Drugs to treat inflammatory conditions, diabetes, and oncology were the top three most expensive therapy classes in 2016, according to Express Scripts. But there are some positive changes on the horizon.
“Managed care executives should be hopeful that new drugs pending approval in 2017 could increase competition within these classes. We are also keeping an eye on the pipeline of drugs to treat Alzheimer’s,” says Aimee Tharaldson, PharmD, senior clinical consultant, Emerging Therapeutics, Express Scripts.
Although the drug pipeline for Alzheimer’s disease has not been as rich as patients and experts would have hoped, there could be some form of a drug to combat this debilitating condition by 2025, CNN recently reported. With more than 20 candidates in phase 3 trials and many more in earlier stages of development, researchers are hopeful that this goal will be realized.
Here’s more on each of these drug classes, and what you can anticipate in the year ahead.
There are two key autoimmune pipeline developments to watch in 2017, according to Tharaldson. They are investigational baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA), and guselkumab, an anti-interleukin-23 (IL-23) monoclonal antibody, for moderate-to-severe plaque psoriasis.
In April, the FDA delayed approval of baricitinib, an oral Janus kinase (JAK) inhibitor. The FDA said that more clinical data is needed because of safety concerns across treatment arms. Baricitinib is also being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients with psoriatic arthritis is expected to be initiated in 2017.
FDA said that more clinical data is needed because of safety concerns across treatment arms of the new investigational drug baricitinib (Eli Lilly and Company, Incyte Corporation). Additional clinical data is needed to determine the most appropriate doses, the two manufacturers said in a statement.
IL-23 is a protein which has been shown to play a key role in the development of immune-mediated inflammatory diseases.
Guselkumab in a subcutaneously administered IL-23 inhibitor in phase 3 development to treat moderate-to-severe plaque psoriasis. At press time, a phase 2 study evaluating the drug for the treatment of moderately to severely active psoriatic arthritis was ongoing.
“Watch for more competition in this space due to an increasing number of therapeutic options,” Tharaldson says. “Biosimilars may also help to increase competition. Although biosimilars for Humira and Enbrel have been approved by the FDA, several biosimilar-related patent disputes have prevented their launch.”
Patrick Gleason, PharmD, FCCP, FAMCP, BCPS, senior director, health outcomes, Prime Therapeutics, says the PBM has identified Dupixent (dupilumab) as a new potential blockbuster drug for the treatment of atopic dermatitis. Dupixent is a self-administered subcutaneous injection, approved by the FDA in March. It is the first biologic to treat atopic dermatitis, a condition typically treated with topical moisturizers, corticosteroids, and calcineurin inhibitors. Dupixent works by inhibiting interleukin-4 and interleukin-13, two key cytokines required for certain immune responses.
Over the past four years, Prime has seen the autoimmune drug class spend increase 25% each year. Gleason expects this trend to continue due to price inflation and more patients using these specialty drugs more quickly when diagnosed.