P-457 A biosimilar FSH is a cost-effective option for women undergoing IVF/ICSI treatment in France
Authors: Lehmann M , Arbo E , Pouly J L , Barrière P , Boland L , Bean S , Jenkins J 
Published: June 2023

Study question

Is Bemfola® a cost-effective treatment option compared to Gonal-f® for women undergoing IVF/ICSI treatment in France based on real-world evidence?

Summary answer

Bemfola® is a cost-effective treatment option, based on real-world evidence, demonstrating lower gonadotropin costs per live-birth following one ovarian stimulation cycle compared to Gonal-f®.

What is known already

Since Bemfola®’s first launch in 2015, real-world data has been collected in France, comparing it with the originator Gonal-f®, in the REOLA study (Barriere P, et al., J Gynecol Obstet Hum Reprod. 2023;52:102510). This study demonstrated comparable clinical outcomes according to follicle stimulating hormones (FSH) starting dose between the two FSH, in terms of oocytes retrieved, cumulative live-birth rate (CLBR), and total FSH dose per cycle. Previous health economic studies comparing the cost-effectiveness of Bemfola® against Gonal-f® utilise clinical trial data and therefore leave ambiguity over the cost-effectiveness as the results may not reflect what happens in clinical practice.

Study design, size, duration

We developed a decision-tree cost-effectiveness model with a one-year time horizon based on the gonadotropin costs and CLBR per ovarian stimulation for Bemfola® and Gonal-f®. The output was gonadotropin cost per live-birth following one ovarian stimulation cycle. CLBR per ovarian stimulation data were taken from the REOLA real-world study while acquisition costs were taken from publicly available databases in France. Model structure and methodology were based on previous publications and validated by clinical experts.

Participants/materials, setting, methods

The model used clinical data from REOLA, a non-interventional, retrospective, real-world study conducted in 17 French Assisted Reproductive Technology (ART) centres including data from 2,319 Bemfola® and 4,287 Gonal-f® ovarian stimulation cycles for IVF/ICSI grouped according to starting dose. Data was collected for ovarian stimulations between the dates of 01/01/16 and 28/02/17 and CLBR included a follow-up to live-birth of all pregnancies following both fresh and frozen embryo transfer within 12 months of oocyte retrieval.

Main results and the role of chance

The REOLA study data utilised within the model comparing Bemfola® vs Gonal-f® grouped according to FSH starting dose (&lt; 150 IU, 150 - 224 IU, 225 −299 IU and ≥ 300 IU) are the median total FSH used - 1100 IU, 1500 IU, 2250 IU and 3300 IU vs 1008 IU, 1500 IU, 2250 IU and 3300 IU, and the CLBR - 30.5%, 25.4%, 21.4% and 12.3% vs 27.0%, 27.3%, 19.6% and 12.0%, respectively. The gonadotropin cost per live-birth for Bemfola® was €2,302.12 compared to €2,856.26 per live-birth for Gonal-f®, saving €554.15 per live-birth. The main reasons for this cost saving was the lower acquisition costs of Bemfola® of €489.01 compared with Gonal-f® costs of €597.36 on average per ovarian stimulation. As this analysis is based on real world data as opposed to results from clinical studies it can be used to estimate potential gonadotrophin cost savings in clinical practice in France. With 27,861 babies born annually in France using ART it can be estimated that if all had been born following Gonal-f® usage then a change to all being born following Bemfola® usage could result in savings sufficient to fund gonadotrophins for an additional 31,572 ovarian stimulation cycles.

Limitations, reasons for caution

The model assumed equal distribution of Bemfola® and Gonal-f® across the starting dose categories and have assumed that the number of fresh and frozen cycles required following ovarian stimulation would be equivalent irrespective of the gonadotropin used.

Wider implications of the findings

Bemfola® is cost-effective compared to Gonal-f® for IVF/ICSI treatment which would potentially enable more women to be treated with the same healthcare budget for the French health system. This might apply for other countries where Bemfola® is available and benefit from lower acquisition costs than Gonal-f®.

Trial registration number

not applicable