More than 7 million Americans are insulin dependent. And recent findings show that 1-in-4 Americans are rationing their insulin, a dangerous way to stretch out their medication, due to cost.
For a drug which was first created to save lives over a 100 years ago, this is unacceptable to many people across the U.S. who are struggling to pay for this basic need.
Several deaths have been reported due to people rationing their insulin, including Alec Smith, a 26-year old who was found dead in his apartment last year.
His mother, Nicole Smith-Holt is now an advocate and has managed to bring the insulin pricing issue to the top of the radar, thanks to her powerful meeting with Eli Lilly executives early last year.
She, along with thousands of other patient advocates, continue to demand accountability through action. And action is exactly what’s taking place at a grass-roots level all over the country.
Maddie McGarvey- NPR
Image Credit: Morgan McGarvey with NPR.
Meet Angela Lautner, pictured above, the founder of a new movement taking insulin affordability battle head-on called, KOI#insulin4all.
The organization’s main goal is to push forward legislation in Kentucky, Ohio, and Indiana that requires transparency from insulin manufacturers in regards to the cost of production and the profits made from a vial of insulin.
KOI is the first U.S. chapter supported by T1International, a global organization based in England, which supports local communities by giving them the tools they need to stand up for their rights so that insulin and diabetes supplies can be accessible to all.
“No human can survive without insulin,” Lautner tells dLife, “with the rising price of insulin, many are forced to choose drastic measures such as rationing their insulin, choosing between paying monthly bills or paying for their insulin, moving in with family and friends while in between jobs and without insurance — just to afford insulin.”
As far as access to technology such as insulin pumps, Lautner says none of that even matters when one can’t afford the insulin that goes into the pump.
“Outside of the price of insulin, no one should be forced to wrangle with providers and insurance companies to have all that they need to manage their type 1 diabetes safely within their lifestyle and career needs,” she says.
The turning point for Lautner was in 2017 when her insurance company removed the insulin that was best suited for her body from coverage.
“It was also at the same time that several types of ‘repeal and replace’ laws were being considered with threats to coverage of those of us with pre-existing conditions,” she explains.
It was at that time Lautner found T1International and they supported her to set up her chapter.
Now, many chapters being set up all over the country including Colorado, Iowa, Illinois, Indiana, Kentucky, Minnesota, New York, Ohio, Oklahoma, and Pennsylvania.
The Reason Behind The Price Hikes
“It’s out of control,” says John Kennedy, the leader of the #insulinforall movement in Ohio, “it’s way too expensive for no reason other than corporate profit,” he says adamantly in a phone interview with dLife.
Kennedy, who was the Democratic candidate running to be Ohio’s 76th District state representative in the last election, says any objective person can look at the numbers and draw the same conclusion.
“This is a pretty straightforward issue,” Kennedy says, who has had type 1 diabetes over the last 25 years, “insulin is a necessity for us, and without it, we all die.”
Kennedy has seen the price of his medication go from $40 per vial in 20 years ago to $300. “Why is that?” he questions, “when the medication hasn’t changed over the last 9 decades.”
Though Kennedy lost the election in a highly Republican area, as he campaigned, he noticed how many heads turned as he talked about insulin and prescription drug affordability whether they were Republican or Democrat.
“When you start talking about healthcare, especially about life-saving insulin, you connect with people and people agree that no one should have to die because they can’t afford their life-saving medication — there’s universal agreement on that –it’s a non-partisan issue,” he says.
As far as reasons for the price hikes Lautner has several hypothesizes: First, she says insulin makers have used every loophole available to them to over-extend their patents.
She points out a recent report from the Initiative for Medicines, Access, and Knowledge (I-MAK), which found that insulin maker, Sanofi Aventis has filed 74 patent applications for Lantus, with 95% of those patents filed for after Lantus was already on the market.
“They have created the possibility for Lantus to be patent-protected and free from market competition for 37 years,” Lautner says.
Second, she attributes the problem to the fact that over 90% of the global insulin market is controlled by only three companies, who she says continue to fight hard to ensure that competition never enters the market.
Third, Lautner says insulin makers continue to raise the price because there is nothing to stop them.
