You can't take a step in the Diabetes World these days without bumping into some mention of high insulin prices. Efforts to address affordability and access are wide-ranging and we've covered them at length here at the 'Mine.

For those of us whose lives depend on insulin, it's not complicated to understand that something drastic needs to be done to help those who can't afford this life-sustaining medication. But unfortunately, the way drug pricing works in this country is complicated indeed, encompassing many overlapping issues -- from Pharma profits and non-transparent business practices, to how Pharmacy Benefit Managers (PBMs) and insurance companies pull strings, to how the same exact products from Canada aren't allowed into the United States, and the general issue of our country's healthcare system that is so much more problematic than anywhere else in the world.

Two new efforts have surfaced recently that are working to offer potential solutions, one from a lobbying standpoint, and one delving into the basic science. Here's the skinny on both:


Affordable Insulin Project

Launched in early October of this year, the Affordable Insulin Project is an initiative created by the Diabetes Patient Advocacy Coalition (DPAC) -- which is founded and run by powerhouse diabetes advocate and longtime type 1 Christel Aprigliano. The group pulled this Project together following a November 2016 gathering of key diabetes leaders and advocates concerned about these issues -- even the three Big Insulin Manufacturers, who were there to talk through the issues and offer suggestions. DPAC eventually announced this new initiative at an advocacy workshop on insulin pricing held by Lilly Diabetes.

As we've noted repeatedly, we're at crisis-level in the insulin affordability and access universe. People are dying as a result of not being able to get insulin. Some big policy and advocacy efforts are underway, but it's clear that even the resources available now aren't always well-known. That's the genesis behind this Affordable Insulin Project, which is essentially a clearinghouse of information and resources aimed at helping PWDs who are struggling with insulin prices.

It offers extensive information for employers and employees on how insulin affordability can be tackled from the workplace angle, re: negotiating for better insurance plan coverage.

Here's what's included:

  • Online downloadable worksheets, tips and best of all, guides -- one for employers and one for employees, explaining why exempting insulin from the deductible or passing rebates to the employee at the point of sale is not just necessary, but financially beneficial for the employer as well as the employee.
  • An excellent explanation of insulin coverage in general, and what paying out-of-pocket means. (It's a fact that some employers don't understand exactly what this means, according to Christel. Clarifying that basic concept, set out in easy-to-grasp print, can make a difference right there.
  • Statistics, facts and charts included in the Employer's Guide to help them explain that covering insulin in an affordable-to-the-employee way is actually a cost-saving step. (The cost is just roughly 22 cents more per person per year for employers to assure that any employees with diabetes remain healthy and productive.)
  • A worksheet (or checklist, if you will) to help patients figure out what they want and need from their insurance.
  • For those without insurance, not concerned about deductibles, or those paying cash due to high-deductible plans, there's a resource page devoted to various discount programs and Pharma's Patient Assistance Programs (PAPs) that can offer help. While these are often insufficient and can't be used by those on government plans like Medicare and participants must meet "eligibility" criteria, they are options to consider in a pinch.

The Affordable Insulin Project website requires a sign-up with your name and email, which DPAC explains is important for follow-up, so they can let involved parties know what comes from this effort. For example, patients may share stories of using the various resources, or experiences and tips on talking with employers about insulin costs and overall health insurance choices.

To address the elephant in the room: Yes, this project is funded in part by Lilly and Novo Nordisk, and also many diabetes organizations that include JDRF.  Fixing this problem requires a sweeping effort that must include manufacturers, Christel points out.

"It's not a diversionary tactic," she says. "We didn't get ourselves into this situation overnight and we aren't going to fix it easily overnight. Every time I'm at Capitol Hill talking to lawmakers, the issue of drug pricing comes up... but it will be some time before Congress is even able to look at this particular issue of insulin, because they're still 'gathering information.' For me, (creating this new set of resources) is just one piece of a complex puzzle, a way that we can do something immediately, beyond just screaming into the void."

We're thankful as always for DPAC's efforts to motivate the patient community to speak up, and to connect us with the powerful orgs that can really help move the needle.

Meanwhile, other ideas for tackling insulin affordability are... um... a bit more unconventional.


FAM Insulin Initiative

Meet the Fair Access Medicines (FAM) group, a non-profit based in California founded by Dr. Jim Wilkins about two years ago with roots in the Ebola crisis that engulfed West Africa in late 2014. With a quarter-century of background in biotech and process development, Wilkins took on the issue of how people couldn't get access to life-saving medications internationally for rare diseases such as Ebola. He noticed that Pharma often focused more on developed, and therefore more profitable parts of the world, and the insulin pricing crisis soon came to his attention. He noted how even those in the so-called "middle class" of America weren't able to afford this medication they need to stay alive and healthy.

"Pharma is a big part of the problem here," he says.

Turning their attention to the USA and insulin market, Wilkins and the FAM organization began looking at how to increase access to this medication. Their solution: create a new form of insulin that could be sold for a fraction of the cost. It's now dubbed the Insulin Initiative, aimed at developing a copy of Humulin R.

Yes, we are talking old-school insulin here. This would basically mimic the Lilly insulin developed in the 1970s that hit the market in the early '80s. It's the same idea that the Open-Source Insulin Project folk are working on, and is still in the very early phases as they determine a production method that could work to make this all happen.

Going off the rough price of $100 for a 10mL vial of Humulin R, Wilkins believes they could develop and sell a bottle of their insulin for one-tenth that cost, or just $10.

Notably, when we spoke with him, Wilkins was a bit unclear on the differences between simple diabetes lingo like "basal" and "bolus" insulin, or what phrases like "long-acting or "short-acting" mean in the context of insulin. But he sees this through the lens of a biotech science guy, in developing what's referred to as a "native insulin" that is the foundation of any type of insulin and can be tweaked and further crafted from there. They already have a strain of yeast that secretes insulin, and they plan to use that as a basis and start small before scaling it up with more development.

Wilkins sees this not only as a potential way address the current affordability crisis, but even goes so far as saying his new copy-insulin could become a new "gold standard" for people with diabetes... Whoa!

With today's modern tech tools including CGM (continuous glucose monitoring) devices, he thinks the active life of his Humulin R version wouldn't matter and could easily be adopted into PWDs' lives just as Humalog, Novolog and modern insulins are today. We spent quite a while debating this over the phone with him, but he just wouldn't seem to budge on this philosophical question of whether a modern version of older insulin could work in today's world of D-care. Hmmm.

Anyhow, all they need now, according to Wilkins, is to raise $700,000 to support development. He says the group is in early talks with a yet-to-be-named foundation as to funding.

Wilkins also doesn't seem concerned about any potential legal challenges from Big Pharma, as he points out his legal team and existing court cases have already offered assurance that court challenges wouldn't endanger their plans.

If all goes as hoped, FAM would ideally get FDA approval for investigational trials on their new insulin version by the end of 2018. From there, it would likely be several more years before they could get through the necessary additional trials to get this to market.

And how would this be sold? Wikins says they'd look to partner with retail chains such as CVS or Walgreens to distribute it nationally, or even sell the insulin online. Another path, though more complicated, is to sell directly to Pharmacy Benefit Managers (PBMs) who Wilkins says could be open to working with FAM on offering lower-cost insulin.

"I think we can do a lot of good for people," Wilkins says. "The paradigm we live in right now isn't working, and it doesn't have to be this way."


As noted, these are just two new ideas for addressing the big insulin affordability crisis here in the States. Here's hoping they succeed in their missions, and/or that other novel approaches come forward with viable solutions very soon!