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 >>
True Or False: You Can Buy Insulin From Canada
True or false: It's illegal for U.S. residents to order and receive prescription medication from pharmacies in Canada. Okay, how about this one - True or false: It's illegal for Canadian pharmacies to ship prescription medications to U.S. residents. The answer: False! Did you get all that? Allow me to explain... So, a couple of weeks ago the news broke that Google got into heaps of trouble with the FDA for allowing Canadian pharmacies to post their ads on American websites using their AdWords service. Of course, Google's $500 million settlement was more like a slap on the wrist considering how much the company is worth, but it drove home the point that Canadian pharmacies — and actually all international pharmacies — are not supposed to sell their goods to U.S. residents. It's against the Food, Drug and Cosmetics Act, which specifically states that it is illegal to import controlled substances and unapproved prescription drugs, whether the product is a foreign-made version of a U.S.-approved drug or the exact same drug that U.S. manufacturers send to Canada. So even if the factory makes the same insulin for both the Canadian market and the U.S., Canada cannot legally turn around and export the insulin to the U.S. Yep, it's true. What FDA Forbids Apparently the folks at FDA have positively convinced themselves that all drugs from outside the United States are evil. Well, sort of... In 2003, William Hubbard (then commissioner and later founder of the advocacy group Alliance for a strong FDA) testified before the Subcommittee on Human Rights and Wellness House Committee on Government Reform that: "In our experience, many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown qu Continue reading >>
Relion Insulin: Everything You Need To Know
For my patients who have no insurance, ReliOn products at Walmart are a lifesaver. In North Carolina, we never funded Medicaid expansion. Some people could receive Obamacare through the federal marketplace, but others were left in the gap where it was too costly for them. The tax penalty was less, so they took the penalty instead of buying coverage. For those with Type 1 and Type 2 Diabetes in the no insurance gap, for those in the “Medicare donut hole,” and for those in disaster situations, ReliOn insulin is available at a very affordable cost. If you want insulin at a cheaper cost, it is important to be aware of some of the differences between ReliOn insulin and name brand insulins. Renee’s story Renee had Type 1 Diabetes, and couldn’t afford her insurance coverage here in North Carolina. After running her insurance cost numbers on the Federal Marketplace, she would have to pay $300 per month for catastrophic coverage that wouldn’t even cover her diabetes medications. Her husband had lost his job, and she worked at a grocery store, where she didn’t make a living wage, or have any insurance benefits. She came in crying. She needed help, because she had lost her insurance coverage, and she was about to run out of her insulin. She was afraid of what might happen to her, and what might happen to her little boy, if she ran out of her insulin. We referred her to a social worker who could help her with needed resources, and see if she could qualify for Medicaid, or start social security disability determination so she could get insurance when determined disabled. In the meantime, we spoke with her doctor, and he gave us conversion doses for Renee to switch to the ReliOn brand of insulins at Walmart. She had to take a combination of ReliOn Humulin N injections twi Continue reading >>
Patient Assistance Program
Even though NovoLog® is covered by most health insurance and Medicare plans,a we know that sometimes things can get in the way of filling your prescription: Having a hard time getting the prescription coverage you need Money issues that make it difficult to pay for your insulin If you have questions about insurance reimbursement for NovoLog®, you can contact our call center at 1-866-310-7549. Please have your insurance information with you when you call. This includes your managed care plan name and your group number, which should be on your insurance card. If you can’t afford the cost of your insulin, we may be able to help. Making our products available to people who need them but cannot afford them is part of Novo Nordisk's commitment to helping people with diabetes. Anyone with diabetes who meets the eligibility requirements for the Patient Assistance Program (PAP) can receive NovoLog®, or any other Novo Nordisk product free of charge as long as they stay eligible. aFormulary data are provided by Fingertip Formulary® and are current as of January 2015. Because formularies do change and many health plans offer more than one formulary, please check directly with the health plan to confirm coverage. Continue reading >>
You Can Buy Insulin Without A Prescription, But Should You?
