Briefing note: follitropin alfa (Bemfola)
What is follitropin alfa used for?
Follitropin alfa is a hormone that is used to treat female infertility due to anovulation (where the ovaries fail to release an egg) or deficiency in hormones (LH and FSH) that stimulate the ovaries to produce and release oocytes (eggs). It can also be used to stimulate ovaries to produce lots of eggs (superovulate) in women undergoing assisted reproductive treatments (ART). These are treatments that are used to help a woman have a baby and include techniques such as in vitro fertilisation (IVF). It can also be used in adult men with hypogonadotropic hypogonadism which is a disease where there is a problem with the pituitary gland or hypothalamus which means the testes produce little or no sex hormones.
How does it work?
Follitropin alfa is a synthetic hormone that is identical to follicle stimulating hormone (FSH) which is produced in the body. It helps to develop eggs in the ovaries in women. It also helps stimulate sperm production in men.
What has SMC advised?
SMC has accepted follitropin alfa for use in adult women for:
• anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.
• stimulation of multi-follicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
• In association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and follicle-stimulating hormone (FSH) deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 units/L.
SMC has accepted follitropin alfa for use in adult men for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.
What is the evidence to support this advice?
• Follitropin alfa (Bemfola®) has been developed as a biosimilar medicine similar to an existing biological product, in this case follitropin alfa (Gonal-f®) . Follitropin alfa (Bemfola®) and the original follitropin alfa (Gonal-f®) are very similar but they are not identical.
• A study showed that in women who were undergoing stimulation of multi-follicular development for superovulation for ART, follitropin alfa (Bemfola®) was as effective as follitropin alfa (Gonal-f®).
• An economic study compared follitropin alfa (Bemfola®) with follitropin alfa (Gonal-f®) for women who were undergoing stimulation of multi-follicular development for superovulation for ART. This found that the balance of costs and benefits for Bemfola® were similar to those for Gonal-f®.
SMC accepted follitropin alfa (Bemfola®) for use because the balance of costs and benefits were acceptable.