Moving the Needle on Insulin Pricing Policy

If you haven't noticed all the Insulin Pricing talk happening lately, you've probably been seriously unplugged. It's everywhere, a constant theme brought up in mainstream press as well as in the political arena.

Most recently, this American crisis over affordability and access came up a half-dozen times during the two-day Democratic 2020 presidential debates held in Detroit, and also when a group of D-advocates made a trek to Canada along with Sen. Bernie Sanders to buy affordable insulin and make a statement in the process as part of his 2020 presidential campaign. (I had the chance to ride along!).

In the face of desperation, where many people with diabetes are forced to ration their life-sustaining insulin and are even dying as a result, some of this may not seem enough. But we are at a point where the public outcry is at record-high levels, and it's paying off with state and federal actions moving the needle on this in meaningful ways.

For example, the IRS and Treasury Department made a significant policy change in mid-July that marks an incredible step forward on helping with affordability for medication and care people with diabetes need. That's not all. There are also new state co-pay caps being introduced, political messaging that puts this on the national stage, and continued grassroots advocacy by big and small D-orgs and individual advocates, elevating the conversation every day.

Here's a look at what's happened to date and more changes we can look forward to soon:


Presidential Candidates Take on Insulin Pricing

Insulin pricing got a half-dozen mentions over the course of the recent Democratic presidential debates, held in Detroit in July. The debates were split over two nights to include the total 22 candidates currently running for president in 2020. Standouts Bernie Sanders and Amy Klobuchar have both taken up the insulin pricing issue specifically and even invited D-Community advocates to be present during the debate.

The #insulin4all advocates attending included D-Mom Nicole Smith-Holt from Minnesota, who lost her son Alec due to insulin rationing as a result of high prices (guest of Klobuchar); and T1D advocates Quinn Nystrom from Minnesota and Jillian Rippolone from Michigan (with Sanders).

The trio were also the main D-advocates leading the two most recent highly publicized trips to Canada for affordable insulin.


Bernie Sanders 'Caravan to Canada' for Affordable Insulin

In late July, I had the opportunity to ride along in what was an official Bernie Sanders presidential campaign event from Detroit to Windsor, ON. I've lived with type 1 diabetes myself for more than 35 years, but on this trip I didn't purchase any insulin, because I was present in the role of a media observer, and mostly because I am not currently in need.

However, this wasn't the first #CaravanToCanada trip I took part in. I went along with a small group in late June that also visited the historic Banting House museum known as the "birthplace of insulin" because insulin co-discoverer Dr. Frederick Banting lived there briefly. Many of the handful of PWDs (people with diabetes) spent thousands of dollars buying insulin in Canada -- that would have cost 10 times that amount here in the States.

It was only 6 miles across the border, yet thousands of dollars in price difference marking the chasm between what's affordable and not. Night and day... In other words: life or death, literally.

That was the message Bernie and the accompanying diabetes advocates emphasized during this trip, which involved two buses full of mostly media and signaled a new international stage for the #insulin4all campaign that's been growing in intensity over the past several years.

The trip included a total of about 50 people -- with the media folk outnumbering the advocates. Roughly 15 diabetes advocates all rode on the larger of the two buses, with Sanders himself riding along with the advocates to talk with them individually and collectively to hear their stories. I rode in the second bus with the media group.

As we arrived at the pharmacy in Windsor, dozens of Canadians gathered with cheers and signs of support, some chanting Sanders' name and others interjecting with shouted criticisms of Big Pharma -- saying how shameful the U.S. companies are. Some were sporting their #insulin4all T-shirts, representing the grassroots nonprofit group T1international that's been loudest on this insulin pricing crisis.

Inside the pharmacy, the D-advocates bought insulin wrapped in packets and carried them out to cheers from the crowd before press conference speeches took place.

