Mom Advocates for Affordable Insulin After Son's Tragic Death

The world changed for Nicole Smith-Holt when she lost her son Alec in June 2017, just a few weeks after his 26th birthday. He had been living with type 1 diabetes for two years, but the Minnesota mom learned after the fact that he'd been unable to afford his insulin, was rationing what he had, and despite the signs recognized only in hindsight, he tragically died from the effects of diabetic ketoacidosis.

Now Nicole is sharing Alec's story across the world.

She's spoken with small and large media outlets including People magazine, and her son's story has even prompted rock star Bret Michaels (who lives with T1D himself) to take notice and vow to do what he can to raise awareness on the crisis of skyrocketing insulin prices. Nicole is also pushing for first-of-its-kind legislation in Minnesota to curb those costs, and wants to see the same happen at the federal level.

Her advocacy comes at a time when the backlash against insulin and drug pricing is hitting a fever pitch nationwide -- the Trump Administration is proposing a "blueprint" for changes, Congress has held a series of hearings, the American Diabetes Association has issued a white paper on the topic, and the American Medial Association is calling for change specific to the insulin pricing system.

"I am overjoyed to see all the attention insulin pricing is currently receiving," Nicole told us during a phone conversation recently. "I am hoping that all the recent talks and attention will bring forth the changes that are needed to save lives, bring down the price of insulin and make diabetic supplies and even insurance affordable. I truly believe we are moving in the right direction, we are gaining more and more support from legislation and I am hopeful we are going to see some major changes soon."

The Tragic Loss of Alec Raeshawn Smith

Diagnosed with type 1 in May 2016, Alec was nearing his 24th birthday at the time. His mom recalls not understanding that adults could be diagnosed with T1D, believing it was only a "juvenile" condition that kids were diagnosed with. Alec had a pretty common D-story -- feeling sick, excessive thirst and frequent bathroom trips, along with worsening leg cramps from the high blood sugars. When he went to the clinic, his blood glucose was nearly 500 and he received insulin and saline drip via IV.

He lived at home in those first several months, and Nicole says he seemed diligent about his diabetes management, keeping her informed about what he was eating and how his BGs were doing. But in December 2016, he was ready to move out of the house, and that's when everything changed.

Alec had a pretty good grasp on his diabetes management at that time, had just gotten a work promotion to manager at a local restaurant and was making more money – ready to be independent and on his own, Nicole recalls. However, thinking back on the weeks before his birthday on June 1, 2017, Nicole remembers noticing that Alec had lost weight and the stress seemed to be wearing on him over the challenge of obtaining insurance and paying for insulin. They had even discussed the possibility of him moving back home because of the cost of insulin, diabetes care and insurance coverage, along with everything else he had to pay for.

“With his newfound independence and mom not around to nag and cook meals, he may have slipped into a bit of 'non-compliance,'” she says. “But I think he was still trying to do right and be healthy. When he started realizing how expensive his diabetes care really was, that brought on more stress and everything spiraled and declined rapidly.” 

Nicole saw Alec seven days before he was found in his apartment, and she says he didn’t appear to have lost any more weight from the week before when she saw him. But when he was found, she remembers being shocked by how emancipated he looked and the difference just a single week appeared to have made. Nicole also recalls cleaning out his belongings and seeing his fridge, which was full of veggies and fruit along with fish in the freezer -- telling her that he was really trying to do his best.

His girlfriend later said that Alec had refused to go to a food truck because he wasn't sure he could keep any of the food down, and on that Monday before he died Alec had called into work due to vomiting and breathing troubles.

He’d been using Humalog pens and Lantus for night-time basal insulin, Nicole says; just one box of five pens of one insulin type alone would cost $800 to last not quite a month. From what she’s been able to piece together from Alec’s prescription history, it seems that he may have waited to fill a prescription a week before his death in order to get to his next paycheck, and instead rationed insulin – probably not using nearly enough than his usual high daily dosage.

“The cost of it alone is just sickening,” she says. “It’s just ridiculous.”

