Functionality of a Novel Follitropin Alfa Pen Injector: Results from Human Factor Interactions by Patients and Nurses

Health & Medicine︱Helen Saunders Functionality of a novel follitropin alfa pen injector: Results from human factor interactions by patients and nurses

® Helen Saunders, working at nfertility is an ever-growing problem Bemfola is regarded a biosimilar Gedeon Richter/PregLem, that was once shrouded with folklores because its chemical components a Hungarian/Swiss based and superstitions before the advent of are biologically similar to a previously I ® biopharmaceutical company, modern medicine. Now, breakthroughs licensed drug known as Gonal-f . They has focused her research in reproductive medicine have given share similar safety and efficacy profiles, on the benefits of a novel infertile couples from all over the world but have some differences in the actual Follitropin alfa pen injector the opportunity to conceive. A relatively format of the injector systems, which known as Bemfola®, which uses new treatment for infertility promises in turn result in differences for use Bemfola® provides a unique opportunity of aiding a greater number of patients with access to infertility care follicle-stimulating hormone to provide hope for many women who and teaching for patients and nurses. for overall reduced costs with an easy to use injector pen. (FSH), a reproductive hormone struggle to remain compliant to current Bemfola® is dispensed as a solution for the treatment of infertility available treatment options. Bemfola®, in a pre-filled pen and administered ® in women and men. Bemfola is a biological medicine and is a replica via an injection. development of the eggs and sperm steps on how the injector should be saves costs by potentially reducing has numerous benefits that of the natural follicle-stimulating so that they can be isolated as required used and has has volume and injection- drug wastage. make it an exciting alternative hormone (FSH) used for the treatment The most recent follitropin alfa pen, for IVF and embryo transfer. Small control mechanisms. It is a single-use to other more complicated of female and some particular male Bemfola®, has been available since errors in dosing can cause too high or injector pen and must be disposed This was further corroborated with treatment options. Through infertility-related conditions. Bemfola® 2014 and this disposable pen provides too low levels of follitropin alfa, which of once medication is administered. a previous scientific study which also Helen Saunders and her team’s now comes in a unique and innovative ease of use compared to other reduce the possibility of correct egg The Bemfola® pen comes with an found that Bemfola® was the preferred research, they aim to provide injector pen system. Researchers previous self-administered injections. and sperm maturation, causing the in-built lock which prevents the pen injection pen, when compared with women with information at Gedeon Richter/PregLem have The success of self-administration by process of fertility treatment to be a from being re-used. the Gonal-f and Puregon pens, related to a simple and cost- effective treatment strategy examined the ease of use and the effect patients using the insulin pen for those very emotional experience for patients. due to its superior handling, priming ® ® for infertility. of teaching the improved Bemfola diagnosed with diabetes, brought Studies have shown that anxiety around The delivery system of the Bemfola and overall use. pen injector may have on patients, about the basis of the design for the incorrect dosing causes patients to injection pen provides only a single nurses and the wider health system. Bemfola® injector pen system. The fear that medication errors will reduce dosage to be administered, which Research findings demonstrate that design of the Bemfola® pen achieved their chance of conceiving and prolong differs from its competitors and patients have more confidence in using WHY BEMFOLA®? the ‘Red Dot’ Design award in 2011 infertility treatment, which also comes Couples who experience infertility for its high design quality. Helen with associated costs. are classified as those who have been Saunders and her team set out to Providing fertility treatment that can unable to conceive within 12 months investigate the experience of the use Therefore, providing fertility treatments without using any form of contraception. of these pens in patients and nurses that can promise ease of use and promise ease, safety and avoid dosing Bemfola® is a treatment that can help to observe their views about the recent teaching and in turn avoidance of couples in cases like this. Bemfola® improvements of injection systems. dosing errors are necessary to ensure errors are necessary to ensure patients contains the active ingredient follitropin patients consistently maintain treatment consistently maintain treatment and alfa. It is almost indistinguishable from NON-COMPLIANCE and improve the chance of conception. the naturally occurring reproductive Follitropin alfa has been clinically Helen Saunders and her team have improve the chance of conception. hormone FSH and is produced available as a self-injection in Europe investigated the improved Bemfola® by means of recombinant since 1996 and provides patients with injection system and assessed patients’ DNA technology. a good prognosis. However, non- and nurses’ views to ascertain the human compliance to hormone treatment factors associated with Bemfola®. Follitropin is administered has been an issue for patients despite to patients to stimulate the ever increasing chances of treatment MAKING IT SIMPLE development of eggs in the success if utilised correctly. Studies have Having easy to use injector pens ovaries in women, and sperm shown that the complexity and physical for both healthcare professionals and in the testes in men. Patients demands of treatment often impact a patients is necessary to provide effective undergoing infertility treatment patient’s ability to stay on the treatment treatment for infertility. Bemfola® comes may use follitropin so that the eggs course, resulting in some couples giving in five different dose strengths which and sperm can be isolated before up hope of having a child prematurely. allows easy fine-tuning of the dosage undergoing medical procedures so that patients are only taking the such as in-vitro fertilisation (IVF) Achieving the right dose of follitropin exact necessary dose for each injection. and embryo transfer. alfa is important for the accurate It comes with clear and easy to follow Components of the Bemfola® pen.

