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Britain is gearing up for an unprecedented boom in Viagra sales, fueled by the availability of much cheaper generic versions of the drug plus a major change in its National Health Service guidelines governing who can get the drug.
Before August 1, 2014, only British men who suffered from impotence as a symptom of a serious diagnosed illness, such as diabetes or prostate cancer, or who had been diagnosed impotent by a specialist could get the little blue pills through the NHS. Now any U.K. male diagnosed with erectile dysfunction by a general practitioner is eligible to obtain the drug through the nationwide service.
Aftermath of Patent Expiration
The mid-2013 expiration of Pfizer’s patent on Viagra in the United Kingdom and elsewhere in the European Union opened the door to a flood of generic formulations of the pioneering impotence drug. As a result, the price of the drug has plummeted.
In an August 23, 2014, article posted on the website of “The Daily Mail,” writer Stephen Adams reported that a four-pill packet of Viagra manufactured by Pfizer cost roughly $32 (in British pounds sterling) shortly before Pfizer’s patent expired.
By the summer of 2014, a four-pill packet of sildenafil citrate, the active ingredient in Viagra, could be purchased for about $2.33 in local currency. This represents a price drop of nearly 93 percent.
Rule Change Largely Welcomed
While most U.K. physicians welcomed the NHS rule change, some voiced concern that the relaxed regulations will result in an increased workload for Britain’s general practitioners.
Mark Speakman, president of the British Association of Urological Surgeons, told Adams that the original NHS regulations were put into place in 1999 to save the U.K.’s healthcare system money.
“They made the fairly arbitrary decision that if you had a discrete illness — like prostate cancer, diabetes, or a spinal cord injury — you could get it [Viagra] on the NHS,” said Speakman. “But if you were a man of a certain age and wearing out a bit, you could only get a private prescription and you had to pay full whack.”
$136.5 Million Spent in 2012
In 2012, the year before Pfizer’s Viagra patent expired in the U.K., the National Health Service spent roughly $136.5 million to provide ED drugs to 180,000 men. Pfizer-branded Viagra accounted for just under 50 percent of that total, according to Adams.
Under its newly relaxed regulations, the NHS expects the number of men provided with ED drugs will nearly double over the next three years to a total of 330,000. However, the sharp drop in the price of generic Viagra is expected to keep the government service’s overall spending on ED drugs at roughly the same level it was in 2012.
May Rescue Some Relationships
However, increased availability of the drug to British men with ED should “make a great deal of difference to the mental wellbeing and happiness of these patients,” according to Dr. John Chisholm, chairman of the Men’s Health Forum charity. “It’s not a myth that relationships can be put in jeopardy by erectile dysfunction. This decision will allow some relationships to flourish when they’re being threatened.”
NHS restrictions on Viagra prior to August 2014 are roughly analogous to the current policy of America’s Centers for Medicare & Medicaid Services. CMS prohibits coverage of “drugs when used for treatment of sexual or erectile dysfunction unless such agents are used to treat a condition, other than sexual or erectile dysfunction, for which the agents have been approved by the FDA.
Rule Change Linked to Price Drop
The about-face in NHS policy on coverage of impotence drugs appears to have been triggered in large part by the precipitous drop in the price of generic versions of Viagra that followed the expiration of Pfizer’s patent on the drug.
Under a U.S. court-approved settlement between Pfizer and Teva Pharmaceuticals, Teva will be allowed to market its generic version of Viagra beginning in December 2017. Teva will pay Pfizer a royalty for a license to produce its generic version. Under the terms of their agreement, Teva will have exclusive marketing rights for a generic form of Viagra until April 2020 when Pfizer’s patent on Viagra will expire.
Gradual Price Decline Likely
While the U.S. introduction of Teva’s generic form of Viagra is unlikely to duplicate the very sharp drop in prices experienced in Britain, the expiration of other impotence drug patents in coming years should result in significantly lower U.S. prices for these drugs over the next few years.
At present, Viagra and all other FDA-approved PDE5 inhibitors are available in the United States only by prescription. That may change beginning in 2018 if a licensing deal between Eli Lilly & Co., the maker of Cialis, and French drugmaker Sanofi wins approval from the FDA.
Cialis OTC on the Horizon?
Under the terms of the licensing agreement, Sanofi would market an over-the-counter version of Cialis in the United States and other markets if regulators approve. Lilly would manufacture the OTC formulation of the drug in its Puerto Rican plant, allowing it to continue to profit from Cialis after the 2018 expiration of its U.S. patent on the drug. Lilly’s patent for Cialis in the European Union will also expire in 2018.
The introduction of Viagra in the late 1990s started a revolution in the way impotence was treated worldwide. Viagra and the other PDE5 inhibitors that followed offered a safe and effective treatment for ED for most healthy men. Side effects were generally mild and transitory.
How PDE5 Inhibitors Work
Viagra, Levitra, Cialis, Staxyn, and Stendra are the five PDE5 inhibiting drugs approved by the FDA for treating ED. This family of drugs gets its name from its ability to temporarily block the effects of the phosphodiesterase-5 enzyme, which can make it difficult to achieve and maintain an erection. In short, these drugs temporarily promote strong blood flow to the penis, facilitating the erectile process.
Men taking nitrate-based drugs for the treatment of angina and other cardiovascular disorders should not take PDE5 inhibitors, because together they could cause a potentially life-threatening drop in blood pressure.
Ordering ED Drugs Online
American men who are looking for a reliable online drugstore where they can order Viagra or one of the other PDE5 inhibitors need look no further than eDrugstore.com. A member of the Secure Medical family of online drugstores, eDrugstore is based in Tempe, Arizona. All drugs purchased through eDrugstore are FDA-approved and are dispensed from U.S. licensed pharmacies.
Studies and surveys have shown that many American men with erectile dysfunction hesitate to seek treatment because they feel uncomfortable discussing this very private matter with their personal physicians. For those men, eDrugstore can arrange an online consultation with one of its contract physicians who will authorize a prescription for an ED drug if he or she deems it appropriate.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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