“Gout is a condition for which there is already low medication adherence,” says rheumatologist Kenneth Saag, MD, MSc, director, Center for Education & Research on Therapeutics of Musculoskeletal Disorders (CERTS) at the University of Alabama–Birmingham in Birmingham, Ala. “Anything that creates a barrier is problematic.” He says the case is important because too many patients can’t afford expensive medication.
The case went to the court on Jan. 9, 2015, for oral arguments. Although as this issue goes to press the court has yet to release its detailed opinion, it did issue an order that same afternoon vacating the district court’s injunction, stating that West-Ward was “free to immediately offer colchicine products for prophylactic use.”
Takeda says it will continue to press its patent infringement lawsuit and will appeal a denial of its request to have FDA approval of Mitigare overturned.
“We remain confident that after a trial, Takeda will prevail,” Takeda general counsel Kenneth Greisman says in a statement on the firm’s website.
Still, rheumatologists are hailing the decision.
“To finally have competition with another group to potentially lower the price is a very, very major thing for our patients,” says Dr. Cohen. “This is a major improvement if we can get another competitor on the market.”
Spiro Gavaris, vice president of sales and marketing for West-Ward Pharmaceutical, did not say what their price point would be.
“Our goal is to provide the most aggressive discounts on generic colchicine in the market with the intent for those discounts to be passed on to adult patients in need of treatment for the prophylaxis of gout flares,” he says.
But regardless of the price, anything below Takeda’s figures is a boon to patients who either could not afford Colcrys or who chose not to use it. That “access to care” angle is one reason the ACR has fought for expanded options.
“We must be constantly vigilant to developments that limit access to medications,” says Eric Matteson, MD, chair of rheumatology for the Mayo Clinic in Rochester, Minn. “High drug costs limit patient access to critical medications, whether covered by insurers or out of pocket. This case highlights the vital importance of affordability of drugs in medical care.”
Setting a Precedent
Dr. Matteson says the ACR’s push against one company monopolizing the market “provided critical input into the current dispute, which led to the court’s decision.
“As this case highlights, whether brand name or generic, it is most important that our patients with rheumatic diseases have access to medications that are safe and effective at the lowest reasonable cost to them,” he says.
