Borgert Benjamin J, Bacchus Michael W, Hernandez Alexandra D, Potts Shelby N, Campbell Kevin J
Florida State University College of Medicine, Tallahassee FL, United States.
University of Florida College of Medicine, Department of Urology, Gainesville FL, United States.
Sex Med. 2023 Apr 10;11(2):qfad004. doi: 10.1093/sexmed/qfad004. eCollection 2023 Apr.
Recent changes to the Biologics Price Competition and Innovation Act of 2009 have created barriers to accessing therapy for men utilizing gonadotropins for hypogonadism and infertility.
In this study we sought to investigate ways to decrease disparities in the treatment of male hypogonadism by increasing access to gonadotropin therapy by identifying 503b outsourcing pharmacies which currently provide gonadotropin therapy.
A review of 503b compounding pharmacies was performed using the online published registry available from the US Food and Drug Administration (FDA). Each pharmacy was contacted regarding their ability to provide gonadotropin therapy. Pharmacies were also queried regarding the impact of FDA-related legal changes and cost considerations.
The study outcomes were the number and location of FDA-approved 503b compounding pharmacies supplying human chorionic gonadotrophin (hCG) and/or follicle-stimulating hormone (FSH) for the treatment of male hypogonadism and infertility.
The 81 503b-compounding pharmacies approved by the FDA to produce hCG and FSH therapy were identified using the FDA registry. Seventy-five of the 81 pharmacies responded to the survey (response rate 92.6%). Of the contacted pharmacies, 5 provided hCG (6.67%). Of the pharmacies offering compounded hCG, 4 offered FSH. No additional pharmacies offered compounded FSH. Eight pharmacies had previously provided hCG and FSH. Six of the 8 pharmacies that stopped making hCG and FSH cited the 2020 FDA mandate as the reason for halting compounding services. Of the 75 pharmacies that responded, only 1 pharmacy provided the cost for FSH ($287 per 100-IU vial), and 3 pharmacies provided the cost for hCG ($50-$83 per 10 000-IU vial).
There are few FDA-approved outsourcing pharmacies currently providing male gonadotropin therapy, and increasing awareness of these pharmacies may decrease barriers to care for patients with male hypogonadism and infertility.
The strengths of this article are the clinical utility of the data presented, as this article may serve as a tool for clinicians to increase patient access to therapy. All FDA-approved 503b outsourcing pharmacies were contacted, and 92.6% participated in this project. Limitations of this article were the following: no non-FDA-approved compounding pharmacies such as 503a pharmacies were contacted, participant-reported outcomes were utilized, and only 3 contacted outsourcing pharmacies provided a cost for FSH or hCG, allowing for an unknown degree of cost variability between outsourcing pharmacies.
There currently exists limited access to FDA-approved compounded gonadotropin therapies for hypogonadism and male infertility, and these results demonstrate the barriers to hCG and FSH access and the need for additional treatment options for this vulnerable patient population.
2009年《生物制品价格竞争与创新法案》的近期修订，给性腺功能减退和不育男性使用促性腺激素进行治疗带来了障碍。
在本研究中，我们试图通过识别目前提供促性腺激素治疗的503b外包药房，来研究增加促性腺激素治疗的可及性，从而减少男性性腺功能减退治疗差异的方法。
使用美国食品药品监督管理局（FDA）在线公布的注册信息，对503b配制药房进行审查。就各药房提供促性腺激素治疗的能力进行联系。还询问了药房有关FDA相关法律变更和成本考虑的影响。
研究结果是FDA批准的为治疗男性性腺功能减退和不育而供应人绒毛膜促性腺激素（hCG）和/或促卵泡激素（FSH）的503b配制药房的数量和位置。
通过FDA注册信息识别出81家经FDA批准生产hCG和FSH疗法的503b配制药房。81家药房中有75家回复了调查（回复率92.6%）。在被联系的药房中，5家提供hCG（6.67%）。在提供配制hCG的药房中，4家也提供FSH。没有其他药房提供配制FSH。8家药房以前提供过hCG和FSH。停止生产hCG和FSH的8家药房中有6家称2020年FDA的指令是停止配制服务的原因。在回复的75家药房中，只有1家提供了FSH的价格（每100国际单位小瓶287美元），3家药房提供了hCG的价格（每10000国际单位小瓶50 - 83美元）。
目前经FDA批准提供男性促性腺激素治疗的外包药房很少，提高对这些药房的认识可能会减少男性性腺功能减退和不育患者的治疗障碍。
本文的优点是所呈现数据的临床实用性，因为本文可作为临床医生增加患者治疗可及性的工具。联系了所有经FDA批准的503b外包药房，92.6%参与了本项目。本文的局限性如下：未联系非FDA批准的配制药房，如503a药房；采用了参与者报告的结果；只有3家被联系的外包药房提供了FSH或hCG的价格，使得外包药房之间成本差异程度未知。
目前，经FDA批准的用于性腺功能减退和男性不育的配制促性腺激素疗法的可及性有限，这些结果表明了获取hCG和FSH的障碍，以及为这一脆弱患者群体提供更多治疗选择的必要性。
