As our community struggles with the skyrocketing prices of insulin, new hope dawns.
After screaming for years that "WE WANT GENERIC INSULIN!," we are now finally entering the long-awaited era of biosimilars (even if they aren't technically called that by U.S. regulatory leaders), that are basically similar lower-cost versions of already-approved insulins.
To be clear, this is a whole new world of insulin products different from anything we've seen before. We’re not talking about those Walmart "generic" insulins that are just cheap forms of older-gen products like R, N, and 70/30 mix simply sold under Walmart’s ReliOn brand name. In contrast, these new biosimilar “generics” are actually novel formulations that copy the biological molecule of an existing insulin.
As of today, Dec. 15, Eli Lilly's new Basaglar basal insulin becomes available to buy here in the U.S. This is the first so-called “follow-on” version of competitor Sanofi's successful long-acting insulin Lantus, and there’s been a ton of buzz about its potential to bring down insulin prices across the board and reshape insurance coverage.
This is the first, and we expect to see a second biosim launched within a year, followed by a variety of these lower-cost insulins, both fast-acting and long-acting.
You may be surprised to see that these copycat insulins are not coming from newcomers, but from established Pharma companies themselves, now that they finally have the opportunity to undercut each other as their signature insulins go off patent. But that's what it is, Folks: Insulin Wars.
And although we may be caught in the middle as patients, we do have a chance to save money with the introduction of these new generics we've been demanding for so long.
Biosimilar Insulins Coming Soon
The three biggest biosimilar insulin products in the works so far are:
Lilly’s Basaglar: This biosim version of Sanofi's long-acting basal insulin glargine, Lantus, was under development by Lilly in partnership with Boehringer Ingelheim for many years before getting FDA approval in December 2015, and officially launching today!
It was also launched in Europe last year, under the name Abasaglar. Here in the States, it's actually the first insulin product approved by the FDA's abbreviated approval pathway (which came to be thanks to the 2010-enacted Affordable Care Act), and interestingly the regulatory clearance for Basaglar relied in part on the FDA's findings on safety and efficacy of Lantus more than a decade ago. Sanofi had sued Lilly on patent infringement claims to stop this insulin from being marketed, and that held up the FDA's review last year, but the companies settled that suit in September 2015 and paved the way for FDA approval.
Like many Lilly insulins, this once-a-day basal insulin will be sold in their signature Kwik Pens that hold 300 total units, with up to 80 units available per injection. Dosing is a unit-to-unit comparison to Lantus, according to the drug information. (See below for more about Basaglar's pricing.)
Merck's Lusduna Nexvue (formerly dubbed MK-1293): This was submitted to the FDA in August 2016 and remains under review. Just like Basaglar, this Merck follow-on biologic will be based on Sanofi's Lantus basal insulin. We reached out to Merck for specifics, but the company would only say they expect to hear back from the FDA in the first half of 2017. Sanofi filed a lawsuit in September 2016 to stop Merck's biosim on patent infringement claims. (UPDATE: FDA granted tentative approval of this insulin biosimilar in July 2017, and also in February 2018 approved a 10ml vial version, but full approval and launch is dependent on resolution of the Sanofi lawsuit). Unfortunately in Ocober 2018, Merck announced that due to the pricing and production pressures it would be scrapping this Lusduna Nexvue insulin.
Sanofi's Humalog Copycat: This would be a follow-on insulin in the short-acting category, basically based on Lilly's lispro (ie Humalog) first approved in the USA back in 1996. Sanofi is developing this drug that it calls Ademlog, and it pursuing regulatory approval in Europe. We don't know what the FDA submission timeline looks like, but some say by the end of 2017 is when we might see this here in the States. This would bring us a meal-time option rather than the basal insulins that many are starting out with. (UPDATE: FDA approved Admelog in December 2017.)
Biocon and Mylan: OK, this one is actually scary in reference to the whole EpiPen pricing debacle... Biotech firm Biocon has been working on biosimilar insulins for years now, originally in partnership with Pfizer until they opted out. For the past three years, Biocon has been teamed up with EpiPen-maker Mylan with plans to make and sell three different types of biosimilar insulins -- a Lantus generic, a lispro Humalog generic, and an aspart Novolog version. The faster-acting versions are apparently in early stage or pre-clinical trial phases, while the Lantus generic is already submitted in Europe as of November 2016 and will likely be filed with FDA in the coming year. To date, we haven't seen any lawsuits from Sanofi on this one, but Mylan has a really bad repfollowing the EpiPen controversy. (UPDATE: In June 2018, the FDA rejected this biosimilar and Mylan is filing additional clinical data for the agency's consideration.)
Big Changes in Pricing and Insurance Coverage?
The latest research on biosimilar pricing shows that we’ll see early discounts, but it won't lead to immediate market changes in overall pricing anytime soon. Dr. Lutz Heinemann, a San Diego-based expert on this front, says that based on findings from his , he believes price reductions may be 10%-40% overall -- much lower than the reductions of 80% seen for most generic medications.
"I do see biosimilars taking over a good portion of the insulin market sooner rather than later, because of the increase in prices in the U.S.," he said. "But (based on what we've seen) in other parts of the world as to pricing, there is no drastic change to be expected.”
Lilly Diabetes tells us the list price of Basaglar will be $316.85 for a pack of 5 pens, and that on a per-unit basis, this represents a 15% discount over Lantus and Toujeo, a 21% discount over Levemir, and 28% discount over Tresiba.
Per Lilly spokeswoman Julie Williams: "This list price discount is consistent with those of other follow-on biologics, including biosimilars relative to their reference products, recently introduced in the U.S. health care market."
