W ASHINGTON – Fifteen years ago, a patient with diabetes would have paid $ 175.57 for a 20 milliliter vial of the long-acting insulin Humulin R U-500.
Today he would spend $ 1,487 for the same small vial, according to Elsevier's Gold Standard Drug Database wholesale data.
It's easy to blame manufacturers of drugs: Only three drug companies, all massive, global companies, have the vast majority of the $ 27 billion global insulin market: Sanofi, Eli Lilly and Novo Nordisk. And they have practically always since the drug was discovered in 1921.
Yet, a thorough review of the drug's nearly 1
As Congress prepares to investigate the market, Sanofi will testify next week to the Senate Finance Committee and Diana DeGette (D-Colo.). has pledged to bring the three big companies to its Energy and Commerce subcommittee – it's worth asking if there's no reason to call others, such as generic drug maker or FDA commissioner Scott Gottlieb.
"Everyone is to blame Walid Gellad, who heads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told STAT.
Mod insulins mimic the insulin hormone normally produced by the pancreas and regulate the amount of glucose in a user's blood. Diabetics inject the product either because their pancreas does not make insulin itself, or because the body is resistant to the insulin that the body produces.
Whoever discovers that the drug was first discovered is controversial. Even the Nobel Prize for his discovery was questioned. Honored researchers, Frederick Banting and John J. R. Macleod, were just two members of a research team at the University of Toronto who finally discovered how insulin can be used to treat diabetes. And Banting was publicly infuriated that Macleod did not deserve the award through an assistant, Charles Best.
Banting sold the patent for the product to the University of Toronto for only US $ 1, hoping that the product would be readily available given the importance of the product. The discovery consisted of treating a once deadly condition.
Eli Lilly was the first drug manufacturer to produce the product on a large scale; early versions relied on insulin from cattle such as cattle and pigs. Since then, the three manufacturers have developed long-lasting and slow-release variations and a variety of other products, some of which are now almost identical to what the body produces on its own.
For the most part of the history of the drug generic manufacturers had little interest in entering the market. The insulin market was not nearly as lucrative as it is today. For example, in 1999 Eli Lilly sold insulin worth US $ 701 million in the United States. In 2017, Lilly raised $ 2.6 billion for just two insulin products.
"Many of these products were so cheap twenty years ago that the value of the investment was not for generics," said David Gaugh, Vice President
That began to change in the last decade, around the same time as the Drug manufacturers raised their prices. In 2008, Humalog, Eli Lilly's best-selling and most expensive insulin product, generated more than $ 1 billion in revenue 12 years after entering the market. In 2017, Lilly sold the drug worth $ 1.7 billion. The higher revenues in Lilly's funds were mainly due to price increases, a fact that Lilly consistently acknowledges in its own annual reports to shareholders.
Today there is only one generic version of insulin – and it's made by Eli Lilly. The product, Basaglar, copies the expensive Sanofi product Lantus, the world's best-selling version of insulin. It's about 15 percent cheaper than Lantus.
There are other factors that have stopped generic drug companies who might otherwise have been interested.
Doctors are reluctant to prescribe older insulin products – those that are eligible for generic competition, according to the American Medical Association. Despite the fact that research shows that many people with diabetes respond equally well to older insulin, according to a study published in Diabetes Care magazine. A 2014 study from the Institute for Clinical and Economic Review also found that there is sufficient evidence that older insulin is as effective for people with type 2 diabetes as newer insulins.
Dr. Kasale Lipska, assistant professor of medicine in Yale, told STAT that prescribing older insulin is "going against the tide".
"This completely eliminates generic competition, because if the patent-free drug is considered to be irrelevant anyway, there is no incentive to invest in it," said Lipska, 19659014. Even the American Medical Association recently affirmed in a policy statement that "Guides and training materials can help younger doctors prescribe cheaper insulin alternatives," some doctors claim should not be blamed for the current crisis in insulin affordability.
"When we first started using Humalog and Lantus "The difference between the two costs was small, but the differences in hypoglycaemia were small." Irl Hirsch, a professor of medicine at the University of Washington, told STAT. "Since the costs were not a big concern, how can you Blame doctors? "
Brand drug companies also have one Share of debt in the concentrated market.
Your strategy to keep competition from generics in check? Submit patents – many of them. Each of the major manufacturers has hundreds of unexpired patents related to its products, the devices used to deliver the drugs, and the methods of making them.
Sanofi, maker of Lantus, has been selected for allegedly recurring small changes to its product in order to file for new patents. According to I-MAK alone, 74 patents were registered for a specific version of this drug.
