• Despite political claims to the contrary, insulin prices are not dropping as a result of President Donald Trump’s actions leading up to the presidential election of 2020.
  • Insulin certainly isn’t “as cheap as water,” as Trump claimed during the presidential debate in late September. His executive orders are controversial and symbolic at best.
  • The underground exchange or “black market” continues to grow, accelerated by the COVID-19 crisis and patients who once relied on insulin from outside the United States.
  • States continue to pass insulin co-pay cap legislation, and California became the first to allow for its own generic insulin development.

Insulin prices continue to dominate the national discussion and remain a divisive topic in the midst of the political debate over drug pricing policy reform.

The common understanding is that U.S. insulin prices have been jacked up to an unconscionable level and that needs to change, but the details on how to address this problem are anything but clear.

Longtime type 1 diabetes (T1D) advocate Paul Madden in Boston knows this well, as he was invited to provide patient testimony at a White House press conference in late July 2020 announcing President Donald Trump’s Executive Order on lowering drug prices. Since then, nothing has been implemented, although supporters continue to praise Trump’s efforts.

“We clearly know he was looking at this as a publicity stunt to boost himself up going into the election,” said Madden, who’s in his sixth decade of living with T1D and now reliant on Medicare. “But we need to take a breath, and look at how we get something out of this that can put us above politics and benefit people with diabetes. Just talking about the high price of insulin is a big win in of itself, so that we keep this on the public’s mind.”

Reflecting on Trump’s mention of making insulin “as cheap as water” during the first 2020 presidential debate, Madden added: “It’s sad… Clearly that’s not true. [Trump’s] all-too-often dishonest statements market to hopefully a decreasing, sadly gullible minority.”

The true facts show that between 2007 and 2018, the list prices of insulin increased by 262% while net prices rose by 51%, according to a study in JAMA published in early 2020.

The emergent Insulin Affordability Crisis in America has forced many people with diabetes to ration their insulin, and some have even died as a result.

In July, Trump announced four new executive orders that he believes have the potential to impact insulin pricing in a positive way:

  1. Empowering federal health centers: The Access to Affordable Life-saving Medications order directs federally qualified health centers (FQHCs) to pass along discounts on insulin and epinephrine received from drug companies to certain low-income Americans.
  2. Importing drugs from Canada: The second order is aimed at Increasing Drug Importation to Lower Prices for American Patients, allowing for states to set up U.S. Food and Drug Administration (FDA)-approved plans to import certain prescription medications. It also allows for the re-importation of certain insulins made in the U.S., creating a new drug code (NDC) so that existing contracts with insurers locking in certain prices won’t be jeopardized. This order would also allow for widespread personal importation, which has been technically illegal but hasn’t been enforced by the FDA nor by border control as long as the drugs brought back are for personal use and generally limited to a few months’ supply. Some states like Florida have already moved toward this pathway, even before the policy is finalized and put into place.
  3. Targeting Pharmacy Benefit Managers (PBMs): Trump’s third order focused on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen. It would prohibit the so-called “secret deals” often struck between drug manufacturers and PBMs, which are typically negotiated behind closed doors and not disclosed publicly. These deals that involve mandatory rebates to PBMs are often cited by drug companies — including the insulin manufacturers — as the big reason for higher medication prices. The deals are also key to ensuring formulary access on insurance plans.
  4. Assuring international pricing equity: The final order announced in July focused on requiring Medicare to negotiate to get comparable low drug prices to those available in other countries. This would apply to both Part B and D beneficiaries, per the executive order. Trump actually signed this Lowering Drug Prices by Putting America First order on September 13, 2020.

While reasonable people and policy experts can debate the merits of these orders, the undeniable fact is that they have not taken effect. While the orders are written according to the U.S. Department of Health and Human Services (HHS) policy, the actions needed to implement them are nowhere close to being finalized. In fact, some of them, particularly the Medicare-focused policy, require law change before they could go into effect.

We also can’t overlook the fact that Pharma companies are sure to file legal challenges to some of these proposals. Then it would be up to the courts to decide whether these orders, or any subsequent policy changes or law revisions, are actually allowed.

A good analysis of the realistic policy implications and practical effects can be found on this FactCheck.org rundown. The UK-based grassroots advocacy group T1International group has also issued a statement on these proposals, specific to their #insulin4all campaign.

