Based on these results and a literature review of the use of colchicine to treat FMF, the FDA granted URL Pharma three-year exclusivity for marketing for the indication of acute gout and seven-year exclusivity for the indication of FMF. Approval for chronic gout/prophylaxis was not granted.
After URL Pharma was granted exclusivity, they filed a lawsuit in California seeking a preliminary injunction against other manufacturers of colchicine. The court denied the motion and granted a request to transfer the injunction to the District of New Jersey.
ACR Speaks to the FDA
To better understand the process resulting in the approval of Colcrys, I scheduled a conference call with Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER) in Silver Spring, Md. She, along with Robert Rappaport, MD, director of the CDER’s Division of Anesthesia, Analgesia, and Rheumatology Products, and several other members of their team, participated in the call to discuss our concerns (a summary of this call is available at www.rheumatology.org). The FDA explained its rationale in bringing “unapproved” drugs under FDA control, citing experience with bioavailability issues discovered with Synthroid when undergoing review. Although the merit of going through the review process was clear, I noted that the FDA’s new policy was associated with unintended consequences that could hamper patient access to the therapy.
The FDA shared our concerns over the dramatic price increase of colchicine and stated it had hoped more manufacturers would come forward and complete the approval process. They agreed to provide us with a list of other colchicine manufacturers so that the ACR could encourage these companies to go through the FDA regulatory process.
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ACR Relays Concerns to URL Pharma
The next step was to communicate the ACR’s concerns to URL Pharma. I have corresponded with Matthew Davis, MD, PhD, the company’s chief medical officer, communicating our concern that the steep price increase will prevent patient access to colchicine. Dr. Davis explained their initial patient assistance program, which URL Pharma has agreed to expand to the following:
- Patients with household incomes up to three times the poverty level (up to $66,000 per year for a family of four) will have access to Colcrys prescriptions for $5 per month;
- Patients with a household income between three and four times the poverty level (up to $88,000 per year for a family of four) will receive Colcrys for $10 per month;
- Patients with a household income between four and five times the poverty level (up to $110,000 per year for a family of four) will receive Colcrys for $20 per month; and
- Patients with a household income between five and six times the poverty level (up to $132,000 per year for a family of four) will receive Colcrys for $30 per month.
Additionally, Dr. Davis stated that this program would apply to all patients, including those with Medicare and Medicaid, which is unusual for pharmaceutical assistance programs. He also said that the program would not be time limited. Patients with acute gout would receive payment assistance for 30 pills per month; those with chronic gout or FMF will receive assistance for 60 or 120 pills per month, respectively, depending on their prescription.
Looking Ahead
Although we are disappointed that the cost of colchicine has increased, progress has been made to ensure access for our patients through the expanded patient assistance program. We will continue to work with the FDA to encourage other manufacturers to seek approval, which will hopefully result in price competition and lower drug cost.
