Low-dose estrogen helps millions with menopausal miseries, yet insurers often restrict or deny coverage

Sister Denise Farrands is not in the habit of talking about her intimate parts. But the 79-year-old nun has been so frustrated trying to obtain the vaginal medication she needs to prevent frequent urinary tract infections that her pique outweighs any concerns about modesty.

“My doctor had to fight and fight and fight to get the insurance company to approve it,” she said.

Sister Denise’s experience highlights one of several obstacles women face trying to treat a constellation of miseries categorized as genitourinary syndrome of menopause, or GSM.

Insurance companies restrict or deny coverage for necessary drugs, an FDA warning on package inserts listing dire illnesses associated with their use scares patients off, and high costs and co-pays make them unaffordable for many.

About 10 years ago, the West Haven, Conn., nun began experiencing symptoms familiar to at least half of all post-menopausal women: vaginal itching, soreness, dryness, burning, pain and recurrent UTIs.

These problems not only make intercourse difficult (clearly not an issue for a nun), but also can interfere with daily activities as simple as walking and lead to illnesses that may prove deadly.

As women age, the tissues in the vagina and vulva grow thinner and fragile, creating a favorable environment for bacteria that cause infections of the urinary tract.

Although there are half a dozen medications to choose from, only Vagifem has a thin enough applicator for Sister Denise’s anatomy, said her doctor, Mary Jane Minkin, a clinical professor of obstetrics, gynecology and reproductive sciences at Yale University. “The key thing is, she was never sexually active.”

The medicine, first introduced in 1988, is a tiny tablet containing a small dose of estrogen that is inserted into the vagina once or twice a week.

It seemed to be a simple fix, Minkin said. And for several years, Sister Denise did well with Vagifem.

“I used it faithfully once a week,” she said. “It worked.”

Like the sister, millions of women have found relief from vaginal low-dose estrogen, yet insurance companies frequently challenge their medical necessity or restrict the choices to only one form.

In late 2019, Humana, her religious order’s insurance company, switched her to Estrace cream, an equivalent medicine with a larger applicator.

“I couldn’t use it,” the sister recalled. “I hurt myself and thought this is for the birds.”

Humana spokesperson Mark Mathis said the company has “an extensive list of covered prescription drugs, or formulary, and when a specific medication is not covered by the patient’s plan, we work with their physician to identify prescription alternatives based on clinical criteria.”

Wanda Ronner, a Philadelphia gynecologist who specializes in post-menopausal care, said she and her staff have to argue with insurance companies several times a week to get approval for the right vaginal low-dose estrogen.

“Just like you need a range of antibiotics and heart and blood pressure meds,” she said, “we should have some options.”

In the 1960s, estrogen therapy was touted as a way to keep women even-tempered during “the change” and to remain “sex kittens,” Ronner said.

Attitudes have evolved. Docility is off the table. But the idea that women need vaginal estrogen primarily for intercourse has lingered.

While these medicines do make sex more comfortable after menopause, and maintaining a healthy sex life is a valid concern, women’s health experts say GSM is not the equivalent of erectile dysfunction.

“This is a serious, prevalent condition that is progressive over time,” said JoAnn E. Manson, professor of medicine at Harvard Medical School and chief of the division of Preventive Medicine at Brigham and Women’s Hospital.

“Some women will do fine with a general lubricant,” Manson says. “But many won’t.”

Numerous studies show these treatments to be as safe as they are effective, said Stephanie Faubion, director of women’s health at the Mayo Clinic and medical director of the North American Menopause Society.

Yet it was not until 2018 that Medicare approved their inclusion for Part D.

The achievement fell short, said Faubion. “These medications are covered now,” she said. “They’re just not covered well.”

Normally, with the advent of generic versions of drugs, prices go down. Not so with low-dose vaginal estrogen, said Tori Marsh, director of research at GoodRx, a company that tracks drug prices nationally and provides coupons to help lower costs.

“People are often blindsided when they find out what they’re being charged,” she said.

Earlier this year, when Pamela Kraut, a 73-year-old retired interior designer from White Plains, N.Y., went to fill her prescription for Estradiol cream, she balked at the $175 co-pay for one month’s supply.

“I said forget this. I can’t afford it,” she recalled, and bought an over-the-counter lubricant. But after several UTIs and rounds of antibiotics, she gave in and got the medicine.

Now, she said, she uses as little as possible to put off the next refill.

Even the most affordable product ― Yuvafem, the generic form of Vagifem ― can cost as much as $155 for a month’s supply and most Medicare Part D insurance plans do not cover it.

Estring, a vaginal ring that slowly releases estrogen over 90 days, was first approved by the FDA in 1999. Copays range from $45 to $563 and there is no generic version.

Yet oral estrogen, which puts much more hormone into the bloodstream, generally costs less than $20 for 30 tablets.

There is no consistent explanation for why drug companies and insurance plans charge so much for vaginal estrogen treatments, Marsh said. “It’s a blame game.”

America’s Health Insurance Plans, a large trade group for insurance companies, declined an interview but issued this statement: “Drug prices are out of control because of prices set and controlled by drug manufacturers.”

Unlike the price hike for EpiPens, which prompted loud public outcry from parents worried about their children dying of allergic reactions, there is less willingness to storm the barricades demanding affordable vaginal medicines for older women.

“No one is standing up for this,” Marsh said.

Women are reluctant to talk to their doctors about GSM in the first place out of embarrassment, or because they are afraid the medications are dangerous.

That fear, she said, stems largely from the misleading black box warning that the FDA requires on every form of estrogen.

It reads: WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA.

For years, women’s health advocates have urged the FDA to remove or at least tone down the warning.

Low-dose vaginal treatments contain a fraction of the hormones found in oral and trans-dermal forms, said Manson, and numerous studies have shown that these products, absorbed through vaginal tissue, do not enter the bloodstream in significant amounts.

In effect, Manson said, the black box warning discourages women from treating a serious problem that is only bound to get worse. “I think it’s really unfair to women,” she said, “when safe and effective therapy is essentially off limits.”

Nevertheless, the FDA stands by the 22-page report it issued in May 2018, which concludes that the warning is warranted on all estrogen products “regardless of dose, route of administration, and duration of use.”

Meanwhile, doctors such as Minkin said they will continue to fight for their patients’ rights to treatment.

“Every year, I have to go through the same rigmarole,” on behalf of Sister Denise, Minkin said.

But the nun may have won special dispensation.

This spring, when Minkin had to renew the prescription, she braced herself for battle with Humana.

“To my surprise, I got it approved in five minutes,” she said. “A miracle has occurred!”

Melissa Dribben is a former Inquirer staff writer.