So yes, this was a publicity stunt specific to Sanders' presidential campaign. That doesn't mean it wasn't necessary or worthwhile. Our whole country certainly benefits from Sanders' public points on how ridiculous it is that prescription drug prices have skyrocketed to the point where we need to travel to Canada or elsewhere abroad to get more affordable meds.

For his part, Sanders used this trip to tout his three-pronged strategy on lowering drug prices on insulin and other drugs:

  • Appoint an Attorney General who'd break up the largest Pharma companies -- Eli Lilly, Novo Nordisk, and Sanofi as it relates to insulin – and use existing anti-trust laws to regulate these companies.
  • Deploy his signature "Medicare for All" legislation, which would in part cap prescription drug pricing so no one would have to pay over $200 per year on medications like insulin.
  • Make the U.S. compare its drug prices to those in other countries, and allow the FDA to negotiate costs with Pharma companies based on those comparative price points.

Whether you agree with Sanders' policies or not, this raises the level of public awareness on insulin pricing to (hopefully) a louder fever pitch than ever before. That's amazing in itself.

Awareness-raising is important of course, but policy changes and legislative actions are even better.


Easing Insulin Importation?

Naturally, no one claims that importing medications is a long-term solution. Rather, it's one stop-gap measure that many are turning to for temporary relief right now.

To help turn the tables, in mid-July the Health and Human Services (HHS) that oversees the FDA announced a new policy proposal that would allow certain medications like insulin to be legally imported into the U.S. at set prices, so patients would no longer need to travel to other countries to obtain them.

Nothing is final on this yet, but it's a two-part proposal:

  • Through the FDA rule-making process, this would ideally create a supply chain process where the FDA could monitor the safety and quality of imported Canadian medications similar to FDA-approved products. Because this is based on existing statute, "biologics" would not be allowed to be imported from Canada specifically and sold here in the USA for a less-expensive price. This part doesn't include insulin, even though insulin isn't officially considered a "biologic" at this time but after 2020 a law change may put it in that category.
  • A second provision that would include insulin would create a new National Drug Code (NDC) to allow medications meant for international markets to be redirected back into the USA, and sold at a less expensive price using a different product code. This would allow Pharma to bypass the rebate system that currently complicates the process, and which Pharma blames as the trigger for higher list prices. The rebates are imposed by Pharmacy Benefit Managers (PBMs) as a way to ensure that a company's drug is listed on insurance plan formularies.

It will be at least a year before we see any of that materialize. And it may be an uphill battle since Pharma has traditionally been aggressive in opposing any drug importation -- insisting that the FDA isn't capable of ensuring the safety and quality of medications shipped back into the U.S. from other countries.

Also, just how much the new NDC program would lower prices is TBD, especially given that Lilly unveiled a half-priced version of its Humalog insulin earlier this year and it's still selling for $136 per vial.


IRS Exempts Diabetes Items from High Deductibles (!)

On July 17, the IRS expanded its list of items it considers "preventative," meaning people with High Deductible Health Plans (HDHPs) no longer have to wait to meet their high-dollar deductibles before insurance coverage kicks in.

"This is a huge step forward," says fellow T1D George Huntley with the National Diabetes Leadership Volunteer Council (NDLVC), which has been advocating on this issue for several years now. "It's first-dollar coverage, not just for insulin but on diabetes items and health services and medications. This is a major win for the Diabetes Community, and beyond for those with other chronic health conditions."

More than half of insured Americans have employer-based health coverage and the latest data from the Kaiser Family Foundation's annual survey of employer-coverage shows that 29% of those with employer-offered plans have HDHPs. The new IRS allows employees on those HDHPs have more ability to sidestep the deductible and use their insurance coverage immediately, whatever the co-pay amount may be on their specific plan. Aside from insulin, the list also includes these other diabetes-related items: glucometers, glucose-lowering agents, A1C testing, retinopathy screening, and statins.

In prior years, the IRS took the position that preventive care did not include any service or benefit intended to treat an existing illness, injury, or condition. But because of the costs associated and how that often led people to poor health outcomes, the IRS has changed its view. It has recognized that failure to address these chronic conditions within its preventative list has demonstrated a higher likelihood of health issues and complications that cost more over time.

