Insulin Price Hikes Tell Us A Lot About What's Wrong With Drug Pricing In America
Ballyscanlon/Getty Images When inventor Frederick Banting discovered insulin in 1923, he refused to put his name on the patent. He felt it was unethical for a doctor to profit off a discovery that would save lives. Banting’s co-inventors, James Collip and Charles Best, sold the insulin patent to the University of Toronto for a mere $1. They also wanted everyone who needed their medication to be able to afford it. Today Banting and colleagues would be spinning in their graves: Their drug, which many of America’s 30 million diabetics rely on, has become the latest poster child for pharmaceutical price gouging. On May 2, the pharmaceutical giant Eli Lilly raised the prices of its insulin medications, Humalog and Humulin, by 7.8 percent, according to newly obtained records from CNBC’s Meg Tirrell. And Lilly is not acting alone: Sanofi and Novo Nordisk, the only two other companies that manufacture insulin in the US, have been jacking up insulin prices recently too. Patients can now expect to pay upward of $400 per month for the century-old drug. Drug companies use the “cost of innovation” argument to justify the price increases — but critics don’t buy their reasoning, and diabetics who depend on the daily lifesaving medication are livid. In January, patients filed a class action lawsuit accusing the three companies of price fixing. The American Diabetes Association's board of directors has also asked Congress to investigate insulin price increases. While the US represents only 15 percent of the global insulin market, it generates almost half of the pharmaceutical industry’s insulin revenue. According to a recent study in JAMA Internal Medicine, in the 1990s Medicaid paid between $2.36 and $4.43 per unit of insulin; by 2014, those prices more than tripled, de Continue reading >>
The Business Of Diabetes: Cvs Caremark's Salvo In Biosimilar Insulin For 2017
Its already mid-2016, and for nearly the past decade, I've been pushing for so-called "biosimilars" or "follow-on biologics" like insulin to be legalized and then introduced in the U.S. (I first investigated this issue back in 2006, and published an article on it in January 2007). The reality is that without any form of generic competition, prices continue to rise with absolutely nothing to stop them. In recent years, there have been some hyper-aggressive price-increases from the insulin oligopoly, especially within the last 3 years or so. The reason: they all KNOW that their insulin analog patents are about to expire soon, so they've made a shameless money-grab with huge price increases before that happens. The retail cost of a vial of insulin is now over $125 a vial, and that's for old varieties like Regular or NPH which have been on the market for like 95 years. I haven't even bothered to price insulin analogs! The Affordable Care Act (a.k.a. "Obamacare") finally legalized biosimilar medicines in the U.S. Before that, there was a lot of complaining and bellyaching from pharmaceutical and biotechnology companies that there was no regulatory pathway, which was only true for some newer biotech medicines. Because insulin was the very first biotech medicine ever approved by the FDA, its grandfathered under the law as a "small-molecule" drug (along with human growth hormone, another very early-generation biologic medicine), so there was no legal impediment for biosimilars. Consider the case of a very early biosimilar version of human growth hormone known as Omnitrope, which was approved on June 1, 2006, several YEARS before the Affordable Care Act was passed into law on on March 23, 2010 and later implemented in 2011. The industry bellyaching was more excuses than anything Continue reading >>
Biosimilar Insulin: The Current Landscape
Abstract The first insulin biosimilar, Abasaglar, is now available in the UK and several more are in development. Biosimilars are manufactured copies of previously approved biopharmaceuticals no longer under patent protection. They are not identical versions of their reference product due to the complexity of their production and resultant protein product. The present article reviews the current biosimilar landscape including manufacture, regulatory requirements, safety and prescribing issues. Abasaglar is used to illustrate the process of biosimilar development and approval. Copyright © 2017 John Wiley & Sons. Continue reading >>
Generic Lantus Availability
See also: Generic Lantus Solostar Lantus is a brand name of insulin glargine, approved by the FDA in the following formulation(s): LANTUS (insulin glargine recombinant - injectable;injection) Has a generic version of Lantus been approved? No. There is currently no therapeutically equivalent version of Lantus available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lantus. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication. See also: Generic Drug FAQs. Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims. Acidic insulin preparations having improved stability Patent 7,476,652 Issued: January 13, 2009 Inventor(s): Brunner-Schwarz; Anette & Lill; Norbert Assignee(s): Sanofi-Aventis Deutschland GmbH The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range. July 23, 2023 ✓ January 23, 2024 ✓ Acidic insulin preparations having improved stability Patent 7,713,930 Issued: May 11, 2010 Inventor(s): Brunner-Schwarz; Anette & Lill; Norbert Assignee(s): Sanofi-Aventis Deutschland GmbH Th Continue reading >>