“The U.S. healthcare system is set up in a way that enables these companies to continue to blame pharmacy benefit managers (PBMs) and others so they do not have to address the fact that they are making billions in profit while people with diabetes are dying,” she says.
“We still do not have clear answers as to why prices climbed so high that people are dying across America, but we know that pharma companies are at the top of the chain setting the price and deciding to price gouge patients, and that must change.” —Angela Lautner, Founder #KOIinsulin4all.
Both Lautner and Kennedy believe there must be legislation to hold every insulin maker accountable so that they answer to why costs continue to climb on a drug that was first used to treat diabetes in 1922.
This legislation, they say, should include transparency to show consumers the costs to the company to produce a vial of insulin, profits made from the insulin, and required explanations for any further cost increases.
“We know there are other players involved in this, and it’s not just the pharmaceutical companies that are responsible for the overall cost,” Kennedy says, “it’s not just big pharma we’re going after, it’s the pharmacy benefit managers, the insurance companies, and all the other feeder entities along the supply chain that are benefiting from the absorbent costs of insulin as well.”
While Lautner and Kennedy believe the system is truly broken and they do acknowledge that it is complex, they are, however, holding the pharmaceutical companies accountable first because they are at the top of the chain setting the list price.
What Do The Pharma Companies Have To Say?
Some pharma company executives even acknowledge the fact that something is wrong with the system.
“No one should have to pay full retail price for insulin or other healthcare services,” Gregory Kueterman, director of corporate communications at Eli Lilly and Company tells dLife.
“Unfortunately, the reimbursement system – particularly high-deductible insurance plans – have forced some people into that position,” he says. “Lilly wants everyone who needs insulin to access it at a reasonable cost,” he says.
That’s why Kueterman says in August, Lilly opened the Lilly Diabetes Solution Center, which provides point-of-sale discounts, insulin donations to approximately 150 free clinics around the U.S., and insulin for people who have immediate needs.
“Already, we are helping up to 10,000 people each month access insulin at significantly lower costs,” Kueterman says, “We want to help as many people as possible, so we encourage anyone using Lilly insulin to dial the helpline at (833) 808-1234 and learn what option best fits their circumstance.”
Kueterman says a live operator who will be happy to help Monday-Friday, 9 am to 8 pm EST.
“Approximately 90 percent of people who use insulin have insurance plans that keep their costs at $50 or less per month,” Kueterman says, “But we need to find better options for the 10 percent who pay significantly more, which is why we opened our Solution Center.”
As far as patents for Lilly’s insulin, Kueterman says the patents for Humalog and Humulin have been expired for years (the exception being Humalog U200, which launched in 2015), and he says there is nothing stopping other manufacturers from producing and distributing insulin.
On December 7th, KOI#insulin4all advocate, Sarah Ferguson, represented the group at a meeting of the Kentucky Diabetes Network, a network of diabetes healthcare professionals, advocates, and industry representatives in Kentucky.
At that meeting, Novo Nordisk representative Will Hancock challenged statistics on escalating insulin prices by stating that Novo Nordisk offers a $25 version of their much older insulin under Walmart’s ReliOn brand.
“To put this into perspective, what we refer to as Walmart insulin is a formulation introduced in 1950 and one used in 1982,” says Lautner. “To argue that the solution to overpriced analog insulin is for a person with diabetes to resort to using insulins that are respectively 68 and 36 years old is nonsense.”
The way that rising costs are impacting Americans with type 1 diabetes, Lautner says her group strongly recommends that people work directly with their endocrinologist before attempting a switch.
“If my life was on the line and $25 Walmart insulin was my only option, I would absolutely use it, but only under direction from my physician,” she says.
These insulins cannot be dosed in the same way as analog insulins. R and NPH insulins would also be a challenge for many people in professional fields where they cannot eat meals at the same times, every day.
John Kennedy, leader of #insulin4all in Ohio, ran 146 miles in Sept. to raise awareness about the rising cost of insulin.
Pushing Forward At The State Level
Still, Lautner believes the “Big Three” insulin makers are not going to voluntarily lower the price of insulin or be transparent when it comes to how the list price is set.
“They will not become benevolent overnight, she says, “so changes in law and policy are the strongest way to get answers and real action,” she says.
