For elders and others, drugs are available that aid sexual experience.

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But insurers and Medicare won’t pay for them.

A tablet of Pfizer’s Viagra, left, and the company’s generic version, sildenafil citrate.

By Michelle Andrews

For some older people, the joy of sex may be tempered by financial concerns: Can they afford the medications they need to improve their experience in bed?

Medicare and many private insurers don’t cover drugs that are prescribed to treat problems people have engaging in sex. Recent developments, including the approval of generic versions of popular drugs Viagra and Cialis, have helped consumers afford the treatments. Still, for many people, paying for pricey medications may be their only option.

At 68, like many postmenopausal women, Kris Wieland, of Plano, Tex., experiences vaginal dryness that can make intercourse painful. Her symptoms are amplified by Sjogren’s syndrome, an immune system disorder that typically causes dry eyes and mouth, and can affect other tissues.

Before Wieland became eligible for Medicare, her gynecologist prescribed Vagifem, a suppository that replenishes vaginal estrogen, a hormone that declines during menopause. That enabled her to have sex without pain. Her husband’s employer plan covered the medication, and her co-payment was about $100 every other month.

After she enrolled in Medicare, however, her Part D plan denied coverage for the drug.

“I find it very discriminatory that they will not pay for any medication that will enable you to have sexual activity,” Wieland said. She plans to appeal.

Under the law, drugs used to treat erectile or sexual dysfunction are excluded from Part D coverage unless they are used as part of a treatment approved by the Food and Drug Administration for a different condition. Private insurers often take a similar approach, reasoning that drugs to treat sexual dysfunction are lifestyle-related rather than medically necessary, said Brian Marcotte, chief executive of the National Business Group on Health, which represents large employers.

So, for example, Medicare may pay if someone is prescribed sildenafil, the generic name for Viagra and another branded drug called Revatio, to treat pulmonary arterial hypertension, a type of high blood pressure in the lungs. But it typically won’t cover the same drug if prescribed for erectile dysfunction.

Women such as Wieland may encounter a similar problem. A variety of creams, suppositories and hormonal rings increase vaginal estrogen after menopause so that women can have intercourse without pain. But drugs that are prescribed to address that problem haven’t generally been covered by Medicare.

Sexual-medicine experts say such exclusions are unreasonable.

“Sexual dysfunction is not just a lifestyle issue,” said Sheryl Kingsberg, a clinical psychologist who is the chief of behavioral medicine at University Hospitals MacDonald Women’s Hospital in Cleveland. She is the immediate past president of the North American Menopause Society (NAMS), an organization for professionals who treat women with these problems. “For women, this is about postmenopausal symptoms.”

Relief may be in sight for some women.

Last spring, the federal Centers for Medicare and Medicaid Services sent guidance to Part D plans that they could cover drugs to treat moderate to severe “dyspareunia,” or painful intercourse, caused by menopause. Plans aren’t required to offer this coverage, but they may do so, according to CMS officials.

The NAMS applauded the change.

“Dyspareunia is a medical symptom associated with the loss of estrogen,” Kingsberg said. “They had associated it with sexual dysfunction, but it’s a menopause-related issue.”

For men who suffer from erectile dysfunction, treatment can confer both physical and emotional benefits, sexual health experts said.

“In my clinical work, I see a lot of older couples,” said Sandra Lindholm, a clinical psychologist and sex therapist who is also a nurse practitioner in Walnut Creek, Calif. “They are very interested in sex, and they feel like they’re able to embrace their erotic lives. But there may be medical issues that need to be addressed.”

About 40 percent of men over age 40 have difficulty getting or maintaining an erection, studies show, and the problem increases with age. A similar percentage of postmenopausal women experience genitourinary syndrome of menopause, a term used to describe a host of symptoms related to declining levels of estrogen, including vaginal dryness, itching, soreness and pain during intercourse, as well as increased risk of urinary tract infections.

Low sexual desire is another common complaint among women and men. A drug called Addyi was approved in 2015 to treat low sexual desire disorder in premenopausal women. But many insurers don’t cover it.

