Momentum seems to be building big time around the outrage over skyrocketing insulin prices, which are making this life-sustaining drug virtually unavailable to those who need it.

In just the past several weeks, we've seen:

  • Sen. Bernie Sanders taking to Twitter to call out players, accusing the "greedy" manufacturers of gouging with price hikes of 700% over the past two decades. Later that same week, Sanders joined Democratic Rep. Elijah Cummings from Maryland in asking the Dept. of Justice to investigate the Insulin Makers for possible collusion.
  • The American Diabetes Association on Nov. 16 issuing both a resolution calling for insulin affordability, and an online petition for the Diabetes Community to sign, calling for Congress to hold hearings on this issue and for more transparency on how costs are determined.
  • The JDRF's Chief Mission Officer Aaron Kowalski (who also lives with T1D) posting a Facebook message stating the group is focused on addressing this issue by engaging directly with health plans and other decision-makers.

Of course, no one has a crystal ball to see where all this is going, but it is encouraging to see this conversation and advocacy picking up steam.

Here at the 'Mine we've recently explored the Human Cost of Unaffordable Insulin Prices, heard the Insulin Makers' Response and Followed the Money to see how Pharmacy Benefit Managers (PBMs) seem to be a huge part of the price increase problem in the United States.

And today, we bring you a report from a recent landmark meeting by diabetes advocates and organizational leaders in our Nation's Capital to discuss this complex problem and what might be done about it.

 

First-Ever Insulin Pricing Roundtable

On Nov. 11 in Washington, DC, the National Diabetes Volunteer Leadership Council (NDVLC) convened what it called the inaugural Access to Insulin Roundtable, bringing together about two dozen diabetes advocates and advocacy groups, as well as execs from all three Big Insulin companies, Eli Lilly, Novo Nordisk, and Sanofi. This has been a long time in the works, and getting all these people around the same table is an incredible undertaking!

We were privileged to attend this meeting.

In attendance with us were: leaders of the American Diabetes Association (ADA), American Association of Diabetes Educators (AADE), JDRF, the Endocrine Society, and the NDVLC itself, alongside advocates Jeff Hitchcock and Ken Moritsugu from Children With Diabetes; Christina Roth of College Diabetes Network; Gene Kunde of the Diabetes Hands Foundation; Christel Aprigliano of Diabetes Patient Advisory Coalition (DPAC); Sarah Odeh of Close Concerns and the diaTribe Foundation; Dan Browne of the New York Stem Cell Foundation; Anna Floreen of T1D Exchange/Glu; Cherise Shockley of the Diabetes Community Advocacy Foundation (DCAF); and clinical nurse diabetes specialist Virginia Valentine, who's now with Pharma marketing company Health-Scripts. From industry, there were three execs each from  Lilly and Novo, and two from Sanofi -- as well as Washington D.C. attorney Edward Correia serving as the antitrust counsel (whose job it was to make sure no "colluding" was going on during discussions of insulin pricing).

In case you're not yet familiar, NDVLC is a relatively new non-profit group founded in 2013 by individuals who previously served in a leadership position of a national diabetes-related organization -- mostly former ADA folks who felt they could make a difference with their collective leadership experience and advocacy know-how. Interestingly, this group is sponsored by Lilly, Novo Nordisk, J&J Diabetes and Roche, but as a nonprofit has a public welfare mission, in this case to advocate on things like FDA regulation for improved accuracy of glucose meters, and this insulin pricing issue.

Yet conspicuously missing at this first meeting was representation from the payer side -- particularly Pharmacy Benefit Managers (PBMs) who actually play a big role in determining pricing and access, but also pharmacy and wholesaler voices.

"Only by working together can we address this," said NDVLC director George Huntley, a longtime type 1 himself who worked with the ADA for more than two decades and chaired the organization's board in 2009. "This is meant to be an open, honest conversation and we need it all out there on the table, so that we can figure out what makes sense and take action. We need it right now."

 

Scoping the Problem

This four-hour meeting was sort of a workshop format -- meaning we spent the first two hours talking about the scope of the issue and trying to get our heads around the best "data profiles" that can be presented to various audiences including Congress, employer groups, Pharma, healthcare professionals and advocates.

