Diabetes Drugs Take Hits in Formulary Updates

Several well-known therapies for type 1 (T1D) and type 2 diabetes (T2D), from a mainstay basal insulin that is now off patent to a GLP-1 receptor agonist shown to have a cardioprotective benefit, were swept off major formularies for 2017 this week, as pharmacy benefit managers (PBMs) look to rein in drug spending.

Express Scripts, the nation’s largest PBM with control of prescription drug benefits for 25 million Americans, announced Monday it would not cover Victoza, the formulation of liraglutide approved in the United States for diabetes. The news came less than 2 months after results presented at the 76^th Scientific Sessions of the American Diabetes Association showed that the glucagon-like peptide-1 receptor agonist was found to reduce cardiovascular death by 22% and reduced cardiac events by 13%.

An Express Scripts spokesman said the PBM does cover Novo Nordisk’s liraglutide formulation for obesity. This version, marketed as Saxenda, is a non-preferred product, according to David Whitrap, senior director for Corporate Communications at Express Scripts.

“There is a prior authorization in place that ensures patients with diabetes aren’t prescribed Saxenda,” Whitrap said in an email. “When we choose to exclude any medication (e.g., Victoza), we do so because there is at least one clinically equivalent (or superior) product on the market that is more affordable for our clients. We will never exclude a product if it is clinically superior.”

Whitrap said there is a medical exception process for patients who have a “specific need” for Victoza.

Victoza’s manufacturer, Novo Nordisk, also saw 2 insulins, Novolin and the rapid-acting NovoLog, put on the exclusion list, along with Sanofi’s mealtime insulin, Apidra. Other diabetes drugs on the Express Scripts’ exclusion list are the GLP-1 receptor agonist Tanzeum (albiglutide), and the dipeptyl peptidase-4 (DPP-4) inhibitors alogliptin and saxagliptin and their combinations (Nesina, Onglyza, Kanzano, Kombiglyze XR) and generic formulations of alogliptin.

CVS Health, the nation’s second-largest PBM, said it would pull the longtime top-selling basal insulin Lantus, along with its successor, Toujeo, off its formulary next year in favor of the biosimilar Basaglar, made by Eli Lilly. “We anticipate significant savings for many clients and members, as the removal of higher cost products will enable near-term value, with additional opportunities for future savings resulting from market competition as new products are launched,” CVS said in a statement with the formulary announcement.

The addition of 35 drugs to its exclusion list will bring CVS’ total to 131, according to news accounts. Express Scripts’ list of exclusions covers 85 drugs.

While Express Scripts said its recommendations are based first on clinical factors and second on price, the Victoza exclusion was seen as primarily based on cost factors. Express Scripts’ statement with the exclusion list said, “We exclude medications only when clinically equivalent alternatives are already covered on our formulary, and only when those exclusions will result in a significant cost savings for our clients and patients.” Overall, Express Scripts said its exclusions would save clients $1.8 billion in 2017.

“This development is surprising," Citigroup analysts wrote in response to the Victoza ruling. "Sentiment near term will be driven by market perception on Novo's success in contracting for 2017 as well as the rebates required to grant access."

Novo Nordisk did not comment on Express Scripts’ decision on Victoza. A statement from Sanofi said that the drugmaker was “disappointed” with the decision and that patients should have choices.

How patients—and drug manufacturers—respond to the actions remains to be seen. Ample polling evidence during this year’s presidential election shows that concerns about high prescription drug costs are the one healthcare issue that unites Democrats, Republicans, and independents.

Both Novo Nordisk and Sanofi are waiting FDA approval on combination drugs that will allow patients to have insulin and a GLP-1 receptor agonist in a single injection. Results for these therapies also attracted significant attention at the ADA meeting in June. It is unclear what effect, if any, this week’s announcements will have on formulary acceptance of those therapies.

“At this time, we cannot comment on the formulary coverage for Xultophy,” Michael Bachner, associate director, Product Communications, Diabetes & Obesity Marketing at Novo Nordisk US, told The American Journal of Managed Care in an email, in reference to the insulin/GLP-1 combination already available in Europe.

The PBM decisions signal growing frustration with soaring costs for diabetes therapies, including insulin, which Bloomberg reports topped $23 billion in worldwide sales last year. Insulin prices, in particular, have been a source of frustration because for persons with T1D, the therapy is essential to stay alive. Insulin costs were topic of a major reports in Lancet Diabetes & Endocrinology and by the World Health Organization, which called for major changes in addressing a disease that now affects 422 million people worldwide.

Diabetes treatments were not the only ones targeted by the leading PBMs. Express Scripts continues to exclude the hepatitis C virus treatment, Sovaldi, and CVS Health took aim at Gleevec, the treatment for chronic myeloid leukemia. In its statement, CVS Health said it was pushing back at what it calls “hyperinflationary” drugs and said 10 drugs on its new list met that test.

“CVS Health is taking aim against egregious drug price increases that unnecessarily add costs for clients and their members,” the statement said. “We are also taking steps to address limited source generics, which are products with limited generic manufacturers resulting in significant cost in the market. These products will be evaluated and, if appropriate, be excluded during the year.”

In the United States and abroad, there is increased focus on prevention, with Medicare announcing that it will pay for the National Diabetes Prevention Program starting in 2018.