Unfortunately, medications that treat these conditions may cost people hundreds of dollars a month if their insurance doesn’t pick up any of the tab. A 10-tablet prescription for Viagra in a typical 50-milligram dose may cost more than $600, for example, while the price of eight Vagifem tablets may exceed $200, according to GoodRx, a website that publishes current drug prices and discounts.

In recent years, much more affordable generic versions of some of these medications have gone on the market.

Generic versions of Viagra and Cialis, another popular erectile dysfunction drug, may be available for just a few dollars a pill.

“I never write a prescription for Viagra anymore,” said Elizabeth Kavaler, a urogynecologist at Lenox Hill Hospital in New York City. “These generics are inexpensive solutions for men.”

There are generic versions of some women’s products as well, including yuvafem vaginal inserts and estradiol vaginal cream.

But even those generic options are often relatively pricey.

Some patients cannot afford $100 for a tube of generic estradiol vaginal cream, said Mary Jane Minkin, a clinical professor of obstetrics, gynecology and reproductive medicine at Yale School of Medicine.

“I’ve asked, ‘Did you try any of the creams?’ And they say they used up the sample I gave them. But they didn’t buy the prescription because it was too expensive,” she said.

— Kaiser Health News

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Viagra rising: How the little blue pill revolutionized sex

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[T]wenty years ago, a little blue pill called Viagra unleashed a cultural shift in America, making sex possible again for millions of older men and bringing the once-taboo topic of impotence into daily conversation.

While the sexual improvement revolution it sparked brightened up the sex lives of many couples, it largely left out women still struggling with dysfunction and loss of libido over time. They have yet to benefit from a magic bullet to bring it all back, experts say.

About 65 million prescriptions have been filled worldwide for the blockbuster Pfizer drug approved by the US Food and Drug Administration on March 27, 1998.

It was the first pill aimed at helping men get erections.

Suddenly, talk of an amazing drug that could make an older man’s penis hard again was all over television and magazines.

The Viagra boom also coincided with the rise of the internet, and the explosion of online pornography.

Ads for Viagra were designed to reframe what had been known as “male impotence” as “erectile dysfunction” or ED, a medical condition that could finally be fixed.

Republican senator, military veteran and one-time presidential candidate Bob Dole became the first television spokesman for Viagra, admitting his own fears about erectile dysfunction to the masses.

“It’s a little embarrassing to talk about ED, but it is so important for millions of men and their partners,” he said.

The strategy worked.

Before Viagra, men wanted to talk about their erectile problems, and did, but the conversations were awkward and difficult, recalled Elizabeth Kavaler, a urology specialist at Lenox Hill Hospital in New York.

“Now, sexuality in general is very out there,” she added.

“Sex has become an expected part of our lives as we age. And I am sure Viagra has been a big part of that.”

MISUNDERSTOOD DRUG

Viagra has had a “major impact” — on a par with the way antibiotics changed the way infections are treated, and how statins became ubiquitous in the fight against heart disease, said Louis Kavoussi, chairman of urology at Northwell Health, a New York-area hospital network.

Viagra’s release also came amid a “sort of a clampdown on physicians interacting with companies,” he said.

“So this was a perfect medicine to advertise to consumers. It was a lifestyle type of medicine.”

Viagra, or sildenafil citrate, was first developed as a drug meant to treat high blood pressure and angina.

But by 1990, men who took part in early clinical trials discovered its main effect was improving their erections, by boosting blood flow to the penis.

For all its popularity, Viagra is still often misunderstood.

“It isn’t an aphrodisiac,” said Kavoussi.

“A lot of men who ask about it say, ‘My wife isn’t very interested in relations,” he added.

“And I say, ‘Viagra is not going to change that.'”

SEXUAL REVOLUTION

In 2000, the comedy show “Saturday Night Live” featured a spoof on ads that showed sexually satisfied men saying, “Thanks, Viagra.”

In it, one eye-rolling actress after another was featured groaning “Thanks, Viagra,” as a horny male partner groped her from behind or gripped her in a slow-dance.

The skit was funny because it reflected a reality few people were talking about.

“We are a very puritanical society, and I think Viagra has loosened us up,” said Nachum Katlowitz, director of urology and fertility at Staten Island University Hospital.

“But for the most part, the women have been left out of the sexual improvement revolution.”