We advocates in the room certainly did our best to represent the patient voice, sharing our fears and concerns and echoing what we've heard from so many in the D-Community who face these insulin pricing issues. I shared my own experience being unable to afford insulin in the past, as did others, and D-Dad Jeff Hitchcock pointed out he was there representing the young man who died as a direct result of not having access to insulin.

The NDVLC presented a plethora of stats and data, but we were specifically asked to not snap photos of the slides or focus too much on the specific figures presented, because so much included extrapolated information and assumptions based on what's publicly available. For example, claims data and healthcare plan enrollment figures do not represent a 100% clear picture of who is using what medications and how much their insurance actually covers.

Generally, some data pointed to the fact that high insulin prices are not necessarily new, but rather hitting patients much harder thanks to High Deductible Health Plans (HDHPs) that force patients to pay high out-of-pocket costs early in each calendar year. One stat showed that out of millions of insulin-using PWDs on commercial and Affordable Care Act exchange plans, 66% (or 1.6M) are exposed to higher pharmacy costs than they were just a few years ago. Also, the notion of coinsurance (where the patient pays, say 20% of all costs) is expanding, and that's one possible channel to start addressing insulin prices, since employers are more likely monitoring this option.

What we saw in the data presented was that many assumptions were made, such as overly conservative estimates that downplay the access problem, while some factions of the D-Community (insulin pumpers, CGM users, and type 2s on insulin) are often not adequately represented in the data collected. That is a point being addressed, we're told.

Certainly, more work is needed before this data can be presented in "making our case" to whomever the audience may be. And obviously the looming issue of national healthcare reform in this uncertain political climate makes everything more complicated.

But a point that I specifically made: If we can somehow separate this Insulin Pricing conversation from the bigger "political hot potato" that is healthcare reform, maybe we stand a better chance at making a difference. Just maybe.

 

Possible Solutions or Short-Term Band-Aids?

The second half of this meeting became a free-flowing brainstorm where everyone tossed out ideas about possible next steps.

Amidst all this was the elephant issue in the room: the fact that we need to get a better handle on all the moving parts here.

While it's important to lobby employers, who make the selections of health plans for so many Americans, it's also become glaringly obvious that the once-invisible PBMs are the key middle-men pulling so many strings on the end-game insulin pricing. For more info on that, see this May 2015 Bloomberg article on shadow-pricing, and a recent ADA Diabetes Forecast infographic illustrating the insulin pricing funnel from start to finish.

To me, one of the big questions was: How do we open a channel of communication with the PBMs?

To be clear, nothing concrete was decided here. Rather, the group collectively created a list of ideas that might make the most sense for practical advocacy. Here's a snapshot of some key themes discussed:

Transparency: One of the first points made and reiterated throughout the meeting was a call for all the players to help shed light on the many middle-men who a part of jacking up the price of this medication. It's not just as easy as publishing a list of all insulin prices and costs that go into those pricetags, however. State and federal laws snake all throughout this process, delving into contract law and anti-trust regulations and even trade secrets play into why various players can't just release info -- at least not without Congressional subpoenas or law changes. So some serious changes need to be made here.

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Source: Diabetes Forecast, March 2016

Middle-Class Affordability: Each of the three main Insulin Makers are quick to point to their Patient Assistance Programs (PAPs) as a way they increase accessibility -- Lilly Cares, Novo's Cornerstones4Care Patient Assistance Program, and Sanofi's Patient Connection. But these programs don't go far enough. Not by a long shot. A huge number of people who explore these options, especially those PWDs on federal insurance like Medicare or Medicaid, find they aren't "eligible." This needs to be addressed, and it's something that many of us in the room echoed during the meeting. And did you know that Medicare actually gets a huge discount on insulin, due to the federal government's ability to negotiate on pricing? The government pays nothing close to what we as patients do, and that's a whole issue in itself, too...

Promoting Assistance Plans: Did you know that Insulin Makers are prevented by law from promoting these Patient Assistance Programs?! This explains why many people don't even realize they exist. Apparently, lawyers tend to be cautious on this front because any promotion of these programs might be considered a "kickback" by federal regulators, and that's a big no-no. One way around this is a law change, but another idea floated would be to have a sort of PAP Clearinghouse by an independent third-party organization so that the insulin manufacturers wouldn't be on the hook for any perception of self-promotion. Patient advocates can also sound the horn more often on these resources, and that's something our Diabetes Online Community can immediately start doing to make more PWDs aware of these possible resources (like this recent diaTribe resource).

