US: same drug, different packaging, $19.8K price difference

Hormone treatment aimed at preventing a preterm birth could cost as little as $200 or as much as $20,000, according to a new analysis from Harvard Medical School.

The research, published in JAMA Internal Medicine, compared the cost of medication and pregnancy outcomes among more than 3,800 women treated with either a compounded, made-to-order form of the synthetic progestin hormone, 17P, or with a brand name packaged version of the same drug.

The two have the same active ingredients and are clinically interchangeable, the researchers say.

There was no statistically significant difference in the rate of preterm births, of 23.9 per cent, among women who got the brand name version, compared with 25.2 per cent in women who received the compounded drug.

However, the difference in cost was dramatic, at $206 per pregnancy, on average, for the made-to-order drug, compared with an average of $10,917 per pregnancy for the brand name medication.

The researchers estimate the annual cost of treating all medically eligible women with the brand name version would exceed $1.4 billion, compared with $27.5 million per year for the compounded form.

“Everyone is talking about how to pay for healthcare but few talk about why healthcare in the US is so expensive,” said investigator Andrew Beam, co-author on the study and an instructor in the Department of Biomedical Informatics at Harvard Medical School. “Uncontrollable drug prices are a major cause of this trend.”

The process of compounding - mixing drug ingredients to order - carries a slightly higher risk of contamination than pre-packaged drugs, the researchers say. However, compounding facilities have been placed under tightened federal regulations in the wake of a 2012 compounding contamination incident that led to an outbreak of meningitis.

The idea behind the analysis was not to single out one drug or pharmaceutical company but to point to a serious glitch in the US drug approval system that fuels ballooning drug spending.

“This case is emblematic of a systemic disorder that is not unique to one particular drug, class of drugs or manufacturer. There is no transparent and systematic link between the price, or cost, of a drug and its actual value or impact in terms of health and disease,” said a co-author of the study, Isaac Kohane, chair of the Department of Biomedical Informatics at Harvard Medical School.

JAMA Intern Med. 2017; doi: 10.1001/jamainternmed.2017.5017