Results from new study could make some cancer drugs more cost effective

On the Medical Watch: Unsustainable. That’s what doctors and the nation’s public health experts call the surging cost of cancer drugs.

Earlier this month the President’s Cancer Panel released a report urging the administration to make the dramatic rise of drug prices a national priority – and better align cost and value. And adding to that conversation just today, new study results that may help offer a solution.

A University of Chicago Medicine researcher took an expensive but effective drug, tested a lower-than-recommended dose in patients and got the same results at one-fourth the cost.

Dr. Mark Ratain, University of Chicago Medicine oncologist: “There’s many examples of drugs where you could give half the dose or less with food and save half the costs of the drug.”

Take abiraterone, for example, a drug that blocks production of the hormones that stimulate prostate cancer growth. It’s given to patients whose disease has spread, most commonly to the bones. Abiraterone, or Zytiga, as it’s known, has what’s called a “food effect.” When taken with a meal, the amount that gets absorbed in the body increases. If too much enters the blood stream, patients might experience negative side effects. That’s why the drug’s maker, Janssen Oncology, recommends taking the medicine on an empty stomach. The instructions are clear: Take four pills a day, or 1000 milligrams. Do not take with food.

Dr Ratain: “We focused in on abiraterone because when it was approved, it’s prescribing information said absolutely don’t take it with food because you might get a 10-fold increase in the blood. I said to myself, ‘That’s crazy. Let’s give a lower dose with food.’”

And that’s exactly what oncologist Dr Mark Ratain and his colleagues did. Instead of the recommended four pills a day, half the patients who enrolled in their study took just one a day with a meal. In other words, they used abiraterone’s food effect to their advantage.

Dr Ratain: “The patients understood if they went into the study they would get one-fourth of the drug. In fact, we showed it works just fine and just as well as the standard way of giving it.”

Now consider the cost. A one-month supply of Zytiga can run more than $11,000 dollars, or 90-plus dollars per pill. If patients took one-fourth of the dose but added food into the equation – not extra pills -- to boost the effectiveness of the drug in the body, that math adds up to a 75 percent savings for a drug that’s been shown to extend the life of patients with metastatic disease by four months. We reached out to Janssen Oncology about the study and received the following statement:

The use of food as a way to increase bioavailability in patients with cancer could present problems and risks. Given the variation in the content and composition of meals, the recommendation is to take ZYTIGA® exactly as described in the prescribing information.

But blood tests showed study patients who took the lower-dose with food actually had more consistent levels of the drug in their bodies compared to those who took it as labelled.

Dr Ratain: “The warning label is appropriate in the context of taking 1000 mg per day. You should not take 1000 mg with food. But 250 mg with food is absolutely fine.”

There are breast and kidney cancer drugs as well as leukemia and lymphoma meds that work the same way. If the same theory is applied – could the savings reach the millions?

Dr Ratain: “Yes, maybe billions.”

Dr Ratain says more clinical trials are needed to definitively prove if these low-cost strategies are effective. He’s even established a non-profit organization to help fund additional studies.