Wednesday, June 10, 2015

Prior authorization for generics

"Some health plans are requiring prior authorization for generics," a delegate from the American Academy of Family Physicians said.

"I had a patient just a week ago, who waited 3-4 years for aripiprazole to go off patent to get the generic, and I got a call from the patient at the pharmacy that the generic cost more than the brand name," he said.

A third delegate said he'd spoken to the vice president of a major pharmaceutical company on the phone. When asked about a price increase in an insulin drug, the VP simply stated that if patients were feeling that increase, "they didn't have a good enough insurance policy."...

"The biggest outrage is phenylephrine,"  Donald J. Cinotti, MD, a New Jersey delegate, said. Phenylephrine is a liquid used in dilation, which, Cinotti said, ran less than $10 for a 15 mL bottle when he started practicing, and only crept to $15 per bottle in 2014.

Cinotti claimed that a pharmaceutical company discovered that the drug didn't have a National Drug Code (NDC) number. This can happens to prescriptions in existence prior to the creation of the FDA. "In their application, they used literature from the 1970s, no research, no added expense to them ... they got an NDC, and the price today is $115 per bottle."

According to Cinotti, all of the other generic manufacturers stopped producing the drug, leaving one manufacturer in Turkey.  ASHP placed phenylephrine on the drug shortage list in April 2015...

"They [pharma] are not uniquely greedy. They are exercising their greed in a unique market. The problem is also on the buy side," Richard B. Warner, MD, of Kansas, said. "People are buying prescriptions with un-real money, with insurance benefits rather than with real dollars."

"You have a mechanism where the seller sets a fictitiously high price. You have a total distortion of a normal market where people pay real things. We need to pay attention to last dollar responsibility."

David M. McKalip, MD, from the Florida delegation brought up the role of the FDA in creating shortages in injectable drugs. "Their attempts at excessive regulation led to companies stopping to produce." McKalip cautioned his fellow delegates against over-regulation of the pharma industry, which might induce more shortages.

However, he said, government created monopolies should be regulated against. "If crony corporations are using the power of government to drive out the competition, that can certainly drive up prices."


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