Matthew W. Davis, MD, RPh, chief medical officer and vice president of clinical development and medical affairs at URL Pharma counters that much more work went into their NDA than the study published in A&R. URL filed the results of 17 clinical studies, including 12 phase 1 drug interaction trials and another four phase 1 trials looking at Colcrys’ pharmacokinetics. These included a large, 54-center phase 3 study.
That research led to new label warning of interactions with statin drugs, among others. URL Pharma also showed that, contrary to the labeling of unapproved colchicine, dialysis was not an appropriate treatment for overdose.
Outdated Treatment Used in NDA?
Dr. Richards disputes the contention that the use of colchicine for the treatment of acute gout is outdated. “Newer rheumatology texts, such as Current Rheumatology Diagnosis and Treatment (2nd edition) released in 2007, advocate dosing to toxicity,” he stresses.2
“There are no guidelines from the ACR or others on using colchicine in gout,” he says. “We are working on educational outreach to healthcare professionals to bring these to their attention.”
Since Colcrys was approved, URL Pharma has produced it under FDA guidelines that unapproved medications are not required to follow. This includes rigorous standards for impurities and making the medication in a facility under yellow lights. Their raw material costs are three to four times that of other colchicine manufacturers because of these requirements.
Healthcare Costs
The potential implications for the patient and healthcare costs in general are another concern of the rheumatologists interviewed. Non-approved colchicine sold for around 10 cents a tablet, while Colcrys is currently being sold for around $5.00.
URL Pharma has established a PAP to address some of the payment issues, especially as they apply to patients with limited financial resources (see “Colcrys Patient Assistance Program,” p. 27). But the rheumatologists interviewed here also raised questions about the impact on healthcare costs overall.
“The function of the PAP may be to lessen the patient complaints about costs while still keeping the prices high for insurance purposes,” says Dr. Fudman. “The system may still pay tens of millions of dollars, if not hundreds of millions, but the individual patient won’t see it.”
The spokesmen for URL Pharma both say that the company has done more to address the patient concerns than most other similar programs.
There has been tension between the company and rheumatologists. In March, URL Pharma’s general counsel sent a letter to many rheumatologists who had discussed this on the ACR Advocacy list serve, suggesting they “clarify the record” by writing to the FDA to say that they do not support the continued availability of unapproved colchicine products, and that they send URL Pharma a copy of the letter. The URL letter says that physicians have created unnecessary exposure for themselves by advocating that “illegal” colchicine remain on the market.
