PHILADELPHIA (CN) – Three insurance companies have filed a class-action complaint against Cephalon, claiming only 1 percent of the prescriptions for its addictive drug Actiq, prescribed for “breakthrough pain” in cancer patients, were medically necessary.
The insurers demand “hundreds of millions of dollars … for the inappropriate and medically unnecessary treatment of pain in non-terminal cancer patients.”
Employers Mutual Casualty Co., Emcasco Insurance Co. and Union Insurance claim that only 1 percent of the 187,000 prescriptions for Actiq filled in the fist six months of 2006 were for uses approved by the FDA. They claim the FDA approved Actiq – fentanyl citrate – “for a narrow class of patients: cancer patients whose pain could not be managed with other narcotic based drugs,” sometimes because patients had built up tolerance to traditional opiates.
The insurers claim the risk of abuse of Actiq is high, that it is “inappropriate and medically unnecessary to use Actiq to treat general aches and pains in the non-cancer population,” but that because “Cephalon knew that the market potential for Actiq in this (proper) context was modest,” it pushed it for off-label uses.
“The impact is clear,” the suit states, “only 1 percent of the 187,076 prescriptions for Actiq filed at retail pharmacies during the first six months of 2006 were prescribed by oncologists treating cancer patients. … One survey of doctors concludes that 80 percent of the patients that were prescribed Actiq between June 2005 and October 2006 do not have cancer and are outside the FDA-approved use. Such an overwhelming amount of off-label use did not come as an accident but is a direct result of Defendant’s off-label marketing activities.”
The insurers seek compensatory and punitive damages. They are represented in Federal Court by David Cohen with Saltz Mongeluzzi Barrett & Bendesky. See complaint.