Joseph Burns
Contributing Editor
Viagra, the “little blue pill,” started a revolution in 1994, sending men to the doctor’s office who would not ordinarily go.

When it comes to seeing their doctor, many men will figure out a way not to. Men have fewer routine encounters with the medical system as young people. They worry they’ll find out something is wrong and they’re uncomfortable with physical exams, particularly the prostate check.

There is one medical problem, however, that tends to send men straight to the doctor: erectile dysfunction (ED). Experts in men’s health say American men who have ED come in seeking prescriptions for one of the three medications available for the condition: Cialis, Levitra, or Viagra.

They discover, though, that most health insurers don’t cover the medications, so many men wind up paying as much as $50 to $60 per pill out of pocket for them. That cost has helped create an illegal online market and demand for ED drugs from Canadian pharmacies. In many instances, men just go without.

David Gremillion, MD

ED almost always has an underlying cause relating to a man’s physical or mental health, says David Gremillion, MD, of the University of North Carolina School of Medicine.
Photograph by Men’s Health Network

If they find another source or give up on ED meds, then doctors no longer have a way to get men to come in for a physical exam or any health screen. “The fact that health insurers no longer cover these drugs is a really big deal,” says David Gremillion, MD, an expert on men’s health and professor of medicine at the University of North Carolina School of Medicine. Perhaps it’s time to offer prescriptions for fewer pills, thus keeping the cost down, he suggests.

Linda Cahn, founder of Pharmacy Benefit Consultants in Morristown, N.J., says health insurers have limited budgets and must manage pharmacy costs for all members. “Health plans that are paying for the bulk of all drug costs have to figure out how to do that and stay afloat,” she says. There is concern among some health plans that many men who use ED drugs do not have medical conditions that would warrant such prescriptions, says Cahn: “Whether health plans should cover these drugs for lifestyle issues is an open question. With limited resources, every health plan needs to determine how best to use its resources. And it may be wisest to eliminate lifestyle treatment coverage and provide coverage for the lowest cost drugs that treat real health conditions.”

Gateway drugs

Men’s health care changed dramatically after the FDA approved Pfizer’s blue, diamond-shaped Viagra, the first ED drug, in 1994, says Gremillion, a specialist in infectious diseases. “The revolution was driven, at least in part, by this new, extraordinary development in medication for erectile dysfunction,” he says. Suddenly men with ED were interested in seeing their doctor, if only for one reason: to get what has come to be called the “little blue pill.”

“Once these men were coming to see the doctor, they would get an exam, and we’d find a large number of other problems,” Gremillion explains. ED almost always has an underlying cause related to a man’s physical or mental health.

But for many American men that dynamic is changing because insurers are taking ED drugs off their preferred lists. Men can still get the medications, of course, but on their own dime. Last year, for example, CVS/Caremark discontinued coverage for Viagra and Levitra. While Cialis remained on formulary for benign prostatic hyperplasia (BPH), the out-of-pocket cost was prohibitive, according to published reports. Lack of coverage for ED medication and the loss of interest in an MD visit could have rippling effects through the man’s life and his family life as well.

“If you have zero coverage you won’t get any men to discuss ED,” says Kenneth Fox, DO, a solo family-practice physician in Levittown, Pa. Mental and physical health issues may go unnoticed and untreated. And unaddressed health issues at the root of ED can lead to anxiety and depression and make the underlying condition worse—all of which drive up health costs, Fox adds.

As an osteopath who treats patients holistically, Fox goes a step further than Gremillion. “If the man doesn’t come in, you miss the opportunity to treat that patient in the early stage of a disease and you miss the opportunity to treat their family members, their lovers, their wives. Because ED affects them too,” he says.

Kenneth Fox, DO

“With ED, as with any other condition, you have to look at the whole aspect of the patient’s life,” says Kenneth Fox, DO, a solo family practice physician.

When that effect on a man’s family leads to anxiety and depression, then “now we need to treat him for a mental disorder,” Fox comments. “That’s why with ED, as with any other condition, you have to look at the whole aspect of the patient’s life.”

