Bemfola^® fixed dose pens potentially reduce drug wastage and associated costs of infertility treatment

Abstract

Bemfola is a recombinant follicle-stimulating hormone (FSH) used during infertility treatment. One main differentiator between FSH products is their delivery device; consisting of multi-dose pens (Gonal-f), vials or multi-dose preparations (Menopur), or adjustable daily disposable dose pens (Bemfola). To determine the potential impact of delivery device on drug wastage during infertility treatment this study retrospectively analysed Gonal-f and Menopur prescription and usage data from five UK clinics. Incurred drug wastage was then compared to potential Bemfola drug wastage. Data collected included: (i) number of treatment cycles; (ii) daily FSH dose; (iii) length of treatment; (iv) dose adjustment following ultrasound scan; (v) FSH formulation(s) prescribed and (vi) agonist/antagonist protocol used. Treatment with Gonal-f (4078 cycles) and Menopur (646 cycles) resulted in an average drug wastage of 160 and 294 IU per treatment cycle. Use of Bemfola instead of Gonal-f and Menopur may reduce the wastage to 104 and 61 IU per cycle, respectively. The use of Bemfola, across all 4724 cycles, could result in a drug wastage reduction of up to 376,800 IUs with an associated cost saving of £100,011. Bemfola is a viable alternative to Gonal-f and Menopur with its drug delivery system potentially reducing drug wastage and associated costs during infertility treatment.

The continuum of ovarian response leading to BIRTH, a real world study of ART in Spain

“…Furthermore, in 2014 Spain reported to the EIM a total of 109,275 ART treatments, which was higher than any other European county [1]. Gonadotrophin treatment contributes a significant proportion of the cost of ART, thus the introduction of biosimilars of recombinant follicle stimulating hormone (rFSH) alpha may alleviate the costs of ART improving affordability [2]. The first rFSH biosimilar launched in Europe was Bemfola® in 2014 [3], which has proven popular in Spain [4].…”

Qualitative risk assessment of follicle stimulating hormone injectable products

“…Either the residual rFSH is discarded or two injections are administered to make up the full dose, introducing an increased risk of incorrect dosing as well as the discomfort of a double injection. Even if patients choose to use the two rFSH pens, a real-world study in the UK of 4,078 IVF cycles with Gonal-f® and 646 IVF cycles with Menopur® suggested FSH wastage would be less if the single-use Bemfola® pen was used, as typical daily wastage with Bemfola would be lower than the terminal wastage in a multi-use option [4].…”

“…Although the focus group size in this study was only sufficient to assess user preferences between very different products, other larger studies have considered user preferences between the different FSH pens. Longobardi et al reported a study of 60 fertility nurses and 120 women with infertility, in which the Gonal-f® pen was rated higher in preference before and after simulated injection compared to Bemfola®, Ovaleap®, and Rekovelle® injection pens [7]; however, the study simulated administration of a dose of 65 IU rFSH (or 9.66 μg for the Rekovelle® pen), which is a dose not used in routine IVF practice [4]. In contrast, a study of 65 women and a further study of 460 women, both simulating an intended administration of 225 IU/day followed by a dose increase to 300 IU, found that Bemfola® pen was preferred by treatment-naïve patients to both Puregon® and Gonal-f® pens, particularly with respect to ease of use [3,5].…”

“…Since the introduction of the single-use, selfadministered, pre-filled injection pen, several studies have compared this option against available alternatives with respect to use and handling, human factor interactions by patients and nurses, and potential drug wastage [3][4][5][6][7].…”

Risk of dosing errors in ART treatment: user experience of single- vs multi-use follitropin alfa pens

“…If patients require a lower dose than the maximum injection volume, another safety feature is an in-built lock, which prevents re-use of the pen device in order to eliminate the possibility of redosing. Despite the single-use nature of Bemfola ® , and the possible perception of potential drug wastage and associated costs of unused portions of the pens, a UK-based multicenter analysis of nearly 5,000 FSH treatment cycles showed that if Bemfola ® had been used rather than a multi-use formulation, there would have been a potential saving of 61 to 104IU per cycle; across nearly 5,000 cycles this amounted to a reduction in drug wastage of 367,800IU, equivalent to a saving of over £100,000 in total drug costs [19].…”