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Onglyza Still Excluded from Express Scripts 2017 Formulary

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Express Scripts continues to exclude diabetes drug Onglyza from its preferred formulary, listing it as an exclusion for 2017.

The prescription benefit plan provider first dropped the medication from its list last year, when it announced that it would no longer provide insurance coverage for this drug due to the risk of potentially serious side effects. It has suggested other, safer drugs for the treatment of type 2 diabetes.

 Express Scripts Examines Clinical Data to Determine Which Drugs to Exclude

On July 31, 2015, Express Scripts released its National Preferred Formulary (NPF), the most widely used formulary in the U.S., which provides coverage guidelines for 25 million Americans. Each year, the company consults with a panel of experts to determine which prescription drugs are most effective for their cost, and which are so-called “me-too” products that often cost, more than established medications but provide no additional clinical benefits.

How does Express Scripts make its decisions as to which drugs it will no longer cover?  It consulted with three different committees:


  1. National Pharmacy & Therapeutics Committee (P&T)—consists of 15 independent physicians and one pharmacist representing a broad range of medical specialties,
  2. Therapeutic Assessment Committee (TAC)—Express Scripts’ internal clinical review body, consisting of pharmacists and physicians, and
  3. Value Assessment Committee (VAC)—considers the value of drugs.

The first two committees looked exclusively at the safety and effectiveness of the drugs, considering things like clinical benefits, and whether the benefits outweigh safety risks. If they do not, the medication is excluded from the formulary. Only one percent of products on the market fall into this category.

For the year 2015, Express Scripts excluded 80 out of more than 4,000 drugs on the market. For each of the medications that were left out, Express Scripts listed clinically equivalent, lower-cost options. By doing so, the company says that it saves plan sponsors about $1.3 billion dollars a year.

One of the drugs that was excluded last year was Onglyza.

 Onglyza Taken Off the List Because of Health Risks

Why was Onglyza taken off the list? Express Scripts cited concerns regarding drug safety when compared to other similar type 2 diabetes treatments.

Indeed, in April 2015, an FDA advisory committee voted that Onglyza’s drug label should include a warning that it could increase risk of hospitalization for heart failure. This was in response to a review of the results of the SAVOR study, which showed that patients already at risk for heart disease who took Onglyza were at a 27 percent increased risk of being hospitalized for heart failure than those taking alternative medications.

Onglyza belongs to a newer class of diabetes medications called “dipeptidyl peptidase-4 (DDP-4) inhibitors,” also called “incretin mimetics,” which stimulate the pancreas to make more insulin after a patient eats a meal. Other drugs in this class include Januvia, Byetta, and Victoza. So far, however, only Onglyza has been found to increase risk of heart failure.

The drug remains off the Express Scripts formulary for 2017, along with other DDP-4 inhibitors including Nesina. The company recommends Januvia and Tradjenta, as alternative treatments for diabetes.