Since 2016, the NDLVC has been working with the JDRF to advocate for a sort of PBM education plan, going to large employers as well as the nation's PBMs to push them for better coverage on items such as insulin. Huntley says one of the biggest pushbacks they've had from employers is that they didn't believe they were actually allowed to put insulin on the preventative list because (until now) it hasn't been on the official IRS list.

"There was a question of interpretation, whether that official list was sacrosanct and written into stone for all you can do, or if there's leeway to add a few similar things as long as you're staying within the general guidelines of it. But now, this IRS rule eliminates that concern and removes all ambiguity," Huntley explains.

While it's a milestone victory, the one caveat is that it's a 'may' and not a 'must' for employers. So Huntley says the NDLV's new focused mission is to continue reaching out to employers on this topic, with the IRS rule in hand to ensure they are driving demand for those employers to push insurance companies to put insulin on the preventative list.

That's where PWDs come in.

It comes down to people making sure their employers understand why it's so necessary for insulin to be included, Huntley says. Resources on how to advocate are available online from NDLVC and the Diabetes Patient Advocacy Coalition (DPAC).

Of course, this isn't a solution for everyone -- including the many people who are uninsured or have Medicare and Medicaid coverage. That's a different part of the puzzle that's also being tackled in related advocacy efforts.

Federal Legislation Aimed at Insulin Pricing

Just before Congress convened for its August recess, there were a handful of different pieces of legislation proposed as a way to tackle the insulin pricing issue on multiple fronts.

As of Nov. 1, 2019: There are currently SIX main federal bills that have "insulin" in the title and a number of others that indirectly hit on diabetes and/or insulin, from generic medication policy to re-importation from other countries to general lowering of prescription drug prices. Those insulin-specific bills (as of 11/1/19) include:

  • Insulin Price Reduction Act (introduced in the Senate on 7/22 and the House on Oct. 29): These are similar bills from each side of Congress. It would create a new insulin pricing model, restricting the use of rebates to PBMs/insurers for any insulin product in which the manufacturer reduces the list price back to 2006 levels on average ~$68, depending on insulin type. That would apply to private insurance as well as Medicare Part D. Insulin-makers that lower their price to that level or below wouldn't have to pay additional rebates, which Pharma largely blames as the big reason for hiking up list price amounts. In future years, Pharma could only raise the list price by as much as the medical inflation rate. Insulin would also be exempt from deductibles and couldn't be excluded on formularies. Both the ADA and JDRF have applauded this legislation, noting that it's part of a larger advocacy effort they're aiming at lawmakers. Those leading the push on those bills are Sen. Jeanne Shaheen (D-NH) who co-chairs the Senate Diabetes Caucus and has a granddaughter with T1D; and Reps Diana DeGette D-CO), whose adult daughter was dx'd at age 4, and Tom Reed (R-NY) who lives with T2D and has a college-age son dx'd at 4.
  • Affordable Insulin Approvals Now Act (7/11): This one comes from Sens. Dick Durbin (D-IL), Tina Smith (D-MN), and Kevin Cramer (R-ND) and is aimed at speeding up generic and lower-cost insulin options here in the States.
  • Emergency Access to Insulin Act of 2019, aka the Alec Raeshawn Smith Act (6/27): Spearheaded by Sen. Tina Smith (D-MN) and Sen. Kevin Cramer (R-ND), this one was introduced on the anniversary of Alec Raeshawn Smith's death as a result of insulin pricing-related rationing. It would provide federal grants to states/territories/tribes to offer a short-term supply of insulin for uninsured and "underinsured" PWDs. It would fund that by imposing a recurring fee and penalty for price-hikes on insulin manufacturers. There are also other provisions aimed at increasing competition in the insulin market. There is a related House proposal introduced in late July by Rep. Angie Craig (D-MN) that would set up similar assistance programs.
  • Affordable Insulin Act of 2019 (2/28): This is an importation bill, introduced by Rep. Peter Welch (D-VT) that would authorize the importation of safe, low-cost insulin from Canada and eventually from other qualified countries that the FDA deems to have safe enough standards.
  • Insulin Access for All Act of 2019 (1/9): Introduced by Rep. Bobby Rush (D-IL), this is a Medicare-specific bill that would eliminate cost-sharing for insulin under Part D or as a covered outpatient drug for beneficiaries.