Obviously, Your Insurance May Vary. With most people paying a fixed co-pay for medications, and others paying a co-insurance percentage, exact costs are tough to predict.
Note that just a few days ago on Dec. 13, Lilly announced a new discount program starting Jan. 1, 2017 called the Blink Health Insulin Patient Access Program. This works through the Blink Health online and mobile app platform, offering a 40% discount on all Lilly insulins, including Basaglar. This is a partnership with Express Scripts, which seems clear to many was a move to avoid the kind of uproar that resulted from Mylan’s EpiPen pricing models.
Again, since insurance coverage varies, the discounts offered will help some patients more than others. What the program does offer all is a first-of-its-kind price-comparison resource for insulins, helping you choose whether your best option is to go through your insurance or just pay the discount price out-of-pocket.
Hey, options are great, no?
But What If You Don’t Want Generic?
Our D-Community was all abuzz earlier this year when headlines hit about Express Scripts changing its basal insulin coverage due to Basaglar, and how both CVS Health and United Health would be cutting out both Lantus and Toujeo from Sanofi in favor of this new follow-on generic.
In August, FirstWorldPharma quoted CVS Health Chief Medical Officer Troyen A. Brennan, saying, “We want to signal that this biosimilar movement is real. We have big hopes for [biosimilars] to reduce drug costs over all.”
According to that article, Brennan suggested that biosimilars are typically priced 10% to 15% cheaper than the original products, although CVS Health negotiates additional discounts on top of that.
A CVS Health spokeswoman told us that despite Lantus being removed, “a formulary exception process is in place for access to non-formulary drugs when medically necessary.” So in other words, you can still get Lantus if you want it, you just have to fight a bit more for it. That spokeswoman tells us drug formulary decisions are based on published guidelines from credible medical associations, as well as from an independent Pharmacy and Therapeutics (P&T) Committee made up of health care providers from outside CVS Health. We pressed for more detail, but didn't get any.
PBM giant Express Scripts tells us they haven't completely dropped brand names Lantus, Levemir, Toujeo or Tresiba for 2017, but may revisit that decision after Basaglar launches.
"This been a difficult class for pharmacy benefit managers to do what we do well in other classes, which is pitting similar competing products against each other and driving down cost. Insulin's been trickier," Express Scripts' former spokesman David Whitrap told us a couple of months ago, before leaving his role as the PBM's corporate communications director.
"But now with Basaglar there's more of an opportunity, and that's why we kept Lantus and the others on there -- to help drive down cost. We can still leverage competition to get better pricing on those products, so if patients want to stay on their ultra long-lasting insulin, they can stay on that."
Overall, he says the goal in creating a "preferred" formulary list is to include medications that work for a vast majority of patients a majority of the time. It's supposed to be a starting point based on economics, but those "exceptional patients" who need a higher-cost or different drug should still be able to access it.
"The rub is when it becomes a difficult process for patients and physicians, in those exceptional cases, to get the drug they need," Whitrap said. "That's where we are trying to roll out programs that improve the Express Scripts prior authorization electronic system, for immediate notification of coverage so they can appeal in the moment of prescription -- so that it's not a back and forth over days."
“It just doesn't make sense when one manufacturer isn't willing to make a product more affordable, and so for us it doesn't make sense to point a majority of patients toward that higher-priced product," Whitrap added.
We see the logic there, since diabetes is a business... but we can't help but wonder who's actually pulling the strings here and what will change with the introduction of biosimilars? Hmmm.
What Took So Long?
Skeptics and conspiracy-theorists can rant about profit-hungry and greedy execs all day long, but there is no doubt that Patent Expiration and the complicated, expensive Manufacturing Processes for making safe and effective insulin have been driving factors holding back the emergence of generic insulin.
It also doesn't help that Big Insulin doesn't hesitate to toss lawsuits into the mix to stop others from copying their money-making insulins (as noted above, re: Sanofi).
Now that we're finally getting biosimilars, there's no real way to know how long it will take this “follow-on” trend to fully materialize, or who the key players will be. According to out D-blogging friend Scott Strumello, who’s been following this issue closely for more than a decade now, the prevailing thought for many years was that smaller, unknown biotech companies would emerge to fill this gap. Eyes were on the Sandoz unit of Novartis, Elona Biotech (founded by two former Lilly execs) and Teva, a pharmaceutical company that invested in research for a compound called DiaPep277, but that was halted in late 2014.
Now the big Pharma players are hitting the market first, despite independent efforts like the open-source insulin project in the works.
"We couldn't predict who it'd be coming from. I thought it would be smaller new players, but it's turned out to be Big Pharma," Strumello says. "That changes the dynamic from the payers' perspective, as they aren't buying this insulin from a nobody, but from a Lilly or Merck. From their POV, the products are all the same and it comes down to how much money it’s going to save them."
Strumello says the focal point here really is the financial interests of insurers and Pharmacy Benefit Managers, and he wonders whether patients will actually see much of the savings through discounts.
"I'm not sure it will be a revolution, as we've seen with other generic medications. But it will probably amount to some smaller change as to pricing. We see signs on the wall for a change in the insulin market, but we’ll just have to wait see what happens,” he added.
A New Insulin Era
We can’t help believing that our Diabetes Community is indeed witnessing a seismic shift in insulin options – maybe even akin to the shift in the early 80s from animal insulin to synthetic human insulin, and in the 90s to analogs.
This includes the broader context of new forms of insulin: inhaled Afrezza, now available and fighting to survive, and the various types of ultra-fast-acting and “smart” insulins in development, and Novo's faster-acting FIAsp insulin that that hopefully aren't too far off into the future.
Whatever happens next as to insulin products, it seems clear that we stand at the dawn of a new era.