Novo Nordisk’s global lead in offering a combined insulin plus GLP-1 product will be nonexistent in the world’s biggest drug market. The US FDA’s simultaneous approval of Novo’s Xultophy and Sanofi’s Soliqua sets the stage for head-to-head launches in early 2017.
As agents entering a crowded diabetes space, the price dimension has already emerged, with both companies pledging that their blended products will not cost as much as separately prescribed insulin and GLP-1. As growth drivers both look modest at best, as both Xultophy and Soliqua expansion will come at the expense of other diabetes drugs in the Novo and Sanofi portfolios.
Xultophy, a combination of the long-acting insulin Tresiba and GLP-1 Victoza, was launched in Europe in 2016 and is forecast to bring in $57m in sales this year, making it Novo’s 16th-largest product. By 2022 those figures rise to $1.4bn and seventh-biggest, slightly ahead of the human insulin and devices franchise.
For Soliqua, formerly known as LixiLan, this US approval is its first, with a European nod also expected as it has a positive recommendation from a European Medicines Agency advisory committee as Suliqua. The combination of long-acting insulin Lantus and GLP-1 Adlyxin will add $951m in sales in 2022, making it Sanofi’s 15th-biggest product.
These products offer patients a way to improve their control of blood sugar – in many cases these will be patients already taking either single-agent insulin or GLP-1 who are in need of an intensification strategy. Bernstein analyst Ronny Gal estimates that 20% of GLP-1 patients are also separately taking insulin; they may very well see the advantage of a single injector pen, along with a single co-payment.
Revenge of the payers
Had Xultophy and Soliqua been launched four or five years ago, this advantage might have been sufficient to claim premium pricing and serve as leverage to drive up sales. Unfortunately for the companies, the tough payer line in diabetes has made such a strategy impossible.
Novo says Xultophy's wholesale acquistion cost (WAC) will be a 20% discount from the combined WACs of the two products. For comparison US federal supply schedule prices, which offer a discount off WAC, are for the Tresiba 100 units/ml pen $401.48 and for the Victoza 6mg/ml pen $313.79. Novo no doubt will be offering payers additional discounts off the Xultophy WAC.
Nordea analyst Michael Novod wrote that Sanofi would price Soliqua on a par with marketed GLP-1s. While Adlyxin has not been on the US market long enough to gain any insight on its price, EvaluatePharma’s estimate of per-pen prices of other GLP-1s include Trulicity’s $289.51 and Tanzeum’s $105.84.
If this is the case Sanofi sees that it could take market share on price. With the usual caveats about across-study comparisons, Xultophy and Soliqua do not look much different, with similar percentages of patients inadequately controlled on a long-acting insulin (57.3% vs 55.1%) beating a target level of 7% HbA1C in a head-to-head test against a long-acting insulin.
Nevertheless, this is a fight over the scraps of the diabetes market – neither one will crack the top 10 type 2 diabetes products in 2022.
|Top sellers in type 2 diabetes|
|Global sales ($m)|
|1||Victoza||Novo Nordisk||GLP-1 agonist||3,029||3,634||3,813||3,736|
|2||Invokana||Johnson & Johnson||SGLT2 inhibitor||1,682||2,328||2,764||3,229|
|3||Jardiance||Boehringer Ingelheim||SGLT2 inhibitor||386||1,283||2,209||3,068|
|4||Trulicity||Eli Lilly||GLP-1 agonist||807||1,731||2,394||2,975|
|5||Januvia||Merck & Co||DPP-IV inhibitor||3,980||4,058||3,931||2,791|
|8||Tresiba||Novo Nordisk||Insulin analogue||411||941||1,500||2,007|
|9||NovoRapid||Novo Nordisk||Insulin analogue||2,355||2,285||2,120||1,960|
|10||Janumet||Merck & Co||DPP-IV inhibitor & biguanide||2,212||2,252||2,219||1,803|
|12||Xultophy||Novo Nordisk||GLP-1 agonist & insulin analogue||57||482||976||1,406|
|19||Soliqua||Sanofi||GLP-1 agonist & insulin analogue||3||254||615||951|