After the initial grieving process, Nicole says she began sharing Alec’s story in late 2017 – starting with a local news station in their Rochester, MN, region. That led to many other outlets picking up on Alec’s story around the first #insulin4all protest in front of Eli Lilly headquarters in September 2017, and a more sweeping media blitz once 2018 began.

She hears stories every day from others in the Diabetes Community who are experiencing similar situations -- rationing insulin because they can’t afford or access what they need, not checking their blood sugars, and not buying food or paying rent because it’s a choice between that and their medications each month.

“We need more people to raise their voices, and need more people to share,” she says. “I felt like Alec’s death was such an isolated incident, and it’s not. This is happening far too frequently.”

Drug pricing and insulin affordability

Fortunately, there is some real movement from key players and advocacy groups that have the ability to influence change. Here's a rundown of some of the most recent important advancements:

American Medical Association Speaks Out

On June 13, this oldest and largest group of medical professionals in the country called for federal and state action related to insulin pricing. Specifically, they want the Federal Trade Commission and the Department of Justice to track insulin pricing and market competition to protect consumers. Specifically, the AMA is calling for

• Support of legal actions from at least five states and a federal prosecutor who are demanding information from insulin manufacturers and Pharmacy Benefit Managers (PBMs), and class action lawsuits that remain pending in federal courts on behalf of patients.
• Help from the fed on systematic failings that hit uninsured patients paying cash -- those with insurance who are still in a high-deductible period, or those who lose access because of forced non-medical switching by insurance companies and PBMs.
• Fed help specific to Medicare and Medicaid beneficiaries, particularly those who are impacted by the Part D "donut hole"  -- especially since coverage for just one long-acting insulin analogue/glargine was the second-highest of all Medicare expenditures in 2015.
• At the state level, establishing model state legislation to promote increased drug price and cost transparency, to prohibit the well-publicized rebate scheme that bumps up drug prices, and the elimination of contractual "gag
  clauses" between pharmacies and PBMs barring pharmacists from telling consumers about less expensive medication options.
• Physician education on pricing and transparency, to allow physicians "to be in a stronger position to help their patients afford insulin if information systems can integrate price information" (see the AMA's TruthinRx.org site).
• Support for further initiatives that educate physicians about the cost-effectiveness of various
  insulin therapies.

“It is shocking and unconscionable that our patients struggle to secure a basic medicine like insulin,” said AMA Board Member Dr. William A. McDade in a recent statement. “The federal government needs to step in and help make sure patients aren’t being exploited with exorbitant costs. The AMA also plans to educate physicians and policymakers on ways to tackle this problem, and transparency from manufacturers and PBMs is a good place to start."

Trump Administration has "blueprint" for insulin pricing

The AMA's statements mirror many of the recommendations brought up at a June 12 hearing before a Senate Health Committee focused on drug pricing. Health and Human Services Secretary Alex Azar, a controversial figure himself due to his former role leading Eli Lilly during a time of incredible insulin price increases fro 2007 to 2017, outlined the Trump Administration's plan to combat systematic drug and insulin pricing problems:

• Preventing PBMs from penalizing Big Pharma if they lower list prices (!)
• Banning gag clauses against pharmacists
• Increasing the amount of generic drugs and the process for getting those to market, something the FDA commissioner has pushed toward in the past year. As to insulin, this could mean biosimilar "follow-on" products or potential new generics that might be even lower cost.
• Insisting that the FDA has the power to require list price disclosure in Pharma commercials in print and on TV. Azar says he believes Congress could act on this, to shore up FDA's authority if needed.

"Everybody wins when list prices rise -- except for the patient, whose out-of-pocket cost is typically calculated based on that price," Azar said during the hearing.

This is one of a series of Congressional hearings over the past year that have highlighted this issue, and explored various ways to possibly address it.

Whether any of this action will happen at the Administration's behest is TBD, and many believe it's all just talk without any hope of meaningful action. For example, in late May President Trump announced that within two weeks we'd be seeing voluntary pricing decreases from insulin manufacturers. That's yet to happen, although Sanofi has acknowledged it plans to meet with Trump soon, and Administration officials say this is all "a work in progress."

