Sanofi’s Soliqua (insulin glargine/lixisenatide) launches in US pharmacies – January 4, 2017

Sanofi announced today that Soliqua (Lantus/lixisenatide) is now available in US pharmacies, following the FDA approval of the fixed-ratio basal insulin/GLP-1 agonist combination in November 2016. According to the company’s news release, Soliqua will be listed at $127 for a 300-unit SoloStar pen, which corresponds to $19.90 per day assuming an average dose of 47 units. Sanofi had previously released its early pricing strategy, in which the company shared that the new combo therapy would be priced on par with currently available GLP-1 agonists (~$20-25/day). We greatly appreciate the impact of this pricing strategy on improving access to this new combination class and we’re glad to see Sanofi follow through on a price that will also enable easy comparisons to other “single” therapies. This new class of combination agents – which includes Soliqua as well as Novo Nordisk’s recently-approved Xultophy (Tresiba/Victoza) – has shown compelling glucose-lowering efficacy, weight loss efficacy, and a milder side-effect profile than basal insulin or GLP-1 agonist monotherapy. Two injectable medicines in one means a lower injection burden for patients – and a single copay versus two – and potentially synergistic results from the combo. Plus, Soliqua and Xultophy lead to a lower required insulin dose for patients, and could thus lower total “system” prescription drug expenses for people with diabetes. What this all boils down to is that there is enormous potential for Soliqua and Xultophy to improve diabetes care and to make diabetes management easier and more effective for patients and providers. We see more than enough room for both Soliqua and Xultophy to be successful on the market; Novo Nordisk is using a more potent insulin in its combo and has two consistent 24-hour compounds, unlike Lantus/lixisenatide. That said, both combos have very positive phase 3 data, so the question for us is less about how they compare to each other and more about how they both compare to single-agent therapy.

Notably, Xultophy has not yet been officially launched in US pharmacies, and Novo Nordisk’s early pricing strategy suggested that the product would be listed at a premium (closer to ~$31/day depending on dosing – there has been a lot of disagreement about this, but it’s the cost of a GLP-1 plus the cost of Tresiba minus 20%). We’re eager for more cost information and the launch plans for Xultophy. Basal insulin/GLP-1 agonist combinations are included in the ADA’s 2017 Standards of Care as part of the algorithm for combination therapy – we’re thrilled to see these products incorporated into clinical diabetes care, and we look forward to real world outcomes data which will hopefully confirm the clinical trial data (we feel more than confident that they will, and may even be better than phase 3 data due to “real world” benefits). For more, see our recent coverage of the Soliqua and Xultophy FDA approvals (both drugs were approved within hours of each other on the same afternoon!) and our report on Sanofi’s and Novo Nordisk’s pricing plans. Stay tuned for Kelly’s test drive of Soliqua on diaTribe.org soon now that it has officially hit the market in the US – she’ll be taking it off label and picks up her pens Friday!

-- by Payal Marathe, Helen Gao, and Kelly Close