Express Scripts Says Novo Insulin Data Not Convincing Enough

  • Novo seeking preferred status for Tresiba on formulary
  • Eli Lilly's forthcoming cheaper copy of Lantus looms large

The studies Novo Nordisk A/S conducted to win better coverage for its newest insulin Tresiba aren’t convincing enough to sway Express Scripts Holding Co., the largest U.S. manager of prescription-drug benefits.

Express Scripts designates Tresiba as a “non-preferred” option available on a higher co-payment tier than Sanofi’s best-seller Lantus and other insulins. It won’t be easy for Novo to improve that positioning, even though two studies have shown its long-acting insulin shot works better than Lantus in reducing the number of dangerous episodes of low blood sugar known as hypoglycemia.

“While I’m not going to tip our hand as to what we’re going to do, we find these data important, but not important enough that they will dictate a decision,” Steve Miller, chief medical officer for Express Scripts, said in a phone interview Wednesday.

Express Scripts has conducted its own studies with other methods that have produced better results in cutting down hypoglycemia episodes than Novo’s trials, Miller said. Those include using wifi-enabled blood glucose meters that allow specially trained pharmacists to continually track patients and address problems in real-time. That approach to diabetes care has benefited patients regardless of the type of medicine they use, he said.

Pricing Pressure

Novo is counting on Tresiba to boost sales and resist pricing pressure from payers. Sales of the drug may reach $2.5 billion by 2020, according to analyst estimates compiled by Bloomberg. The Danish drugmaker has said the recent studies, dubbed Switch 1 and Switch 2, will support discussions it will have with payers. Novo declined to comment today.

Novo fell 2.6 percent to 356.40 kroner in Copenhagen. The stock has returned 15 percent in the last year.

Tresiba is one of several new drugs from companies including Sanofi and Eli Lilly & Co. for diabetes, which is the most expensive category of prescription drugs for U.S. payers, according to Express Scripts.

One of the most anticipated developments in the diabetes market is the expected U.S. entry in December of Basaglar, Eli Lilly’s cheaper copy of Lantus, an insulin glargine, which also poses a threat to Tresiba and other competing products.

Contract Options

“A lot of patients may be able to get away with what’s currently on the market that’s going to come down in price,” Miller said. “We’re very excited about how this is going to evolve in the near future.”

That could mean an exclusive contract for one insulin glargine, which is “always an option,” depending on whether the payer can come to agreement with multiple drugmakers on affordable prices, he said.

Sanofi in October said diabetes sales will probably drop 4 percent to 8 percent through 2018 as revenue from Lantus, an injected insulin, slumps and more patients turn to oral alternatives.

Novo is expected to announce data this month from another trial of more than 9,000 patients testing its Victoza diabetes medicine for heart safety. While Victoza is the market leader among drugs known as GLP-1 analogs that stimulate insulin production, it’s currently excluded from Express Scripts’ formulary. If the study shows a cardiovascular benefit from Victoza, that will influence Express Scripts’ decision on the drug, Miller said.

In pricing negotiations for diabetes drugs in general, manufacturers, particularly those based in Europe, are showing more flexibility and realism than in the past, with discussions occurring earlier in the process, he said.

“They under-appreciated our ability to move market share several years ago,” Miller said. “Now, all of the leadership teams have come up to speed on that.”

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