When You Can't Afford The Insulin That You Need To Survive | How To Use The Cheap "old-school" Insulin
Note: BootCamp for Betics is not a medical center. Anything you read on this site should not be considered medical advice, and is for educational purposes only. Always consult with a physician or a diabetes nurse educator before starting or changing insulin doses. Did you know that all type 1 diabetics and some type 2 diabetics need injectable insulin in order to live? Put another way, if a diabetic needs insulin in order to live, and the diabetic does not get insulin, the diabetic will die. Diabetic death from Diabetic Ketoacidosis is a grisly process, during which acid starts running through your bloodstream, searing your vessels and organs while your body shrivels up in dehydration as it tries to push the acid out of your body through your urine and lungs, and, left untreated, the condition shuts down your organs one by one until you are dead. If you're lucky, your brain will be the first thing to swell itself into a coma and you'll be unconscious for the remainder of the organ failures. In some cases, this grisly diabetic death can take a few days or weeks to complete its process. Or, if you're one of the luckier less-resistant insulin-dependent type 2 diabetics, you may actually get away with staying alive for quite a few years and suffer only some heart disease, stroke, kidney damage/failure, neuropathy, limb amputations and blindness. (my intent in describing how lack of insulin leads to death is not to cause fear in people with diabetes or their loved ones; rather, my intent is to make clear the reality that injectable insulin is absolutely vital to diabetics who depend on injectable insulin to live) While I'd love to go off on a political rant about how insulin should be a basic human right for all insulin-dependent diabetics (and why the hell isn't it?), that' Continue reading >>
Merck Aims To Be First To The Finish Line With Generic Of Lantus
U.S. pharmaceutical company Merck & Co. Inc. (NYSE:MRK) announced Monday that it’s partnering with Samsung Bioepis to create a generic version of Sanofi SA’s (NYSE:SNY) best-selling insulin drug, Lantus, according to a Reuters report. The agreement between Merck and Samsung Bioepis threatens to annihilate Sanofi’s January victory against Eli Lilly & Co. (NYSE:LLY) in a patent infringement suit over the diabetes medicine. Eli Lilly was dealt a 30-day Food and Drug Administration delay that paved the way for Sanofi’s own generic version, the promising U300. As a result of the lawsuit, it’s unlikely the Eli Lilly-made generic of Lantus will appear before 2016, but if Merck’s version of the drug, known as MRK-1293, sneaks through the approval process ahead of Lantus’ patent expiry date, then it has the potential to pose a very real threat to Sanofi’s market share, per FierceBiotech. “The relevance of today’s announcement to Sanofi is the potential for greater price erosion and market share loss from two ‘generic’ Lantus,” analysts at Bernstein said in a research note, per Reuters. “We currently model the ‘generic’ erosion of Lantus in our Sanofi model in the mid-2016 timeframe. This erosion could accelerate more quickly now that a second player is likely to enter in the 2016 timeframe.” Currently, the drug makes the French pharmaceutical company approximately $7 billion per year, and sales rose 20 percent in 2013. Lantus is a long-acting human insulin analog that improves patients’ glycemic control in adults and children with type 1 diabetes as well as adults with type 2 diabetes, according to Sanofi’s website for the drug. The French drugmaker’s patent on the drug doesn’t expire until 2015. It’s still unclear whether Sanofi and i Continue reading >>
Soaring Insulin Prices Prompt Insurance Shift
USA TODAY - Many parents of diabetic children and adults suffering with type 1 or type 2 diabetes are bracing for changes in insurance coverage of their insulin next year, as prices of the vital medication continue to soar. Higher insurance deductibles and changes in the prescription brands covered by some insurers are raising concerns among some people with diabetes. CVS Caremark, a pharmacy benefit manager (PBM), will no longer cover the insulin brand Lantus in favor of a new biosimilar version, Basaglar. Biosimilars are considered the generic versions of "biologic" drugs that are based on natural sources. The company also announced a program last week to further keep diabetes costs down, following a similar move in August by competitor Express Scripts. Diabetes is an epidemic in the United States, affecting nearly 10% of the population or about 29 million people, according to the Centers for Disease Control and Prevention. Of those, more than 8 million people are undiagnosed. Type 1 diabetes — often still called juvenile diabetes — can occur when people are children or adults. Type 2 diabetes is becoming more common with the increase in obesity and sedentary behavior. Prices for Humalog and many insulin brands have increased from about $300 to $500 between January 2013 to October 2016, according to drug discount search company GoodRx. Lantus increased about 60% — from $240 to $380 — in the same time period, GoodRx says. "It’s definitely unfortunate prices are going up so much and impacting the people who need it to stay alive," says Henry Anhalt, an Englewood, N.J., pediatric endocrinologist. "But I think a big part of the problem is how much (insurers) cover and how much they fight you." The amount of insulin a diabetes patient needs every day depends on w Continue reading >>
