The product, Vagifem, is one form of a drug, estradiol, that is used to improve women’s sex lives by treating a painful, often unspoken condition experienced by older women: a dry vagina, which can cause uncomfortable intercourse and complications like urinary tract infections.
Estradiol has been around for decades, but the price of the various creams, vaginal rings and tablets that contain the drug has climbed steadily in recent years, according to an analysis by the consumer website GoodRx. And insurance coverage is spotty — many plans refuse to cover some products or require that patients pay high out-of-pocket costs.
While women privately fume about the costs, drugmakers have been able to raise their prices without a public outcry in part because the topic — women’s sex lives and their vaginas — is pretty much taboo.
“Unlike EpiPen, women are not going to be rising up and saying, ‘My vagina is dry and I don’t want to pay $2,000 to $3,000 a year,'” said Dr. Lauren Streicher, medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause.
This week, the FDA approved a new estradiol product, Imvexxy, a development that in any other market may have offered hope for some price relief. But in the upside-down world of prescription 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 did not elaborate.
The story of estradiol products echoes others in the prescription-drug market, where older medicines like insulin or multiple sclerosis drugs have become more expensive, even when rivals are introduced and should make prices competitive.
The increases often result from secret, back-channel deals: Drug companies, pharmacy benefit managers and insurers all play a part, profiting along the way. Drugmakers set higher prices because of 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 those rebates, which are generally not shared with consumers, creating what some have described as a perverse incentive to keep list prices high.
Insurers, on the other hand, say drug companies keep raising prices to make more money.
Health insurance has traditionally covered the bulk 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 larger share of the costs to patients in the form of high deductibles or copayments.
Drugs to treat sexual health, like the estradiol products, are frequently placed on a higher formulary tier, meaning some patients have to pay as much as half the list price, said Adam J. Fein, chief executive of the Drug Channels Institute, which studies the industry.
“Although it is technically covered by the insurance company, your insurer is paying very little for the drug,” Fein said.
The prices for estradiol products for vaginal use have risen significantly over the past five years. The price of a tube of Estrace cream has more than doubled, to a pharmacy cash price of $372.17 in May, from $183.98 in January 2013, according to GoodRx. The Estring, a ring that is inserted in the vagina for three 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 and that they offered assistance to patients who could not afford them.
“These are medications that many women have to take for several years,” said Thomas Goetz, chief of research at GoodRx. For those with poor insurance coverage or none at all, “people are being exposed to what can be profound increases in price.”
Hanson, 71, of San Francisco, has resorted to ordering her drug from overseas at a cost of about $80 for a three-month supply. “It’s absurd,” she said.
The newcomer, Imvexxy, has a few features that its manufacturer hopes will distinguish it. It comes in a lower, 4-microgram dose (the lowest Vagifem dose is 10 micrograms). The soft gel capsule — in pink, naturally — is manually placed in the vagina, compared to Vagifem, which is used with a disposable plastic applicator.
In 2017, TherapeuticsMD announced that the FDA had turned down its application for approval because there was no long-term safety data beyond 12 weeks of use. The company later submitted a review of safety data on existing estradiol products to demonstrate that, like the others, its own product did not 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, according to IQVIA, which tracks drug sales.
Some said Imvexxy had a role to play. Many women are worried about taking estrogen because of 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 do not significantly increase estrogen levels throughout the body. All of the products, including Imvexxy, carry an FDA warning that they can increase the chance of developing cancer and other serious disorders. But several women’s health experts said those risks have never been substantiated and they have been lobbying the FDA to remove it.
“Hopefully this will be a solution for the woman with breast cancer who is going without,” Streicher said. TherapeuticsMD paid her to lead one focus group for women that discussed sexual health and did not mention Imvexxy, she said.
“If we were having this conversation in the context of drug prices being reasonable across the board — hey, good news,” said Cynthia Pearson, executive director of the National Women’s Health Network, a consumer group. “It’s just infuriating that the price has gone up and up and up for no good reason.”
She said the issue has not gotten more attention because “how many people will say ‘vagina’ in a public setting?”
Some companies are using a playful marketing approach, signaling the issue is not as taboo as it once was. The website of Imvexxy — which rhymes with sexy — features an image of a ripe, juicy peach, boasting the product is “distinctly designed for sweet relief.” A similar product, Intrarosa, which does not contain estradiol, features a photo of a nude older woman, her head thrown back in pleasure.
Some of these products may soon come down in price. In October 2016, a generic of Vagifem, called Yuvafem, entered the market at a slightly reduced list price. Then, in July, Teva Pharmaceuticals began selling a second generic at an even cheaper price. But the pharmacy cash price for Teva’s product — $163.91 for a month’s supply of eight tablets in May — is still higher than what Vagifem cost in 2015, according to the GoodRx analysis.
If more generic manufacturers enter the market, the price could tumble more and Vagifem could become an inexpensive drug like many cholesterol or blood pressure medicines. The same could become true for Estrace cream, which lost its patent protection at the end of last year and now has several generic competitors.
With two generics for Vagifem now available, the drug companies are most likely negotiating big discounts with insurers, meaning patients with coverage may see their costs drop. Elizabeth Traynor, an illustrator in Guntersville, Alabama, had tried virtually every estradiol product and balked at the prices, frequently doing without. But she recently called her insurer, the Government Employees Health Association, and learned she would have to pay $20 for a three-month supply of Yuvafem. “It’s about time,” she said. “Hooray!”
Estradiol has been around for so long that it has survived several rounds of debate over high prices. In 1959, a Senate inquiry found that drugmaker Schering, now part of Merck, had marked up estradiol — which comes in many forms — by more than 7,000 percent over the cost of materials.
In an echo of modern-day industry talking points, a Schering executive was quoted in an article in The New York Times, saying the high prices were necessary to finance new medical research. “The consumers of today must contribute to the benefits which the future will bring,” the drug executive said.
This article originally appeared in The New York Times.
KATIE THOMAS © 2018 The New York Times