Review of TempraMed VIVI Cap 1: Reusable Insulin Cooler Cap

The TempraMed VIVI Cap 1 is a reusable insulin cap cooler that promises to keep your insulin safe in extreme weather – protecting it from both hot and cold. Your insulin won’t overheat, and it won’t freeze. This is a great tool for the hot summer months or the dead of the winter. Wouldn’t you like to stop worrying about your insulin and just live in the moment?

What Does It Do?

This device offers supercharged insulation for your insulin pen.

The VIVI Cap 1 is scientifically proven to keep your insulin at room temperature, which allows you to spend time in extreme weather conditions without worrying about your insulin going bad. With a built-in temperature sensor and a temperature indicator, you can rest assured that your insulin will stay cool and safe.

VIVI Cap 1 is a simple solution that is easy to use and requires no maintenance. Just discard the cap that comes with your regular insulin pen, and slide the pen into the VIVI Cap 1. It will click into place, and you’re ready to take it along as you would normally. It doesn’t require any re-charging, no water, no ice – you’re good to go! When you’re done with your pen, just slide a new one into the cap.

How Can I Get VIVI Cap 1 and How Much Does it Cost?

You can purchase TempaMed’s VIVI Insulin Cap Cooler directly off their website. You can also make use of your FSA/HSA when purchasing this product.

VIVI Cap 1 costs $95 dollars and comes with a 30-day money-back guarantee if you are not pleased. It also comes with a 3-year warranty.

The company graciously offered our readers a 15% off each purchase discount code: DDAILY

The VIVI cap is compatible with many different insulin pens:

Pre-Filled Pens

  • FlexPen
  • NovoLog | NovoLog Mix | Levemir | Victoza |  NovoRapid | Insulin Aspart | Novolin R
  • FlexTouch
  • NovoLog |  NovoRapid | Tresiba (Degludec)  | Fiasp | Levemir U-100 & U-200 | Saxenda | Ryzodeg | Xultophy | Ozempic
  • KwikPen
  • Humalog | Humalog U-100 & U-200 | Humalog Jr | Humalog Mix |  Basaglar | Humulin Mix | Humulin | Humalog R U-500 | Lyumjev U-100 & U-200 | Insulin Lispro U-100
  • Solostar
  • Apidra | Lantus | Admelog | Soliqua

Refillable Pens

  • Eli Lilly
  • Luxura | Luxura HD | Ergo II | Savvio
  • Novo Nordisk
  • NovoPen 4 | NovoPen 5 | NovoPen Echo
  • Sanofi
  • ClickSTAR
  • Medtronic / Companion Medical
  • InPen

My Review

I think VIVI Cap 1 is a great product for anyone using pens for multiple daily injections. I’ve tried other insulin insulation products, but most require ice packs, water, batteries, or cords, all minor annoyances that I’d strongly prefer to do without. This product is extremely lightweight and can easily fit into a small purse or pocket, no problem. It was easy to set up and didn’t add any fuss.

Sometimes my blood sugar is erratic, and when I troubleshoot I realize that my insulin has lost effectiveness due to extreme temperature exposure. This product can help avoid that issue and save you money and a headache as well! I highly recommend giving this product a try!

Source: diabetesdaily.com

Insulin at 100, Part 3: Insulin’s Uncertain Future

This content originally appeared on diaTribe. Republished with permission.

This is Part 3 of James S. Hirsch’s exploration of the riveting history of insulin, on the occasion of its 100th birthday.

Part 1: The Discovery

Part 2: Failed Promises, Bold Breakthroughs

Insulin’s Uncertain Future

Insulin

Image source: Emily Ye, Diabetes Daily

As further refinements in insulin occurred, the insulin narrative should have become even more powerful – that insulin not only saves people, but in reaching new pharmacological heights, it is allowing patients to live healthier, better, and more productive lives. These should be insulin’s glory days – as well as days of unprecedented commercial opportunity. According to the International Diabetes Federation, in 2019, the global population of people with diabetes had increased a staggering 63 percent in just nine years – to 463 million patients.

Insulin sales should be booming, with a new generation of Elizabeth Evans Hughes and Eva Saxls to tell the story. In fact, insulin sales are declining, and insulin has no spokespeople. Reasons vary for these developments, but one fact is undeniable: insulin has lost its halo.

Insulin is still essential for any person with type 1 diabetes, though even with type 1 patients, insulin is sometimes under-prescribed as doctors fear getting sued over a severe hypoglycemic incident. The belief is that patients are responsible for high blood sugars, doctors for low blood sugars.

Where insulin has lost its appeal is with type 2 patients, which has driven the diabetes epidemic in the U.S and abroad. According to the CDC, from 2000 to 2018, America’s diabetes population surged 185 percent, from 12 million to 34.2 million, and an estimated 90 percent to 95 percent of that cohort has type 2. (The global percentage is similar.) These patients have long had options other than insulin – metformin, introduced in 1995, remains the ADA’s recommended first-line agent. But as a progressive disease, type 2 diabetes, in most cases, will eventually require a more intensive glucose-lowering therapy. Nothing achieves that objective better than insulin, but insulin is delayed or spurned entirely by many type 2 patients.

Some concerns are longstanding; namely, that insulin can lead to weight gain because patients now retain their nutrients. Some type 2 patients wrongly associate insulin with personal failure surrounding diet or exercise, so they want to avoid the perceived stigma of insulin. Some people just don’t like injections. Meanwhile, other patients associate insulin with the medication that an ailing patient takes shortly before they die: insulin as a precursor to death. Some clinicians who care for Hispanic patients refer to insulin pens as las plumas to avoid using a word that carries so much baggage.

What’s striking is how dramatically the cultural narrative has changed, from insulin the miracle drug to insulin the medical curse. And where are the commercials, the movies, the documentaries, and the splashy publicity campaigns about the wonders of insulin? They don’t exist.

The greatest impact on insulin use in type 2 diabetes has been the emergence of a dozen new classes of diabetic drugs. These include incretin-based therapies known as GLP-1 agonists and DPP-4 inhibitors (introduced in the 2000s) as well as SGLT-2 inhibitors (introduced in 2014). diaTribe has covered these therapies extensively, and their brands are all over TV: Trulicity, Jardiance, Invokana, and more. They all seem to have funky names, and like insulin, they can all lower blood sugars but – depending on which one is used – some have other potential advantages, such as weight loss. (Some have possible disadvantages as well, including nausea.)

The expectations for these drugs were always high, but what no one predicted was that GLP-1 agonists and SGLT-2 inhibitors have been shown to reduce the risk of both heart and kidney disease – findings that are a boon to type 2 patients, who are at higher risk of these diseases. These findings, however, were completely accidental to the original mission of these therapies.

Insulin, the miracle drug, has been eclipsed by drugs that are even more miraculous!

Consider Eli Lilly, whose Humalog is the market-leading insulin in the United States. In 2020, Humalog sales fell 7 percent, to $2.6 billion, while Trulicity, its GLP-1 agonist, saw its sales increase by 23 percent, to $5 billion.

That’s consistent with the global insulin market. Worldwide insulin sales in 2020 declined by 4 percent, to $19.4 billion, marking the first time since 2012 that global insulin sales fell below $20 billion.

It’s quite stunning. Amid a global diabetes epidemic, and with the purity, stability, and quality of insulin better than ever, insulin sales are falling. (Pricing pressures from insurers and government payers have also taken a revenue toll.) In 2019, Sanofi announced that it was going to discontinue its research into diabetes, even though its Lantus insulin had been a blockbuster for years. More lucrative opportunities now lay elsewhere.

Falling sales may not be the insulin companies’ biggest problem. Public scorn is. Though the insulins kept getting better, the prices kept rising, forcing many patients to ration their supplies, seek cheaper alternatives in Canada or Mexico, or settle for inferior insulins. Some patients have died for lack of insulin. According to a 2019 study from the nonprofit Health Care Cost Institute, the cost of insulin nearly doubled for type 1 patients in the United States between 2012 and 2016 – they paid, on average, $5,705 a year for insulin in 2016, compared to $2,864 in 2012.

