- Express Scripts, the largest pharmacy benefits manager (PBM) in the nation, has finalized its formulary for 2016. A total of 20 new drugs are not covered in the new formulary.
- Glaxo's asthma drug Breo has made the cut (after being rejected for 2015), but AstraZeneca's diabetes drugs Onglyza an Kombiglyze are out.
- Express Scripts cited "me too" products as one group that most likely won't make it onto its formulary, especially if another version of the same drug offers comparable clinical benefits at a more affordable price.
Here's how it works: Express Scripts appoints an independent group of physicians to review clinical data and determine what the most clinically effective and cost-effective options are within a given therapeutic category. The determinations made by these physicians—what amounts to a very strong evidence base—are what drive formulary decisions, including who's in this year, and who's out.
For 2016, some of the drugs that were rejected are J&J's Olysio for hep C; Gilead's Sovaldi and Harvoni, in favor of AbbVie's Viekira Pak (this is old news, but Gilead tried again to get into the Scripts formulary); and GSK's respiratory medication, Arnuity.
And now for some winners: Trajenta, the new diabetes drug from Eli Lilly/Boehringer Ingelheim (BI) and Pernix Therapetics' Zohyrdo, the chronic-pain opioid medication that stirred some controversy last year.
Regarding the newly approved PCSK9 inhibitor, Praluent from Sanofi/Regeneron, the decision-making process is ongoing. The benefits manager is going to push this one out a bit, as there is clearly a great deal of hand-wringing going on, notwithstanding the almost apocalyptic pronouncement from Scripts CEO Tim Wentworth earlier this year that, in essence, not restraining coverage of PCSK9 inhibitors could jeopardize the sustainability of the healthcare system, costing the U.S. about $55 billion per year.
If there's one takeaway from Express Scripts' 2016 formulary decisions, it's, "The future is now." For some time, Express Scripts has positioned itself as an activist PBM, with a clinically competent and economically restrained approach to making its very sobering decisions. Nonetheless, the upside for a group of preferred customers is $1.3 billion in savings.
One unexpected byproduct of this is the shifting relationship between pharma and PBMs. There is a reinvigorated relationship between Express Scripts and the pharma companies that approach it for support determining what constitutes meaningful data, thereby maximizing the possibility of inclusion.
While 2016 is only just finalized, many companies are focusing on getting onto the formuary for 2017. Given how high the stakes are when it comes to being on formulary at the largest PBM in the U.S., starting now makes perfect sense.