In court decision to approve generic colchicine for gout, American College of Rheumatology arguments about the risk to patients of exorbitant pricing may have played an important role. Is this a harbinger of something?
Monday, January 12, marked the end of five years of high-priced gout medication, as Prasco Pharmaceuticals began shipping generic brands of colchicine, in an agreement with Takeda Pharmaceuticals, manufacturers of the brand medication, Colcrys.
This happened within days a January 9 Federal Circuit Court decision to permit another distributor, Hikma Pharmaceuticals (and its US subsidiary, West-Ward), to distribute its own generic brand of colchcine, Mitigare.
This is expected to lower the price of the medication for gout flares, after a lengthy legal battle ended a six-year monopoly for the Colcrys brand.
Here are the basics about the (sometimes literally) painful history of a traditionally good gout treatment gone bad:
• 2009: Despite its use as a gout remedy for over 200 years, colchicine was approved by the FDA only in 2009. This gave URL Pharma, the company responsible for pre-approval testing, a 7-year exclusivity contract (as opposed to the usual 3), because the drug was approved not only for gout flares but also as an "orphan drug" for familial Mediterranean fever.
• 2010: FDA ordered generic colchicine off the market. URL Pharma raised its price from as low as 10 cents per (generic) pill to $5 per pill.
• 2012: Takeda purchased URL Pharma for $800 million, only to sell it to Sun Pharmaceutical a few months later, after acquiring ownership rights to Colcrys.
• 2014: FDA approved Hikma’s generic brand, Mitigare, for gout flares. Takeda sued the FDA for breaking its exclusivity contract and obtained a Temporary Restraining Order against Hikma.
In December, lawyers for the American College of Rheumatology (ACR) filed an amicus brief in the case, urging renewed approval for the release of Mitigare. Its arguments included concern over the tendency of gout patients faced with exorbitant prices to discontinue treatment or to seek treatment from foreign countries.
An ACR press release reported that nearly 30% of patients in the US take "risky and potentially dangerous steps" to save money on medications, such as skipping doses or skipping medication altogether. Patients with rheumatic diseases are especially at risk, said Mayo Clinic chair of rheumatology Eric Matteson MD, because they may become disabled as a result.
The ACR takes credit at least in part for persuading the court to annul the Takeda injunction and permit distribution of Mitigare, pending further litigation.
“We hope this will serve as precedent for why the voice of the medical community is a vital component to judicial proceedings that have the potential to affect the public’s access to care,” said ACR President William St. Clair in the press release.
So far the prices for Mitigare and Takeda generic brand colchicine have not been announced publicly. Although further appeals are possible, the Federal Circuit Court quickly denied Takeda's appeal for an immediate emergency injunction in response to the judgment.