Onglyza Risks Lead Express Scripts to Drop Drug from 2016 Formulary

A major pharmacy benefits manager says it will no longer provide insurance coverage for the diabetes drugs Onglyza and Victoza, due to potential health risks associated with the medications and the availability of safer drugs for treatment of type 2 diabetes. 

On July 31, Express Scripts released its 2016 national preferred formulary, which is a list of drugs that the pharmacy benefits manager decides should be covered by insurance. The list included 80 drugs that the company will not agree to cover, out of a list of about 4,000 medications on the market.

Among the list of drugs that will no longer be covered are Onglyza, Kombiglyze XR (a combination of Onglyza and metformin), Victoza and Nesina. All are diabetes drugs which already have clinical equivalents on the market and which have been linked to serious health concerns.

Express Scripts says its National Preferred Formulary is the most widely used formulary in the U.S. It’s prescription drug coverage guidelines affect which drugs are insured for about 25 million Americans.

The company says that it decides to cover drugs based on whether they are clinically superior or provide afforable alternatives to other drugs. However, a story by Medical Marketing & Media on August 3 said Express Scripts was dropping Onglyza and Kombiglyze XR due to concerns about the potential health risks

According to the report, Express Scripts’ senior director of corporate communications, David Whitrap, told the publication in an email that Onglyza heart risks played a role in why the drug was dropped. Those same risks are not known to be present with its competitor, Januvia.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009, for treatment of type 2 diabetes, The medication is part of a class of drugs known as incretin mimetics, which also includes Januvia, Janumet, Byetta, Victoza and other widely used medications.

In April, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential risk of heart failure from Onglyza side effects, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart problems and all-cause mortality.

Onglyza is a DPP-4 inhibitor, which works by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal. The diabetes drug brought in more than $700 million in sales in 2012. Other DPP-4 inhibitors include Nesina and Januvia.

The FDA launched an investigation into the potential heart risks with Onglyza last year, following the publication of the SAVOR study by the New England Journal of Medicine in 2013.

Victoza Health Concerns

There was no information given on Express Scripts decision to exclude Victoza, a diabetes drug similar to Byetta. It is also part of the same class of medications known as incretin mimetics.

A number of Victoza lawsuits have been filed in courts nationwide on behalf of former users diagnosed with pancreatic cancer. Similar allegations have been raised in hundreds of other Byetta lawsuits, Januvia lawsuits and Janumet lawsuits, claiming that the entire incretin mimetic class of drugs increases the risk of pancreatic cancer for diabetics.

Byetta (exenatide) was the first member of the incretin mimetic class of diabetes drugs, which was introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection.

Novo Nordisk introduced Victoza in 2010, as a longer acting injectable diabetes drug and Amylin introduced Bydureon (exenatide extended-release) in January 2012 as a once-weekly version of Byetta.

Januvia (sitagliptin) was introduced by Merck as an oral incretin mimetic diabetes drug in 2006, and has become one of the most widely used members of the class. A combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet.

In August 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a single consolidated proceeding in the federal court system for all incretin mimetic lawsuits brought by users who developed pancreatic cancer. Given the similar factual and legal issues involved in the case, the litigation has been centralized before one judge for coordinated pretrial proceedings.