Its already mid-2016, and for nearly the past decade, I've been pushing for so-called "biosimilars" or "follow-on biologics" like insulin to be legalized and then introduced in the U.S. (I first investigated this issue back in 2006, and published an article on it in January 2007). The reality is that without any form of generic competition, prices continue to rise with absolutely nothing to stop them. In recent years, there have been some hyper-aggressive price-increases from the insulin oligopoly, especially within the last 3 years or so. The reason: they all KNOW that their insulin analog patents are about to expire soon, so they've made a shameless money-grab with huge price increases before that happens. The retail cost of a vial of insulin is now over $125 a vial, and that's for old varieties like Regular or NPH which have been on the market for like 95 years. I haven't even bothered to price insulin analogs!
The Affordable Care Act (a.k.a. "Obamacare") finally legalized biosimilar medicines in the U.S. Before that, there was a lot of complaining and bellyaching from pharmaceutical and biotechnology companies that there was no regulatory pathway, which was only true for some newer biotech medicines. Because insulin was the very first biotech medicine ever approved by the FDA, its grandfathered under the law as a "small-molecule" drug (along with human growth hormone, another very early-generation biologic medicine), so there was no legal impediment for biosimilars. Consider the case of a very early biosimilar version of human growth hormone known as Omnitrope, which was approved on June 1, 2006, several YEARS before the Affordable Care Act was passed into law on on March 23, 2010 and later implemented in 2011.
The industry bellyaching was more excuses than anything else as far as insulin was concerned. Frankly, there just wasn't very much incentive from pharma to pursue biosimilar insulin products like Regular and NPH because most American patients were already being switched to more expensive, patent-protected insulin analogs. But its now fair to presume that this particular money tree has just dropped its last leaf for the likes of Lilly, Sanofi and Novo Nordisk. The real question is how patients with diabetes will be impacted?
On Monday (August 2, 2016), Express Scripts notified (see HERE for the news) its PBM customers that starting in 2017, 85 medicines would be excluded from its national formulary, and, as a result, that company anticipates about $1.8 billion in savings, up from $1.3 billion in 2016.
CVS Caremark wrote to its PBM clients "CVS Health is taking a stand against egregious drug price increases that unnecessarily add costs for clients and their members. On a quarterly basis, products with egregious cost inflation that have readily available, clinically appropriate, and more cost-effective alternatives may be evaluated and potentially removed from the formulary."
There was some murmur from people with diabetes about another choice being taken away from them, especially since formularies have become ever more aggressive in pursuit of lower prices for "therapeutically equivalent" medicines in recent years. For example, over the last 7 years, my employer's insurance company PBMs have switched from Lilly Humalog (U-100 insulin lispro rDNA origin) to Novo Nordisk Novolog (which known as Novorapid in many other markets, but is U-100 insulin aspart rDNA origin) back to Lilly, back to Novo Nordisk, and back to Lilly over a few years. I just got tired of routine switching to similar, but not identical, insulins that require new ratios and testing to make the switch to a new brand of insulin happen (insurance fights to give me any more test strips as it is). True, one of the brand switches involved a switch to new insurance carrier, but the point was that I was being treated like a ping pong ball, and I grew tired of routine annual switching to save the insurance company money while my co-pays go up, so I pushed my endo to challenge the switch to slow-mo-log (slow motion from Novo), and after a few appeals, I did manage to get my way. But that should not have happened, what doctors prescribe is supposed to based on medicine, not necessarily costs unless patients have a need.
I made a number of comments to the FDA on labeling and the like when the docket opened for biosimilars a while back, and I think FDA has tried to incorporate patient concerns into its final guidance. But the business environment is something FDA has very little control over. The CVS Caremark move to drop Sanofi's Lantus from its 2017 formulary is an acknowledgement that big pharma has gotten a little too greedy with the price increases. I would add that market share leader Novo Nordisk has started paying a price for it.
When Novo Nordisk announced its earnings today (on August 5, 2016), the company's shares fell by 8% after Novo cut its forecast for 2017 full-year profit growth, and said it expected tough competition in the U.S. to pressure prices next year. As a point of reference, Novo Nordisk gets around half its revenue from the U.S.
Diabetic Investor David Kliff has been warning of this for several years, arguing in 2013 that:
"The insulin market, both short and long acting, is transforming itself into a commodity market where price trumps performance. The GLP-1 is also undergoing this transition albeit at a slower rate." He was also quite critical of Novo Nordisk management for naïvely believing that it could maintain very aggressive prices/price increases for its products faced with the genuine possibility of "generic" (biosimilar) competition for the first time.
Today, Novo Nordisk chief executive Lars Rebien Sorensen told investors "In the USA, the market environment is becoming increasingly challenging and contract negotiations for 2017 have reflected an intensifying price competition."
"Because of competition and biosimilar entries, we've had to increase our rebates to retain that level of access in the marketplace," Soerensen said by phone on August 5, 2016 (see HERE). "In reality, the only way you can insulate yourself from pricing pressures are by, long-term, introducing new and better products."
Meanwhile, rival Lilly, much as David Kliff told investors in 2013, anticipated that the insulin market was transforming into a commodity business, and in recent years, Lilly has aggressively competed on price to win a spot on various insurance company formularies ranging from Kaiser Permanente to United Healthcare. Previously, Lilly hadn't paid very much attention to insulin, and that lack of attention allowed rival Novo Nordisk to usurp Lilly insulin from so many insurance company formularies. But in December 2016, Lilly and its German partner Boehringer Ingelheim will introduce their own Lantus biosimilar (U-100 insulin glargine rDNA origin) branded as Basaglar.
Lilly isn't alone, either. Rival Merck (along with its South Korean partner Samsung Bioepis) will also introduce a Lantus biosimilar, too. Although they haven't yet come up with a brand name or logo yet, its Lantus biosimilar is now called MK-1293, which received the same FDA pre-approval as Basaglar did a a while ago (see the news HERE and HERE) and both Lilly and Merck's versions of Lantus are expected to compete aggressively with Sanofi's Lantus on price, hence CVS Health (Caremark) will have a few new choices for the best-selling insulin Lantus that it never enjoyed before. The thing is, these are biosimilars, which are better than "therapeutically equivalent" switches that insurance has routinely put patients through recently. But Lantus is merely the first and biggest insulin; products like Humalog, Novolog, Levemir and Aprida all face patent expirations soon.
Other potential competitors for biosimilar insulin include the Sandoz generics unit of Novartis, as well as Israeli drug giant Teva. Although I did not anticipate competition coming from fellow big pharma giants like Merck and Lilly, the day of biosimilar insulin will indeed be here in early 2017.
For me, the main issue is not who makes the insulin, but the insurance companies routine switching that is starting to get on my nerves!
Update, September 1, 2016: The news that Novo Nordisk's longstanding CEO, Lars Rebien Sorensen will retire early (at the end of 2016) was a direct result of pricing pressures mounting for the company (see HERE for more), as noted above. Novo is much more reliant on fat profits from the U.S. even though it operates worldwide, profits outside the U.S. are much smaller. The recent news is something of acknowledgement that the era of easy profits from the U.S. are going to be much harder in the future as large U.S. payers flex their muscles as described above.
Update, September 22, 2016: In addition to PBM CVS Health (Caremark), there was news today that United Healthcare will be dropping Sanofi's Lantus (U-100 insulin glargine rDNA origin) from its formulary (see the news at HERE for more detail). As the giants like CVS and United Healthcare drop costly insulin varieties, 2 possible responses could occur: either more follow suit, or Sanofi gets aggressive and lowers its prices.