As noted, those are just the bills specific to insulin at the time. There are others from Sen. Sanders and Sen. Warren -- both 2020 presidential candidates -- as part of their own ambitious legislative efforts, including importation and versions of #MedicareForAll as well as pushes for more generic competition. And most likely, we'll see more introduced specific to insulin price-gouging as that discussion continues on a national stage.

*UPDATE: As of Jan. 1, 2020, several more bills have been introduced in both the House and Senate related to insulin and price-gouging. The count is more than a dozen pieces of legislation, so far!

Another effort comes from Rep. Diane DeGette (D-CO) and Tom Reed (R-NY), who lead the Congressional Diabetes Caucus, and though insulin is not in the title, their press release poses a specific way to increase generic insulin production and help lower the price. As with anything from Congress, it's all TBD on whether any of these proposed measures passes voting.


State Co-Pay Caps on Insulin

At the state level, one of the biggest efforts underway is capping co-pays on insulin for those with insurance plans. Colorado was the first state to adopt legislation capping co-pays at $100, and now other states are also moving in this direction.

While these are good measures, they have their shortcomings.

Notably, state governments can only pass laws that impact their own specific state-offered health plans. So this wouldn't even apply to private insurers offering employer-based plans in their home state (Colorado or elsewhere).

Even more significant is that per the Affordable Care Act (ACA) otherwise known as "ObamaCare," states can't cap co-pays on insurance plans without reimbursing the plans for that difference. While this rule isn't clear and may never have been enforced in the decade since ACA became the law of the land, some wonder whether this insulin co-pay cap could force lawsuits attached to that provision about reimbursement.


Continued Advocacy, in the Face of Tragedy

Clearly, it's all a big puzzle with many moving parts... and unfortunately, we PWDs are left struggling with high insulin prices and waiting for action as these policy debates wage on.

It seems like every week or two we hear of another loss in our D-Community stemming from a lack of insulin affordability -- the latest being 24-year-old Jada Louis, who passed away on July 4 because she had to choose between paying her rent or purchasing outrageously priced insulin. 

Another recent national story involves a 27-year-old Pennsylvania man named Josh Wilkersen, who aged out of his parents' insurance not long before and couldn't afford the high cost of analogue insulin. So he switched to the over-the-counter ReliOn brand sold at Walmart as that was more affordable for him and his fiancee, who also lives with T1D. That insulin didn't appear to work for him for whatever reason, according to the news accounts, and he died.

That story has gone viral and is being used as a case-in-point example of why "Walmart insulin" is dangerous and not an adequate alternative for PWDs in need.

Indeed, diabetes advocates have long insisted that "old-school" human insulin is different and less reliable than the modern formulations first rolled out in 1996 with Humalog. It's just not the same, though some in our D-Community do use it effectively, and with proper training and caution it can be used safely in emergency situations.

The UK-based organization T1international -- which launched the #insulin4all hashtag in 2014 and has chapters in 34 states plus DC -- will be holding a candlelight vigil outside the Eli Lilly headquarters in Indianapolis on the evening of Sept. 14, 2019. It's aimed at paying tribute to those who've lost their lives due to insulin rationing and protesting the high price of insulin. Several chapters from surrounding states will be traveling to join the event, and the Utah #insulin4all chapter will be holding a parallel event.

While we understand that change takes time, and we're seeing more mainstream attention than ever before on insulin pricing, it clearly isn't happening quickly enough.


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