Lautner and Kennedy believe that if enough states take up this issue, it will force the attention of Congress to start to move bills that have been going nowhere for a few years.
“That’s why we are going to work aggressively in our state in 2019 to push through a drug transparency bill much along the lines of what’s already been done in Nevada and tried, with some success, in the state of Colorado,” Kennedy says.
Kennedy is hopeful that once one state moves forward with legislation, there will be momentum, and other states will take note of that and follow.
“The U.S. Congress will then say, ‘look what’s happening in these states: they have introduced drug pricing legislation, and this is how it could work at the Federal level,’” Kennedy says, who believes the states are great testing grounds for trying out public policy.
“There are diabetics everywhere and other states need to follow suit,” Kennedy emphasizes, “we need a movement across the country.”
And the momentum is slowly gaining.
The relentless voices of people across America in meetings with legislators and taking the issue to local and national media has gotten the attention of FDA Commissioner Scott Gottlieb who announced new guidance stemming from the Affordable Care Act with regard to how insulin is regulated as biologics.
The new guidance would also eliminate the 12-year exclusivity period.
What Lautner says she still does not yet have answers to is what they intend to do with the above-mentioned practice of patent extensions.
Is The Problem Exclusive To The U.S.?
Physicians in the U.S. also seeing cost as an issue in their clinics.
“The financial burden of diabetes is always an issue,” says Dr. Steven Chessler, an associate professor at the division of endocrinology, department of medicine at the University of California, Irvine.
“I don’t see the dollars and cents, but there’s always a question what insurance will cover whether it’s the medication or devices.”
Chessler says there’s a lot of paperwork and going back and forth in his clinic to figure out which medication is covered and which is not. He says some medications are often too expensive for patients which frequently complicates care.
“Some have very good insurance, but yes, it’s a problem for those that don’t have good insurance when it comes to what kinds of medication or devices they can get, and which brands that will be covered at the best costs,” Chessler says.
Physicians using integrative medicine, an approach that does not use pharmaceuticals to treat type 2 diabetes also see the issue.
“Patients could take drugs that are covered by insurance, but my patients choose not to,” says Dr. Rajsree Nampudripad, who has seen her patients have dramatic results by changing their diet and taking high-quality supplements instead.
“I do see the medication costs going up really high, and I know patients on insulin who are getting the medication from overseas because it’s cheaper,” she says.
With Medicare coverage going down, Nampudripad indicates the prices of prescription drugs are “just skyrocketing.”
“People are getting smarter,” Nampudripad says, “they’re getting drugs from other countries like Canada and India because it’s less expensive.”
Lautner says citizens in developed countries around the world are paying what we should all be paying for a vial of insulin because their countries regulate the price of insulin in various ways.
“They simply don’t allow the practice of price-gouging of insulin necessary to keep their citizens alive,” she says.
Lautner was recently on a business trip to Winnipeg in Canada, where she was able to purchase a vial of Humalog insulin at a Costco pharmacy, without a prescription, for $21 USD.
“I didn’t have to make a phone call to my insurance company from the pharmacy while in tears pleading for my life,” she says. “I didn’t have to fill out any paperwork showing how much money I did nor did not make. I didn’t have to call Eli Lilly to beg for help. I got a vial of insulin for hundreds of dollars cheaper. This is the way that it should be for everyone.”
Lautner and Kennedy are hopeful for change to come in the U.S. but there’s a lot of work to be done.
“I will play my part, by leading insulin for all in Ohio, but it’s going to take the effort of a lot of other people on the ground,” Kennedy says. “It’s going to be about regular folks who are fed up and won’t take this anymore.”
How To Get Involved
KOI#insulin4all invites people who are affected by the insulin cost crisis to email and call their elected officials.
T1International has an editable Open Letter to elected officials that anyone can download to share brief facts and their own personal story.
“We also hope that more people will also ask for meetings with their representatives to continue to put the face of the insulin price crisis – people who must inject insulin to survive – in front of their legislators,” Lautner says.
You can find a list of current state chapters for #insulin4all to get involved locally or get information on how to start your own chapter here.
Image credit: Featured image, KOI#insulin4all at Eli Lilly demonstration earlier this year. Provided by T1International.