Many patients are outraged and have used social media to rally support – one trending hashtag was #makeinsulinaffordable. Patient advocates have traveled to Eli Lilly’s headquarters to protest. In March of this year, nine Congressional Democrats demanded that the Federal Trade Commission investigate insulin price collusion among Eli Lilly, Novo Nordisk, and Sanofi, asserting they “are using their stranglehold on the market to drive up costs.” The letter notes that as many as one in four Americans who need insulin cannot afford it, and at least 13 Americans have died in recent years because of insulin rationing.

The criticism has been unsparing. In April 2019, in a hearing for the U.S. House of Representatives on insulin affordability, Democrats and Republicans alike pilloried the insulin executives. At one point, Rep. Jan Schakowsky (D-Illinois) said to them, “I don’t know how you people sleep at night.”

Insulin is hardly the only drug whose price has soared, but as the Washington Post noted last year, insulin is “a natural poster child of pharmaceutical greed.”

In response, the insulin companies have adopted payment assistance programs to help financially strapped consumers. They also blame the middlemen in the system – the PBMs, or the Pharmaceutical Benefit Managers – for high insulin prices, who in turn blame the insulin companies, and everyone blames the insurers, who point the finger at the companies and the PBMs.

Drug pricing in America is so convoluted it’s impossible for any patient to accurately apportion blame, but the history of insulin explains in part why the companies have come under such attack. When Banting made his discovery, he sold the patent to the University of Toronto for $1. He said that insulin was a gift to humankind and should be made available to anyone who needs it. Insulin was always profitable for Eli Lilly and the few other companies who made it, and critics have complained that the companies found ways to protect their patents by making incremental improvements in the drug.

But for years, those complaints were easily dismissed. The companies were revered for their ability to mass produce – and improve – a lifesaving drug that symbolized the pinnacle of scientific discovery while doing so at prices that were affordable.

When prices became unaffordable – and regardless of blame – the companies were seen as betraying the very spirit in which insulin was discovered and produced, and their fall from grace has few equivalents in corporate history.

Is the criticism fair?

Hard to say, but even the companies would acknowledge that they’ve squandered much good will. Personally, I’m the last person to bash the insulin companies – they’ve kept me and members of family alive for quite some time. Collectively, my brother, my son, and I have been taking insulin for 117 years, so I feel more regret than anger: regret that at least one insulin executive didn’t stand up and say loudly and clearly:

“Insulin is a public good. No one who needs it will be without it. And we will make it easy for you.”

Insulin

Image source: Emily Ye, Diabetes Daily

Whatever that would cost in dollars would be made up for in good will – and such a public commitment would honor the many anonymous men, women, and children, before 1921 and after, who gave their lives to this disease.

The next chapter for insulin? It will almost certainly include continued improvements. Both Eli Lilly and Novo Nordisk are trying to develop a once-a-week basal insulin to replace the current once-a-day options – that would be a major advance is reducing the hassle factor in care. Research also continues on a glucose-sensitive insulin, in which the insulin would only take effect when your blood sugar rises. That would be a breakthrough, but investigators have spent decades trying to make it work.

Since its discovery, the ultimate goal of insulin has been to make it disappear, as that would mean diabetes has been cured. It turns out that insulin therapy may indeed disappear someday, even if no cure is found. Since its discovery, the ultimate goal of insulin has been to make it disappear, as that would mean diabetes has been cured. It turns out that insulin therapy may indeed disappear someday, even if no cure is found.

Stem-cell therapy has long held promise in diabetes – specifically, making insulin-producing beta cells from stem cells, which the body would either tolerate on its own (perhaps by encapsulating the cells) or through immunosuppressant drugs. Progress has been halting but is now evident. Douglas Melton began his research in this area in 1991, and in 2014, he reported that his lab was able to turn human stem cells into functional pancreatic beta cells. The company that Melton created for the effort was acquired by Vertex Pharmaceuticals, and earlier this year, Vertex announced that it had received approval to begin a clinical trial on a “stem-cell derived, fully differentiated pancreatic islet cell therapy” to treat type 1 diabetes. Another company, ViaCyte, also announced this year that it will begin phase 2 of a clinical trial using encapsulated cells in hopes that they will mature into insulin-secreting beta cells.

It may take 10 to 15 years, but leaders in the field are cautiously optimistic that a cell-based therapy will someday provide a better option than insulin.

Diabetes would survive, but the therapy once touted as its cure would be dead.

Because I have a soft spot for happy endings – and because so much of own life has been intertwined with insulin – I have my own vision for insulin’s last hurrah.

A group of researchers in Europe are conducting a clinical trial to prevent type 1 diabetes. Called the Global Platform for the Prevention of Autoimmune Diabetes, the initiative began in 2015, and researchers are testing newborns who are at risk of developing type 1 to see if prevention is possible.

And what treatment are they using?

Oral insulin.

Like the discovery of insulin itself, this effort is a longshot, but if it works, insulin will have eradicated diabetes – a fitting coda for a medical miracle.

I want to acknowledge the following people who helped me with this article: Dr. Mark Atkinson, Dr. David Harlan, Dr. Irl Hirsch, Dr. David Nathan, Dr. Jay Skyler, and Dr. Bernard Zinman. Some material in this article came from my book, “Cheating Destiny: Living with Diabetes.”

About James

James S. Hirsch, a former reporter for The New York Times and The Wall Street Journal, is a best-selling author who has written 10 nonfiction books. They include biographies of Willie Mays and Rubin “Hurricane” Carter; an investigation into the Tulsa race riot of 1921; and an examination of our diabetes epidemic. Hirsch has an undergraduate degree from the University of Missouri School of Journalism and a graduate degree from the LBJ School of Public Policy at the University of Texas. He lives in the Boston area with his wife, Sheryl, and they have two children, Amanda and Garrett. Jim has worked as a senior editor and columnist for diaTribe since 2006.

Source: diabetesdaily.com

Insulin at 100, Part 2: Failed Promises, Bold Breakthroughs

This content originally appeared on diaTribe. Republished with permission.

By James S. Hirsch

Insulin

Image source: diaTribe

The discovery of insulin in 1921 was heralded as the cure for diabetes. The reality was different.

Insulin, to be sure, could temporarily lower blood sugars to near-normal ranges, but it could also cause hypoglycemia – blood sugars that are too low – that could lead to shakiness and confusion or, in extreme cases, seizures, loss of consciousness, or death. Insulin was a daily, self-administered drug, but if used incorrectly, it could kill a patient just as well as it could save a patient. No self-administered therapy, before or since, has quite those same attributes.

What’s more, insulin’s therapeutic powers were overestimated. Yes, insulin lowered blood sugars, but maintaining near-normal levels was still very difficult – and elevated blood glucose over time was still dangerous. As a result, by the middle of the 1930s, patients who were taking insulin began developing serious complications caused by elevated glucose levels, including damage to the eyes, kidneys, nerves, and heart. Insulin hadn’t cured anything but had turned diabetes from a deadly condition into a chronic condition, and a perilous one at that. At the dawn of the insulin age and for many decades thereafter, even those who understood the importance of maintaining near-normal blood sugars did not have the tools to do so. Blood sugar levels were measured by proxy through urine tests, in which samples had to be boiled for three minutes. Simpler methods were developed by the 1940s, but home glucose monitoring was not available until the late 1970s.

Until then, patients – unaware of their blood sugar levels – gave themselves insulin doses flying blind.

But few people outside the diabetes world knew about the daily rigors and risks of the disease – not only because it affected a relatively small percentage of people but also because the insulin narrative was too powerful.

Diabetes, after all, had been cured or at least resolved. That’s what all the pictures showed. That’s what the headlines blared. And that’s what the ads promoted.

Eli Lilly’s ads, for example, initially touted insulin as “An Epoch in the History of Medicine” and later featured a beautiful bride on her wedding day, kissing her beaming father, with the tagline, “Our favorite picture of insulin.”

Even that picture paled in comparison to the astonishing newspaper and magazine stories about insulin, and not just those about Elizabeth Evans Hughes. Insulin was a redemptive tale about science and survival.

Eva and Victor Saxl were Czech immigrants who fled to Shanghai during World War II. There, Eva was diagnosed with diabetes, and when her insulin supplies ran short, Victor, a textile engineer, found a book that described how to make insulin and, using the animal organs from a nearby slaughterhouse, brewed up enough insulin for his wife to survive. After the war, they immigrated to the United States, and when their story was discovered, they soon found themselves on numerous radio and television shows, including Edward R. Murrow’s, and a movie was also produced – about a husband’s devotion to his wife, expressed through the salvation of insulin.