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Employer Influence: As mentioned, employers are a key part of all this. One thing I learned at this Roundtable was how much flexibility employers actually have in adopting their insurance plan formularies and coverage. They can often tweak these plans, although customizations do boosts the cost. But some employers are specifically doing this already in terms of insulin coverage, by requesting that insulin be listed as a "preventative" medication, making it either lower-cost or even one of the $0 co-pays on the insurance plan! In fact, there are companies within our own D-Industry embracing this concept and it's a perfect case study to explore how this works. This was a discussion point that is going to be analyzed more in-depth, to learn how we may push for more of these types of coverage work-arounds.

Did you know there's a new employer corporate alliance focused on this type of thing? Yep, we reported back in October  about the newly-formed Health Transformation Alliance (HTA) of about 30 of the country's biggest employers who aren't happy with the money they spend each year on health benefits, and they see PBMs as a key part of the problem. The coalition is developing a database to allow its corporate members to compare healthcare pricing and outcomes. And there's a second project aimed at helping health plans better control their drug benefits by shedding light on how PBMs are spending the money they're paid -- which employers obviously don't know enough about currently! This came up at the recent meeting as a potential part of the solution.

Prescriber Prevails: The patient-physician relationship should not have to change with politics or the reform of our healthcare payment system, because after all, healthcare and medicine are about making decisions that are best for the person being treated. This is where advocacy efforts on insulin pricing overlap with our D-Community's #DiabetesAccessMatters push to mobilize our medical professionals to start raising their voices collectively to tell payers that the practice of medicine is being interfered with, and that needs to stop! A lot is happening here, and we'll be publishing an update soon.

More Research: During the meeting a repeated point was how little (aka ZERO) research exists showing the actual clinical outcomes resulting from higher insulin prices, and reduced access. Sure, we can all recite anecdotes. But we need science showing the effect, as that's going to make the biggest difference. This could very well be an area the ADA, JDRF, AACE, or AADE explores in the coming months leading up to their big conferences.

Lobbying Lawmakers: No doubt much of this flows back to discussion about Congressional change and what can be done with and without legislative authority. Some of it can, some can't. The big challenge now is exploring those nuances and deciding what specific areas can be advocated on -- such as the ADA's recent push for increased transparency and Congressional hearings (Note: this was not mentioned at the Insulin Roundtable, but was announced less than a week later by the ADA).

To sum it up, we need to better understand all of this before we can fix it. Obviously, costs are too high. But it's not as simple as just shouting "Lower the prices!" or just pointing fingers at Insulin Makers or PBMs (or anyone else) without ackowledging all the intertwined pieces of this puzzle.

The NDVLC is working its own official meeting recap report, as well as an action plan/next steps document that we're told will be released soon. We're looking forward to that, and we hope to see all parties collaborating better as we move forward.

 

Just Say No?

At the close of the meeting, I couldn't help voicing my humble vision:

In my crystal ball, I see a world where big powerful employers with stakes in diabetes, like Google, Apple, Samsung, and Ford Motor Company -- along with every diabetes company across the board -- are the first to come together and refuse to sign with any insurer who doesn't offer insulin as a "preventative" medication to increase access and affordability. Suddenly, if insurers and PBMs are hit directly in their pocketbooks, they may well decide to re-examine their practices and business models.

The takeaway that stuck with me most from this meeting was the fact that we have such a deep-rooted problem here with healthcare costs across the board, yet our advocacy efforts always seem to be "treating the symptoms" rather than diagnosing and addressing the core issue. 

Right now especially, it feels like the rest of the world is shaking its head at our wealthy country that somehow has let insulin prices spiral out of control. It's a fraction of the cost outside the US. Maybe it comes down to a simple recognition that healthcare and access to life-sustaining medication is a human right, not a "privilege if you can afford it" as it now seems here in the States. Whatever the underlying reason, it clearly needs to be addressed.

In any case, this Insulin Roundtable meeting was a starting point and will hopefully serve as a launch pad for real, concrete action.

 

Stay tuned for more on the Insulin Pricing saga coming here soon.