John La Puma, M.D.

John La Puma, M.D.

Viagra is on every man's lips, but not as much as we'd like. Managed care organizations have started to limit access. According to the Associated Press, Aetna offers no coverage. Kaiser Permanente is studying it. Prudential and United HealthCare cover some patients, depending on the plan. Cigna will pay for six pills monthly — two fewer than were used in clinical studies.

Should managed care ration a reasonably effective, emerging therapy for a wildly prevalent but underdiagnosed medical problem? Should all enrollees pay for the sexual potential of 30 million newly hot men? And what about the women?

When hot and bothered, sometimes I cool off with Jonsen, Siegler and Winslade's four-point framework on clinical ethics. It's not the same as 40 minutes on the NordicTrack, but it gets the job done.

Medical indications

The disease? Erectile dysfunction (ED) or impotence: failure to attain an erection of sufficient strength to attain normal ejaculation. But is this a disease or just a deficiency?

How is the diagnosis made? No blood test, no widely used objective standard, few quantifiable criteria except nocturnal penile tumescence testing. Drugs, endocrine disorders and neurogenic diseases may be proximate and reversible causes.

Prevalence? Big. Very big. Etiology? Mostly organic, though psychogenic impotence is also prevalent — especially in younger men. In "Is Sex Necessary?", James Thurber and E.B. White write, "Sex is less than 50 years old, yet it has upset the whole western world. The sex urge involves, for its true expression, another individual. It is this 'other individual' that causes all the trouble."

Usual treatment? Ah, here's the rub: nothing. Before Viagra, physicians seldom diagnosed erectile dysfunction, except to note it in a review of systems. Until March, the only therapy was distressing.

Caverject, for example, is injectable into the base of the penis. It is often effective, but it is cold, painful and inconvenient. There is also Muse — an intraurethral penile suppository. Again, sometimes effective, but not without side effects.

What about Viagra (sildenafil citrate)? There is little widely available clinical data. The package insert, however, is 35 inches long. Oral absorption is rapid, peaking between 30 and 120 minutes. Metabolism and excretion are hepatic. Unpublished clinical studies show 70 to 80 percent effectiveness in diabetic, spinal cord-injured, postprostatectomy and psychogenic ED patients. Effectiveness means increased frequency of successful penetration and maintenance of erections after penetration. Headache, flushing and dyspepsia are the most common adverse effects; administration with nitrates is contraindicated.

Patient preferences

How about 40,000 prescriptions daily?

But hold on there, fella. How about women? There are no clinical studies. But women have vaginal engorgement through the same nitric oxide enhancement/phosphodiesterase inhibition mechanism. Sure enough, there are anecdotal reports of first orgasms in years.

Quality-of-life factors

The ability to have sex is pure quality of life: in vitro fertilization eliminated necessary erectile function for procreation. Pfizer is considering dissolvable wafers impregnated with the right stuff to get Viagra in faster.

Are there precedents for managed care paying for quality-of-life treatments? Yes, within a medical context. Many managed care organizations send out self-treatment books, promoting self-confidence and independence. Some cover fertility drugs for women, considering infertility a disease, but up to a point — in vitro fertilization is usually not a covered benefit.

Many quality-of-life treatments are not covered — liposuction, cosmetic surgery and massage therapy come to mind. Finasteride for baldness (but not for benign prostatic hyperplasia) and Retin-A for acne (but not for wrinkles) are cosmetic. Contraception and elective abortion are often not covered.

Unlike other quality-of-life treatments, fraud and abuse are unlikely to be a problem with Viagra. But that's just what managed care organizations are worried about. Too many men without erectile dysfunction, taking it just for fun, pushing their doctors to prescribe it, making payers raise premiums yet again. Too much quality of life could be bad for managed care companies' profits.

Socioeconomic factors

Here's where the action is. Caverject isn't cheap — about $18 per 10 microgram dose, syringe and wipe included. Muse is also expensive — about $21 for a 250 microgram intraurethral pellet. Viagra's $10 price seems a bargain to men who have been only able to fantasize, with little to show for it.

But the real cost is not what managed care has been paying, but what it could pay-- inappropriately. Should you spend your time and capitation dollars on the woes of men who want to recapture youth — perhaps unwisely — or on your patients who experience the daily physical agony of Crohn's or osteoarthritis?

Deploying resources wisely is a trust. Managed care organizations that are one big capitated family can vote with their dollars, moving money from one pot to another. Few allocation decisions have been put to members systematically — with a few exceptions, such as Group Health Cooperative of Puget Sound. The fairest way to decide about Viagra would be to ask enrollees to prioritize their tradeoffs.

Prepare before prescribing

Like phen/fen before it, Viagra should be used for medical reasons — not cosmetic ones. There are women who were not obese but wanted to lose a few pounds who have heart valve problems now. Many necessary valve replacements and many more unnecessary echocardiograms have been performed because too many physicians yielded to the pressure to prescribe.

Men should have a legitimate ED diagnosis to receive Viagra. They should not have to try Caverject or Muse first. Studies should be conducted in women to learn whether they encounter adverse effects and experience improved quality of life.

The main ethical issues raised by Viagra use are the definition of medical necessity (disease vs. deficiency), truth-telling by physicians to insurers, gaming the system, potential discrimination against the indigent and appropriate resource allocation within a limited budget.

Analysis of these and other issues will have to wait. As is often the case, ethics was caught with its pants down while technology seized the stage.

John La Puma practices internal medicine at Alexian Brothers Medical Center in Elk Grove, Ill., and is a Chicago-based speaker and educator. He is the author of Managed Care Ethics: Essays on the Impact of Managed Care on Traditional Medical Ethics, recently published by Hatherleigh Press (1-800-367-2550). It is based on his Managed Care columns.

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.