Not a ‘lifestyle medication’

On this point, Gremillion agrees with Fox, saying that for all these reasons, it is incorrect to consider medications for erectile dysfunction simply as a way to serve men’s leisure-time wishes. “Even though we think of ED drugs as a lifestyle medication, the ability to get an erection is a health issue,” he argues. “An erection and sexual activity are important aspects of overall health, both mental health and physical health.”

Or put another way: “A general rule is that if a male is having erections he is generally healthy and if he is not having erections then he is generally unhealthy and needs care,” Gremillion adds.

ED affects about half of men, and, not surprisingly, prevalence increases with age, according to the Massachusetts Male Aging Study, which has not been without controversy. About 40% of men aged 40 reported having ED, and about 70% of men aged 70 did so, according to the study.

Diabetes, hypertension, depression, and alcohol or drug abuse are common origins of ED. “When you consider these causes of ED, then you see that the pathway to resolving these conditions is this medication,” Gremillion says. “Because of that pill and the others that followed, we were seeing patients who previously were not willing to go to a doctor.”

Men seeking care for their ability to function as sexual beings were highly motivated to find a cure and thus they were willing to engage in conversations about the need for screening for diabetes and hypertension, and to participate in discussions about whether they were abusing alcohol or drugs. Doctors found they could talk to men about what New Jersey psychotherapist Terrence Real calls the hidden epidemic of male depression.

But that carrot—if you will—is no longer affordable for most men. “Now I fear that when we stop reimbursing for ED drugs those opportunities are lost,” Gremillion says. To save money, insurers could simply reduce the number of pills they pay for each month, he suggests. “But to just cut it out entirely is counterproductive and I question the wisdom of it.”

Couples are entitled to an active and fulfilling intimate life, say some experts. Denying coverage for ED then detracts from what would otherwise be a good, wholesome, and robust life. And there is a growing realization that regardless of age, sexual relations can be fulfilling and help keep people in good mental health.

In 2015, CVS/Caremark dropped coverage for Levitra, and last year it discontinued Viagra, according to the company’s formulary. Cialis in a low-dose form for daily use and a higher dose to be taken when needed remains on the formulary. After it dropped Levitra and Viagra, the PBM issued a statement to CBS News, saying, “equally effective products with lower overall costs remain available on the formulary.” CVS/Caremark did not respond to a request for comment on this story.

Last year and this year, Express Scripts covered Cialis and Viagra but not Levitra. Having a drug on formulary does not make it affordable, however. In December, the Associated Press reported that consumers without insurance coverage for Viagra and Cialis paid $50 per pill, three times what consumers paid for those drugs in 2010. Of course what a consumer pays out of pocket varies with insurance plan, and some plans may set high copayments.

Doug Hirsch

Some insurers argue that ED medications are not medically necessary and so attach high copayments or limit the number of pills a man can have, says Doug Hirsch of GoodRx.

Medicare, for example, lists four conditions for which it will pay nothing for drugs. One of those conditions is erectile dysfunction, says Doug Hirsch, co-CEO of GoodRx, a website that collects prices for FDA-approved drugs and aggregates information about coupon offers. Some commercial plans have similar coverage policies, arguing that ED meds are not medically necessary, and so may carry high copayments or limit the number of pills a man can get per prescription.

At the heart of the matter is the fact that the health system’s financial incentives are unaligned, explains F. Randy Vogenberg, a member of the Managed Care editorial advisory board and a principal with the Institute for Integrated Healthcare.

Physicians have some financial incentives to provide preventive care to their patient, and health plans under the ACA were required to cover some services, explains Vogenberg. But health plans also need to keep a lid on rising medication costs, so they hire pharmacy benefit management companies to manage drug spending—and PBMs have a very narrow goal: controlling drug costs. “It’s not surprising that there are a lot of drugs they don’t cover, including medications for ED,” says Vogenberg. “In this situation, PBMs are working against the aims that physicians have because what they get paid has nothing to do with the incentives that physicians and health plans have.”

When men can no longer get insurance coverage, Fox estimates that they spend a year or more searching for other sources, either in Canada or online. “After they’ve tried all that, then some will return to discuss their ED again,” he adds. “But by then, all that time has gone by when they could have been treated and worked up appropriately.”

F. Randy Vogenberg

PBMs have a very narrow goal: control drug spending. It’s no surprise then that ED drugs often don’t get covered, says F. Randy Vogenberg of the Institute for Integrated Healthcare.

