Sure, the American Diabetes Association's huge annual conference held in San Francisco in early June was abuzz with the newest scientific discoveries and latest in technology and tools for diabetes care. But Access and Affordability was a major theme that hung in the air, if not formally on the program as much as it probably should have been.
ADA's President of Health Care & Education, Certified Diabetes Educator Gretchen Youssef, did address this in her keynote, encouraging everyone in attendance -- healthcare providers, industry folks and patient advocates alike -- to step up and call for improved patient access to both care and tools.
“For the person with diabetes, access is the foundation of optimal health, outcomes, quality of life, and affordable medical costs,” Youssef said, noting that it's been nearly impossible in the past couple years to read or watch the news without hearing about the staggering costs of insulin and impact on PWDs (people with diabetes).
“For the healthcare system and society, improved access will help to control the rising health impacts and cost burdens of diabetes," she said.
At a Monday evening forum hosted by TCOYD and DiaTribe, a discussion panel among experts meant to focus on cutting-edge diabetes developments and highlights from the ADA event repeatedly turned to access and affordability. One of the panelists even urged the ADA to consider making that a key theme of next year's 80th Scientific Sessions being held in Chicago.
Of course, it's TBD on what materializes for 2020. But the most recent 2019 ADA event was full of chatter about just how broken our healthcare system truly is, what an international embarrassment that is, and how the deepening disparities in healthcare across this country are hitting diabetes hard.
Netflix's 'Designated Survivor' Tackles Insulin Pricing
In a coincidental and ironic twist, Netflix released its third season of the TV series Designated Survivor on the first day of the conference on Friday, June 7, and the storyline of that first episode included high drug prices and insulin affordability. It featured an interview with D-Mom Nicole Smith-Holt, who lost her 26-year-old son Alec as a result of insulin rationing due to unaffordable pricing.
In this fictional storyline, the Administration is taking on a pharmaceutical company over the high price of drugs and insulin in particular. Political leaders actually threaten to order the FDA to force the company to lower the price of insulin through a real-life law provision in the little-known Patent and Trademark Law Amendments Act of 1980 (aka the Bayh-Doyle Act). This law is largely focused on fostering drug innovation, but it gives the federal agency the authority to break a drug patent when that particular product is “not available to the public on reasonable terms.”
In the Netflix show, the pharma exec balks, and in response they show a pre-recorded interview with #insulin4all advocate Nicole Smith-Holt tearfully talking about her son’s real-life death due to insulin pricing. She’s on the screen for just about a minute and criticizes the fictional company – clearly a stand-in for actual insulin manufacturers Eli Lilly, Novo Nordisk and Sanofi.
“I have to live the rest of my life without my son,” she says on screen. “A part of my soul is gone because the greedy people think it’s okay to randomly increase the price of life-saving medications to the point where they’re unaffordable for the people who need them to stay alive. It’s unfair, it’s unethical, and it’s unjust, and it needs to end.”
We quipped about Congressional hearings on insulin pricing earlier this year being worthy of binge-watching on HBO or Netflix, but we didn't really expect it to make an actual appearance coinciding with the ADA conference!
While the Netflix show wasn't tied to ADA in any way, it came up in multiple conversations over the five days of the conference. And it wasn't the only mention of the death of Alec Smith and advocacy of his mom Nicole at the event, as they came up in the "Making Insulin Affordable" session on day three.
Insulin Affordability Session at #ADA2019
This Sunday morning session attracted about 150 attendees. It was a lively discussion between panelists representing the Pharma industry's trade group, a health plan, a PBM (Pharmacy Benefit Manager), and a national advocacy organization. Unfortunately the discussion ended up rehashing the worn theme of complexity of the drug pricing system in America, followed by the usual finger-pointing regarding who's gaming the system most.
Honestly, this slide summed up the session pretty accurately:
Dr. Alvin Powers of Vanderbilt University Medical Center, who gave an overview on the supply chain behind insulin pricing, mentioned the death of Alec Smith in his opening remarks. He noted that 52% of privately insured patients' out-of-pocket expenses currently go toward medications at full list price, largely because of high deductibles -- that's gone up from 23% in 2012. These stats are starkly different from the numbers Pharma normally cites on the topic.
A big point was that every time the list price goes up, every player in the system makes more money. That makes it impossible to effect change without eliminating or revising the roots of the whole system directing revenue flow to the various players.
Dr. Aaron Kowalski, recently named CEO of JDRF, was part of this discussion and seemed like a sole voice of reason. He pointed out that in traveling the country these days, insulin pricing and high list price exposure is the Number One issue people mention to him as head of JDRF -- more even than the questions about cure research that used to be at the top of the list. Kowalski also noted how 1 in 4 people are rationing insulin the U.S., and how rates of hospitalization for DKA in this country increased by ~55% from 2009 to 2014, and one can only presume that's partly caused by insulin unaffordability and rationing.
"How do we stop this vicious cycle? This is completely unacceptable," Kowalski said, clearly frustrated following the presentations by other speakers that largely blamed each other. "This is not a hard discussion: People with diabetes need access to insulin. That we even have to discuss this pricing crisis issue is an indictment that our system is broken."
