Access is dwindling for many older, off-patent, essential drugs as companies use an emerging strategy to acquire therapies in niche markets where there are few or no alternatives, and then jack up the price.
Authors of a perspective piece published in the May 19 issue of the New England Journal of Medicine identify a list of 17 anti-infective drugs, listed as essential by the World Health Organization, that could be the next targets for such a strategy.
Seven of them treat tuberculosis (rifapentine, rifabutin, pyrazinamide, capreomycin, streptomycin, aminosalicylic acid, and ethionamide), and others are the recommended first-line treatments for leprosy (clofazimine), sever malaria (intravenous quinidine gluconate), scabies and lice (permethrin 5% cream), or Chagas disease (benznidazole). Other drugs on the list are ivermectin, dapsone, clofazimine, sulfadiazine, inhaled and intravenous pentamidine, and paromomycin.
"We speculate that these medications may experience dramatic price increases in the future, which would disproportionately affect vulnerable populations in the United States," write Jonathan D. Alpern, MD, from the Division of Infectious Disease at University of Minnesota in Minneapolis, and colleagues.
Many of the drugs fit the takeover profile, meaning they lack alternatives, they treat conditions with high morbidity and mortality, and they are made by only a few manufacturers.
Jeremy A. Greene, MD, PhD, associate professor of medicine and the history of medicine at Johns Hopkins School of Medicine in Baltimore, Maryland, told Medscape Medical News he was not surprised by the names on the list.
"It is precisely drugs for diseases that we do not perceive to be high-profile markets in the United States that become susceptible to this behavior," he said.
Perception Is That Some Problems Have Been Solved
He said at the core of the problem is that "American pharmaceutical policy has been overwhelmingly directed toward innovation, rather than access." As a consequence, drugmakers that could be offering alternatives tend to neglect the drugs created decades ago, thinking those problems have already been solved.
Tuberculosis is a case in point, he says. Tuberculosis is still prevalent in the United States, but we tend to think of it as happening in other places, so the competition for drugs has dwindled.
Another example is hookworm, which was endemic to the southeastern United States in the early 1900s, but has been largely eradicated in the United States. The first-line treatment for hookworm and several other parasitic diseases is albendazole. But the US market for albendazole is seen as very small and has not generated competition even though the drug has been off-patent for decades, he notes.
That is why albendazole was ripe for this kind of takeover strategy, and the drug that cost $5.92 in 2010 per daily dose, as reported by Medscape Medical News, now costs more than $150 per daily pill in the United States, when it's "incredibly cheap" elsewhere, Dr Greene said.
"You'd actually be better off having hookworm in a place that has had less success in eradicating the disease because there hookworm would represent a viable market and there would be generic competition," Dr Greene said.
Proposals to Increase Competition
Timely market solutions are needed when prices come as a result of monopolies, the authors write.
They point to one barrier, in that the process of getting a new competing drug approved by the US Food and Drug (FDA) in a niche market is so difficult and expensive that few try. There is little incentive for a generic drug company to enter a niche market.
But that is changing, they note. The FDA recently announced that it will expedite review of simplified new drug applications for generic entrants when only one manufacturer exists.
The authors also call for the FDA to allow temporary importation of cheaper versions of vulnerable medications from places outside the United States that have strong regulatory processes.
"We believe that empowering Medicare to negotiate drug prices and opening U.S. markets to imported drugs would be a welcome regulatory response," the authors write. "[S]afety could be ensured by reliance on reputable regulatory agencies such as the European Medicines Agency and Health Canada."
Dr Greene agreed and said that although he understands the FDA's hesitation in allowing importation of drugs in general, the severity of the access problem to medications patients urgently need calls for flexibility.
Just having that FDA option "would take away any lucrative appeal to the strategy of price hiking on old essential drugs we've seen running rampant over the last 10 years," he said.
He added that he would also like to see Congress continue to investigate drug price hikes.
Dr Alpern and colleagues warn that without creative solutions, "pharmaceutical companies will continue to grow wealthy at the expense of taxpayers and vulnerable patients.... Meanwhile, providers are left prescribing medications that they know are unaffordable, relying on options other than first-line therapies, or assisting patients in acquiring medications through alternative, unregulated sources," they write.
The authors and Dr Greene have disclosed no relevant financial relationships.
N Engl J Med. 2016;374:1904-1907. Extract
Source: Medscape