In this questionnaire-based survey, the routine use of the prefilled follitropin alfa FbM, ready-to-use injection pen was well accepted, and associated with favourable patient perceptions in 5328 ART cycles. Patients reported that use of the follitropin alfa pen required less training compared with a syringe and vials/ampoules of follitropin alfa. The prefilled pen was perceived as being easier to use than existing injection procedures/devices, including the reusable follitropin beta pen, and there was a general preference for the follitropin alfa pen.
Injection-pen devices are used to self-administer medications that require daily injection on a long-term basis. Most experience of injection-pen devices to date has been obtained in diabetic patients who self-inject insulin. Pen devices are the preferred mode of administration for insulin, as they have made the injection process easier, less painful and more convenient. This has resulted in increased patient acceptance of therapy, and has improved patient compliance with therapy and treatment outcomes, as demonstrated by improvements in glycaemic control [7–10].
Previous studies have highlighted a number of benefits for the use of pen devices for the administration of r-hFSH. Compared with the use of syringes and vials/ampoules, women undergoing fertility therapy find the use of pen devices to be less painful, less stressful, easier and more convenient, and their use is associated with greater patient satisfaction [11–14].
Results from comparative studies of the two available pen devices for injection of r-hFSH indicate a preference for the prefilled follitropin alfa pen among both patients and nurses [15, 16]. In a small pilot study, patients undergoing ART procedures at a German centre were randomized to either the prefilled follitropin alfa pen or to the reusable follitropin beta pen . A greater proportion of patients in the group using the prefilled follitropin alfa pen found the pen very easy to handle, and quicker to learn to use and prepare for injection than those using the reusable follitropin beta pen. Overall, the desire to continue using the device was substantially higher among patients who used the prefilled follitropin alfa pen than those who used the reusable follitropin beta pen .
A study of patients undergoing ART at an Australian centre compared the prefilled follitropin alfa pen with previous experience of the reusable follitropin beta pen [15, 16]. Patients who had used both pen devices scored many attributes of the prefilled follitropin alfa pen more favourably than those of the reusable follitropin beta pen, including the device storage, device use and dose preparation . Patients also reported less confusion with use of the prefilled follitropin alfa pen . In the same study, nurses were asked to complete a questionnaire about their experiences with the prefilled follitropin alfa pen and they were also very positive about the pen .
A survey conducted at a centre in the USA provided questions for patients about their preferred administration device following nurse-led training in different injection-administration methods . Of 94 participants who expressed a preference for a particular device, the prefilled follitropin alfa pen was the most popular (chosen by 68.1% of respondents). This was significantly more than the proportion of participants who chose the reusable follitropin beta pen as their preferred device (24.5%; p < 0.0001). In the same study, factors cited as being important for device selection included simplicity and reliability of the dosing mechanism, a design to minimize the chances of dosing errors and ease of use.
The current study is a much larger evaluation of the use of the prefilled follitropin alfa pen in routine clinical practice than those previously conducted. During the 1.75-year study period, approximately 35,000 prospective ART cycles were performed per year in Germany . These data, therefore, represent 8.7% of all cycles conducted in Germany during the study period. As is typical in trials utilizing participant questionnaires, not all participants answered every question. Furthermore, participants may have been inconsistent in their answers. Although we acknowledge the limitations of this study, our results confirm the findings of previous studies, which together indicate a high level of patient satisfaction with the prefilled follitropin alfa pen for daily self-administration of r-hFSH. This may reduce the burden of fertility treatment, help to improve adherence to therapy and reduce drop-out rates [18, 19].
It has been suggested that pen devices may also improve the efficacy of ovarian stimulation regimens, with better clinical outcomes associated with use of a pen device to administer r-hFSH compared with a conventional syringe [13, 20, 21]. However, more definitive evidence is needed, and a direct link between use of pen devices and effect on patient adherence to treatment has yet to be demonstrated. Clinical outcomes in this study were favourable, with a mean (SD) number of oocytes retrieved per cycle of 9.75 (5.83) and a clinical pregnancy rate per embryo transfer of 32.21%. As this was not designed to be a comparative study, only historical comparisons can be made between the outcomes obtained in this study with use of the prefilled follitropin alfa pen and those using other administration methods. Furthermore, such direct comparisons have inherent problems, as different study designs and study populations are used, and data are often inconsistently reported.
In summary, this study represents almost 9% of ART cycles conducted in Germany over a 1.75-year period. The results confirm previous findings on the acceptance, ease of use and preference for the prefilled follitropin alfa pen among women who self-administer r-hFSH for ART. The findings from this and previous user surveys are reflected in an audited report of pharmacy data obtained (post-study) for the 2004-2009 period which show that the majority of patients who have utilized follitropin alfa in Germany in the last 6 years have done so in the form of a prefilled pen.