MedicalResearch.com Interview with:
Andrew L. Beam, PhD
Instructor in Biomedical Informatics
Department of Biomedical Informatics
Harvard Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study is one piece of a larger story regarding the use of 17-alpha-hydroxyprogesterone caproate (17P) to treat recurrent preterm birth. This drug was originally only available in a compounded form, but since receiving an orphan drug designation in 2011, a branded and manufactured form was marketed under the name “Makena”. This branded form was then sold for a much higher price than the compounded version, but a study that provided concrete data on pricing and outcomes had not been done.
Our study used a large nationwide insurance database to look at women who received either formulation of 17P. Our primary finding was the branded version cost approximately $11,000 for an entire course on average, while the compounded form only cost about $200. We also looked at whether the rates of preterm birth differed between women who received the two different forms of 17P, since that was the primary outcome the drug is indicated to treat. We found no statistically significant difference in the rates of preterm birth between women who received the branded vs. compounded versions of the drug. We should caution that we used observational data so we are not able to say conclusively whether the two versions are equally effective.
MedicalResearch.com: What should readers take away from your report?
Response: Readers should be aware that in healthcare cost and value may not be as tightly coupled as one may hope, and that branding does not necessarily imply higher quality or innovation. This is especially important for patients with high copays who may have to shoulder these additional high costs at their own peril.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Head-to-head, prospective studies between the compounded and branded versions of 17P would help us understand if these high costs are justified. Additionally, further studies on how the Orphan Drug Act (the mechanism by which the branded version of 17P was given market exclusivity) on drug costs would help illuminate the often byzantine way drugs are priced.
Disclosures: Mr. Fried received support from the Aetna Life Insurance Company as part of the Aetna Research Collaboration with Harvard Medical School.
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Fried I, Beam AL, Kohane IS, Palmer NP. Utilization, Cost, and Outcome of Branded vs Compounded 17-Alpha Hydroxyprogesterone Caproate in Prevention of Preterm Birth. JAMA Intern Med. Published online October 02, 2017. doi:10.1001/jamainternmed.2017.5017
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