Sanofi also fought Lilly over his Basaglar product, claiming patent infringement – delaying the drug's attempt for nearly two and a half years in 2014 while the two set it up in court. And Mylan, another imitator for Lantus, has his own patent dispute with Sanofi, which began in 2017. (Mylan's product has not yet been approved by the FDA.)
"The inventions of our scientists are novel Not obvious, as recognized by the patents granted to us by the US Patent and Trademark Office," the spokesman said by Sanofi, Ashleigh Koss, opposite STAT. "By protecting our patented inventions, we pave the way for the discovery of new drugs to meet unmet medical needs."
The fear of similar patent litigation may also discourage other generics manufacturers from considering less lucrative imitators [GaG] from the lobby of generics told STAT.
"There are all sorts of patents involved," said AAM's Gaugh. "Whether it's process patents, manufacturing patents, equipment patents, packaging patents, trademark patents, and trademarks, all are different methods of preventing [competition]."
At the moment, however, the biggest A roadblock for a generic insulin could actually be regulatory.
Insulin regulation is more messy than any other drug because of its science and unique history.
Insulins are technically biological drugs, a label that is used to describe medicines or therapies that come from life cells and organisms. However, Washington policymakers lacked a framework for the regulation of biologics and their imitators, the biosimilars, by 2010, when Congress set this framework in its Biologics Price Competition and Innovation Act. As part of this law, the Congress said that insulin – which had previously been regulated like any other drug – would be biologically regulated from 2020.
The Congress left the logistics of this transition to the FDA – and the transitional plan of the agency was not foreseen. It is not as flexible as generic manufacturers had hoped, at least for the promotion of a generic insulin.
The FDA directive requires that an application for insulin still pending before the agency on March 20, 2020, be denied. Each applicant would then have to start over and reapply in a new, biosimilar way.
Given the lengthy period for drug development – along with an uncertain and often timely FDA regulatory process – the tough stop in 2020 for drug manufacturers has become questionable
Even companies that have insulin products in development and are ready to submit their applications to the FDA, now waiting for their application until after 2020, as they would like to avoid passing the time and money of the application in 2019, only rejected on March 20, 2020, AAM told the FDA in March 2016. 19659003] "[T] The policy already affects the current development programs for Europe from many key protein products, including insulins," AAM wrote in its recent letter to the FDA on the subject, adding that the directive "complies with relevant laws collides, arbitrary and capricious "is often used as a signal for a company policy.
When it was first proposed, generic companies blasted the cliff in 2020, saying it would affect patients' access to affordable alternatives to insulin and other medicines.  At an industry conference in December, Gottlieb said the FDA had "carefully reviewed all comments received on the previous draft guidelines". The FDA, however, rejected the major changes that generic manufacturers wanted to call for: to amend the FDA's guidelines for drug-related drug applications on March 20, 2020.
"We're already able to March 20, 2020 to review pending applications to minimize disruption to development programs, "said FDA spokesman Lyndsay Meyer told STAT. "Currently, the agency estimates that it will have little or no application impact."
"Sponsors have been aware of this transition for a decade. They had time to prepare, "Meyer added.
Several lobbyists and consultants STAT shared with all that the FDA can interpret the law as meaning that generic insulins will not be delayed.AAM has suggested that the FDA simply relies on data contained in an application that is already pending on March 20, 2020, and allows a sponsor to amend its application for additional information that may be needed as the application is now reviewed by the FDA becomes biology, not a drug.
"" The ability of the FDA to really accelerate competition is enormous, "said Gillian Woollett, senior vice president of Avalere Health. "The sponsorship opportunities are all now available. What I do not understand is why FDA and HHS say all that they say [about encouraging new generic competition] and they do not do the things they can do now, which would actually boost competition. "
19659003] Since the legislature of both parties sees drug prices as a potential area for consensus and cooperation between both parties, it is obvious that insulin is at the top of the congress's to-do list.
Three separate congressional committees have held during the last two hearings Months in drug pricing and in each question the question of the affordability of insulin has been of great importance. Two committees have already begun investigations on insulin manufacturers, and another plan to testify on an insulin producer later this month is foreseeable.
Legislators are also already considering legislation to reduce insulin costs. The Congress for Diabetes Congresses has proposed a comprehensive package of proposals to increase the affordability of insulin, which includes a legislative proposal requiring insulin manufacturers to disclose their pricing, and another, which the FDA directs, to review insulins to accelerate lower costs.
"Who would believe that only three manufacturers exist 100 years later?" Said House Ways and Means chairman Richard Neal (D-Mass.). "It's pretty wild, considering that."
Ike Svetlitz contributed to the coverage.