More than 80 autoimmune diseases have been identified and more than 23.5 million Americans are affected by them, according to the Office of Women’s Health at HHS.
Autoimmune diseases occur when a person’s immune system becomes unable to tell the difference between normal and unhealthy cells, causing the immune system to attack the body’s healthy organs and tissues.
Spending on autoimmune drugs continues to increase and utilization is rising, says April Kunze, senior director, clinical formulary development and trend management strategy at Prime Therapeutics. Autoimmune drugs are the number one drug spend category at Prime, comprising approximately 14% of the overall drug spend in the pharmacy benefit.
“Autoimmune disease is not a specific condition but rather an umbrella term that encompasses multiple individual diseases including lupus, celiac disease, multiple sclerosis, rheumatoid arthritis, and type 1 diabetes, among many others,” says Farrah Wong, PharmD, RPh, senior director, pipeline and drug surveillance at OptumRx. “Autoimmune diseases are among the most prevalent in the United States, affecting millions of Americans and, for reasons unknown, are becoming more and more prevalent.”
According to the 2016 “Medicines in Development for Autoimmune Diseases” report from the Pharmaceutical Research and Manufacturers of America (PhRMA), more than 300 medicines are in the research pipeline.
• Sun Pharmaceuticals’ tildrakizumab, an interleukin-23 inhibitor in development for the treatment of psoriasis with estimated FDA approval in the second quarter.
• Eli Lilly and Incyte’s baricitinib, a Janus kinase inhibitor in development for the treatment of rheumatoid arthritis.
“These particular drugs target a large number of patients,” says Wong. “It is estimated that there are approximately 7 million Americans living with psoriasis and about 1.3 million with rheumatoid arthritis. Because these are chronic diseases, ongoing management is necessary.”
Biosimilars for autoimmune diseases are prevalent, but ongoing challenges impede their use.
“The FDA continues to approve biosimilar products, but unfortunately, due to patent litigation, they are unable to launch,” says Kunze. “Another issue deterring biosimilar uptake is that although biosimilars are highly similar to their reference products, none of the approved products are interchangeable, [so] the doctor has to specifically prescribe for the biosimilar product.”
Biosimilar developments to watch include:
• Erelzi (etanercept-szzs) from Novartis, a biosimilar of Amgen’s Enbrel (etanercept). This is approved but cannot launch yet due to patent litigation.
• Amgen’s Amjevita (adalimumab-atto) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). These are FDA approved biosimilars for AbbVie’s Humira (adalimumab). These also have not yet launched.
“As more biosimilars become available, there may be a decrease in price among the product thereby decreasing the pressure on the healthcare system and patients by providing a more cost-effective alternative to brand name products,” says Kunze.