The High Cost Of Insulin
As a provider who treats patients with diabetes, one of my roles is choosing which medication or type of insulin to prescribe. Although there has been an increase in insulin options available, the financial burden on patients is significantly rising. One of the major challenges for doctors and advanced practitioners is trying to stay familiar with the numerous insurance companies, different plans within each, and changes in formulary (preferred medication) when prescribing. Choice of insulin for our patients is driven more and more by cost. As the author describes the historical context of insulin production, it is perplexing that costs are skyrocketing when this medication has existed for nearly a century. In the past 20 years, the cost of a 10 mL bottle of rapid-acting insulin analogue (Novolog or Humalog) has increased from approximately $25 in 1996 to more than $250 in 2016! (Business Insider, May 15, 2017) More disturbingly, the companies that produce these insulins (Novo Nordisk and Eli Lilly respectively) appear to follow a “shadow pricing” technique that increases the price of these similar products simultaneously, eliminating a competitive market. Despite widespread criticism from advocacy groups like the American Diabetes Association, politicians and even a patient-initiated class action lawsuit last fall, both companies raised the list price of their insulins by another 8% in 2017. The uncertain future of U.S. healthcare, including proposed cuts to Medicaid funding, leaves many patients with anxiety surrounding the affordability of these life-saving medications. Such uncertainty could lead to more people choosing high deductible plans to ensure coverage, leaving them vulnerable to rising out-of-pocket costs that even discount cards offered by pharmaceutic Continue reading >>
In A Race For A New And Cheaper Insulin Glargine, Legal Troubles May Delay New Products From Coming To Market
Do you ever wonder why there aren’t cheaper “generic” insulin products available? This may soon change as the patents for branded insulin begin to expire. In fact, the patents for Sanofi’s top-selling Lantus (basal insulin glargine) are set to expire in the US in 2015, and other companies are racing to produce new “generic” insulins that could provide more choices for patients and importantly, push down the prices. The term “generic” traditionally applies to small molecules that are chemically and structurally equivalent to the original drug. Biosimilars created for products like insulin are biologically created products that tend to be more complex and sensitive. Thus it is difficult to completely prove that a biosimilar drug is identical to the original like a true “generic” drug. To learn more about “generic” insulin products and how they are defined, please read on in diaTribe #26. The race has already started. On December 20, Eli Lilly and Boehringer Ingelheim announced the submission of a new basal insulin glargine to the FDA. The compound, called LY2963016, is under regulatory review in the US, Europe, and Japan. In January, we learned that Sanofi has filed a lawsuit against Lilly alleging patent violations of the original top-selling Lantus (insulin glargine) – the lawsuit could delay the FDA’s decision on drug approval for up to 30 months, which would push back potential approval to 2016. This is a bit of a surprise and we’re working on “unpacking” this to better understand the moves on each side. Other companies are getting into the game as well. Merck and Samsung Bioepsis announced a partnership in February to develop a “generic” insulin glargine, and phase 3 testing of the drug candidate will begin “soon” for its can Continue reading >>
Insulin Glargine
Insulin glargine, marketed under the names Lantus, among others, is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours, with a "peakless" profile (according to the insulin glargine package insert). Pharmacokinetically, it resembles basal insulin secretion of non-diabetic pancreatic beta cells. Sometimes, in type 2 diabetes and in combination with a short acting sulfonylurea (drugs which stimulate the pancreas to make more insulin), it can offer moderate control of serum glucose levels. In the absence of endogenous insulin—type 1 diabetes, depleted type 2 (in some cases) or latent autoimmune diabetes of adults in late stage—insulin glargine needs the support of fast acting insulin taken with food to reduce the effect of prandially derived glucose. Medical uses[edit] The long-acting insulin class, which includes insulin glargine, do not appear much better than neutral protamine Hagedorn (NPH) insulin but have a significantly greater cost making them, as of 2010, not cost effective.[1] It is unclear if there is a difference in hypoglycemia and not enough data to determine any differences with respect to long term outcomes.[2] Mixing with other insulins[edit] Unlike some other longer-acting insulins, glargine must not be diluted or mixed with other insulin or solution in the same syringe.[3] However, this restriction has been questioned.[4] Adverse effects[edit] Cancer[edit] As of 2012 tentative evidence shows no association between insulin glargine and cancer.[5] Previous studies had raised concerns.[6] Pharmacology[edit] Mechanism of action[edit] Insulin glargine has a substitution of glycine for Continue reading >>
Why Can't You Get Cheaper Insulin?
