- UnitedHealthcare to exclude Sanofi’s Lantus (insulin glargine) from formulary beginning April 1, 2017. Lilly/BI’s biosimilar insulin glargine Basaglar will be the preferred alternative.
- Access to basal insulins is increasingly difficult in the US, which likely does not bode well for potential access to upcoming GLP-1 agonist/basal insulin fixed-ratio combinations.
News out this morning from UnitedHealthcare on its 2017 formulary moving to Lilly/BI’s biosimilar insulin glargine Basaglar from Sanofi’s Lantus (insulin glargine); see UnitedHealthcare’s webcast on the decision (diabetes discussion starts at chapter 10, 3:43 into the webcast) – and see UnitedHealthcare’s full formulary for its Advantage and Traditional plans, respectively, for more. The pharmacy benefits manager (PBM) – the third largest in the nation, after Express Scripts and CVS Health – released its 2017 formulary exclusion list this morning, revealing that it plans to exclude Sanofi’s Lantus (insulin glargine) in favor of Lilly/BI’s biosimilar insulin glargine Basaglar. The exclusion will go into effect April 1, 2017.
This follows a string of stricter formularies planned for 2017, reflected in CVS Health’s decision to exclude Lantus in favor of Basaglar as well. Express Scripts, on the other hand, will include Lantus and Basaglar on equal footing in its 2017 formulary. We’ve been increasingly wondering about how patients in the US will be able to access basal insulin – both older basal insulin analogs Lantus and Novo Nordisk’s Levemir (insulin detemir), given the advent of biosimilars, as well as next-generation products Sanofi’s Toujeo (U300 insulin glargine) and Novo Nordisk’s Tresiba (insulin degludec). UnitedHealthcare is also excluding both Toujeo and Tresiba from its 2017 formulary and these products look increasingly out of reach for the average patient. These basal insulin challenges of course also raise the question of access to GLP-1 agonist/basal insulin fixed-ratio combinations (Novo Nordisk’s IDegLira [insulin degludec/liraglutide] and Sanofi’s iGlarLixi [insulin glargine/lixisenatide]). Given the problems with adherence and engagement, we believe denying access to these combinations is a major negative – but given how strict the current payer environment appears (making patients take biosimilars rather than even Lantus or Levemir, much less next-generation basals) it seems like there will be trickle-down negativity for access to IDegLira and iGlarLixi. Just last week we heard that at Sutter Health, it's not only more work for doctors to try to suggest something different for certain patients who might need it - their income is actually negatively influenced when they try to do anything off-formulary.
As a reminder, 2015 basal insulin sales totaled $10 billion, down from $11 billion in 2014 and up from $2.3 billion in 2006. Based on data to date (the basal insulin market has remained flat after two quarters in 2016, compared to 1Q15 and 2Q15 numbers), we’d expect significantly more challenges in 2016 and ahead. Though if access is better for the population of people with diabetes globally, these pressures will be offset to some degree by greater access to basal insulin globally, driven by biosimilars in particular. We continue to believe far more patients should be on basal insulin and/or should intensify it, and would be grateful from a patient perspective if manufacturers could focus increasingly on access, better individualization of patient therapy, and reducing stigma surrounding using insulin. It goes without saying that intensification of therapy beyond basal insulin is also needed (GLP-1 agonists, mealtime insulin for those with no beta cell function). Needless to say, in many countries globally, the need for basal insulin is particularly high - we hope that the availability of biosimilar insulin will make this much more possible. Politically, the negativity surrounding insulin prices cannot be understated. We expect payers will wield sole-source formularies as a powerful tool and we’re hopeful for conversations with payers in which they realize wider insulin use is a positive and work out appropriate individualization.
-- by Helen Gao and Kelly Close