Prices Keep Rising for Drugs Treating Painful Sex in Women

For years, Lenny Hanson has watched in alarm because the price of a drug she takes has ticked steadily upward, doubling within the past five years to quite $200 a month today.

The product, Vagifem, is one sort of a drug, estradiol, that's wont to improve women’s sex lives by treating a painful, often unspoken condition experienced by older women: a dry vagina, which may cause uncomfortable intercourse and complications like tract infections.

Estradiol has been around for many years, but the worth of the varied creams, vaginal rings, and tablets that contain the drug has climbed steadily in recent years, consistent with an analysis by the buyer website GoodRx.

And coverage is spotty — many plans refuse to hide some products or require that patients pay high out-of-pocket costs.

While women privately fume about the prices, drug makers are ready to raise their prices without a public outcry partially because the subject — women’s sex lives and their vaginas — remains just about taboo.

“Unlike EpiPen, women aren't getting to be rising up and saying, ‘My vagina is dry and that I don’t want to pay 2,000 to 3,000 dollars a year,’” said Dr. Lauren Streicher, the medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause.

This week, the F.D.A. approved a replacement estradiol product, Imvexxy, a development that in the other market may have offered hope for a few price relief.

But within the upside-down world of prescribed drugs, that isn’t happening. Imvexxy’s manufacturer, TherapeuticsMD, said that its new product would be sold at “parity” with others on the market, and didn't elaborate.

The story of estradiol products echoes others within the prescription-drug market, where older medicines like insulin or MS drugs became costlier, even when rivals are introduced and will make prices competitive.

The increases often result from a secret, back-channel deals: Drug companies, pharmacy benefit managers, and insurers all play a neighborhood, profiting along the way.

Drugmakers set higher prices due to the way they sell their product to insurers and employers.

Instead of offering an upfront discount, companies pay after-the-fact rebates that are negotiated with pharmacy benefit managers like CVS Health or Express Scripts.

These managers keep a percentage of these rebates, which are generally not shared with consumers, creating what some have described as a perverse incentive to stay list prices high.

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Insurers, on the opposite hand, say drug companies keep raising prices to form extra money.

Health insurance has traditionally covered the majority of patients’ drug costs, so until recently, prices weren’t on people’s radars — drugs weren’t seen as a consumer product like, say, breakfast cereal.

But as manufacturers have raised prices, insurers have passed a bigger share of the prices to patients within the sort of high deductibles or co-payments.

Drugs to treat sexual health, just like the estradiol products, are frequently placed on a better formulary tier, meaning some patients need to pay the maximum amount as half the asking price, said Adam J. Fein, chief executive of the Drug Channels Institute, which studies the industry.

“Although it's technically covered by the insurance firm, your the insurer is paying little or no for the drug,” Mr. Fein said.

The prices for estradiol products for vaginal use have risen significantly over the past five years.

the worth of a tube of Estrace cream has quite doubled, to a pharmacy spot price of $372.17 in May of this year, from $183.98 in January 2013, consistent with GoodRx.

The Estring, a hoop that's inserted within the vagina for 3 months, cost $520.66 in May, compared to $284.11 in January 2013.

Representatives for drug manufacturers said their products were generally covered by insurance which they offered assistance to patients who couldn't afford them.

“These are medications that a lot of women need to deem several years,” said Thomas Goetz, chief of research at GoodRx.

For those with poor coverage or none in the least, "people are being exposed to what are often profound increases in price.”

Ms. Hanson, 71, of San Francisco, has resorted to ordering her drug from overseas at a price of about $80 for a three-month supply. “It’s absurd,” she said.

The newcomer, Imvexxy, features a few features that its manufacturer hopes will distinguish it.

It comes during a lower, 4 microgram dose (the lowest Vagifem dose is 10 micrograms).

The soft gel capsule — in pink, naturally — is manually placed within the vagina, compared to Vagifem, which is employed with a disposable plastic applicator.

In 2017, TherapeuticsMD announced that the F.D.A. had turned down its application for approval because there was no long-term safety data beyond 12 weeks of use.

the corporate later submitted a review of safety data on existing estradiol products to demonstrate that, just like the others, it is on the product didn't pose a risk.

The company has said 32 million women suffer from the condition that their drug addresses, but only about 7 percent — or 2.3 million — receive treatment.

Sales for menopause-related treatments totaled nearly $3 billion in 2017, consistent with IQVIA, which tracks drug sales.

Some said Imvexxy had a task to play. many ladies are worried about taking estrogen due to earlier studies that showed taking oral hormones carried serious risks.

The lower dose may allay those concerns, although other vaginal estradiol products have also shown that they are doing not significantly increase estrogen levels throughout the body.

All of the products, including Imvexxy, carry an F.D.A. warning that they will increase the prospect of developing cancer and other serious disorders.

But several women’s health experts said those risks haven't been substantiated and that they are lobbying the F.D.A. to get rid of it.

“Hopefully this may be an answer for the lady with carcinoma who goes without,” Dr. Streicher said.

TherapeuticsMD paid her to steer one focus group for ladies that discussed sexual health and didn't mention Imvexxy, she said.

“If we were having this conversation within the context of drug prices being reasonable across the board — hey, good news,” said Cynthia Pearson, the chief director of the National Women’s Health Network, a consumer group.

“It’s just infuriating that the worth has gone up and up and up for no good reason.”