The information URL gathered to file their NDA is a source of debate, with many rheumatologists suggesting that URL had not performed enough research to justify the price increase. These rheumatologists point to the limited information coming from a small dosing study showing that low-dose colchicine was a better treatment for acute gout than dosing to toxicity. These data were part of the NDA.
The study, published in Arthritis & Rheumatism (A&R), was a double-blind, placebo-controlled trial in acute gout comparing low dose (1.8 mg total over one hour) and high dose (4.8 mg over six hours) colchicine versus placebo. The researchers found the low-dose colchicine had comparable pharmacodynamics and efficacy as to high-dose administration and was comparable to placebo in side effects.1
“No one treats acute gout with that much colchicine anymore,” notes Edward Fudman, MD, a rheumatologist in private practice in Austin, Texas. “[URL Pharma] set up a straw man to knock it down.”
Colcrys Patient Assistance Program
One question that keeps being asked regarding the approval of Colcrys and the rise in price that followed is, What will the impact on patients be? URL Pharma is offering certain patients coverage assistance under their PAP.
For Patients on Government Programs
The program provides a Colcrys prescription with a co-pay of $5 per month to those who are uninsured or Medicare Part D patients with household incomes of up to four times the federal poverty level ($88,000 for a family of four). The plan has a co-pay of $25 per month for similar patients with household incomes between four and six times the poverty level ($132,000 for a family of four).
A patient’s physician must have recommended Colcrys and the patient must have a diagnosis of gout, acute gout, or familial Mediterranean fever (FMF). Patients can visit needymeds.org for links to the Colcrys PAP application or apply via phone at 1-888-811-8423.
Because of federal regulations, patients will be required to verify that they will not claim co-pay payments on Medicare, Medicaid, or other state or federal programs. This lets Medicare patients get their medications without having to worry about entering the “donut hole” in Part D. The patient only has to apply once each year, and the initial approval process takes up to two weeks. Both the patient and physician must sign the application. For refills, the patient calls the phone number above. The refilled prescription will generally be sent within 48 hours directly to the prescribing physician.
Private Insurance Assistance
Patients with private insurance who do not qualify for the PAP may benefit from co-pay assistance coupons. Many patients can have their co-pay reduced to $25. More information on coupons is available by calling 1-800-657-7613.
