Type 1 diabetes
Nicolosi says most new products for type 1 diabetes are combinations and repackaging of existing products. Changes are primarily seen in less frequency or oral drugs versus injections.
Aaron Glatt, MD, chairman, Department of Medical and Hospital, South Nassau Communities Hospital, Oceanside, New York, agrees that there is limited activity among drugs for type 1 diabetes, saying that most of the new medications are me-too drugs, and those in the pipeline are not expected to be major players.
A procedure in the works described by the American Diabetes Association (ADA)—although experimental—is transplantation of islet cells from a pancreas of a deceased organ donor that are purified, processed, and transferred into another person. “It could be a game-changer,” Glatt says.
RA drugs—Humira, Remicade and Cimzia (certolizumab pegol)—are crossing over as treatments for Crohn’s disease, as well as plaque psoriasis, Nicolosi says. Although injections such as Humira and Cimzia and an infusion for Remicade can be more expensive than oral drugs, he sees an increase in the use of injectables because they are a more effective option for treating severe Crohn’s and have proved to work better than orals that have been tested and failed in some cases.
It is common to start individuals with Crohn’s taking an immunological agent on a high dose initially (loading dose or starter kit) and then stabilizing them on a lower maintenance dose, Nicolosi says; however, this triggers higher costs. For example, when using Humira, patients typically start treatment taking 160 mg on day one and then 80 mg on day 15. After the initial dose, patients are frequently stabilized on 40 mg every other week as their maintenance dose.
Virginia Ladd, president and executive director of the American Autoimmune Related Diseases Association, is a firm believer in moving away from drugs for Crohn’s and taking a closer look at the human microbiota consisting bacteria, fungi, archaea and viruses, many of them in the gut.
“We need a balance of bacteria in the body so it is important to normalize or regulate them,” she says. “Medications have done that, but microbiome treatment is much less expensive.”
Stelara (ustekinumab), a monoclonal antibody approved in 2009 for the treatment of plaque psoriasis and approved in 2013 for psoriatic arthritis, set the pace for a new class of drug—interlukin-17 (IL-17) inhibitors. Stelara has since shown effectiveness in treating Crohn’s disease and was approved for that use in 2016.
Three IL-17 receptor drugs for the treatment of plaque psoriasis and/or psoriatic arthritis built upon Stelara have entered the marketplace in the last two years: Cosentyx (secukinumab) in 2015, Taltz (ixekizumab) in 2016 and Siliq (brodalumab) in 2017.
Both Cosentyx and Siliq are subject to black box warnings; Cosentyx’s availability is restricted through the Risk Evaluation and Mitigation Strategies program (REMS), while Siliq faces a risk mitigation marketing program restriction.
In November 2016, Janssen submitted its application to the FDA for guselkumab, an IL-23, to treat plaque psoriasis.
What is expected to be the biggest game changer or perhaps even a blockbuster in psoriasis-related conditions is Dupixent (dupilumab) for atopic dermatitis (eczema), which is currently in phase 3 trials, Gleason says.
It is expected to be approved by the end of March but will come with a high price tag—$50,000 a year. “It should work better than adding more corticosteroids if patients cannot control their condition,” he says.
Mari Edlin, a frequent contributor to Managed Healthcare Executive, is based in Sonoma, California.