On top of those orders, the diabetes community saw a big Medicare-focused news announcement earlier in the year that would offer beneficiaries a $35 insulin co-pay cap for plans starting in 2021. That so-called “Senior Savings Model” is focused on Part D prescription drug beneficiaries and it only applies to a small number of people on Medicare, but it’s still worth noting as a new way to potentially save money. Open enrollment for Medicare runs October 15 through December 7, 2020, so this will be the time to explore those particular enhanced plans potentially offering this new savings model.

For Madden, the issue of insulin pricing is personal given his own T1D story. But it’s also an advocacy issue he’s been knee-deep in for many years, from his time as a leader in the American Diabetes Association to his latest appearance at the White House announcement on insulin pricing.

Paul Madden

Diagnosed as a 9-year-old about six decades ago, Madden is now on Medicare and said he’s seen firsthand the impact on his own health outcomes as a result of unaffordable insulin and other cost burdens. But he’s one of the lucky ones, as he knows so many struggle to get the life-sustaining medication they need to survive.

How did he wind up behind a White House podium this summer? Madden said he received a call from the Diabetes Policy Advocacy Coalition just a couple of days before the scheduled press conference, asking if he’d be willing to speak on the issue. He agreed, despite his personal politics and feelings about the president.

“Even if it’s a PR stunt, even if it was a political maneuver ahead of an election, it still has the potential to raise awareness on the issue of insulin pricing and even may have the potential to push policy change as well as cost savings,” he said.

“[Patients] are looking to influence policy discussions,” Madden added. “It’s about investing in that idea. I will say thank you to Donald Trump if there is a significant savings from his executive orders.”

In truth, Madden doesn’t believe we’ll see an actual price drop from these policy proposals, and he’s sickened by the recent presidential debate mention of insulin being “as cheap as water.”

In Madden’s mind, the July policy announcement, covered by all major networks and 200+ major newspapers and online publications, was an opportunity “to get on stage and get expanded media coverage so millions could more understand this obscene, life-hurting challenge of criminally high insulin prices.”

Just by mentioning this insulin pricing issue, Trump may have done some good. “Maybe we got the exposure we desired. Some new Democrats and even some new Republicans are talking about this topic and maybe that will help us address these excessive prices,” Madden said.

One of the executive orders Trump signed related directly to importing insulin from Canada. This policy initiative was first announced in 2019 by HHS Secretary Alex Azar (who happened to have led Eli Lilly prior to his appointment in 2017).

Americans have turned to other countries for years to get affordable insulin, Canada and Mexico in particular. And as noted, although it’s technically illegal, there’s been a long-standing FDA policy not to interfere as long as the insulin brought in is only for personal use, and not for resale. Now with that being reflected in FDA policy change, it seems as though we’re seeing the legalizing of personal insulin importation — so that’s a win.

But with the COVID-19 pandemic closing borders, the ability for people with diabetes (PWDs) to travel abroad for insulin has come to a dramatic halt in 2020. Many have been unable to get what they need, pushing more people toward the private underground exchanges within the U.S.

In September 2020, the FDA issued a final rule stemming from Trump’s orders that would allow states to legally import certain prescription drugs from Canada, including FDA-approved insulins. But among other things, it still requires Canadian approval, regulatory inspection for safety, and manufacturers’ sign off on protocols. So there’s no real way to know if and when it could actually take effect.

In recent years, despite all the discussion and proposed legislation in Congress, it’s become clear that states are where the rubber meets the road when it comes to taking real action on insulin affordability.

Multiple states have enacted co-pay caps on insulin for those with insurance, with 13 states passing specific legislation by early October and several others still mulling their own measures. While these co-pay caps have limitations, certainly don’t apply to everyone with insurance, and have their own red tape, they at least have real potential to help some struggling PWDs.

Meanwhile, other states like Minnesota have been working on important laws on emergency insulin access for those in need. They are also tackling the issue of Non-Medical Switching — a tactic in which insurance companies force people to switch medications based on the company’s costs and profit margins, rather than a doctor’s advice or the patient’s real medical needs.

In 2020, California became the first to take a novel approach with a new law allowing the state to develop its own generic versions of medications, including insulin. The state is now able to contract with existing manufacturers to produce lower-cost drugs, and it is possible that the grassroots researchers at Open Insulin in Northern California may be able to participate in this effort. Time will tell.

These are great moves forward at the state level, even as federal policy changes are being announced but not yet implemented. Meanwhile, other efforts continue to help PWDs in need get the insulin they need. See the new Beyond Type 1 program GetInsulin.org, which is a sort of clearinghouse for manufacturer-offered savings programs.

Gradually but surely, help is on the way for people whose lives depend on insulin.