Diabetes, autoimmune disorders, and oncology continue to be high areas of interest to managed healthcare executives in 2018. With a variety of new, high-cost drugs, chronic obstructive pulmonary disease (COPD) joins the top four therapeutic categories.
The projected specialty/biotech trend is 17.7% in 2018, down from the 18.7% in 2017, according to Segal Consulting. Although the trend is lower, specialty drugs still consumed one-third of total drug costs in 2016, with expected growth to 50% by 2020, according to Segal.
Prime Therapeutics, a pharmacy benefits manager (PBM), reports that through mid-year 2017, specialty spending on the medical and pharmacy benefits combined was about 45%.
Here are some of the latest developments in the top four therapeutic areas for 2018:
Merck’s follow-on insulin glargine product, Lusduna Nexvue, was granted “tentative approval” in 2017, but its market availability—probably 2018 or 2019—is contingent upon resolving ongoing patent litigation.
“Although not A-rated, or a substitute at the point of service with Lantus, an already approved insulin glargine, it is a therapeutic option,” says Christopher Peterson, director of clinical evaluation and policy for Express Scripts, a PBM.
At press time, approval of Mylan’s product, Basalog, another insulin glargine, is expected in July 2018, but like Merck’s product, it might face patent litigation before it becomes available.
Sanofi’s Admelog (insulin lispro), a follow-on protein to Eli Lilly’s Humalog, received approval in December 2017, and availability will likely occur in 2018, Peterson says.
Another class of diabetes medications to watch is the glucagon-like peptide-1 (GLP-1) receptor agonists, Peterson says. Novo Nordisk’s semaglutide injection, Ozempic, a once-weekly GLP-1, received approval in December 2017. This product joins the company’s diabetes portfolio, which currently includes the once-daily GLP-1 analog, Victoza (liraglutide). Other GLP-1 receptor agonists include AstraZeneca’s Byetta (exenatide) and Eli Lilly’s Trulicity (dulaglutide).
At press time, it is also anticipated that Merck and Pfizer will receive approval shortly for their new sodium glucose cotransporter-2 (SGLT-2) inhibitor, ertugliflozin, an oral therapy resulting in excretion of excess glucose in the urine and decreasing blood glucose levels.
“The SGLT-2 inhibitor class will continue to grow due to the positive cardiovascular outcomes data from studies with Invokana and Jardiance,” Peterson says.
Manufacturers are also combining diabetes drugs for increased effectiveness. Merck is expected to receive approval for ertugliflozin combination products shortly after press time, which will be taken with metformin and Merck’s Januvia (sitagliptin). In addition, Victoza joins a long-acting, basil insulin, such as Lantus or Levemir, as a rela tively new way to treat diabetes.
“This combination makes it work better and helps to reduce post-meal hyperglycemia and weight gain that can sometimes occur if a long-acting drug is taken by itself,” says Julie Rubin, director of clinical services for CompleteRx pharmacy consulting firm.
She says, however, that the combination of drugs might increase costs for already expensive drugs because patients are now using two drugs at the same time.
On the other hand, Patrick Gleason, senior director of outcomes for Prime Therapeutics, says combinations might increase utilization, providing more opportunity for controlling diabetes, even if the costs are higher. “The value is in preventing heart attacks, something that might take years with just glucose control,” he says.