Encouraging options to high-cost specialty drugs

By Mona Chitre

Have you ever wondered why health care spending in the U.S. often exceeds that of other industrialized nations who have health care outcomes similar to ours? It turns out that one reason for this difference is our lack of approved biosimilar medications to compete with high-priced, brand-name biologics.

Biologics are heavily advertised and very expensive specialty medications that have radically changed the treatment of a range of conditions, from cancer to autoimmune disorders. Biologics can cost from $1,000 to $100,000 per month. Here in the U.S., biologics account for just 2 percent of prescription drug utilization, but amount to 40 percent of prescription drug spending, and the percentage is rising.

Many biologics have lower-cost counterparts known as biosimilars, and the U.S. Food and Drug Administration says they will produce a similar result. Unfortunately, the U.S. is far behind many parts of the world, including Western Europe, when it comes to making biosimilars available. Just a few biosimilars are currently available here, while in Europe, there now are 28 biosimilars for a variety of conditions. Biosimilars are safe, effective and affordable alternatives to their high-priced biologic counterparts.

Remicade® is a biologic produced by Johnson & Johnson to treat inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis and ulcerative colitis. In the United States, the average annual cost of Remicade is $28,000 per patient. Johnson & Johnson has raised the price of Remicade by 57 percent over the past five years (many of those years had two price increases).

Lower-cost biosimilars to Remicade have been available in Europe since 2013, and two are FDA- approved for use in the U.S.: Inflectra is produced by Pfizer, and Renflexis is produced by Merck. These biosimilars are challenging Remicade with desperately needed price competition.

The Rand Corporation predicts that by 2024, biosimilars could reduce spending on biologics in the U.S. by more than $54 billion. Let’s hope so!

Everyone involved in health care here in the U.S., including patients, employers, physicians and health insurers, has hoped that competition could help to control the rising cost of biologics and add affordable treatment options for patients. Biosimilars offer that competition, and their growing availability in this country means that safe, effective and affordable alternatives to high-cost specialty drugs are available for those who need them.

The FDA has more information on biosimilars at www.fda.gov/biosimilars.

Mona Chitre, Pharm.D., is Chief Pharmacy Officer and Vice President of Medical Operations and Health Innovations at Univera Healthcare.