Physician Views – Sanofi secures US Toujeo approval, but are endocrinologists convinced?
As expected, Sanofi's incoming CEO will have a shiny new product franchise to launch when he takes the helm in April. The French company confirmed on Wednesday that Toujeo – a more potent version of its $7 billion-a-year Lantus franchise – has been approved by the FDA and will reach the US market in Q2.
Olivier Brandicourt and his team have some interesting decisions to make, however. Versus previous suggestions from Sanofi that Toujeo may be priced at a premium to Lantus, labelling approved by the FDA provides no mention of a nocturnal hypoglycaemic benefit for Toujeo.
Such a distinction, although not statistically significant, was demonstrated in Phase III head-to-head clinical studies and Sanofi may be able to leverage data published in medical journals to support its marketing effort, suggested analysts at JP Morgan. Furthermore, labelling for Toujeo reflects the ""lack of significant weight"" that the FDA places on nocturnal hypoglycaemia, they add, which could prevent Novo Nordisk's Tresiba from gaining such a claim in the future.
This appears to be little consolation in the view of other analysts, however. Analysts at Bank of America Merrill Lynch described Toujeo's label as ""weak"" but in line with their bearish expectations, while those at Bernstein suggested the label was less differentiated than most investors had expected.
Launch of Toujeo will be watched with great interest, given Sanofi's recent need to cut prices to retain share for Lantus and the expected launch of Novo Nordisk's Tresiba and Eli Lilly/Boehringer Ingelheim's biosimilar Lantus over the next few years, which are expected to further increase the competitiveness of the market and could stoke a price war similar to that witnessed in hepatitis C.
Confirmation that Eli Lilly has postponed regulatory submissions for its branded basal insulin peglispro has also upped the ante, by potentially providing more rationale for biosimilar Lantus to be priced at a greater discount (ViewPoints: Delayed or departed? – the fate of Eli Lilly's peglispro and implications for its biosimilar Lantus launch).
These factors will certainly shape the pricing strategy for Toujeo, with Sanofi now faced with the challenge (given its label) of convincing not only patients and physicians of its attributes, but also payers, warned Bernstein's Tim Anderson. While Sanofi will not disclose the price of Toujeo until launch, Anderson argues that a 15 percent discount versus Lantus will be necessary to gain traction with payers.
Reasons to Purchase
With Toujeo now approved, we are polling US-based endocrinologists to ascertain how they anticipate using the product and how they expect it to perform. Specifically we are asking them…
Labelling for the newly approved basal insulin Toujeo (insulin glargine; provides no mention of a nocturnal hypoglycaemia benefit versus Lantus (it states ""there were no clinically important differences in hypoglycaemia between Toujeo and Lantus in Type 1 diabetes patients""). This eliminates the primary point of differentiation for Toujeo versus Lantus.
Neither agree or disagree
Toujeo requires one third of the injection volume to deliver the same number of insulin units as compared to Lantus and has effectively demonstrated non-inferiority in terms of efficacy. In your opinion, what level of advantage does Toujeo provide over Lantus?
Very significant advantage
What proportion of existing Lantus patients would you anticipate switching to treatment with Toujeo by the end of 2015 (assuming a Q2 launch for Toujeo)?
Based on its label, what are you expectations for uptake of Toujeo over the next few years?
Based on your assessment of Toujeo versus Lantus, what is your view on how Toujeo should be priced (in order to support moderate uptake)?
Toujeo should be priced at a premium to Lantus – it is a superior product