www.researchoutreach.org www.researchoutreach.org The research highlighted the importance nurses play in educating patients on how to use the injection pen. Behind the Research Notably, acceptance and confidence in the injector system by health care Helen Saunders professionals can impact the success of patient education and therefore compliance. T: +41 22 884 0354 Personal Response Research Objectives

Saunders, H., Bitaine, L., Eftekhar, C., Howles, Gedeon Richter/PregLem SA is dedicated to the C., Glaser, J., Hoja, T. & Arriagada, P. (2018). development and commercialisation of innovative drugs Functionality of a novel follitropin alfa pen injector: for women’s reproductive medicine. Results from human factor interactions by patients and nurses. Expert Opinion on Drug Delivery. 15. 10.1080/17425247.2018.1459559 Detail Quintero, L.A., Merino, V.V., Bitaine, L., Vela, R., Rayward, J., Afonso, A., Quintana, D.B., Pinochet, Helen Saunders C.Á., Giménez, M.Á., Trías, A.G. & Jenkins, J. (2016). PregLem S.A. An evaluation by potential ivf/donor oocyte patients of Route de Frontenex 41A, 1207, the use and handling of the Bemfola® pen compared Geneva, Switzerland with the gonal-f ® pen and puregon pen®. Revista the injector pen because of its single has helped the team at Gedeon Richter/ compared with Gonal-f and Menopur, Iberoamericana de Fertilidad y Reproduccion Humana. Bio use. By using only one injection a Preglem improve the documentation Bemfola® outweighed these treatment 33. 42-51. Helen is a Medical Affairs Director with a background in day and disposing of it, this reduces and subsequent understanding of options because of the cost saving medical science/biostatistics and a specialist in infertility/ the complexity of the drug and in the patients and nurses in the use of benefits it provides for patients, in Mora, F. & Fauser, B. (2017). Biosimilars to recombinant women’s health with over 25 years’ experience. She has turn reduces patient stress. The study Bemfola®. The instructions for use of this turn reducing cost and resulting in less human FSH medicines: comparable efficacy and safety been involved in the running of many different phases and also found that the fear of dosage product contain simple diagrams to the drug wastage. in infertility care. Reproductive BioMedicine Online. 35. types of clinical trials and in the registration and publication errors was also reduced which in turn instructions for the Bemfola® injection 10.1016/j.rbmo.2017.03.020 of several products within the infertility setting. reduced the stress that patients were system alongside easy to understand THE FUTURE OF BEMFOLA® Foxon, G., Mitchell, P., Turner, N., McConnell, under when it came to correct dosing simple instructions to reduce the chance Numerous studies support Helen Funding A., Kendrew, H. & Jenkins, J. (2017). Bemfola® of fertility treatment. of errors. Saunders’ research, with many patients Gedeon Richter, PregLem S.A. fixed dose pens potentially reduce drug wastage demonstrating a preference for and associated costs of infertility treatment. Helen Saunders and her team’s research Bemfola® pens due to its ease of use SAVING COSTS Human fertility (Cambridge, England). 21. 1-6. found that the majority of both patients Subsidised financial coverage for and training and subsequent handling 10.1080/14647273.2017.1328131 Personal Response and nurses described the Bemfola® fertility treatments often fall short over the alternatives. Further research injection pens as is required to Imthurn, B., McVeigh, E., Stiller, R., Arnold, M., What do you think will be some of the most easy to use, with investigate whether Pringle, F., Irps, C. & Rettenbacher, M. (2014). an average score …most patients and nurses described the the use of these exciting developments for injector pen systems Evaluation of the use and handling of three different and infertility over the next few years? of 8.0-8.5 out of ® type of single pen systems considered for in vitro fertilization 10, and so patients Bemfola injection pens as easy to use and injector pens will treatment. Expert Opinion on Drug Delivery. 11. 1-6. There is currently an increasing trend in IVF to freeze all embryos in cases of over response and for fertility felt confident in translate into an 10.1517/17425247.2014.965676 preservation and in these cases, it is unnecessary to independently patients felt empowered independently actual increase change dose during stimulation, allowing a simpler taking the injection taking the injection at home. in treatment more convenient treatment for patients. Research is at home. Overall, compliance and also ongoing using Artificial Intelligence to identify patients scored an average of 8.7 out of and therefore it can be considerably and increase in the chance to conceive prognostic factors to allow better identification of the 10 regarding confidence to use the pen expensive for couples. As many couples for infertile couples. required dosing regimens for patients. In all of these alone. Nurses also felt very confident in pay out-of-pocket costs for treatment situations the Bemfola® pen injector will be well suited training patients on how to use the pen across the world, the cost-effectiveness Bemfola®’s low development costs given its easy to use and single dose administration injector, with an average score of 9.3 of providing effective fertility treatment and the further development of which in turn may encourage patients to continue longer with IVF treatment, and reverse current trends where out of 10. The research also highlighted is an important consideration. Overall, biosimilars who will compete for entry many patients discontinue IVF while further treatment the importance nurses play in educating biosimilars therefore represent a more into the market, will reduce the cost may be successful. patients, in this case, on how to use cost-effective approach for follitropin of the average price of treatment over the injection pen. Notably, acceptance alfa treatment, whilst maintaining time. If current trends prevail, Bemfola® and confidence in the injector system the efficacy of the originator products. provides a unique opportunity of aiding by health care professionals can impact a greater number of patients access the success of patient education and A previous study investigating cost- to infertility care for overall reduced therefore compliance. This research effectiveness of drugs found that when costs with an easy to use injector pen.