Other life-saving medical breakthroughs occurred – antibiotics in the 1940s, the polio vaccine in the 1950s – and these would treat more people than insulin. But the unique circumstances of insulin’s discovery, with the young, untested scientists finding the potion that would bring children back from the brink of death, was too dramatic to ignore. In 1988, that story was the subject of a television movie on Masterpiece Theater called “Glory Enough for All,” based on Michael Bliss’s definitive book, “The Discovery of Insulin.”

I watched the movie on PBS when it was released, and it featured the brawling Toronto researchers – Banting and Collip literally came to blows over control of the experiments. But ultimately, the movie was about the triumph of medical science in saving dying children, and among the researchers, there was “glory enough for all.”

And then the movie ended.

There was nothing about living with diabetes – about the wildly fluctuating blood sugars, about the relentless demands, about the injections and the doctor visits and the complications, about the dietary restrictions, about the stigma and the isolation and the limitations of insulin.

“Glory Enough for All” was introduced by Alistair Cooke. An American-born Brit with a silver tongue, Cooke was enthralled not only by insulin’s inspirational story but also by the phrase “islets of Langerhans,” used to describe the island of pancreatic cells discovered by Paul Langerhans. “Islets of Langerhans” just rolled off Alistair Cooke’s tongue. To him, insulin was not just a miracle. It was poetry.

The lyrical beauty of insulin was lost on patients. Many of them, in fact, were frustrated that their own stories weren’t being heard. The parents of young patients were frustrated as well.

In 1970, a professional singer in Philadelphia, Lee Ducat, had a 10-year-old boy with type 1 diabetes, and she was miffed by the breezy disregard of his doctor, who told her that “insulin was the cure.” Ducat knew that wasn’t true, so with several other parents, she formed the first chapter of the Juvenile Diabetes Foundation (which is now the JDRF). Other parents soon opened chapters in New York, Washington, New Jersey, and Miami, and their mission was to educate the public about the stark challenges of diabetes in hopes of raising money and finding a cure.

They had no use for the American Diabetes Association, which was founded in 1940 and for many years was little more than a social club and referral service for physicians. As far as the parents were concerned, the ADA was complicit in perpetuating the jaunty insulin narrative that had hurt the cause for decades. Unless the truth about diabetes was known, how could lawmakers, regulators, philanthropists, and journalists – not to mention clinicians – do what had to be done to improve the lives of people with diabetes?

That question was driven home when the JDF chapter in Miami bought a full-page newspaper ad in 1972 to publicize its cause. The ad featured a little boy in a crib holding a glass syringe, and it described the many complications that could arise from diabetes, including blindness and amputations. The headline read, “The Quiet Killer.”

On the day the ad appeared, Marge Kleiman, whose son has type 1, was working in the JDF office, and the phone rang.

“I’m Charles Best,” the caller said, “and I discovered insulin.”

Now retired, Best had become an icon who, after Fred Banting died in 1941, carried the mantle for the Nobel-winning team that had discovered insulin. Best had been praised by the pope, the queen of England, and other heads of state, and he had given the keynote address at the ADA’s first meeting and later served as its president. He happened to be in Miami on the day the JDF ad appeared, and he was outraged.

“What kind of propaganda are you using?” he screamed. “You’re frightening people! This is not the way it is!”

Kleiman knew better. “Dr. Best, what you did was wonderful,” she said. “It allowed people to live longer. But we’re not trying to frighten people. If you tell the truth, maybe they can avoid these complications. Please don’t tell us to keep quiet.”

The JDRF, now a massive international organization focused primarily on type 1,  has continued to tell the truth about diabetes – and fund research – ever since, but changing the insulin narrative was not going to be easy.

Patients could at least take solace that the insulins kept getting better. The first extended-action insulins were introduced in 1936 and continued with widely used NPH insulin (1946) and the Lente insulins (1951). But the real improvement came in the 1970s, spurred by concerns about actual insulin supply. Meat consumption was declining, and slaughterhouses were cutting production, while the number of people with diabetes had been rising steadily (in 1976, there were about 5 million Americans with the disease). At some point, insulin demand could outstrip the animal-based supply.

As described in the book Invisible Frontiers: The Race to Synthesize a Human Gene, by Stephen S. Hall and James D. Watson, the specter of an insulin shortage triggered a race to develop genetically engineered insulin using recombinant DNA technology. Investigators succeeded by inserting the insulin gene into bacteria, which produced insulin that was chemically identical to its naturally produced counterpart.

The first human insulins, Humulin (made by Eli Lilly) and Novolin (made by Novo Nordisk), were introduced in the 1980s. Whether they were superior to animal-based insulins is a matter of debate, but they alleviated fears about an impending global insulin shortage.

Moreover, researchers soon discovered that changing the order of two amino acids in the human insulin molecule created a faster-acting formulation, and that led to the introduction of Humalog (1996) and Novolog (1999). Known as “insulin analogs” because they are more analogous to the body’s natural release of insulin, they were considered clear advancements. Another huge leap came with long-lasting basal insulin analogs, specifically Lantus (by Sanofi in 2000) and Levemir (by Novo Nordisk in 2005). These insulins keep blood sugar levels consistent during periods of fasting and, typically taken once a day, replicate the insulin release of a healthy pancreas. They were immensely popular and also used by many type 2 patients – Lantus was a $5 billion a year drug by 2011.

The improved insulins changed how patients cared for themselves, as the new formulations led to “basal-bolus” therapy – a 24-hour insulin complemented by a mealtime insulin – and that became the standard of care for type 1 diabetes. (Insulin pumps use the same basal-bolus framework.)

A new era of diabetes care, thanks to these insulin breakthroughs, appeared to beckon.

Stay tuned for part three of this riveting story next week!

I want to acknowledge the following people who helped me with this article: Dr. Mark Atkinson, Dr. David Harlan, Dr. Irl Hirsch, Dr. David Nathan, Dr. Jay Skyler, and Dr. Bernard Zinman. Some material in this article came from my book, “Cheating Destiny: Living with Diabetes.”

About James

James S. Hirsch, a former reporter for The New York Times and The Wall Street Journal, is a best-selling author who has written 10 nonfiction books. They include biographies of Willie Mays and Rubin “Hurricane” Carter; an investigation into the Tulsa race riot of 1921; and an examination of our diabetes epidemic. Hirsch has an undergraduate degree from the University of Missouri School of Journalism and a graduate degree from the LBJ School of Public Policy at the University of Texas. He lives in the Boston area with his wife, Sheryl, and they have two children, Amanda and Garrett. Jim has worked as a senior editor and columnist for diaTribe since 2006.

Source: diabetesdaily.com

How to Explain Insulin Price Insanity in Just One Image. Or Several Images.

Insulin prices in the United States are insane. This isn’t exactly news—if you have insulin-treated diabetes, you surely already know it. And even those without a connection to diabetes should recognize that insulin affordability is one of the most talked-about healthcare topics in politics. It’s also the rare issue that finds widespread agreement across the political spectrum, at least with regard to the existence of the problem, if not the solution.

What’s less well-understood is exactly why insulin prices are so outrageously high. This one image may help you understand:

source: Drug Channels

Oh, what’s that? It didn’t explain everything?

Maybe one image wasn’t enough. Try this one. It’s a bit simpler:

Source: diabetespac.org

If you’re confused, well, that’s the point. It’s a total mess! But don’t worry, we’ll walk you through it.

These two images were bravely prepared by Dr. Adam Fein of Drug Channels and the Diabetes Patient Advocacy Coalition (DPAC), an influential nonprofit diabetes advocacy group. There are many other versions of this chart, and none of them is easy to understand.

The “insulin-payment journey” is a bizarre and complex path that is poorly understood by outsiders. A recent congressional investigation took two years to conclude, and relied on an immense volume of internal documents to tease out what the heck is going on.

The relationships are messy, but a couple of things are clear:

  • The amount of money that you fork over the pharmacy counter has essentially nothing to do with supply and demand.
  • The higher the price, the more everyone benefits. Everyone except for you.