As anyone with diabetes can tell you, managing the disease with insulin usually means regular checkups at the doctor's office to fine-tune the dosage, monitor blood-sugar levels and check for complications. But here's a little known fact: Some forms of insulin can be bought without a prescription. Carmen Smith did that for six years when she didn't have health insurance and didn't have a primary care doctor. She bought her insulin without a prescription at Wal-Mart. "It's not like we go in our trench coat and a top hat, saying, 'Uh I need the insulin,' " says Smith, who lives in Cleveland. "The clerks usually don't know it's a big secret. They'll just go, 'Do we sell over-the-counter insulin?' " Once the pharmacist says yes, the clerk just goes to get it, Smith says. "And you purchase it and go about your business." But it's still a pretty uncommon purchase. Smith didn't learn from a doctor that she could buy insulin that way. In fact, many doctors don't know it's possible. When she no longer had insurance to help pay for doctors' appointments or medicine, Smith happened to ask at Wal-Mart if she could get vials of the medicine without a prescription. To figure out the dose, she just used the same amount a doctor had given her years before. It was a way to survive, she says, but no way to live. It was horrible when she didn't get the size of the dose or the timing quite right. "It's a quick high and then, it's a down," Smith says. "The down part is, you feel icky. You feel lifeless. You feel pain. And the cramps are so intense — till you can't walk, you can't sit, you can't stand." Smith says her guesswork put her in the emergency room a handful of times over the years. The availability of insulin over the counter presents a real conundrum. As Smith's experience shows Continue reading >>
Cheaper Insulin Is On The Way
With commentary by Alissa R. Segal , Pharm.D., RPh, CDE, CDTC, a Clinical Pharmacist at the Joslin Diabetes Center. Biosimilar insulin promises the same blood sugar control at a lower price, but is it as good as brand-name, and will you really save money? The first “biosimilar” insulin—made with a formula that copies an approved, name-brand insulin— is set for sale in the U.S. later this year. Now a new study in the journal Diabetes, Obesity & Metabolism says it works as well as the brand-name drug it’s based on. But as insulin costs skyrocket, experts say the “copycat” insulin Basaglar, made by Eli Lilly, may give consumers a small price break—and note that switching may require extra attention to blood sugar levels at first. The U.S. Food and Drug Administration (FDA) approved Basaglar in late December; it is expected to hit pharmacies in late 2016. The drug has the same basic protein structure as the popular, long-acting insulin glargine Lantus and is made by a similar process. For regulatory reasons, the FDA calls copycat insulin a “follow-on” product, but the drugs are widely described as biosimilars by diabetes experts here and in other countries where they’ve already gained approval or are on sale. The new study, conducted by Eli Lilly, followed 452 type 1s and 299 type 2s who had been using Lantus and switched to Basaglar. After six months, their blood-sugar levels were the same on the new drug. According to the U.S. Food and Drug Adminstration (FDA), possible side effects with this insulin are in line with side effect risks with any type of insulin and include hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, fluid retention and weight gain. 1 Experts contacted by EndocrineWeb say con Continue reading >>
How To Get Insulin At A Cheaper Price
Insulin can be expensive. If you’re one of the 6 million Americans with diabetes relying on this main-stay treatment, you could be paying out-of-pocket costs anywhere from $120 to $400 per month, according to a 2015 New England Journal of Medicine commentary. Drugs such as Lantus (insulin glargine) and Levemir (insulin detemir) have seen significant cost increases, according to a recent trend report by pharmacy benefit manager Express Scripts. One reason for the high prices is the lack of generic options for insulin. So for now, you’re stuck having to search around to find affordable options. Where do you shop for more affordable insulin? For some people though, high drug costs can mean making difficult financial choices. Our national polls show people might cut back on groceries and paying bills to pay for their medications. To minimize your costs, consider these options: Prescription Assistance Programs If you don’t have health insurance or are without drug coverage, look into applying for a patient assistance program (PAP). Through the nonprofit NeedyMeds, you can find some programs that offer free or low-cost insulin as long as you meet the eligibility requirements. Those are usually based on your insurance status, income, and diagnosis. You might also qualify for a diagnosis-specific program that can help you save on syringes, pumps, and other diabetes supplies. Pharmacists are also a great resource and can help you find a PAP that meets your financial needs. Switch Drugs Another way to save is by asking your doctor whether there’s a lower-priced insulin that’s right for you. While “long-acting” is a more popular type of insulin, it's also more expensive, but that doesn’t necessarily mean it works better. “It’s mostly a marketing ploy,” says M Continue reading >>
Insulin Is Too Expensive For Many Of My Patients. It Doesn't Have To Be.
