COMMENTARY

Why Is an Old Drug So Expensive?

Jonathan Kay, MD

Disclosures

March 18, 2011

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Hello, I'm Dr. Jonathan Kay, Professor of Medicine in the Division of Rheumatology at the University of Massachusetts Medical School in Worcester. Today we're going to talk about the use of colchicine in the treatment of gout. I was prompted to think about this last week when a 92-year-old man came to see me because of a right elbow effusion that had been aspirated in an emergency department. No crystals were observed, but regardless he was treated with colchicine 0.6 mg taken by mouth daily. His right elbow effusion improved, but he developed such severe diarrhea that he had to stop colchicine. The diarrhea resolved when he was off colchicine. However, his daughter told me that they spent $105 to obtain a 1-month supply of Colcrys® (URL Pharma, Inc.)

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 the Hatch-Waxman Act of 1984: the act that defines the pathway for approval of generic drugs. In [2007] URL Pharma, Inc. a company in Philadelphia, Pennsylvania, initiated 17 pharmacokinetic and pharmacodynamic studies as well as drug-drug interaction studies and a randomized, placebo-controlled trial of colchicine in the treatment of acute gout. They used a shortened course of colchicine (1.2 mg followed 1 hour later by a single dose of 0.6 mg) and compared that with the traditional regimen of 1.2 mg followed by 0.6 mg administered hourly for 6 hours. Both of these regimens were compared with placebo and were found to be superior to placebo. In addition, the shortened regimen had a significantly lower incidence of nausea and diarrhea than the traditional 6-hour regimen for the treatment of acute gout.

Thus, approval was granted in July 2009 for the marketing of Colcrys for the treatment of acute gout and on the basis of the Orphan Drug Act for the treatment of familial Mediterranean fever. As a result, URL Pharma was granted 3 years of market exclusivity for the use of colchicine in acute gout and 7 years of market exclusivity for its use in familial Mediterranean fever. 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 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 the xanthine oxidase inhibitor to prevent acute flares of gout. Thus, when patients are initiated on allopurinol or febuxostat 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. However, one needs to think critically about how much should be charged for a single dose of medication. We don't want medications to become inaccessible to our patients, and we want patients to receive optimal therapeutic management. Thus, 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. The patient who I saw last week no longer needs colchicine and can't tolerate it. However, other patients present frequently with gouty arthritis and need to have affordable colchicine so that they receive optimal management of their gouty arthritis. I talked today a little bit about the regulatory aspect of Colcrys: why it was approved and why it was granted market exclusivity. I welcome your comments and look forward to seeing you again on Medscape. Thank you very much.

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