More than 7Â millionÂ Americans are insulin dependent. And recent findings show that 1-in-4 Americans areÂ rationingÂ 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 herÂ 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 whatâs taking place at a grass-roots level all over the country.
Meet Angela Lautner, pictured above, the founder of a new movement taking insulin affordability battle head-on called, KOI#insulin4all.
The organizationâs 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 byÂ T1International,Â 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.
âNo human can survive without insulin,â Lautner tells dLife, âwith 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 â just to afford insulin.â
AsÂ far as access to technology such as insulin pumps, Lautner says none of that even matters when one canât afford the insulin that goes into the pump.
âOutside 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,â she says.
TheÂ turning point for Lautner was in 2017 when her insurance company removed the insulin that was best suited for her body from coverage.
âIt was also at the same time that several types of ârepeal and replaceâ laws were being considered with threats to coverage of those of us with pre-existing conditions,â 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.
âItâs out of control,â says John Kennedy, the leader of the #insulin4all movement in Ohio, âitâs way too expensive for no reason other than corporate profit,â he says adamantly in a phone interview with dLife.
Kennedy, who was the Democratic candidate running to be Ohioâs 76th District state representative in the last election, says any objective person can look at the numbers and draw the same conclusion.
âThis is a pretty straightforward issue,â Kennedy says, who has had type 1 diabetes over the last 25 years, âinsulin is a necessity for us, and without it, we all die.â
Kennedy has seen the price of his medication go from $40 per vial in 20 years ago to $300. âWhy is that?â he questions, âwhen the medication hasnât changed over the last 9 decades.â
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.
âWhen 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 canât afford their life-saving medication â thereâs universal agreement on that âitâs a non-partisan issue,â 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 recentÂ reportÂ 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.
âThey have created the possibility for Lantus to be patent-protected and free from market competition for 37 years,âÂ 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.
âThe 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,â she says.
âWe 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.â âAngela Lautner, Founder #KOIinsulin4all.
BothÂ 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.
âWe know there are other players involved in this, and itâs not just the pharmaceutical companies that are responsible for the overall cost,â Kennedy says, âitâs not just big pharma weâre going after, itâs 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.â
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.
Some pharma company executives even acknowledge the fact that something is wrong with the system.
âNo one should have to pay full retail price for insulin or other healthcare services,â Gregory Kueterman, director of corporate communications at Eli Lilly and Company tells dLife.
âUnfortunately, the reimbursement system â particularly high-deductible insurance plans â have forced some people into that position,â he says. âLilly wants everyone who needs insulin to access it at a reasonable cost,â he says.
Thatâs whyÂ 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.
âAlready, we are helping up to 10,000 people each month access insulin at significantly lower costs,â Kueterman says, âWe 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.â
Kueterman says a live operator who will be happy to help Monday-Friday, 9 am to 8 pm EST.
âApproximately 90 percent of people who use insulin have insurance plans that keep their costs at $50 or less per month,â Kueterman says, âBut we need to find better options for the 10 percent who pay significantly more, which is why we opened our Solution Center.â
As far as patents for Lillyâs insulin,Â 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,Â 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 Walmartâs ReliOn brand.
âTo put this into perspective, what we refer to as Walmart insulin is a formulation introduced in 1950 and one used in 1982,â saysÂ Lautner. âTo 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.â
The way that rising costs are impacting Americans with type 1 diabetes,Â Lautner says her group strongly recommends that people work directly with their endocrinologist before attempting a switch.
âIf 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,â 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.
Still, Lautner believes the âBig Threeâ 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.
âThey will not become benevolent overnight, she says, âso changes in law and policy are the strongest way to get answers and real action,â 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.
âThatâs why we are going to work aggressively in our state in 2019 to push through a drug transparency bill much along the lines of whatâs already been done in Nevada and tried, with some success, in the state of Colorado,â 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.
âThe U.S. Congress will then say, âlook whatâs happening in these states: they have introduced drug pricing legislation, and this is how it could work at the Federal level,’â Kennedy says, who believes the states are great testing grounds for trying out public policy.
âThere are diabetics everywhere and other states need to follow suit,â Kennedy emphasizes, âwe need a movement across the country.â
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 ofÂ 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.
WhatÂ Lautner says she still does not yet have answers to is what they intend to do with the above-mentioned practice of patent extensions.
Physicians in the U.S. also seeing cost as an issue in their clinics.
âThe financial burden of diabetes is always an issue,â says Dr. Steven Chessler, an associate professor at the division of endocrinology, department of medicine at the University of California, Irvine.
âI donât see the dollars and cents, but thereâs always a question what insurance will cover whether itâs the medication or devices.â
Chessler says thereâs 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.
âSome have very good insurance, but yes, itâs a problem for those that donât 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,â Chessler says.
Physicians using integrative medicine, an approach that does not use pharmaceuticals to treat type 2 diabetes also see