Without care for the underlying condition, treatment costs are likely to rise. “What’s happening is that health insurance companies are making it harder for us to treat these men early in the course of the problem,” says Fox.

Fox finds insurers will cover Cialis for patients with severe diabetes or benign prostatic hyperplasia. But gaining approval for such payment is challenging. “You have to prove that you’ve tried every other drug under the sun, and even then insurers will limit the amount they will pay for each month,” he says. “Some will approve three pills a month and some six a month—if you’re lucky.”

Mental health might suffer

For all other comorbidities, whether a physical health issue or one related to depression, anxiety, or other mental health condition, ED meds go uncovered, Fox says. At that point, the man’s mental health is likely to affect the entire family, leading to depression and anxiety for all involved. “Ultimately, it costs insurers more money,” Fox observes.

Lacking coverage, men can seek discounts from manufacturers, says Hirsch, of GoodRx. ED drugs are among the most popular that consumers search for on the site, he says, and patients can find good deals if they do some online legwork. In January, for example, Pfizer was offering a coupon worth $200 toward a year’s supply of Viagra.

Consumer Reports suggests that doctors might prescribe a generic version of Revatio, which is used to treat pulmonary arterial hypertension and contains sildenafil, the active ingredient in Viagra. The generic version of Revatio is sold in a 20-mg pill, as opposed to Viagra, which is available in three dosages of 25, 50, and 100 mg. Generic Revatio costs $1 per pill, according to Consumer Reports.

In March 2016, the FDA approved a generic version of Viagra, but both Teva Pharmaceuticals and Mylan have agreed with Pfizer not to launch those drugs until this year.

Until then, both Vogenberg and Gremillion suggest that lack of coverage for ED medications is an example of how the health care system can work against men, despite the fact that it has been stacked in their favor in many respects. The aging of the baby boom will mean a wave of male newcomers to health care, and they may face frustration and disappointment.

“They find out that care is costly, that they have to pay out of pocket, and some things aren’t covered. This turns them off to the whole health care experience and maybe they don’t go back unless they really need care,” Vogenberg adds. “What that means is that the system is working against itself and so we have created this ticking time bomb when men don’t seek the care they need.”

VA offers coverage for ED medications

One insurer that is bucking the trend toward leaving medications for erectile dysfunction uncovered is the Veterans Administration.

“The VA employs numerous treatments for veterans having difficulty obtaining and maintaining an erection,” the VA said in a statement sent by email. “The VA covers such ED drugs as Viagra or Levitra when it is deemed medically necessary.

“In addition, VHA Prosthetic Service provides vacuum erection devices (VED) to eligible veterans as a medically necessary item when determined and requested by their provider, usually a urologist. Once a medical provider and veteran conclude that a VED is the best option, Prosthetic Service will provide the device.”

Many veterans returning from Iraq and Afghanistan have blast injuries from improvised explosive devices that are buried just below the surface and trigger when a soldier steps nearby. The explosive force goes upward, damaging limbs and organs, including those for sexual function. Recent research into combat injuries showed that such blasts were common causes of acute genitourinary injuries.

In August, The Journal of Urology reported that an unprecedented number of U.S. service members suffered genitourinary injury while fighting in Iraq and Afghanistan. Between October 2001 and August 2013, 1,367 male U.S. service members sustained one or more such wounds, most of which involved the external genitalia (1,000, 73%), including the scrotum (760, 56%), testes (451, 33%), penis (423, 31%), or urethra (125, 9%), wrote researchers from the San Antonio Military Medical Center.

“Combat blast injuries can cause injury to multiple organs including the upper urinary tract (kidneys and ureters), lower urinary tract (bladder and urethra) and external genitalia (penis, scrotum and testicles),” the VA said. “Loss of penile tissue, injury to the penis and loss of testicular tissue can result in infertility or erectile dysfunction.” For these veterans, the VA provides a range of services, including counseling, medication, and treatment of erectile dysfunction.

Injuries from such blasts were uncommon among veterans of earlier wars, says David Gremillion, MD, a men’s health expert at the University of North Carolina School of Medicine. Insurers will cover ED meds for veterans who have penile or testicular damage, he adds, but such coverage requires going through the time-consuming steps for prior authorization.