The country’s second-largest prescription benefits manager, CVS Caremark, has dropped Invokana and Invokamet from its 2016 prescription drug formulary. According to a report published by Reuters, patients taking either of the Type 2 diabetes medications will need to switch to alternatives or pay full price for the treatments if their employer’s prescription drug benefits are managed by CVS.
The Reuters report did not indicate why CVS Caremark decided to include Invokana and Invokamet among the 31 medications being dropped from its 2016 formulary. But the report did note that such decisions usually depend on whether a pharmacy benefits manager can obtain favorable pricing for a drug.
Invokana and Invokana aren’t the only Type 2 diabetes medications being kicked off the CVS formulary. Bydureon, a once-weekly treatment from AstraZeneca Plc, is also being excluded. Instead, the formulary will favor diabetes medications marketed by Lilly and Novo Nordisk, Reuters said.
Invokana and Invokamet, which belong to a class of diabetes medications called SGLT2 inhibitors, have been available for two years, and their combined sales hit $318 million in the second quarter of 2015. However, in May the U.S. Food & Drug Administration (FDA) announced that it was investigating a potential association between SGLT2 inhibitors like Invokana and diabetic ketoacidosis, a serious condition that can lead to diabetic coma and death.
According to the FDA, 20 reports of acidosis (reported as diabetic ketoacidosis, ketoacidosis, or ketosis) in SGLT2 inhibitor patients were logged with its adverse event reporting database between March 2013 and June 6, 2014. All of the incidents were serious, and resulted in the need for emergency medical treatment or hospitalization. The FDA noted that diabetic ketoacidosis commonly occurs in patients with Type 1 diabetes and is usually accompanied by high blood sugar levels. But the majority of these reports involved Type 2 diabetics, and blood sugar levels, when reported, were only slightly elevated.
The FDA’s review will determine whether changes are needed in the prescribing information for SGLT2 inhibitors. Meanwhile, patients treated with these medications should seek medical attention if they experience any indicators for ketoacidosis, including difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.
Type 2 diabetics who were hospitalized for diabetic ketoacidosis while using Invokana or another SGLT2 inhibitor may be entitled to compensation for their associated medical expenses, lost wages, and other damages. To schedule a free, no-obligation safety review with an attorney at Bernstein Liebhard LLP, please call today.