Cutting the Cost of Parenthood: The Efficacy and Cost Savings of Compounded Follicle Stimulating Hormone

Objective:
Injectable follicle stimulating hormone (FSH) is used to establish or restore fertility in men with hypogonadotropic hypogonadism (HH) and provides ovarian stimulation (OS) in women undergoing both in vitro fertilization (IVF) and oocyte cryopreservation (OCP). Brand FSH (B-FSH) is prohibitively expensive and can be a major roadblock to couples pursuing fertility treatment. Here we provide the first analysis of the clinical efficacy and cost-effectiveness of compounded FSH (C-FSH) in both men and women.

Materials and Methods:
Retrospective chart review identified all men prescribed C-FSH with azo/severe oligozoospermia (<5 million sperm) and HH refractory to clomiphene citrate. FSH levels, semen analysis, and pregnancy outcomes were noted and median pre/post-treatment levels were analyzed using the Wilcoxon test. All females referred for IVF that used C-FSH for IVF or OCP were included. All C-FSH prescriptions were obtained through the same specialty compounding pharmacy in Houston, TX. Average cost of B-FSH was derived from the top 9 commercial pharmacies listed on www.GoodRx.com and compared to C-FSH to determine the estimated cost of a typical male or female course of therapy.

Results:
16 men were prescribed C-FSH and met inclusion criteria (Table 1). Median FSH levels showed a significant, 16-fold increase from baseline (p<0.0004). All 13 men with semen analysis data showed improved sperm concentration and total motile count (TMC) with C-FSH therapy. Of 9 men attempting pregnancy, 6 (66.7%) achieved with 8 live births (2 twins). 6 female patients initiated IVF or OCP, resulting in a median retrieval of 14.5 (7-29) mature oocytes, a 72% fertilization rate, 8.5 (5-13) mature blastocysts, 2 transferred embryos and 2 singleton pregnancies. Cost analysis demonstrated significantly lower cost for C-FSH ($0.20) compared to B-FSH ($2.20).

Conclusions:
In this novel analysis, C-FSH therapy resulted in significantly improved serum FSH levels, sperm concentration and TMC in men with HH. It also showed excellent OS of women undergoing IVF and yielded several pregnancies, validating the clinical effectiveness of C-FSH. Compared to B-FSH, C-FSH provides unprecedented cost savings to male and female patients undergoing FSH therapy and may allow some couples to achieve parenthood who otherwise would be prohibited by cost.

Support:
None

Authors: Alexander J. Tatem, J. Abram McBride, Jonathan Beilan, Jabez Gondokusumo, Daniel J. Mazur, Larry I. Lipshultz | Category: Infertility – Therapy Keywords: Fertility, hormonal therapy, economics | Affiliations: Scott Department of Urology, Baylor College of Medicine, Houston, TX | Character Count: 2053 + table/225 = 2278 (2280 limit)