The images above identify the many different players shoving their fingers into the pie. Here’s a look at who some of these different forces are, and how they conspire to push your insulin costs into the stratosphere.

The Drug Company

It’s probably safe to say that most people in the diabetes community tend to blame high insulin prices on the greed of the insulin manufacturers.

Just three companies—Lilly, Novo Nordisk, and Sanofi, each a multinational pharmaceutical giant—make 90% of the world’s insulin and 100% of the insulin approved for sale in the United States. It sure seems like the Big Three have locked down the market and can charge whatever the heck they want. Patients, especially those with type 1 diabetes, have little or no ability to shop around or reduce their reliance on the life-giving medication, and get stuck paying the price whatever it is.

Make no mistake—the insulin manufacturers have plenty to answer for. The Big Three engage in a variety of hijinks, such as “evergreening” patents and paying off (or suing) would-be makers of affordable biosimilars, to help keep their iron grip on the insulin market. The insulin makers tend to raise prices almost in lockstep. This image from Business Insider should cause outrage:

source: Business Insider

But it turns out that insulin manufacturers are by no means the only organizations pushing prices up. If you look at the first two images, you’ll see multiple other participants in the insulin-payment journey—insurance companies, pharmacies, pharmacy benefit managers and drug wholesalers—all of whom profit when insulin prices increase.

In a nutshell, everyone makes more money when prices go up, and patients have hardly anything that they can do about it.

The Pharmacy Benefit Manager

If there’s a second major villain in this story, it’s the pharmacy benefit managers (PBMs), perhaps the one source pushing insulin prices up even more forcefully than the insulin manufacturers.

The PBMs is a middleman that negotiates deals between the big pharmaceutical companies, health insurance companies, and pharmacies. And because PBMs determine which medications insurers will cover—deciding whether millions of patients will use this insulin or that one—they wield immense power. There’s another Big Three here: CVS Caremark, Express Scripts, and OptumRx combine to dominate the market.

PBMs like high prices because they take a cut out of every transaction, through administrative fees and insulin rebate programs. The higher the price, the higher the rebate, so PBMs are strongly motivated to choose higher-priced medications. The result is that insulin makers find themselves competing with each other to raise prices in order to offer higher rebates to PBMs. PBMs aggressively encourage this competition.

The size of rebates has increased “exponentially” in the last decade. For more detail on this ridiculous situation, check out this summary from Beyond Type 2.

The Insurer and the Wholesaler

Insurance companies also share some of the PBM’s bounty, as the PBM’s usually pass through a percentage of those big rebates. In theory, some of this value should get trickle down to individual patients in the form of reduced insurance premiums. In reality, it is still patients with chronic conditions like diabetes that bear the brunt of the system, especially those that can only afford to choose high-deductible plans.

There’s something similar going on with drug wholesalers, middlemen that purchase insulin directly from manufacturers and then sell it to pharmacies and other medical facilities.

Believe it or not, there’s yet another Big Three here—in 2018, just three businesses held over 95% of the American drug wholesale market—again facilitating the use of monopolistic practices. These powerful drug wholesalers can bully their suppliers and customers; the Senate report mentioned above reports that they use “aggressive disruption techniques” to secure favorable deals and boost their profits.

The Consumer

There’s a reason you come last: the consumer is an afterthought in this system. When insulin manufacturers set the list prices of their medications, they think an awful lot about how that price will impact their relationships with PBMs and drug wholesalers, and insurance companies, and somewhat less about the number that eventually hits the patient. After all, you have virtually no ability to “vote with your wallet”. Whether you had to pay $30 or $300, the manufacturer long ago made its profit.

Bottom Line

There’s a lot of blame to go around. Insulin prices are determined by a closed system of warped incentives, full of greedy middlemen that hike up the price with no discernible benefit to patients. It’s a vicious cycle in which higher prices make more money for everyone except the patient.

The inefficiencies and absurdities that drive up insulin prices are at work in many other ways throughout our byzantine healthcare system. Insulin is particularly plagued by these problems because there are no generic insulins available and because demand is inelastic.

You can help advocate for change, big or small. New laws in several states have capped insulin prices, and many similar grassroots efforts are underway throughout the nation. You can also advocate for yourself, your loved ones, and even your employees on a smaller scale: check out DPAC’s Affordable Insulin Project, which connects people with diabetes to patient assistance programs, and helps those with employer-sponsored insurance get the most out of their plans.

 

Source: diabetesdaily.com

Why #insulin4all Advocates Targeted Beyond Type 1

Beyond Type 1, the diabetes nonprofit, found itself in hot water recently after the organization sent a letter stating its apparent opposition to LD673, a proposed bill for an insulin safety net program in Maine. The Maine bill is modeled after Minnesota’s popular Alec Smith Insulin Affordability Act, and guarantees that people with diabetes can access inexpensive insulin in an emergency.

The letter stated that LD673 would “create not only administrative burdens to the Maine government and pharmacies in the state, but also unintended additional out-of-pocket expenses to people living with diabetes.” The organization seemed to argue that its own GetInsulin.org program, a partnership with the major insulin manufacturers, rendered further legislation “duplicative” and unnecessary. 

Some diabetes advocates were outraged at Beyond Type 1’s stance, and accused the nonprofit of favoring the big pharmaceutical companies over people with diabetes.

Late last week, the organization appeared to modify its stance with a new letter, this one explicitly supporting Maine’s new bill. Was it all just a misunderstanding, or did rowdy online activism cause Beyond Type 1 to change its tune?

LD673

Alec Smith, the Minnesota bill’s namesake, died of diabetic ketoacidosis (DKA) in 2017, at the age of 26. At the time, he had recently aged out of his parents’ health insurance plan, and the cost of his insulin had skyrocketed to about $1,300 a month, around half of his total earnings. 

Smith’s mother believes that he died because he could not afford to pay for the insulin that he needed to live. She has become a noted insulin activist, and helped turn his death into a major rallying cry for people protesting the nation’s outrageously high insulin prices.

Minnesota signed the Alec Smith Insulin Affordability Act in April 2020, to widespread acclaim in the diabetes community. 

The new bill in Maine, named An Act To Create the Insulin Safety Net Program, would similarly aim to provide cheap, emergency insulin to those with an urgent need. The emergency insulin would carry a maximum cost of $35 for one month’s supply. The bill also mandates standards for the insulin manufacturers’s otherwise voluntary patient assistance programs (PAPs).

The Letter

In the letter that would cause an uproar, Beyond Type 1 never explicitly stated opposition to the new legislation. Whatever its intentions, however, it’s fair to say that the organization strongly implied its opposition.

The letter argues that state-level legislation such as LD673 is no longer necessary, because nationwide circumstances have changed dramatically since the Alec Smith act was passed in Minnesota:

At the time of its passage, GetInsulin.org did not exist, nor did the urgent need programs offered by the manufacturer. Additional insulin copay, cash pay, and patient assistance programs became available after the Minnesota bill became law that insulin manufacturers’ patient assistance programs (PAPs) are enough to fill the gap in assistance, and that the state statute is not needed. 

While insulin is still disgracefully expensive in most of the US, it is true that there are now more avenues for patients in need than there were only a few years ago. Part of that is due to the success of advocacy efforts, such as the one that coalesced around Alec Smith’s death, that turned insulin affordability into a political hot topic. The Covid-19 pandemic has also shined a spotlight on healthcare inequities, pushing the insulin manufacturers to expand their affordability programs in the last year.

The Beyond Type 1 letter also concentrates heavily on extolling the GetInsulin.org website. GetInsulin.org is essentially a user-friendly portal for the PAPs, aggregating the information from all three major insulin manufacturers in a single space. The website was created in partnership with the big pharmaceutical companies and is at least partly funded by them, facts that raise the suspicions of many people with diabetes, who are often inclined to see Big Pharma as an adversary rather than a partner. 

Are PAPs Really Good Enough?

Patient assistance programs can be valuable and even life-saving resources for people struggling to afford insulin. In some cases, PAPs may even provide more generous support for patients in an emergency than that mandated by the Alec Smith Act and Maine’s proposed law. And because these patient support programs have a reputation for being difficult to access and navigate, there’s no reason to doubt that GetInsulin.org provides a valuable public service.