A list of very general possible solutions (often seen before) called on all the players to alter their methods. There were also slides promoting the ADA's own campaign for "Make Insulin Affordable" that launched in late 2016. They have gathered nearly 500,000 signatures on a petition that "calls upon all entities in the insulin supply chain, including manufacturers, wholesalers, PBMs, insurers and pharmacies to substantially increase transparency in pricing associated with delivery of insulin to the end user patient." The petition also calls for Congressional Hearings on the topic, which have now taken place, but without leading to much tangible change to date.
The many audience questions reflected Kowalski's frustration. One person asked how many healthcare providers in the room spend lots of their time dealing with insulin affordability and access-related issues, and it appeared that all hands went up.
Insulin Makers on Display
On the exhibit hall floor, it was tough (as always) to avoid seeing -- and feeling a bit unsettled about -- the large, flashy displays from the three big insulin manufacturers Lilly, Novo, and Sanofi. Some included wall-size displays promoting thier Patient Assistance Programs and Cost Savings Cards. Sanofi was also rolling out a new "Diabetes Your Type" campaign aimed at embracing the personalized needs of PWDs, as in "Your Diabetes May Vary." Meanwhile, Lilly's booth with plush carpeting led attendees up a staircase to view a virtual "Alcatraz" -- one of the sights of San Francisco. For anyone thinking about patients struggling to get the insulin they need for life, the prison analogy was not flattering.
Many attendees were overheard remarking that this stuff just felt very tone-deaf.
More than one HCP we spoke with, or overheard, remarked that maybe Congress-folk should have made a special trip to ADA's Exhibit Hall, to see the massive displays the insulin makers had there.
Notably, none of the big three insulin makers were part of the sole insulin affordability session that took place on Sunday. Instead, their interests were represented by a leader from the PhRMA trade group that represents the Pharma industry at large.
Novo Nordisk did host a small gathering of patient advocates to hear their perspectives on the issue of insulin affordability. Our own Amy Tenderich attended, along with Kelly Close of diaTribe and David Edelman of Diabetes Daily. The Novo folks asked the advocates to help them spread the word about their own NovoCare financial assistance programs, and to provide input on the topic that they could channel directly to their CEO Lars Sørensen. After the meeting, we at DiabetesMine sent them a list of testimonials from people suffering because they can't afford insulin, and asked for any assistance they could possibly provide in alleviating this crisis in America.
What Good Is Innovation Without Access?
There was certainly plenty of recognition of access barriers by presenters across the board; it felt like there was an asterisk attached to every mention of new technology or tools noting that, 'this is only useful if people can get it.'
For example, try discussing the future Eli Lilly Ultra-Rapid Lispri insulin (URLi) that's in late-stage clinical trials and was presented at this ADA 2019 event, without people in the room wondering just how affordable it will be to the masses who are already struggling to pay for their needed medications to live. The question also arose why many T2s who might need insulin but are scared of being stigmatized by their doctors as "failures" would want to turn to this newer insulin at all if they can't even afford it.
Research presented by the T1D Exchange showed PWDs are avoiding their doctors and CDEs because they just can't afford the visits. Gaps between visits ranged from 101 days to 135 days, despite international and ADA recommendations for T1D kids and adults to visit their clinicians every three to six months.
Dr. Daniel Drucker from Toronto pointed out that no matter how much we talk about "innovation" these days, none of it means much in light of that T1D Exchange data and the fact that a large percentage of PWDs are not meeting their A1C goals or desired diabetes outcomes due to lack of access and unaffordable prices.
One presenter put it out there: "Attendees from all the countries that cover the cost of insulin and healthcare in general must think the USA is crazy when they see how our system is structured and how high the prices are!"
Yep, shame on the USA.
Hacking Cost Savings
In several sessions, presenters offered tips for HCPs to assist their patients in financial need. One of those was actually a "hack" idea that came from Dr. Jean Francois-Yale at McGill University, who suggested that physicians could prescribe higher doses of SGLT-2 inhibitors (Invokana, Jardiance, Farxiga) or GLP-1 agonist drugs like Victoza, Trulicity, Ozempic) to patients, but have them cut their doses in half and take them separately -- resulting in a lower copay, since the dosage amounts would be the same price. That's a novel strategy he uses in his practice, and he said it can make a dramatic difference to help patients save money.
We love the ingenuity here, but it's kind of sad of course that doctors have to result to "hacking prescriptions" just to be sure their patients get proper treatment.
Note that just recently at DiabetesMine, we published a list of practical tips and tricks for patients to save money, including links to various Pharma discount programs.
All of these efforts are band-aids, of course, that really don't address the systemic issues we face in healthcare.
We hope the ADA recognizes that the critical issue of Access and Affordability deserves more official attention than a single session in which players essentially patted themselves on the back, and offered nothing but the same back-and-forth we've been hearing for years now.
While the organization likes to tout its advocacy on Capitol Hill and elsewhere, it's hard to take that seriously when they miss an opportunity to really prioritize this issue in front of the 15,000+ medical professionals attending this year's conference. Just think if the ADA put a call to action out there to mobilize these doctors, educators and advocates who are all in the same place at once...
We're hoping for more from the country's biggest and most influential diabetes organization; we're hoping they can help envision a path for real change.