Sanofi has turned to one of its own to take the reins of its global diabetes and cardiovascular business. Stefan Oelrich, who’s been leading that operation in North America since July, is moving up to an EVP slot on the French drugmaker’s executive committee, replacing Peter Guenter, who left last month.
Oelrich will have a tough task ahead. It’s been a rough couple of years for that business, as competitive pressures and increasingly tough reimbursement gatekeepers have put a damper on diabetes growth, and the company’s top cardiovascular launch, the cholesterol drug Praluent, ran into unexpectedly high barriers.
The new appointment also marks a third executive turnover at the top of Sanofi's diabetes and CV business in just over two years. Oelrich replaces Guenter, who left Sanofi last month to take up the CEO post at the Spanish drugmaker Almirall. Guenter himself replaced Pascale Witz, who departed last May after running that business since mid-2015.
Those challenges remain, but Oelrich contends that Sanofi is girded for competition—and not just on pricing. "Beyond just competing on rebates, you still want to also to compete on value, and that value is exemplified by clinical differentiation," he said in an interview last month. "It's going to even be a criteria just to preserve the volumes, not just your prices."
Indeed, two developments this week underscore the challenges Sanofi and its fellow diabetes drugmakers face—as well as the continuing obstacles to Praluent and head-to-head rival in the PCSK9 class, Amgen’s Repatha.
UnitedHealth, one of the biggest insurers in the U.S., rolled out its 2018 formulary with some bad news for Sanofi and Novo Nordisk: Lantus, Sanofi’s long-dominant basal insulin, and the company’s follow-up launch Toujeo, both were excluded from that coverage list in favor of Basaglar, the Lantus biosimilar rolled out by Eli Lilly and Boehringer Ingelheim last December. UnitedHealth also excluded Novo’s Tresiba, the Danish drugmaker’s own longer-acting basal insulin.
Those exclusions come even as Sanofi and Novo have been racking up new data backing up Toujeo and Tresiba safety in head-to-head trials against Lantus, including new studies rolled out at last month's European Society for the Study of Diabetes meeting. And in a convergence of Sanofi's diabetes and cardiovascular streams, Praluent also totted up new numbers at EASD showing its benefits specifically for people with diabetes.
Basal insulins aren't the only big category in diabetes, however, and Sanofi is in the midst of launching its GLP-1 drug Adlyxin in the U.S., along with a combination med, Soliqua, pairing Adlyxin with Lantus. In partnership with Lexicon, the drugmaker is bringing along an SGLT1/2 drug, sotagliflozin. It would compete with the SGLT2 drugs already on the market, including Eli Lilly and Boehringer's Jardiance, which now has an FDA approval for reducing CV risks.
Meanwhile, a JAMA Network article last week added more stats showing that PCSK9 drug prescriptions just aren’t getting filled. At launch, payers raised serious hurdles, requiring patients to try maximal statin doses and, often, add-on therapy with Merck & Co.’s Zetia, which fights cholesterol in a different way.
That extra paperwork—plus high out-of-pocket costs for the drugs, with list prices more than $14,000 and net prices in the $8,000 range—deterred physicians and patients to the point where, in the first year after launch, only 47.2% of patients prescribed the drugs won insurance approval, and of those, more than one-third never filled the scripts at the pharmacy. Patients’ share of the costs are typically based on list prices, rather than the discounted costs paid by their insurance.
Those figures follow a study presented by Amgen at the American College of Cardiology meeting in March. Some 83% of PCSK9 scripts were rejected by insurers on the first try, with 43% approved with a second round of paperwork. That translated into an overall approval rate of just 43%.
And all this is complicated by the fact that Amgen's Fourier failed to wow market-watchers when detailed data were presented in March. That outcomes study showed Repatha delivered a cardiovascular benefit, and Amgen has since asked the FDA to update the med's label as such, but analysts suggested the data wasn't impressive enough to make a huge difference in uptake.
Praluent's trial is designed differently, though, and Sanofi is hoping that the Odyssey Outcomes data—due next year—will turn up better numbers on cardiovascular benefits. If so, that could give the PCSK9 med a boost. In the meantime, however, Praluent has to survive a patent challenge from Amgen, with an appeals court decision due any day.