For insulin affordability advocates, that’s not nearly good enough. The Shot, a weekly digest of insulin affordability news, put the case plainly:

While it’s true that patient assistance programs have become more robust … the programs, like Beyond Type 1’s GetInsulin.org, are voluntarily offered by the companies — often at no cost to them as PAPs are generally tax deductible. The Maine bill, like the Minnesota one that precedes it, locks the companies into providing assistance that patients would otherwise have no guarantee will exist tomorrow.

The PAPs are only reliable as long as the manufacturers don’t dilute them in the future (or disband them entirely). Given that many Americans now feel that insulin is practically a byword for medical exploitation, one can hardly be surprised when people with diabetes regard these programs with suspicion.

The big three – Eli Lilly, Novo Nordisk, and Sanofi – are reliable opponents of government efforts to cap insulin prices. And it would seem that PAPs owe their recent expansion more to the immense public relations pressure that manufacturers have lately had to endure than to any one corporation’s sense of generosity or public service.

Experts do agree that insulin manufacturers do not alone bear the blame for high insulin prices. Manufacturers, pharmacy benefit managers, insurance companies, and pharmacies all benefit from high insulin prices, and our byzantine healthcare market incentivizes all of them to push for price increases. Patients can’t easily vote with their wallets, and are therefore left with little recourse to effect meaningful change.

Insulin affordability continues to be a disaster in the diabetes community. Insulin rationing due to high cost is widespread in the United States, a situation that has probably only gotten worse since the dawn of the pandemic and the economic devastation that has followed. 

The upshot of Beyond Type 1’s argument to the Maine legislative committee was that the PAPs, as accessed through GetInsulin.org, are pretty much good enough. If this wasn’t what the organization intended to communicate with its letter, it made a bad mistake – and on an electric issue.

Online Reaction

Insulin access advocates discovered the letter online, and were outraged. Several accused the organization of corruption and betrayal:

Twitter personality Miss Diabetes illustrated a particularly devastating comic, featuring a caricature of Beyond Type 1 co-founder Nick Jonas:

source: @miss__diabetes

A little context: when Beyond Type 1 was founded in 2015, the organization avowed a principled refusal to accept money from the pharmaceutical industry. Things have changed. Now, according to their website, “Beyond Type 1 partners with pharmaceutical companies, including insulin manufacturers, when the organization finds that doing so furthers mission and impact.” 

This isn’t unusual. Most other prominent diabetes nonprofits also accept Big Pharma money (#insulin4all campaigner T1International is one notable exception). Nevertheless, Beyond Type 1’s position on this issue seemed unusual. The American Diabetes Association, for example, took the opposite stance and penned a letter in support of the bill. 

BT1’s About-Face

Despite the controversy, Beyond Type 1 kept silent for weeks, further disappointing some in the diabetes online community.

In response to a request for comment, a Beyond Type 1 spokesman told Diabetes Daily that the original letter was written not to oppose the legislation but “with the intent of providing information to legislators about existing programs and tools for people with diabetes who are insulin-dependent.” 

Additionally, the spokesman said, “Our team has followed the community response closely, and we know some have interpreted our testimony as one of opposition.”

Soon thereafter, the organization sent a new public letter to Maine’s legislative committee, claiming that it did support LD673, and that it always had:

We’re writing today to clarify and state unambiguously that Beyond Type 1 does support the passage of this legislation. This legislation will help individuals in Maine who may be struggling under urgent or ongoing circumstances to access affordable insulin due to high list prices. Our hope is that people with diabetes who need financial assistance to pay for this life-essential drug may find it through existing programs or potentially those created through Maine’s efforts.

After news of the new letter broke, Hilary Koch, a Maine resident and a Policy Manager for T1International, declared victory on Twitter – but also qualified her celebration with a reminder of how much work needs to be done to achieve universal affordable insulin access.

One can only guess as to the effect that Beyond Type 1’s clarification might have the bill’s chances. Lawmakers may well have already been inclined to support the bill. Just last year, Maine passed more sweeping legislation capping insulin costs for those with state-regulated insurance.

 

Source: diabetesdaily.com

How Insulin Rebates Work

This content originally appeared on Beyond Type 1. Republished with permission.

By Lala Jackson

A major contributor to high insulin list prices that is often misunderstood – because it is designed to be complex and opaque – is the Pharmacy Benefit Manager (PBM) and rebate system. Rebates are a percentage of the list price of a medication, given by a drug manufacturer to a Pharmacy Benefit Manager (PBM), in order to be listed on the health insurance plan formulary or placed in a pharmacy.

Essentially, rebates function a bit like a “broker’s fee” of sorts and can account for 30-70% of the cost a person has to pay at the counter for insulin if they don’t have insurance, or if they are paying the full cost of insulin until they hit their insurance deductible. The PBM takes a portion of the rebate as their own profit, then gives the remainder to their client, which can be the federal government (Medicare), an employer’s health plan, or a standalone health insurer.

Insulin manufacturers choose to participate in this system that drives list prices up because it benefits their business – by giving PBMs a large cut of their profits, their products get placed on insurance formularies more often, leading to more sales. This system creates up to 70% of the current list price of insulin in the US, and it doesn’t have to be this way.

Rebates – They Don’t Mean What They Sound Like

The math is infuriating, but here’s the heavily-simplified basics of how rebates work – if you made a product for $5 and wanted to sell it, you may set the price at $10, to create a $5 profit. With that $5 profit, you can invest back in your company to create better products, pay yourself – whatever you want to do with your $5.

But let’s say you want your product to be in more places and available to more people. You might hire a middle person to place your product in new stores across the country, and they’ll charge a fee, which is reasonable.

When you begin, their fee is $1. So that you can keep your $5 profit, you raise your price to $11. Still reasonable. But over time, your middle person makes themselves indispensable and knows it. You’re making way more money because of how many products you’re able to sell, so you’re not about to drop your middle person.

And oh oops – you also signed a contract with your middle person to ensure you’ll always get your product placed in these nation-wide stores, so you’re locked in. And part of that contract was a promise that you won’t lower your price, since that would impact your middle-person’s profit.

And oh oops – your middle person also has contracts with your competitors, and the contracts signed with those competitors make it so that if your competitor gives the middle person a little bit more of their profits, your middle person won’t sell your product in certain stores for a year. You can fix this by raising your own price to give the middle person more profits, so you can kick your competitor out of a store the next year.

So now, your product costs $50. It’s the same product – you’ve never improved it. Your customers are receiving no more value than when the product costs just $10. Over time, you wanted to make more money from it, so your profit is now $10.

It’s still $5 to make your product.

You get $10 profit, doubled from your original earnings.

And your middle person? They’re making $35, 70% of the list price, off a product they don’t make or even touch.

But you’re definitely not going to get rid of your middle person, because they’re the reason you’re able to sell so many products and make the money that you do.

For a regular product like a water bottle, no worries, your customer will just go somewhere else.

But what if your product was water, and your customer needed it to survive?

The Role of Pharmacy Benefit Managers (PBMS)

PBMs are third-party intermediaries who negotiate prices and drug placements on insurance formularies between pharmaceutical companies and insurance companies. Sometimes they are standalone companies, other times they are attached to national pharmacies or insurance companies.

For their negotiating services, they take a share of the profits from prescriptions. This share is known as ‘rebates.’ They also profit from “administrative fees” for each unit of drug sold, which can be up to 5% of the list price.

Speculated about for some time but difficult to prove because of private contracts (fully legal through the US system, which is notoriously bad at regulating drug pricing) is the sheer amount of cash being collected by PBMs. Originally created to help get needed drugs to patients more efficiently, PBMs have unfortunately become a key agitator to high out-of-pocket drug costs.

From a January 2021 Senate Finance Committee report, we now definitively know that “…drug manufacturers increased insulin WAC [wholesale cost], in part to give them room to offer larger rebates to PBM and health insurers, all in the hopes that their product would receive preferred formulary placement. This pricing strategy translated into higher sales volumes and revenue for manufacturers.”

The big legislative stumbling block we now face is just how reliant on PBMs the US healthcare system has become. In a more simple system, a pharmaceutical manufacturer could provide their medications to a pharmacy for direct disbursement to patients who require them. But in a system with a shaky foundation to start with and many players in the space, across private and public entities, the water gets significantly muddied.

