OLD DRUG, NEW PRICE

June 9, 2011 in Gout, Medications
Tags: access to medications, Allopurinol, approval of generic drugs, colchicine, Colcrys, drug interaction studies, drug market exclusivity, FDA, Food and Drug Administration, patient welfare, placebo-controlled trial, prevent acute flares of gout, prevent gouty arthritis, prophylaxis of gouty arthritis, reduced copay for medication, The American College of Rheumatology, treatment of acute gout, Uloric, unapproved drugs, Unapproved Drugs Initiative, URL Pharma, xanthine oxidase inhibitor

 

Why is colchicine so expensive? It turns out that colchicine was never evaluated by the US Food and Drug Administration (FDA) for safety prior to its marketing because it was available before the Food, Drug, and Cosmetic Act took effect in 1938. This act required the FDA to assess newly introduced drugs but not drugs that had previously been available. In 2006 the FDA began an Unapproved Drugs Initiative in which they encouraged companies to investigate unapproved drugs and to gather the necessary safety data for FDA approval. The incentive for companies to do this was 3 years of market exclusivity granted under an act that defines the pathway for approval of generic drugs. In 2007 URL Pharma, Inc. a company in Philadelphia, Pennsylvania, initiated 17 studies as well as drug-drug interaction studies and a randomized, placebo-controlled trial of colchicine in the treatment of acute gout. Thus, approval was granted in July 2009 for the marketing of Colcrys for the treatment of acute gout. As a result, URL Pharma was granted 3 years of market exclusivity for the use of colchicine in acute gout. In October 2009 they were also granted market exclusivity for 3 years for prophylaxis of gouty arthritis.

This is a reasonable reward for a company that invests a significant effort in studying a medication, even if the medication has been available in an unapproved form. However, as a rheumatologist I’m concerned about the ability of my patients to have access to medications. When initiating treatment with a xanthine oxidase inhibitor, such as Allopurinol or Uloric, to lower serum uric acid levels chronically and prevent gouty arthritis, it has been shown that one should use colchicine prophylaxis for the first 6 months of those medications to prevent acute flares of gout. Thus, when patients are initiated on allopurinol or uloric they need to take 6 months of colchicine to prevent acute flares of gout. Prior to the approval of Colcrys, unapproved colchicine sold for about 10 cents a pill.

Once Colcrys was approved the price increased 50-fold to about $5 a pill. This is often difficult for patients to afford. To mitigate this problem URL Pharma has established a rather generous patient assistance program in which patients with incomes up to 6 times the federal poverty level are able to receive Colcrys with a reduced copay. The American College of Rheumatology has encouraged URL Pharma to consider patient well-being and patient welfare in the pricing and marketing of these agents.

Rodney Bluestone Medical doctors are rheumatology specialists located in Los Angeles, California. We provide treatment for all types of arthritis including osteoarthritis, gout, rheumatoid arthritis and lupus. For more information, including treatment and symptoms of arthritis, please visit www.rodneybluestonemedical.com.