Dive Brief:

• The Food and Drug Administration on Tuesday cleared Sanofi SA's Toujeo Max SoloStar, a delivery device for the long-acting insulin that the French drugmaker characterized as the highest-capacity pen on the U.S. market.
• Toujeo Max SoloStar holds 900 units of product, significantly more medication per pen that a typical insulin pen holds.
• Sanofi said the move to cram more product into the disposable prefilled pens may cut down on out-of-pocket costs by potentially lowering the number of times patients need to refill their prescriptions at a pharmacy.

Dive Insight:

For many patients, going to the pharmacy regularly can seem like a chore — and in the case of procuring insulin, sometimes an expensive one.

In what Sanofi says is an effort to help patients reduce drug costs and boost convenience, the company introduced Toujeo (insulin glargine 300 units/mL) Max SoloStar. The new device holds more insulin than standard pen, so patients theoretically would have to pay a copay less frequently than they might otherwise when picking up refills of a standard insulin pen.

Sanofi will also offer a copay card to patients. Eligible, commercially insured patients wouldn't have copay costs for their first three prescription renewals provided they are new to Toujeo. After that, they would have $10 copays for the next 12 refills, the French pharma said.

Sanofi spokesperson Ashleigh Koss said the company chose to keep the unit price the same to align with its pledge to boost transparency and keep patient costs under control. Last year, Sanofi announced it would keep price increases for its medicines at or below the national health expenditure growth projection calculated by the Centers for Medicare and Medicaid Services.

For Toujeo, the wholesale acquisition cost checks in at $235.73 per 3 mL pen, which works out to a daily list price of $11.79 assuming a patient uses 45 units per day.

For an adult living with diabetes taking that assumed amount of Toujeo each day, the older SoloStar pen would allow for 10 injections while the Max SoloStar pen would allow for 20 injections.

Considered a "next-generation insulin," Toujeo contains three times more insulin per 1 mL than the standard version of the medication. In December 2017, Sanofi determined from a head-to-head study that Novo Nordisk A/S' Tresiba (insulin degludec) and Toujeo had similar effects on blood sugar levels. Full results from this study will be presented later this year, Koss said.

Because insurance coverage differs and each plan may handle reimbursement differently, fewer copays does not necessarily mean that patients are paying less for Toujeo per year overall — it's possible the copay amount for Toujeo Max SoloStar could work out to be a higher amount than expected, even if it were paid less frequently.

But Sanofi says it is committed to making absolutely sure patients have access to Toujeo and its related drug delivery device.

"We continue to work aggressively to ensure Toujeo Max SoloStar is available to adults living with diabetes on a favorable tier that will minimize out-of-pocket costs. With the same net cost per unit as Toujeo SoloStar, Max SoloStar is anticipated to have the same coverage in each account," Koss said in an emailed statement.

As of today, added Koss, Lantus and Toujeo "have secured formulary access for 75% of the total covered lives," (number of commercial lives: 184 million in 2017 and 2018).

Toujeo Max SoloStar will become available in retail pharmacies across the U.S. starting in the third quarter of 2018.