CVS Caremark is booting the type 2 diabetes drug Jardiance as a preferred option in favor of Invokana, despite Invokana showing more adverse events than its competitor.
Eli Lilly and Boehringer Ingelheim’s Jardiance, and Johnson & Johnson’s Janssen Pharmaceuticals’ Invokana are in the same drug class known as SGLT2 inhibitors. Both drugs have posted a 14 percent composite reduction in cardiovascular risks in studies, a highly desirable marker for a diabetes drug. But the move by CVS has some analysts scratching their heads.
While both drugs provide cardiovascular benefit, many drugs in the class have been rife with adverse events resulting in new or strengthened warnings. Jardiance has come out comparatively unscathed. For CVS to choose Invokana over Jardiance is likely a “Price play,” Bernstein analyst Ronny Gal wrote. “But it shows how fungible these classes have gotten.”
Invokana, which hit the market in 2013, was the first SGLT2 inhibitor to be approved by the Food and Drug Administration (FDA). Jardiance was approved the following year. In May 2015, the FDA issued a new warning that all SGLT2 inhibitors were linked to an increased risk of ketoacidosis, a serious condition in which too much acid buids up in the blood. At the same time, the FDA warned that SGLT2 inhibitors also increased the risk for serious urinary tract infections, some of which resulted in a serious blood infection called urosepsis, or kidney infection called pyelonephritis.
Four months later, the FDA notified the public that it was strengthening warnings for Invokana and Invokamet regarding an increased risk of bone fractures and decreases in bone mineral density.
In June 2016, the FDA announced it was strengthening existing warnings on Invokana, Invokamet, Farxiga and Xigduo regarding acute kidney injury. Jardiance was not included in this warning.
A year later, the FDA ordered a black box warning on Invokana and Invokamet regarding an increased risk for lower limb amputations.
CVS Caremark’s decision “restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit to reduce the risk of CV death,” a Boehringer Ingelheim spokesperson told FiercePharma. “While we cannot comment on why CVS made this decision, the positive benefit-risk profile of Jardiance brings critical value to patients and health care providers.”