How is a drug that has been around for nearly 100 years still not available as a low-cost generic? That is the question that researchers recently asked about insulin, the diabetes treatment that was created in the 1920s but still can't be purchased as a cheap generic. Simply put, insulin is too complex for generic drug makers to manufacture cheaply and isn't as lucrative as other products. "Generic drugs have been a remarkable boon for affordability and access to potential medicine. That progress doesn't spread evenly across all kinds of medicine," said Dr. Jeremy Greene, an associate professor at Johns Hopkins and co-author of an article on the subject in the New England Journal of Medicine. Insulin can cost an uninsured patient between $120 to $400 per month, the journal article said. By comparison, some generics would only cost about $4. The 1984 Hatch-Waxman Act made it easier for generic drugs to enter the market. Under the law, a brand-name drug can become a generic after its patent expires. A generic drug maker can apply for regulatory approval to make an exact copy of the product. Because a generic manufacturer doesn't have to put in the billions of dollars in research as the brand name company did, it can sell the product for far less, sometimes even 80 percent off. From 2003 to 2012, generic drug use is estimated to have generated more than $1.2 trillion in savings to healthcare systems. About 85 percent of all prescriptions are filled with generics, according to the Food and Drug Administration. While generics offer all sorts of low-cost alternatives, manufacturers often choose to copy more profitable blockbusters such as anxiety drugs, Greene said. Another hurdle is insulin is hard to make compared with more traditional drugs. Insulin is also considered a bi Continue reading >>
Where's The Generic Insulin?
You can buy generic birth control pills, HIV antivirals, and chemotherapy drugs, but you can't buy generic insulin; it doesn't exist. In fact, the history of insulin in the United States is a case study for how the brand-name-then-generic system can fail patients. Generic insulin would certainly be a big boon to many Americans, five million of whom depend on insulin to manage their Type 1 and Type 2 diabetes, illnesses that are deadly when left untreated. For those without insurance, brand-name insulin costs $120 to $400 for a month's supply. In 2014, the website Insulin Nation interviewed insulin users about their troubles. One person gave up doctor's visits and teeth cleanings to buy her medicine. Another stocked up when he found it for a good price, and sent extra to a family member who couldn't afford it. Normally, companies start creating generics when big-name drug-makers' patents expire. The generics sell for less because their makers didn't bear the cost of discovering and developing the drugs. This should have happened to insulin already—the first patent for it dates to 1923. But a combination of patent-refreshing and generics companies' reluctance to tackle making the insulin protein, which is hard to copy, has kept insulin patented and pricey, two physician-researchers report in the New England Journal of Medicine today. "It's hard to say that contemporary patients who cannot afford their insulin are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago." In recent years, some researchers and journalists have called out drug companies for "evergreening," or making trivial improvements to drugs whose patents are close to expiring. The tweaks let com Continue reading >>
Generic Insulins Out Of Reach For Now
A Diabetes Health reader writes in to ask: Is there a generic alternative to Humalog insulin? If so, what is its cost compared to Humalog? Generic drugs are amazing. They offer lifesaving promise for a cheap price tag, and given that the underlying drugs have been tested and proven, there’s no doubt about safety or effectiveness. But don’t expect to see generic “human” insulin any time soon. If you do spot it eventually, don’t expect it to be too cheap or widespread. It seems that the complex manufacturing involved in insulin drugs isn’t easily duplicated. The processes are so complicated–and government guidance in the area so lacking–that there are still no generic alternatives to insulin brands with expired patents in the United States. Humulin insulin, for example, saw its patent expire in 2000, but Eli Lilly still sold $1.3 billion worth of the brand last year. Lilly’s patent on Humalog will expire next year, but its most worrisome