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Branded progestin drug costs significantly more than original formulation
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Despite a 5,200% higher mean cost of the branded synthetic progestin, 17-alpha hydroxyprogesterone caproate, compared with the original compounded drug, both formulations equally prevented or delayed preterm birth, according to findings published in JAMA Internal Medicine.
“[17-alpha hydroxyprogesterone caproate] has been proven effective in preventing or delaying preterm birth in singleton pregnancies for women with a history of spontaneous preterm birth. Once widely available as an inexpensive compounded drug, it now has a branded version (Makena; AMAG Pharmaceuticals) that costs approximately 100 times more than the original,” Inbar Fried, MSc, from the department of biomedical informatics at Harvard Medical School, and colleagues wrote, adding that the branded version is comprised of the same active ingredients as the original.
Fried and colleagues sought to compare the use, costs and outcomes of the branded and compounded versions of 17-alpha hydroxyprogesterone caproate. Researchers examined prescriptions for the drug using a deidentified insurance claims database of nearly 4,000 pregnant women who were commercially insured (not by Medicaid) from Jan. 1, 2008, to Dec. 31, 2015. They used National Drug Code descriptors to identify trends in utilization of branded and compounded 17-alpha hydroxyprogesterone caproate and women who had a pharmacy claim for either formulation. Researchers also used a unique Current Procedural Terminology code to identify women who were injected with the compounded drug at a homecare agency.
For each participant, the researchers calculated the total allowed cost from the initial injection of the drug to delivery, not applying discounts. In addition, they used logistic regression to compare preterm birth rates between branded and compounded 17-alpha hydroxyprogesterone caproate, controlling for maternal age.
The study only included women who delivered a single liveborn or stillborn. Overall, 535 women with 540 pregnancies received the branded drug, while 3,350 women with 3,481 pregnancies received the compounded drug.
Data showed that there was an increase in use of both formulations over the study period until 2015 when there was a decline in use of the compounded drug. Researchers reported that the mean per pregnancy costs were $10,917 for the branded drug and $206 for the compounded drug.
In women receiving the branded drug vs. the compounded drug, there was no statistically significant difference in preterm birth rates (OR = 0.99; 95% CI, 0.95-1.02). During treatment, the frequency of infections was similarly low for both formulations.
“This analysis raises concerns about the value of branded 17-alpha hydroxyprogesterone caproate. ... According to our analysis, if given to every eligible woman, the branded version would cost more than $1.4 billion annually, whereas the compounded version would cost $27.5 million annually. This finding broadly illustrates that branded drugs with market exclusivity have become one of the primary drivers of rising medication costs,” Fried and colleagues concluded.
According to a recent presentation at the NIH’s workshop, “The Human Microbiome: Emerging Themes at the Horizon of the 21st Century,” the unique microbiome in the female reproductive tract may eventually be used to predict a woman’s probability of giving birth prematurely. – by Alaina Tedesco
Disclosures: Fried reports receiving salary support from the Aetna Life Insurance Company. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Larry Rand, MD
Complication from preterm birth (delivery <37 weeks) is the leading cause of death in children under 5 years of age worldwide, and progesterone supplementation is currently the only medication shown to reduce the recurrence of preterm birth (by approximately one-third) among women who have had a previous preterm birth.
This intriguing study should give providers of obstetrics services significant pause, particularly in the context of simultaneously emerging reports with conflicting results on the efficacy of this intervention, reminding us of the need for additional research examining dosing, frequency, and co-morbidities. As efficacy data continue to be evaluated and national provider organizations deliberate over whether or not to update current clinical practice recommendations, this intervention remains standard of care among women who have had a previous preterm birth.
As such, it would behoove payors (both private and public) to carefully review these data and consider which drug formulation makes most sense to have on their formularies. If the 133,000 women estimated to be eligible for this drug intervention in 2005 were to actually receive it, the cost of the compounded formulation would be $27.5 million annually. In comparison, the cost of the branded formulation would be $1.4 billion – an option that is simply not sustainable.
Unfortunately, we actually still have a way to go to attain optimal implementation of this intervention among eligible women and a lower drug cost may result in greater reach and further reduction of the massive health costs associated with prematurity. As a potentially affordable intervention, the need for ongoing investigation of other risk groups that might benefit from this drug beyond those with previous preterm birth is further underscored.
Finally, the current study was conducted only among privately insured women. Since Makena is also covered by Medicaid, a similar study should be conducted in a Medicaid population where the risk of preterm birth may be greater.
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