To keep PBMs happy, ensuring they negotiate the placement of each manufacturer’s insulin on insurance formularies, rebates for insulins have increased exponentially, particularly since 2013.

In July 2013, Sanofi offered rebates between 2% and 4% for preferred placement on a formulary. The same product in 2018 provided a 56% rebate. That’s more than half of the out-of-pocket cost of insulin being handed to companies that don’t make the insulin.

This is one example, but every single insulin manufacturer does this. As the report states, “What is clear is that the money that flows through PBMs is nothing short of enormous. As discussed throughout this report, rebates have grown at a rapid pace in the insulin market in recent years, which is not true in all therapeutic markets.”

The Bigger the PBM, the Greater the Power

The three largest PBMs – CVS Caremark, Express Scripts, and Optum Rx – wield significant power in the market commanding large rebates. Lilly documents show that they offered a 22% rebate to a small PBM, but offered Optum Rx a 68% rebate for the same products in order to get placement in Medicare’s Part D prescription plan. As noted in the report, this robust ability to negotiate has led to “…some PBMs securing rebates as high as 70% in recent years.”

Manufacturer contracts with PBMs, previously confidential but exposed by the Senate Finance Committee report, are written in percentages. This means that it is to the PBMs’ benefit to encourage list price increases, making their portion of payout larger.

PBMs actively encourage manufacturers to raise the list price so that they may receive more money, and use threats of removing insulins from insurance formularies as leverage. The bundling of multiple products (increasing one product’s rebate amount to get other products included) is also a tactic used in PBM and manufacturer negotiations, especially in exclusivity contracts.

“As Eli Lilly explained to its investors in 2019, failing to secure formulary placement can “lead to reduced usage of the drug for the relevant patient population due to coverage restrictions such as prior authorization in formulary exclusions, or due to reimbursement limitations which result in higher consumer out-of-pocket cost, such as non-preferred co-pay tiers, increased co-insurance levels, and higher deductibles.”

The Bottom Line

The US healthcare system is deeply broken, and insulin pricing is one of the clearest examples that an unregulated drug pricing system motivated by profit will always put cash flow over patient lives. PBMs and the rebate system exacerbate the problem, but every participant within the system is at blame. Each entity has chosen profit over people.

Significant rebate reform and an overhaul or removal of the PBM system could slash the list price of insulin by up to 70% and would impact not just insulin, but many medications and devices that are subject to the rebate system. Robust federal healthcare reform could create a system where drug prices could be negotiated on a federal level, and current proposals like rolling back prices to more reasonable levels could be a step.

A deeply broken system requires layered solutions. Without a full overhaul, we risk fixing the insulin pricing issue with a bandaid, while driving up prices and limiting access to other life sustaining medications and life changing technology.

Substantial healthcare policy change takes the voice of many, and individual advocates make a resounding and impactful difference. If you are looking to get involved with diabetes access advocacy, start here. Reach out and get to know your state’s congressional representatives in the House and Senate. Make sure they know your personal experience and how issues of healthcare, drug pricing, and access impact you.

Source: diabetesdaily.com

Can You Manage Diabetes Well Without Lots of Money?

If you live in a country like the United States, where the majority of health insurance is privatized and there is no strong social safety net, it can feel as though managing a chronic disease like diabetes requires nothing but lots of money. And it does. As of 2017, diabetes cost the United States a staggering $327 billion dollars per year on direct health care costs, and people with diabetes average 2.3x higher health care costs per year than people living without the disease.

Diabetes is also devastatingly expensive personally: the cost of insulin has risen over 1200% in the past few decades, with no change to the chemical formula. In 1996, when Eli Lilly’s Humalog was first released, the price for a vial of insulin was $21. In 2019, that same vial costs around $275. Studies show that 1 in 4 people ration insulin simply due to cost. Diabetes Daily recently conducted a survey study, with almost 2,000 participants, of which an overwhelming 44% reported  struggling to afford their insulin.

So where does this leave patients who don’t have tons of money to spend on insulin and supplies, or who don’t have adequate health insurance coverage for the technology to help prevent complications? Can you manage diabetes well without lots of money? The short answer is yes. The long answer is a bit more complicated.

Best Practices for Managing with Less

If you have insurance coverage, but are unable to afford a continuous glucose monitor (CGM) or insulin pump, it’s advisable to follow best practices for optimal diabetes management. According to the Mayo Clinic, one should test their blood sugar:

  • Upon waking
  • Before meals and snacks
  • Before and after exercise
  • Before bed
  • More often during illness
  • More often when traveling or changing a daily routine
  • More often if on a new medication

One study has even shown that following a lower carbohydrate diet can improve health outcomes, reduce complications, and cut down on medication costs for people living with diabetes.

The study goes on to say that, “…insulin dependent diabetics can expect to half or third their insulin requirements. Less insulin injected results in more predictable blood sugars and less hypoglycemia.” However, no patient should ever feel pressured to follow a low carbohydrate diet solely to control the cost of their medications. There can be more effective ways to manage the cost of medications and supplies.

Photo credit: Adobe Stock

No Matter What You Think, Get Coverage

People with diabetes need health insurance coverage. In the short term, this makes sense, as insulin and things like insulin pumps, continuous glucose monitors, syringes, and test strips are expensive. But it also makes sense long term as well. People with diabetes can face serious complications as they age: diabetes is the leading cause of adult blindness and amputations, and is a leading cause of stroke, kidney failure, heart disease and premature death in its sufferers. Having health insurance helps pay for things like surgery, preventive screenings, doctors’ appointments and follow-up care, and any additional medicine and needs that’s needed.

It may seem cheaper to forego coverage, but don’t. Check to see if you’re eligible for Medicaid in your state. If you are, this comprehensive coverage will help you access affordable medication, doctors’ visits, emergency and preventive care. If Medicaid is not an option, see if you qualify for a tax subsidy on the federal or your state’s health exchange. There, you can find a range of affordable options that will cover your diabetes care and (especially) insulin prescriptions.

Get Help Paying for Insulin

Even if you have health insurance coverage, the cost of your insulin may be prohibitively high. According to the CDC, between 2007 and 2017, the percentage of adults aged 18-64 enrolled in a high deductible health plan rose from 10.6% to 24.5%. These plans have a high dollar amount that consumers must meet before their plan kicks in to help pay for things like prescriptions or hospital stays. Some high deductible health plans have deductibles as high as $10,000. This means that someone with diabetes could potentially pay the full $275 a vial for their insulin, every time they fill their prescription, until they reach their $10,000 deductible. These types of plans are cheaper monthly (have lower premiums), but don’t offer great coverage.

If you need help paying for your insulin, you can get low cost insulin through these assistance programs:

  • Eli Lilly’s $35 Co-Pay Program: Launched in early April in response to the COVID-19 crisis, Eli Lilly is introducing their Lilly Insulin Value Program, which allows anyone with commercial insurance and anyone without insurance to fill their monthly prescriptions of insulin for $35.
  • Novo Nordisk: Novo Nordisk has recently launched a $99 program, where people needing insulin assistance can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens or any combination of insulins from Novo Nordisk Inc. for $99.
  • Sanofi: Launched in 2019, Sanofi’s program allows people living with diabetes in the United States to pay $99 for their Sanofi insulins (with a valid prescription), for up to 10 boxes of pens and/or 10 mL vials per month.
  • Medicare: Medicare recently unveiled a pilot program that would cap the cost of insulin. The Medicare Part D Senior Savings Model would cap insulin co-payments to $35 per month, starting in January 2021. Seniors must sign up for a plan that will qualify under the pilot during the open enrollment period, which is October 15 through December 7.
  • Buy a State-Regulated Health Plan: If you live in Colorado ($100 per prescription per month), Illinois ($100 per 30 day supply), Delaware ($100 per 30 day supply), New York ($100 per 30 day supply), Utah ($30 per 30 day supply), West Virginia ($100 per 30 day supply), Maine ($35 per 30 day supply), New Mexico ($25 per 30 day supply), Virginia ($50 per 30 day supply), Washington ($100 per 30 day supply), or New Hampshire ($30 per 30 day supply) and you buy a state-regulated health plan, you are eligible for a copayment cap on insulin (implementation dates pending, but Colorado was the first bill to be implemented and it went into effect January 1st, 2020).