Pfizer finally did include women in its marketing for Viagra, in 2014. The commercials featured sultry women, including at least one with a foreign accent, speaking directly to the camera, telling men to get themselves a prescription.

‘FEMALE VIAGRA’

In 2015, the FDA approved a pill called Addyi (flibanserin), which was cast in the media as the “female Viagra,” and was touted as the first libido-enhancing pill for women who experienced a loss of interest in sex.

The pill was controversial from the start.

A kind of anti-depressant, women were warned not to drink alcohol with it. It also cost hundreds of dollars and came with the risk of major side effects like nausea, vomiting and thoughts of suicide.

“It didn’t go over too big,” said Katlowitz.

Valeant Pharmaceuticals bought Addyi for $1 billion in 2015, but sold it back to the developer, Sprout Pharmaceuticals, at a steep discount last year.

Older women’s main problem when it comes to sex is vaginal dryness that accompanies menopause, and can make sex painful.

Solutions tend to include hormones, or laser treatments that revitalize the vagina. They are just beginning to grow in popularity, but still cost hundreds to thousands of dollars, said Kavaler.

“We are at least 20 years behind men,” she said.

For Katlowitz, Viagra was a prime example of “the greed of the pharmaceutical industry.”

Viagra cost about $15 per pill when it first came out, and rose to more than $50. It finally went generic last year, lowering the price per pill to less than $1.

“There was absolutely no reason to charge $50 a pill,” said Katlowitz.

“It was just that they could, so they did.”

Complete Article HERE!

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Following in the footsteps of Viagra, female libido booster Addyi shows up in supplements

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By Megan Thielking

[F]ollowing in the footsteps of its predecessor Viagra, the female libido drug Addyi has snuck into over-the-counter supplements that tout their ability to “naturally” enhance sexual desire.

The Food and Drug Administration announced a recall Wednesday of two supplements marketed to boost women’s sex drive. The supplements Zrect and LabidaMAX — both manufactured by Organic Herbal Supply — actually contained flibanserin, a medication approved by the FDA in late 2015 to treat hypoactive sexual desire disorder in women. It’s the first time federal officials have recalled a product contaminated with the drug.

“It’s the latest example of brand-new drugs being found in supplements,” said Dr. Pieter Cohen, a physician at Harvard Medical School who studies dietary supplements.

The problem has long plagued the male sexual enhancement supplement market. Viagra has turned up in dozens of over-the-counter pills that never declared they contained the drug. The FDA regularly checks supplements shipments for the presence of Viagra, and has added flibanserin into their scans since the drug was approved.

“FDA lab tests have found that hundreds of these products contain undisclosed drug ingredients,” said Lyndsay Meyer, a spokesperson for the agency.

The massive dietary supplement industry is largely unregulated. The products can be sold without a prescription in supermarkets, supplement stores, and, increasingly, online. The products currently being recalled were sold on Amazon through February.

And while supplement makers are not allowed to claim that their products cure or treat a particular condition, they are allowed to make general claims that their products support health or, in this case, promote sexual desire.

“There’s nothing that you can actually put into the pill that lives up to advertised claims, so there is this temptation to introduce a pharmaceutical drug that attempts to meet those claims,” said Cohen. Organic Herbal Supply, which is recalling its products, did not respond to a request for comment.

The FDA said it has not received any reports of adverse events tied to either of the supplements. But Cohen said they are far from safe — and argued a lack of regulation will allow those risks to remain.

“We have no idea the harms being caused by these products. As long as these products can be sold as if they improve your sexual health, there’s going to be no stopping this,” he said.

The amount of undeclared flibanserin in a supplement could vary widely from one pill to the next, as has been the case with Viagra. It’s also possible the drug could be introduced into a supplement along with other potentially libido-boosting compounds, exacerbating those effects.

“We don’t know what danger this poses because these combinations have never been studied before they’re sold to unsuspecting consumers,” Meyer said. Consumers can report adverse events tied to these or other dietary supplements to the agency online.

Cohen said the message from the recall is clear: “Consumers should just completely avoid sexual enhancement supplements. They either might be safe and don’t work, or they might work but are likely to be dangerous.”

Complete Article HERE!

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