By Mona Chitre
Per capita health care spending in many industrialized nations is less than it is here in the United States, but in many cases, those countries have health care outcomes that are similar to ours. Contributing to this parity in quality but disparity in spending is the lack of approved biosimilar medications to compete here with high-priced, brand-name biologics.
Biologics are heavily advertised and very expensive specialty medications that have radically changed the treatment course for 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.
The U.S. lags many parts of the world when it comes to bringing biosimilars to market. Just a few biosimilars are available here. In Europe, where the first biosimilar was approved for use in 2006, there now are 28 biosimilars available for a variety of conditions. They are safe, effective and affordable alternatives to their high-priced biologic counterparts. According to the U.S. Food and Drug Administration, patients can expect a biosimilar to produce a result that’s similar to the result produced by its comparable biologic.
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.
In many European countries, by law, approved biosimilars automatically are substituted for biologics. This is similar to the generic fill law here in New York State that requires a prescription to be filled with a generic unless the brand name version is specified by the provider.
The Rand Corporation predicts that by 2024, biosimilars could reduce direct spending on biologics in the U.S. by more than $54 billion. Let’s hope so!
Health care stakeholders in the U.S., including patients, employers, providers and insurers, have hoped that competition could temper the rising cost of biologics and broaden the list of approved treatment options for patients. Biosimilars are that competition, and their growing availability in this country assures 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, doctor of pharmacy, is chief pharmacy officer and vice president of medical operations and health innovations at Univera Healthcare.