Check the fine print of any health insurance plans on the federal or your state’s exchange to see if they are eligible for the copayment cap. More states are introducing legislation in 2021, so keep an eye out for a bill proposing some similar changes in your state!

Get Help Paying for Supplies

Several companies have launched affordability programs in response to the COVID-19 pandemic. A few new programs are:

  • Dexcom: Is offering up to two shipments of 90-days of Dexcom G6 Continuous Glucose Monitoring System supplies, with each shipment consisting of one transmitter and three boxes of three sensors for $45 per 90-day supply shipment. For existing customers only, if you qualify.
  • Omnipod: Is offering a six-month supply of products (60 pods) free of charge. The program is focused on current US customers who have lost jobs and health insurance as a result of the pandemic.
  • One Drop: This online subscription package charges the consumer a monthly fee, and you get access to cheaper test strips, online personal health coaching, and a mobile app to track your progress. If your health insurance doesn’t adequately cover test strips, this can be an affordable and effective way to go.
diabetes advocacy

Photo credit: T1International Instagram

Advocate for Change

If you see or are experiencing injustice, you should always try and advocate for change. This means writing letters to your elected officials, calling your members of Congress, petitioning your health insurer, testifying for bills that support better health care coverage, and raising your voice to improve policies that will benefit all people living with diabetes. Get involved in the diabetes online community on Facebook or Twitter. Sign up to become an advocate with T1International. Donate to your favorite diabetes charity who’s working to make things better.

Show up at your state capitol and talk to people about what it’s like to live with diabetes, how expensive it is, and how crucial good coverage and affordable medications really are. You can live a great life with diabetes, but coverage, laws, regulations, and policies can always be better. And things won’t improve until we have everyone at the table, advocating for change.

How are you able to manage well with less to spend? What policies or changes would you like to see in the US healthcare system that would make management easier for you? Share this post and your story, below!

Source: diabetesdaily.com

What to Do If You Need Insulin Right Now

This content originally appeared on Beyond Type 1. Republished with permission.

By Lala Jackson

What to Do If You Have No Insulin at All

Go to the emergency room. Under US law (The Emergency Medical Treatment and Active Labor Act), the emergency room cannot turn you down in a life-threatening emergency if you do not have insurance or the ability to pay.

If Emergency Room staff is telling you they cannot treat you, stay put. Be clear that you are in a life-threatening emergency because you have type 1 diabetes (T1D) but do not have insulin. Do not leave. Please note that urgent care centers are not required to abide by the same laws.

Once you are stabilized and before you leave the hospital, hospital staff is required to meet with you to make sure you understand that you are leaving the hospital of your own accord. At this time, let the hospital staff person know about any financial situation you are in. Some hospitals are aligned with charities that can help you pay. Other hospitals offer payment plans based on your situation. No matter your financial situation, know that your life is the most important thing.

What to Do If You Have Some Insulin, But Are About to Run Out

Utilize Kevin’s Law

If you have an existing prescription at your pharmacy, but have not been able to get ahold of your healthcare provider to renew the prescription, you may be able to take advantage of Kevin’s Law. Kevin’s Law was named for a man with T1D who passed away after not being able to access his insulin prescription over the New Year’s holiday. Under the law, pharmacists are able to provide an emergency refill of insulin in certain states, without the authorization of a physician to renew the prescription. Rules around the law vary from state to state and not all states have the law in place. Kevin’s Law only applies to those who have an existing prescription and, depending on where you live, your insurance may or may not cover the refill. Learn more about Kevin’s Law, including whether or not your state has it, here. Please note, your pharmacist may not know the law by name, or know that the law exists. If you are in a state with Kevin’s Law and working with a pharmacist who is unaware, stay put and ask to speak to someone else in the pharmacy.

Ask Your Physician for Samples

While this is not a long-term access option, your care provider may be able to provide you with a few vials/pens for free, and bringing your HCP into the access conversation means that they can help direct you to other options that might be available to you, like local community health centers with insulin available.

Utilize Patient Assistance Programs – Standard out of Pocket Cost $0

  • If you take Lilly insulin (Humalog, Basaglar) call the Lilly Diabetes Solutions Call Center Helpline at 1-833-808-1234
    for personalized assistance. You may be eligible for free insulin through LillyCares.
  • If you take Novo Nordisk insulin (Fiasp, NovoLog, NovoRapid, Levemir, Tresiba) and demonstrate immediate need or risk of rationing, you can receive a free, one-time, immediate supply of up to three vials or two packs of pens by calling 844-NOVO4ME (844-668-6463) or by visiting NovoCare.com
  • If you take Sanofi insulin (Admelog, Lantus, Toujeo): the Patient Connection Program provides Sanofi insulins to those who qualify, which is limited to those with no private insurance and who do not qualify for federal insurance programs and who are at or below 250% of the federal poverty level – with a few exceptions.

Utilize CoPay Cards – Standard out of Pocket Cost $35 – $99 per Month

Copay cards that reduce the out-of-pocket cost you pay at the pharmacy exist for most types of insulin. Some copay cards can be emailed to you within 24 hours. Currently, copay programs exist for:

  • Lilly, capping copays at $35 per month for those with no insurance or with commercial insurance
  • Novo Nordisk, capping copays at $99 for those with no insurance or with commercial insurance
  • Sanofi, capping copays at $99 for those without prescription medication insurance
  • Mannkind, capping copays at $15 for some of those with commercial insurance

Unfortunately, copay cards are typically not available for those insured through Medicaid or Medicare. Use the tool from the Partnership for Prescription Assistance to search in one place for discount programs and copay cards you qualify for here. Please be aware that you will need to search by brand name (i.e. Humalog, Novolog), not just “insulin.”

Get R & NPH Human Insulins – Standard out of Pocket Cost $25-$40 per Vial

R (Regular) and N (NPH) human insulins are available over-the-counter in 49 states and cost much less ($25-$40 per vial at Walmart) than analog insulins such Novolog, Humalog, Lantus, or Basaglar. They also work differently than analog insulins – they start working and peak at different times – but in an emergency situation can be a resource. Speak with the pharmacist or your healthcare provider if possible before changing your regimen and keep a very close eye on your blood sugar levels while using R & N insulin.

Research Available Biosimilar (Generic) Insulins

The biosimilar insulin market is changing rapidly as the FDA adopts new regulatory pathways to more efficiently approve interchangeable insulins that may be available for a lower price. Ask your healthcare provider for the most up-to-date options for you. A few options available are:

  • A generic version of Humalog — Insulin Lispro — is available at pharmacies in the U.S. for $137.35 per vial and $265.20 for a package of five KwikPens (50% the price of Humalog.) If you have a prescription for Humalog, you do not need an additional prescription for Lispro; your pharmacist will be able to substitute the cheaper option. Insulin Lispro is not currently covered by insurance.
  • Authorized generic versions of NovoLog and NovoLog Mix at 50% list price are stocked at the wholesaler level. People can order them at the pharmacy and they’ll be available for pick up in 1-3 business days

If you have enough insulin to last you a few days, but need to figure out where to get a more reliable, consistent supply, visit our Get Insulin page to find further resources.

Source: diabetesdaily.com

How Do We Afford Our Insulin During an Economic Crisis?

COVID-19 has caused widespread panic across the globe, and that has quickly become apparent given the recent bear stock market, which hasn’t been seen since the Great Recession over a decade ago. You may have seen your IRAs and 401ks plummet in recent weeks because investors are scared.

Some economists are predicting that the United States could even see up to a 30% unemployment rate, as layoffs sore from the mandatory closings of restaurants, bars, gyms, coffee shops, and retail stores across the nation, trying to prevent the spread of COVID-19, the disease that is caused by the novel coronavirus. You may have experienced a recent layoff or reduced hours as a direct result of COVID-19, and if you have, your health insurance may have taken a hit as well (or gone away altogether). So, how can we afford our insulin during an economic crisis? Here is our (hopefully!) helpful advice:

If You’ve Lost Your Job

File for unemployment insurance immediately. Most states require that you’ve lived/worked in the state in which you’re applying for benefits for at least six months to qualify, and you don’t qualify if you quit or were fired from your most recent job. These bi-weekly payments have a cap (depending on your income and the state in which you live), but can definitely help you in the short term until you’re able to find new employment. Congress recently passed the COVID Stimulus Package, which includes expanded unemployment benefits (extending by 13 weeks), and enhances said benefits for four months. The program has also been broadened to include freelancers, furloughed employees and gig workers, such as Uber and Lyft drivers.

