they’re doled out to people — there’s a randomness to it. It can depend upon where you happen to live or work or if you are on Medicaid — it’s an equity issue.”
Dr. Mark Fendrick, director at the University of Michigan Center for Value-Based Insurance Design, said the U.S. healthcare system is fragmented in how it chooses which medication is covered for certain conditions. It would be more effective — and quicker — Fendrick said if everyone worked together on the issue holistically.
“The sheer enormity of the people who could potentially benefit from these drugs has really led to a significant level of foot dragging among public and private payers, and it’s not because they don’t believe that these pharmaceuticals actually work in terms of improving patient outcomes,” he told Straight Arrow.
“What they are is kind of pressed with the fact that how are we going to pay for them,” he said. “Often, people, in my opinion, who may benefit more from a GLP-1 actually have to pay more out of pocket.”
There are three paths to make GLP-1s more affordable and widely accessible, Fendrick said.
The first, he said, is for prices to come down through government intervention or wider availability. The second is volume: While most people do not take the medication’s highest doses, Fendrick said, the FDA’s financial models use that amount. The third way, which Fendrick said is among the most controversial, is to cut other services from health insurance.
“There’s a long list of things that we’re spending billions on that I hope that we could spend less on, and then we can instead buy more GLP-1s,” Fendrick said. “I want to ration harmful care and only harmful care, but I do want to ration care.”
Is it safe to buy GLP-1 medications overseas or online?
Bethany Hughes, 38, from Somerset, Kentucky, was 14 years old the first time she had a cyst rupture.
Her periods were debilitating, her hair was thinning, she had cystic acne and she was gaining unexplained weight. Doctors kept having her take pregnancy tests.
It wasn’t until years later and hours of her own research that she found a physician willing to test her hormone levels. Her testosterone was elevated, along with her A1-C, which measures blood sugar levels. Both are markers of PMOS, and combined with her symptoms and history, she was officially diagnosed.
Hughes tried metformin to help manage her symptoms. It didn’t work and caused severe side effects.
READ MORE: Why the new endometriosis guidelines frustrate advocates, doctors
Her doctor suggested a GLP-1, especially since her insulin-resistant PMOS contributed to her inability to lose weight. But, like Roberts, she faced what is an increasingly common hurdle: It was $1,500 a month for the medication because her insurance won’t cover it.
“That’s almost a house payment for me and I’m a single mom, I can’t afford that,” she told Straight Arrow.
Hughes, a nurse, had all but given up hope of better managing her symptoms. Then, a few months ago, a friend of hers who is a nurse practitioner told Hughes she and several friends had ordered Zepbound from overseas, where the medication is cheaper and more widely available.
She would have to reconstitute the medication herself, but it would only cost about $200 for the year.
It can be dangerous to buy medication through third-party websites, pharmacies or overseas.
The medication could be improperly stored, according to the U.S. Food and Drug Administration, and the potential for getting fraudulent medication is higher because there is less oversight. An investigation by the Houston Chronicle found that state and federal oversight efforts are murky with compounding pharmacies because they don’t have to disclose reports of patient harm. And most regulatory bodies, including the FDA, are not routinely tracking where the pharmacies send their drugs or the volume of drugs the pharmacies produce.
“It’s a dangerous slope,” Johns Hopkins Dr. Zilbermint said, adding that it’s impossible to know what is really inside the medication. “As a board-certified endocrinologist and evidence-based clinician from Johns Hopkins, I cannot ever recommend that people should go and get compounded semaglutide.”
However, given Hughes’ medical background — and her knowledge that her friend and the wider group had been doing it for about a year with no out-of-the-ordinary side effects — she decided it was worth the risk.
In the month since her first injection, Hughes has lost 5 pounds. Her acne is clearing up, she is less inflamed and swollen, and she has more energy. For the first time, she said, her condition feels manageable.
“My doctor was right,” she said. “This medication helped me immensely. I could see how staying on this long term could have huge benefits for what’s going on.”
Will GLP-1 drugs ever get FDA approval for PMOS?
On July 1, Medicare rolled out its GLP-1 Bridge Program, which will allow increased access to the medication for weight loss, for $50 a month for those who qualify. The program is set to run through the end of next year, which Hempstead said may help increase overall access. Once something is covered by Medicare, she said it can be difficult to not cover it in other areas.
Sasha Ottey, executive director at PCOS Challenge, a nonprofit patient advocacy group, said the organization has worked hard to create more research opportunities around the hormonal disorder along with “knocking on every door in Congress” and educating people at the federal level.
“There are zero drugs and zero interventions that are FDA approved for PMOS, and so this is an area that is of great importance,” she told Straight Arrow.
For a medication to become FDA approved for a certain condition, it can often be a lengthy process that requires an extensive amount of research. However, experts say the process is becoming quicker — especially if there is a high level of interest and competition.
While a fix for GLP-1 coverage for PMOS won’t happen overnight, experts told Straight Arrow they are cautiously optimistic that it could happen sooner than anticipated.
Sleep apnea, which affects about 1 in 3 U.S. adults, had medications from Novo Nordisk and Eli Lilly fast-tracked to help, Fendrick said. Zilbermint said he has also seen an improvement in having GLP-1s covered for his Type 2 Diabetes patients, especially those on Medicaid.
“If there’s enough money to be made, interest will do the work to get that on-label indication,” Fendrick said.
Roberts is trying to stay positive. But, she said, it’s often easier said than done.
She is continuing to work with a nutritionist and to exercise, but the scale won’t budge. She can’t lose weight because of the hormonal imbalance. Recently, she started going to therapy. That, she said, is cheaper than the GLP-1 she was prescribed.
“It’s hard to process that I have this issue, I finally know what it is and how to best treat it and then I can’t afford the treatment,” she said.
Round out your reading
- What does low water at the Hoover Dam mean for power in the American West?
- Could GLP-1 drugs become the first longevity medications? Scientists think it’s possible.
- ChatGPT told him he wouldn’t face charges. Then came the arrest warrant.
- How one small city built a second act as a bio hub inside empty cigarette factories.
- If permanent Daylight Saving Time is so popular, why is it dead in the Senate?