Sunday , November 19 2017
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Missing the Point

david_kliffFriend of Diabetes in Control and frequent guest author David Kliff, Diabetic Investor, shared his views on some of the news coming out of EASD. As always, his ideas are thought-provoking. We reached out to some of our Advisory Board members to get their responses to David’s piece, and they provided additional strong viewpoints for your consideration.

According to a company issued press release: “Sanofi announced today that adults with type 2 diabetes treated with Toujeo®(insulin glargine 300 Units/mL) experienced a consistently lower rate of confirmed or severe hypoglycemia both at night and at any time of the day compared with those treated with Lantus® (insulin glargine 100 Units/mL), at all levels of HbA 1c<(average blood glucose over the previous three months) achieved at month 6. The results of this new patient-level meta-analysis from the EDITION 1, 2 and 3 Phase 3 clinical trials in patients with type 2 diabetes were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.”

Another:

“Novo Nordisk today presented data showing the odds of reaching fasting plasma glucose (FPG) targets without hypoglycaemia and weight gain were significantly greater for Xultophy® (IDegLira) compared to up-titration with insulin glargine U100 in adults with type 2 diabetes uncontrolled on insulin glargine U100 (20-50 units). Xultophy® is the first once-daily combination of a long-acting insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide) in Europe. Results were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.”

Yet another:

“Novo Nordisk today announced that semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, significantly improved glycemic control compared to placebo, as add-on to basal insulin alone or in combination with metformin, in adults with a mean type 2 diabetes duration of 13 years. Results from SUSTAIN 5 were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.”

kliff-callout-1-vinikAs I’ve noted before, an avalanche of data is coming out of EASD. Only problem is all the data in the world won’t solve the problems faced by every diabetes drug company. Diabetes drugs have become a commodity and with few exceptions nothing is going to change this fact. Look at the three studies – Toujeo is one of 5 — count them: 5 — long-acting insulins available. Xultophy is one of 2 GLP-1/insulin combo’s. Semaglutide is one of 4 long-acting GLP-1’s.

Also, these companies continue to stress the wrong issues. This fascination with hypoglycemia has got to end. We all know that hypoglycemia is a serious, potentially life-threatening event. Yes, it’s an economic issue too, as it can cause a costly emergency room visit. Yet, it is also true that when a
kliff-callout-3-schwartzpatient is well-trained on insulin therapy there is a lower incidence rate of hypoglycemia, no matter which insulin they use. It is also true that even the most diligent patient, well trained in insulin therapy, experiences hypoglycemic events. Factors beyond insulin dosing impact hypoglycemia and these factors cannot be controlled.

Now if these companies really want to prove a point, then why not prove that their particular drug is not a commodity? Problem is they can’t. Look at the 5 long-acting insulins: lay the data side by side. Better still, blind the names of the drugs, lay the data side by side, and then pick one. Even better ask this question: would a patient be adversely impacted using one over another? Payors have already answered this question and the answer is, when it comes to long-acting insulin, price is what matters, as the 5 all do the same thing the same way.

kliff-callout-2-campbellNovo is about to get a dose of this when semaglutide gets approved and faces 3 other long-acting once-weekly GLP-1’s. Semaglutide may have a better delivery system but payors don’t care about that. Payors care about price.

Drug companies need to realize that coming out with drugs that are only incrementally better than the drugs they are supposed to replace is not a winning strategy. Payors aren’t going to provide favorable formulary position or premium reimbursement for these drugs. Payors hold the keys to the kingdom, and unless drug companies develop something truly innovative payors will continue to hold the upper hand.

Lilly is a good example. They know that lean and mean is the order of the day; that it’s better to have a complete portfolio of drugs and force the competition to play defense. Sure, they too will publish studies that cover the same ground, but their tactics differ from those used by Novo and Sanofi. Lilly is playing hardball and using a very heavy bat. They are not afraid to use outcomes-based contracting or price as weapon.

While Novo and Sanofi are trying to compete on study data, Lilly is competing on the only playing field that matters – price. Everything else frankly misses the point.