When Novo Nordisk enters talks with US payers during the launch of its next major diabetes product, it will do so fully armed. The Danish group reported that its once-weekly phase III GLP-1 agonist semaglutide reduced cardiovascular events when added to other standard of care treatments, a finding that could allow it to argue for a premium price.
If semaglutide is launched on schedule next year, it could now come with the cardiovascular benefit on its label, something that Lilly’s once-weekly incumbent Trulicity might not be able to claim until 2019. Semaglutide’s entry into the once-weekly space should inaugurate a spirited competition, and with the Lilly product having a three-year headstart Novo needs every edge it can get.
Novo shares rose 2% to DKr369.70 in afternoon trading today after the announcement that the Sustain 6 trial showed that patients taking semaglutide had statistically fewer cardiovascular deaths, heart attacks or strokes than those taking placebo. Enrolees in both arms were taking a backbone of standard of care glucose-lowering medications.
The group did not disclose many specifics beyond meeting the primary endpoint of non-inferiority and achieving the statistically significant reduction in cardiovascular events in the 3,300-patient trial – 250 events were recorded. With the American and European diabetes scientific meetings approaching in June and September it seems probable that more information will be available there.
The result is not necessarily a surprise given the similarities between Novo's once-daily drug Victoza and semaglutide and the former’s success in its own outcomes trial earlier this year (Leader could give Novo pushback power in payer wars, March 4, 2016). Semaglutide incorporates changes designed to improve the molecule’s binding to albumin and the GLP-1 receptor.
|Novo Nordisk's semaglutide phase III programme|
|Sustain 1||387||NCT02054897||vs placebo in treatment-naive patients|
|Sustain 2||1,200||NCT01930188||vs Januvia as an add-on to metformin and/or TZD|
|Sustain 3||813||NCT01885208||vs Bydureon as add-on to 1-2 oral antidiabetic drugs|
|Sustain 4||1,089||NCT02128932||vs Lantus as add-on to metformin, with or without sulfonylurea in insulin-naive patients|
|Sustain 5||397||NCT02305381||vs placebo as an add-on to basal insulin, with or without metformin|
|Sustain 6||3,297||NCT01720446||Long-term cardiovascular outcomes trial|
Still, the study was needed as it is vital that cardiovascular safety at a minimum is proven with drugs aimed at diabetics – their numbers and their risks of heart disease and stroke had made this an FDA imperative. But, with other agents like Jardiance setting a very high bar by showing that they can reduce these events, new agents need to be able to match this if they wish to remain competitive (Cardiovascular radiance for Jardiance, August 21, 2015).
What the market will bear
Competition has taken its toll on Novo. Its relationship with the biggest US pharmacy benefit manager, Express Scripts, has been tense for three years, with the payer having shut out premium products like Victoza, Novolin and Novolog. The new long-acting insulin Tresiba is covered, but is on a “non-preferred” tier with greater patient cost-sharing.
Thus the showing of a cardiovascular benefit for Victoza was an opportunity for Novo to push Express Scripts on price, whether or not executives would explicitly say so. First of all, it was the first GLP-1-modulating drug to achieve this accolade. Secondly, in averting hospitalisations resulting from myocardial infarctions and strokes Novo can plausibly argue that Victoza can reduce costs for health insurers, justifying a higher price.
In the case of semaglutide, having cardiovascular data before negotiations even start could pay dividends. Differentiation will be essential as diabetes becomes an ever-more-crowded space.