Express Scripts drops Onglyza from 2016 formulary over safety concerns

Express Scripts drops Onglyza from 2016 formulary over safety concerns
Express Scripts drops Onglyza from 2016 formulary over safety concerns

Express Scripts will drop coverage of Onglyza in 2016, citing the diabetes drug's safety concerns when compared to similar treatments and bringing back formerly excluded brands to the formulary.

The PBM plans to exclude AstraZeneca's Type-2 diabetes treatments Onglyza and Kombiglyze XR in lieu of Merck's portfolio of Janumet and Janumet XR and Boehringer Ingelheim's Jentadueto in the class of diabetes treatments called DPP-4 inhibitors.

The moves were announced when pharmacy benefit manager Express Scripts released its formulary for 2016, including which drugs will no longer be covered and which ones will have preferred status. The formulary is known as the 2016 Preferred Drug List Exclusions.

An FDA advisory committee ruled 13-1 in April that Onglyza has an “acceptable cardiovascular risk,” but it also recommended that the drug's label be amended to take account of the 27% greater risk of heart-failure hospitalization seen in a study of patients who took Onglyza compared to those on placebo. The FDA approved Onglyza in 2009 and Kombiglyze XR in 2010.

David Whitrap, senior director of corporate communications, echoed those same concerns in an email to MM&M. “Onglyza is associated with increased risk of hospitalization due to heart failure,” he said. “The market leader, Januvia, showed no risk...With the availability of other DPP-4 inhibitors, the benefits of initiating therapy, particularly with Onglyza, over other agents is less compelling.”

AstraZeneca did not respond to a request for comment by press time.

PBMs and other payers have been tasked with narrowing formulary decisions in the wake of rising drug prices. These stakeholders often attempt to bring down costs by negotiating discounts with drugmakers for a strong formulary position.

Express Scripts added a number of drugs back onto its formulary after excluding them last year. One drug, Jentadueto, a Type-2 diabetes treatment marketed by Boehringer Ingelheim, was excluded last year. “The manufacturer came back to us this year with better pricing for our clients and patients,” Whitrap noted.

The PBM will cover the formerly excluded drugs in 2016: Betaseron, Tradjenta, Euflexxa, Zohydro ER, Oxycodone HCL ER, Kadian, Pegintron and Breo Ellipta.