Leader could give Novo pushback power in payer wars

Over to you, Express Scripts. Novo Nordisk’s announcement today that its diabetes injection Victoza helps reduce cardiovascular events is new ammunition in a battle to get its third-biggest seller back onto the formulary of the largest US pharmacy benefit manager.

With competitors set to erode Victoza’s dominant market share Novo needed a win in the Leader trial to defend its position and argue for higher prices. The cardiovascular outcomes trial for the most significant threat, once-weekly Trulicity, might not read out for another three years, giving Novo time to capitalise on the findings.

“This will be quite an interesting discussion,” Novo's chief executive, Lars Rebien Sørensen, said of ongoing negotiations with Express Scripts during a conference call with analysts. Novo shares climbed 6% to DKr379 ($56m) in mid-afternoon trading.

Three-way benefit OK

The Leader trial in 9,300 patients showed that Victoza plus standard treatment was superior to standard treatment alone on a composite measure of myocardial infarction, stroke and death. Novo disclosed little else, saving full results for the American Diabetes Association meeting in June.

Some insight was provided by its science chief, Mads Krogsgaard Thomsen, who said the benefit resulted from improvements in all three aspects of the composite measure. This is a departure from the benefit shown by the SGLT-2 inhibitor antidiabetic Jardiance, which won on a composite measure thanks to prevention of cardiovascular death, but did not show significance on non-fatal strokes or heart attacks (EASD – Lilly blooms with full Jardiance outcomes data, September 18, 2015).

Mr Thomsen speculated that the SGLT-2’s diuretic effect helped prevent sudden death in diabetes patients with heart failure in Empa-Reg Outcomes – whereas Victoza's effect on blood sugar might have a broader impact on heart disease.

The results make Victoza the first GLP-1 to show superiority to standard treatments on cardiovascular measures. The first test was with Lyxumia, which showed non-inferiority but not superiority in the Elixa trial (Lyxumia data good enough for approval, but that’s it, December 4, 2015).

Regardless of whether a new product has any hope of showing a cardiovascular benefit, diabetes drugs must usually now undergo an outcomes trial because regulators want to rule out risk because they are taken by so many patients. Lyxumia is due an FDA approval decision by mid-2016.


The Leader findings should open a new chapter in the long-running Novo vs Express Scripts saga. The big PBM first knocked Victoza and other premium diabetes products like Novolin and Novolog off its national formulary in 2013, and all three are on the excluded list in 2016 (Another prize slips through Novo’s hands as big PBM looks elsewhere, Sepember 4, 2013).

Long-acting insulin Tresiba is on a non-preferred tier, requiring patients who want it to pay more out of pocket. Yesterday, Bloomberg quoted Express Scripts' medical chief, Steve Miller, as saying the data on Tresiba were not persuasive enough to put it on the same tier as Novo’s Levemir or Sanofi’s Lantus; on the other hand, he told the news service that the Leader results could influence its views on Victoza.

Novo said it was unable to speak directly to Express Scripts because of off-label marketing prohibitions, but Mr Miller is able to read press releases and medical journals. Physicians treating Express Scripts covered diabetics at high cardiovascular risk, meanwhile, could begin asking pointed and uncomfortable questions of the PBM.

It might not necessarily be enough for Express Scripts to pay Novo’s asking price, but it should be enough to get to a begrudging and discounted yes.

Trial name ID
Leader NCT01179048
Empa-Reg Outcome NCT01131676
Elixa NCT01147250

To contact the writer of this story email Jonathan Gardner in London at [email protected] or follow @ByJonGardner on Twitter

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