Special Enrollment Period

It’s well-known that one must sign-up for health insurance during “open enrollment”, which is a time period, usually once a year, when individuals and employees of companies and organizations may make changes to or buy different health insurance plans. Under the Affordable Care Act, a change in your personal situation, such as getting married, having a child, or losing your health coverage (by way of losing your job) makes you eligible for a Special Enrollment Period, which allows you to enroll in health insurance outside of the typical open enrollment period.

In response to COVID, many Governors are creating SEPs (Special Enrollment Periods) to specifically address people’s concerns over having health insurance and affording their medication during the global pandemic. If you currently do not have health insurance (by choice), but are worried about affording your insulin, or are particularly concerned about contracting COVID19, you may be able to take advantage of a SEP in your state.

See If You Qualify for Medicaid

As of now, 36 states have expanded eligibility for their state Medicaid programs (to 138% FPL), which offer extremely affordable insulin and diabetes care. If you’re a low-wage worker whose employer doesn’t offer health insurance, and you can’t comfortably afford to buy a plan, see if you qualify for Medicaid. Many Governors are looking into expanding Medicaid even further during the national public health emergency.

Cash Relief is Coming

Congress recently passed a $2 trillion Coronavirus Stimulus Package that includes direct cash payments to all American taxpayers. Lawmakers agreed to provide $1200 in a direct (single time) payment to taxpayers making up to $75,000 per year, with $5 less for every $100 per year a person makes all the way up to $99,000. Families will receive an additional $500 per child, in an attempt to create a safety net for people whose jobs and businesses have been negatively affected during this public health turned economic crisis. This bump of cash will help millions of Americans, including people with diabetes, afford their medications easier in the short term while longer-term policy solutions are worked out to help everyone during this crisis.

If All Else Fails, Reach Out for Help

If you’re still struggling to afford your medication, you can reach out to your insulin manufacturer for help: Lilly Cares, NovoCare, and Sanofi Patient Connection can help get you free or discounted insulin when you’re in a desperate spot. Currently, insulin manufacturers are not anticipating any supply-chain issues as a result of COVID-19.

Additionally, the diabetes online community (on Facebook, Instagram and Twitter) is an amazing resource of dedicated activists and helpful hands who are always more than willing to help fellow people with diabetes in need. Reach out to your friends and family and let them know you’re struggling. Ask your doctor if they have any samples of insulin you can take from the clinic for free. Let your struggle be known, so people can help you. Do not suffer in silence.

Have you had issues affording your medications and/or insulin during this global pandemic turned economic crisis? What strategies have helped you? Share this post and comment below, we love to hear your stories and suggestions!

Source: diabetesdaily.com

Insulin Co-Payment Cap Bills

America has a unique problem: prescription drug prices are too expensive for many people. In 2018 alone, 1 in 5 Americans (or 37 million non-elderly adults) went without a prescription drug due to cost. One of the most egregious examples of the high cost of prescription drugs is the rising cost of insulin in the United States. There are over 34 million Americans with diabetes, and at least 8 million are dependent on insulin to live. The list price of insulin has nearly tripled since 2002 and the average price of the drug has increased by 64% since 2014 alone. Most tellingly, a pivotal Yale study recently reported that as many as 1 in 4 people with diabetes have rationed their insulin due to cost. So, what are lawmakers doing about the problem?

Insulin co-payment caps have become a wildly popular idea by state lawmakers to curb the price of insulin for some insured patients in their states. Notably, Colorado was the first state in the nation to pass such legislation, making national news in May 2019. The bill, which caps monthly co-payments (for some insured patients) at $100, went into effect on January 1, 2020.

The main bill sponsor, Representative Dylan Roberts, said, “Colorado is leading the way with this measure, but this is just a first step. We won’t stop until all the pharmaceutical companies and drug middlemen start taking more accountability and stop gouging patients with their high costs.”

Other states have followed suit. The Illinois Governor signed into law similar legislation this past January (although the law doesn’t take effect until January 1, 2021), and there are currently similar bills pending in 36 other states.

insulin sensitivity

The average cost of a vial of insulin in America is over $300. | Photo credit: Adobe Stock

This is great news for many people with diabetes. The average cost of a vial of insulin in America is over $300, and people with insulin-dependent diabetes often require multiple types and vials of insulin per month, which can drive up the price (to live!) into the thousands. Capping co-payments, or essentially “carving” out a $100 co-payment (especially for people on high-deductible health plans who are paying the full list price of insulin until they hit their deductible, which can sometimes be in the high-thousands) can save people thousands of dollars and will undoubtedly help save lives.

Some people may think this solves the insulin pricing crisis, but it doesn’t. These bills are a great start to bring attention to the exorbitant cost of prescription insulin, but there are many people who don’t qualify under these new laws. State legislatures only have jurisdiction over state-regulated health plans, and thus cannot determine pricing on ERISA plans, or health insurance plans that are fully or partially managed by the federal government, such as Medicare, Medicaid, or the Veteran’s Health Administration. Additionally, any large, private employer plans would not fall under the law. Most importantly, anyone who’s uninsured does not receive protection under this law, and must still pay the full list price of insulin at the pharmacy counter.

For states that have expanded Medicaid, this doesn’t pose as much of a problem, as more people are covered by some sort of insurance (Medicaid co-payments are usually set between $1-3). States with robust exchange programs also benefit more under these laws, as by definition these are state-regulated plans that are subject to the co-payment caps. But for people who don’t qualify for Medicaid, cannot afford a health exchange plan, and find themselves without insurance, they’re still stuck paying these outrageous prices, which is sometimes a matter of life or death.

And the problem isn’t going away. The Health Care Cost Institute reported that the price of insulin doubled in a span of four years, between 2012 and 2016. According to their report, the average price a patient with type 1 diabetes paid for insulin in 2012 was $2,864 but that doubled to $5,705 by 2016.

Why is the cost for a nearly 100-year-old drug continuing to rise? For one thing, there are no generic competitors, and only three companies manufacture the drug. Secondly, insulin products are protected under patent laws, which allow the manufacturer to sell a product unchallenged in the market before a generic can be introduced. Novo Nordisk, Eli Lily, and Sanofi, the three main insulin manufacturers, have continued to “tweak” their insulin products in order to extend their exclusivity rights and hold onto their patent longer, without facing competition from generics. In fact, Sanofi has filed lawsuits in the past against Merck and Mylan to prevent them from going to market with a generic version of Sanofi’s Lantus insulin. Additionally, our government (unlike most other countries in the world) does not negotiate drug pricing with pharmaceutical companies, and thus there are no regulations on how high pricing can be set.

This national crisis has even gotten the attention of current and former Presidential hopefuls: Mayor Pete Buttegieg, Senator Amy Klobuchar, Senator Elizabeth Warren, Senator Bernie Sanders, Tom Steyer, and even Vice President Joe Biden have all called out insulin specifically when talking about outrageous drug pricing.

Congress has also started paying closer attention, and H.R. 3, the Lower Drug Costs Now Act has been introduced that would allow for The Centers for Medicare & Medicaid Services to negotiate drug prices on certain drugs (including insulin) to lower the costs, among other measures. Co-Chairs of the Congressional Diabetes Caucus, U.S. Representative Diana Degette and Representative Tom Reed, have also introduced the Insulin Price Reduction Act, which, if enacted, would decrease the price of insulin nearly 75% for Americans, to costs equal to those in 2006. These are all great first steps to addressing American’s cries for help, and to help reduce the burden millions of people with diabetes are facing every day.

Any legislation will have its pros and cons, but people with diabetes suffering due to high drug pricing don’t have to suffer in silence any longer. Politicians are taking note and action, and one day I hope we can all declare the crisis solved.

Have you been negatively affected by the high price of insulin in the United States? Share this article and post your story in the comments below, we’d love to hear from you!

Source: diabetesdaily.com

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