competitor, a company in India associated with Pfizer, called off its generic insulin work in March. That’s expected to keep Humalog sales strong into the near future. Some semi-generic forms of human insulin are available in other countries, but they’re called “biosimilars” because they’re only similar, not identical, to the name brand stuff. Patients don’t necessarily react to them in the same way. The US Department of Health and Human Services is working on rules for these generic insulins, and a plant to manufacture them is being built. But companies will still have to run tests on the new insulins–something they don’t have to do for most other generic drugs–which will slow their introduction even further. Ultimately, insulin is a highly specialized drug that’s used by a relatively small number of Continue reading >>
Why A Lifesaving Drug That's Been Around Since 1923 Is Still Unaffordable
Insulin is administered by injection. AP An essential drug that has been on the market for decades still has a sticker price out of range for some patients who need it. Insulin, a lifesaving treatment for diabetes, was first patented in 1923. Unlike many common, even newer medicines, a generic option does not exist. At the same time, the cost of insulin has more than tripled. According to a 2016 analysis in the Journal of the American Medical Association, in 2002, the cost per patient per year was $231. In 2013, it was closer to $736. Today, almost 22 million Americans are diagnosed diabetics. Of those, about 26% take insulin to manage the chronic disease. (The rest take pills only or no medication at all.) The reasons these Americans don’t have a cheaper option for insulin by now isn't simple. It has a lot to do with biology and regulations. Those issues are compounded by historical and economic factors, a 2015 paper in the New England Journal of Medicine reported. Insulin's biology makes it tricky to copy Typically, new prescription drugs are available only from the company that developed and patented them for the first few years after gaining FDA approval. The brand-name drug is allowed to monopolize the field so drug companies have incentive to invest heavily in research and come up with new medicines. After a few years, however, other companies are allowed to start making generic versions of the drug — cheaper, “off-brand” options that are otherwise exactly the same as the original. Because there’s no longer a monopoly and generic manufacturers are only trying to turn a profit — not recoup high research and development costs — generics can be much less expensive and thus more accessible treatment options for the general public. But insulin didn't foll Continue reading >>
Insulin Glargine (lantus)
What is INSULIN GLARGINE-INJECTABLE, and how does it work (mechanism of action)? Insulin glargine is a bioengineered (man-made) injectable form of long-acting insulin that is used to regulate sugar (glucose) levels in type 1 and type 2 diabetes. Individuals with type 1 diabetes do not produce insulin on their own; and individuals with type 2 diabetes do not produce enough insulin, or insulin is not as effective due to insulin resistance. Insulin glargine works the same way as natural human insulin, but it's action lasts longer. It helps diabetic patients regulate glucose or sugar in the body. Insulin glargine works by promoting movement of sugar from blood into body tissues and also stops sugar production in liver. Insulin glargine is man-made insulin that mimics the actions of human insulin. The FDA approved insulin glargine in April 2000. What are the side effects of INSULIN GLARGINE-INJECTABLE? Common side effects of insulin glargine are: Local allergic reactions that may occur at the injection sites are: Long term use of insulin glargine can lead to thickening of fat tissues at the injection site. Severe allergic reactions are: Swelling under the skin Bronchospasm (tightening of chest that leads to difficulty breathing) Individuals should contact a healthcare professional if they experience any of the above reactions. What Is Type 2 Diabetes? Type 2 diabetes can affect all people, regardless of age. Early symptoms of type 2 diabetes may be missed, so those affected may not even know they have the condition. An estimated one out of every three people within the early stages of type 2 diabetes are not aware they have it. Diabetes interferes with the body's ability to metabolize carbohydrates for energy, leading to high levels of blood sugar. These chronically high blo Continue reading >>
