Makena or Compounded 17P?

To the Editor:

I read with great interest the article in the July issue of P&T, entitled “Controversies in Practice,” by Drs. Patel and Rumore regarding weekly injections of 17P for the prevention of preterm birth.¹ Lacking, sadly, was a return on investment (ROI) comparison as well as a summary of the facts surrounding this controversy. Had those been included, I am confident that the authors would have arrived at a very different conclusion. Absent that, they came up with a costly recommendation that accrues no proven additional health care benefit.

Pharmacoeconomic Comparison

Assume that 200 patients experienced a previous preterm birth. All of these women received hydroxyprogesterone caproate (Makena), self-administered compounded 17P, or nurse-administered compounded 17P in the home. The advantage of nurse-administered injections is that compliance can be monitored; this alleviates a problem identified in a trial conducted by the National Institutes of Health.² One could reasonably expect 40%, or 80 patients, to deliver a preterm infant if none of the 200 were treated. If all were treated, about 33% of those who would have delivered early (26 patients) would be spared. The average cost of a preterm birth is roughly $49,000, compared with $4,500 for a healthy birth, according to the March of Dimes.³ Therefore, all three treatment methods could be expected to yield savings of $49,000 × 26 patients = $1,274,000.

The ROI can be easily calculated by multiplying the total cost of the intervention and dividing by the savings. An example of each method follows:

• Self-administered compounded 17P costs $15 per injection × 20 weeks = $300 per pregnancy × 200 treated patients = $6,000 total cost; $1,274,000 divided by $600 = $212 ROI. Therefore, for every $1.00 spent, $212 is saved.
• Compounded 17P injection, administered by a home nurse, costs approximately $150 × 20 weeks = $3,000 per pregnancy × 200 patients = $600,000 total cost; $1,274,000 divided by $600,000 nets a respectable $2.12 ROI; simply put, for every $1.00 spent, approximately $2.12 is saved.
• Makena costs approximately $15,000 per pregnancy × 200 treated patients = $3,000,000 total cost. Divide the total cost by the savings, and the ROI comes out to negative $2.35. As a result of the high cost of Makena, $2.35 is spent to save $1.00! For Makena to cost as much as it saves, the price per pregnancy would need to be reduced from $15,000 to $6,370 ($1,274,000 savings divided by 200 patients).

Fact Summary

• Compounded 17P was in use exclusively from 2003 until Makena was approved on February 4, 2011, with no evidence of harm resulting from the compounded drug.
• The FDA supports the use of compounded 17P.
• The American College of Obstetricians and Gynecologists (ACOG) is supportive of compounded 17P use for the appropriate clinical indication.
• The Society for Maternal-Fetal Medicine has not found any problems with compounded 17P use. George Saade, the society’s President, said:⁴
  

  The Society for Maternal-Fetal Medicine commends the FDA on its recently released position that it will exercise enforcement discretion with respect to compounding hydroxyprogesterone caproate. This action will ensure that this lifesaving treatment will continue to be available for all those who need it. Affordable access to hydroxyprogesterone caproate is critical in ensuring the health and full-term birth of babies in the U.S.

• No randomized controlled trial has ever demonstrated improved birth outcomes or a more favorable safety profile of Makena compared with compounded 17P.
• Compounded 17P is substantially equivalent and readily available anywhere in the U.S.

When a pharmacoeconomic comparison is performed and the facts are assembled, it is difficult to imagine how the authors could conclude that Makena should be used. The only explanation is the overemphasized and unfounded concern regarding liability. In reality, one has to wonder how this qualifies as a controversy when the issue seems so clear.

Sincerely,James P. Reichmann, MBASenior Vice President of Sales & MarketingAmerican HomePatientBrentwood, Tennessee