American Diabetes Association's insulin pricing stance

In early May, the American Diabetes Association (ADA) appeared before a Congressional committee to discuss the issue and also outline recent activities of its Insulin Affordability Working Group (which began in May 2017 and took a year to study the crisis and issue its white paper).

Among their recommendations:

• Transparency across the board, Yo. Everyone in the insulin supply chain needs to push for this -- Pharma, PBMs, Payers, Medical Professionals, and Lawmakers at the state and federal level. List prices should more closely reflect net prices, and the current system of rebates, discounts should be minimized.
• Prices need to be integrated and openly discussed by providers, insurance plans, and pharmacies.
• Research is need on the comparative effectiveness and cost-aspects of various insulins.
• More biosimilars are needed too, and the FDA should encourage innovation on different forms of insulin.
• "Providers should prescribe the lowest-priced insulin required to effectively and safely achieve treatment goals," to include making sure physicians are trained appropriately on older human insulins that may work for certain patients
• Clear information on medicine Pros, Cons and financial implications should be easily available for medical professionals and patients alike.

Interestingly, some within the D-Community have interpreted the ADA's white paper as suggesting that older insulins like R and N should be a standard of care for all, or that it's somehow being recommended as a solution to the insulin pricing problem.

That's not accurate, says ADA Chief Medical and Scientific Officer Dr. William Cefalu.

“We put in the white paper, and carefully suggested, that select individuals may choose and benefit from using these older insulins,” Cefalu said. “We did not say this is a solution to insulin pricing, nor that it’s an option for everyone. We simply suggested that there are those patients who may benefit, and in those cases, physicians should be educated on how to prescribe them safety. Saying otherwise is taking one of our paper’s statements out of context.”

Reading the white paper, what Cefalu says appears to be quite accurate. While it's disappointing how slowly ADA seems to have moved to fully embrace the insulin pricing crisis, we're glad to see this white paper taking the right direction and hopefully gaining attention from Congress, other decision makers, and the general public.

What happens next on all these various fronts remains to be seen.

Meanwhile, passionate advocates like Nicole Smith-Holt, who has her son's memory in her heart and mind, are not sitting back passively waiting for change.

A mom's advocacy on insulin pricing

In recent months, Nicole has become a vocal #insulin4all advocate.

She attended an Eli Lilly shareholder board meeting in the spring, and also met with Lilly Diabetes execs afterward to share Alec's story and urge them to do better.

On the legislative front, Nicole's been working with state legislators to pass a bill providing for emergency insulin access. Known as the Alec Smith Emergency Insulin Act, the companion legislation was introduced in each sides of the legislature during Spring 2018 by State Senator Melissa Wiklund and Rep. Erin Murphy, creating a free or sliding-fee scale based on income for people without insurance to get emergency insulin -- whether they lost a job and didn't have insurance, or aged out of their parents' healthcare coverage. There isn't anything like this in the country as far as her state lawmakers know, and Nicole hopes to see other states propose similiar legislation.

The bill didn't get through committee, but Nicole says she's working hard to get it reintroduced later in the year once the state legislature reconvenes.

Nicole says the legislation that was first introduced did not address emergency refills for insulin – like what Ohio and several other states have passed in the name of Kevin Houdeshell, who died in 2014 after being unable to access an emergency insulin refill at his local pharmacy over the Holidays. The Minnesota legislation also doesn’t touch on insulin pricing transparency, and other aspects of the system that are clearly broken. 

“I think they all need to be weaved together into the same piece of legislation,” Nicole says about a federal package picking up on what various states have done or tried to do. “Having these individual measures can help to a point, but it doesn’t fix the greater issues that will lead to a major change in our healthcare system. It needs to be overall.”

“We want laws in place to prevent pharmaceutical companies from randomly raising prices, and pushing people to make such horrible decisions on how they can afford life-saving medication,” the D-Mom says. “Type 1s need daily injections, so we would like transparency, we would like to see list prices go down and laws in place to prevent big pharma from price-gouging people.”

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Originally published at DiabetesMine