At age 15, I developed an unquenchable thirst and frequent urination, and lost 20 pounds. I had developed Type 1 diabetes, an autoimmune disease that destroyed my body's ability to produce insulin. Without insulin, I would have eventually developed a condition called diabetic ketoacidosis, which is lethal without (and even sometimes with) treatment. Years later, I'm a practicing endocrinologist. I could never have imagined back when I first started taking insulin that one day I would have so many patients who could not afford the medication because of skyrocketing prices. When the drug was discovered in 1921, the original patent was sold to the University of Toronto for $1 so that no one else could patent it and "secure a profitable monopoly." Numerous improvements later, insulin is produced by a three-company oligopoly. When the first of the newer insulin "analogs," Humalog, hit the market in 1996, it sold for $21 a vial. Today, vials of analog insulins, including Humalog, sell for about $300. Patients with Type 1 diabetes typically require two or three vials of insulin per month, but patients who are more resistant to insulin, such as those with Type 2 diabetes, may require six or more. A recent paper in the Journal of the American Medical Association found that insulin nearly tripled in cost from 2002 to 2013. A lawsuit filed in January accuses insulin companies of price collusion for allegedly raising prices repeatedly and in lockstep to match their competitors. Prices have gotten so bad that the American Diabetes Association recently launched an online petition at MakeInsulinAffordable.org, which has been signed by more than 248,000 people. Because insulin is so expensive, some people take less than their prescribed dose, causing higher blood sugars, which may lead Continue reading >>
Insulin: Newer Vs. Cheaper
As we discussed last week here at Diabetes Flashpoints, the cost of medications for people with diabetes has been rising steadily for years. Part of the reason for this escalation is that newer, more expensive drugs — mostly for Type 2 diabetes — have entered the market in recent years. But newer drugs alone don’t explain the increase in drug spending. Certain drugs that have been on the market for years — particularly insulin — are getting significantly more expensive. A recent opinion article in the Journal of the American Medical Association outlines just how much more expensive certain insulins have become. Between 2000 and 2010, for example, the price of a vial of insulin lispro (brand name Humalog) rose from $35 to $234 — a 585% increase — and the price of a vial of human insulin (Humulin, Novolin, and others) rose from $20 to $131, a 555% increase. By comparison, the national inflation rate during this period was 33.7%. The most expensive insulins, both now and 15 years ago, are known as insulin analogs. These insulins resemble natural insulin produced by the pancreas, but have had their molecular structure altered to achieve a desired effect — such as a very rapid or a long, sustained course of action in the body. The authors of the JAMA article argue that in many cases, doctors should prescribe older, less expensive varieties of insulin to lower the cost for their patients. A Medscape Medical News article about the opinion piece summarizes the arguments made by the authors, both of whom are doctors at the University of Washington School of Medicine in Seattle. The authors note that even as prices rose dramatically, the use of insulin analogs increased from 19% of the insulin market in 2000 to 96% of the market in 2010. This increase, they argue, Continue reading >>
Why Isn't There Any Cheap, Generic Insulin?
HealthDay Reporter WEDNESDAY, March 18, 2015 (HealthDay News) -- New research examines why people with diabetes who depend on injections of lifesaving insulin still have no cheaper generic options to treat their disease. "Surprisingly, this issue has not been talked about, so we're asking the question: Why is there no generic insulin?" said senior study author Dr. Kevin Riggs, a research fellow at Johns Hopkins University School of Medicine in Baltimore. In their report, published March 19 in the New England Journal of Medicine, Riggs and his colleague Dr. Jeremy Greene describe how the unique development of insulin allowed pharmaceutical companies to continually improve the medication while extending patents for decades. Generic drugs cannot be made until a patent on a brand-name drug expires. One expert pointed out the possible repercussions. "This is a big issue. Some patients simply cannot afford to pay for the insulin that keeps their blood sugar down, even people who have health insurance," explained Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City. He added that if insulin prices remain out of reach for some, the health care system will end up paying more in hospitalizations and treatments for complications related to undertreated or untreated diabetes. The cost of insulin for someone who doesn't have insurance runs from $120 to $400 a month, the researchers noted. Insulin is a naturally occurring hormone that's necessary for the body to use the sugars found in foods as fuel for the cells in the body and brain. In people with type 1 diabetes, the body's immune system mistakenly attacks the insulin-producing cells (called beta cells) in the pancreas. This destroys their ability to make enough insulin to surv Continue reading >>
Why Is Insulin So Expensive In The U.s.?
