Diet and Dosage: How Much Could Patients Save?

Still, Dr Ratain says, knowing that food increases the absorption of some therapies presents the possibility of easily — and significantly — lowering treatment costs.

“I think in any resource-constrained space or in any scenario where patients have significant copayments,” he said, “I think that physicians could offer this as an alternative.”

It’s not the first time Dr Ratain has challenged drug companies over the food effect. In a 2007 article commenting on a study that found that concentrations of lapatinib increased when it was taken with food, he and his co-author wrote:

“The economic implications of this food effect study are particularly remarkable. At the current price of $2,900 per month, a cost savings of 60% or $1,740 per month would be realized if the drug were taken with food.”³

In 2010, Dr Ratain and a colleague reviewed 99 oral oncology and non-oncology drugs approved by the FDA in the previous decade. They found a stark contrast between the dosing recommendations.

“When food markedly enhanced bioavailability,” they wrote, “8 out of 9 non-oncology drugs were labeled ‘fed’ to take advantage of the food-drug interaction while all oncology drugs (n=3) were labeled to be administered in ‘fasted’ states.”⁴

The then-director of the FDA’s Office of Clinical Pharmacology in the Center for Drug Evaluation and Research responded in an editorial that “although it is true that consistent co-administration with a high-fat meal may allow a lower-dosing level, inconsistent dietary habits could result in significant intradose variation in bioavailability.”⁵

Dr Ratain, however, contends that the potential for reducing dosages, and costs, demands further study.

“There are many drugs for which we can reduce treatment costs without reducing price by giving lower dosages or giving them less frequently,” he said. “There should be carrots and sticks associated with getting the dose right and we don’t really have that.

“The only thing that seems to matter is first to market as opposed to being right.”

References

1. Szmulewitz RZ, Peer CJ, Ibraheem A, et al. Prospective international randomized phase II study of low-dose abiraterone with food versus standard dose abiraterone in castration-resistant prostate cancer. J Clin Oncol. 2018 Mar 28. doi: 10.1200/JCO.2017.76.4381 [Epub ahead of print]
2. Segal EM, Flood MR, Mancini RS, et al. Oral chemotherapy food and drug interactions: a comprehensive review of the literature. J Oncol Pract. 2014;10(4):e255-68. doi: 10.1200/JOP.2013.001183
3. Ratain MJ, Cohen EE. The value meal: how to save $1,700 per month or more on lapatinib. J Clin Oncol. 2007;25(23):3397-8.
4. Kang SP, Ratain MJ. Inconsistent labeling of food effect for oral agents across therapeutic areas: differences between oncology and non-oncology products. Clin Cancer Res. 2010;16(17):4446-51. doi: 10.1158/1078-0432.CCR-10-0663
5. Jain RK, Brar SS, Lesko LJ. Food and oral antineoplastics: more than meets the eye. Clin Cancer Res. 2010;16(17):4305-7. doi: 10.1158/1078-0432.CCR-10-1857