Dr. Jeremy Greene sees a lot of patients with diabetes that's out of control. In fact, he says, sometimes their blood sugar is "so high that you can't even record the number on their glucometer." Greene, a professor of medicine and history of medicine at Johns Hopkins University, started asking patients at his clinic in Baltimore why they had so much trouble keeping their blood sugar stable. He was shocked by their answer: the high cost of insulin. Greene decided to call some local pharmacies, to ask about low-cost options. He was told no such options existed. "Only then did I realize there is no such thing as generic insulin in the United States in the year 2015," he says. Greene wondered why that was the case. Why was a medicine more than 90 years old so expensive? He started looking into the history of insulin, and has published a paper about his findings in this week's issue of the New England Journal of Medicine. The story of insulin, it turns out, starts back in the late 1800s. That's when scientists discovered a link between diabetes and damaged cells in the pancreas — cells that produce insulin. In the early 1920s, researchers in Toronto extracted insulin from cattle pancreases and gave it to people who had diabetes, as part of a clinical trial. The first patient was a 14-year-old boy, who made a dramatic recovery. Most others recovered as well. Soon, insulin from pigs and cattle was being produced and sold on a massive scale around the world. But for some, the early forms of the medicine weren't ideal. Many people required multiple injections every day, and some developed minor allergic reactions. Over the next few decades, scientists figured out how to produce higher-quality insulin, Greene says. They made the drug purer, so recipients had fewer bad reaction 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 >>
Verify: Insulin Cheaper In Canada
LOCAL NBC Nightly News reports that the price of insulin, which is used to treat Diabetes, has shot up more than 1,000 percent in the U.S. in the past 20 years. 2 On Your Side was able to confirm and verify that the injectable form of insulin in a pre-loaded pen is actually much, much less expensive in Canada than the U.S. Fort Erie, Canada - NBC Nightly News reports that the price of insulin, which is used to treat Diabetes, has shot up more than 1,000 percent in the U.S. in the past 20 years. In fact, it's estimated the U.S. now spends more than $322 billion dollars each year to treat the disease. It has reached the point where some families are now taking desperate measures to get the vital medication their children and loved ones need to survive. That includes turning to the black market as some parents rely on secret online groups to swap and trade the insulin that their insurance covers so that they can obtain the insulin for their kids. Back in February, a similar situation unfolded with another drug many people depend on for epileptic seizures. A Two On Your Side investigation with Reporter Steve Brown found that people here could get epipens much cheaper and legally at pharmacies in Canada. 2 On Your Side was able to confirm and verify that the same is true for insulin. We determined that the injectable form of insulin in a pre-loaded pen is actually much, much less expensive in Canada then in the U.S. That's crucial for some people with diabetes who need the insulin to control blood sugar levels And considering that about eleven percent of Western New York residents are diabetic, according to a local doctor at UBMD Internal Medicine, it's especially important. At the Remedy's RX drug store in Fort Erie, Ontario, Canadian pharmacist Gerard Longval says diabetic Continue reading >>
The Cost Of Fast Acting Insulin, Are There Cheaper Alternatives?
As diabetics, we are all well aware of fast acting insulin and the vital role it plays when it comes to keeping us alive and upright, but for those newly diagnosed diabetics (type 1 and type 2), Insulin is secreted by the beta cells in the islets of Langerhans in the pancreas, a small organ between the stomach and liver. This hormone regulates the sugar levels in the human body. When the pancreas stops secreting insulin, it results in hyperglycemia which is a common and lethal symptom of diabetes. There are several rapid acting insulin brands, and as a type 1 diabetic, I am extremely reliant upon fast acting insulin, Novolog in particular. When discussing a topic over on The Organic Diabetic Facebook page, we got onto the subject of all the negative side effects associated with insulin and blood sugar regulation. So for all you newly diagnosed type 1’s, lets take a peek at some of the most dangerous side effects associated with fast acting insulin. Also, what drives the cost of insulin and are there programs to help defer the costs? Lets take a closer look! Diabetes And Insulin: Less common, but potentially more serious, is generalized allergy to fast acting insulin, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient (preservative to keep insulin potent). Fast Acting And Hyperglycemia: Hyperglycemia, diabetic ketoacidosis, or diabetic coma may develop if the patient takes less fast acting insulin than needed to control blood glucose levels. This could be due to insul Continue reading >>
A Cheaper Version Of The Lifesaving Diabetes Medication Just Launched In The Us
A Type 1 diabetes patient holds up bottles of insulin.Reuters/Lucy Nicholson A new form of insulin just hit American markets. It's called Basaglar, and it is 15% less than the list price of Lantus and Toujeo, two long-acting insulins made by Sanofi Aventis, 21% less than the list price of Levemir, and 28% less than Tresiba, two long-acting insulins made by Novo Nordisk. Basaglar was approved in December 2015, but had to wait a year before launching on Thursday. A spokeswoman for Eli Lilly, the company that makes Basaglar and other insulins, told Business Insider that the list price for a pack of 5 pens is $316.85 — that's before any discounts, or factoring in what insurance might cover. It is part of a group of medications called "follow-on biologics" and together, they are expected to save the US billions of dollars over the next decade. Why there's no generic form of insulin For people living with Type 1 diabetes and some who live with Type 2, injections of insulin — a hormone that helps people absorb and process the sugar in food — are a necessary part of daily life. And insulin, in one form or another, has been around since the 1920s. But because it's made of living cells, it’s what doctors call a biologic product, and it's more complicated and difficult to manufacture than the medicines most often produced generically. That's why Basaglar isn't considered a generic, it's called a "follow-on biologic." Others taking this approach have gotten approved as biosimilars, and like Basaglar have come in at a slight discount — roughly 15% — off the list price of the original drug. To become a follow-on biologic, Basaglar had to show that its version of the drug was "sufficiently similar to Lantus to scientifically justify reliance," and the drug had to be tested Continue reading >>
