Authors' objectives:

To assess the relative efficacy of recombinant-follicle stimulating hormone (r-FSH), as well as the cost-effectiveness of the drug consumption, compared to urinary origin FSH for the 2 main therapeutical indications of this hormone: controlled ovaric hyperstimulation in assisted human reproduction and ovulation induction in the hypothalamic-hypophyseal portal system.

Authors' results and conclusions: R-FSH is more effective than u-FSH in controlled ovaric hyperstimulation. The amount of oocytes obtained with r-FSH is around 8 mature oocytes or 10.7 total oocytes, while the mean of mature oocytes obtained with u-FSH is 6.2 or 8.9 total oocytes. Also the rate of pregnancy in progression in women treated with r-FSH is close to 25%, while the rate for women treated with u-FSH is around 21%. The cost per oocyte is close to 18,950 Pta. with r-FSH, while the cost with the urinary preparations does not seem to exceed 13,400 Pta./oocyte. The mean incremental cost per oocyte with r-FSH is around 47,550 Pta. (43,550 Pta. per additional mature oocyte). The cost per pregnancy is 850,492 Pta. with FSH-r, while the cost using u-FSH is 601,017 Pta., approximately. The incremental mean cost of an pregnancy obtained with r-FSH is 2,209,321 Pta. In case of ovulation induction, the pregnancy rate tends to be slightly higher among the population treated with r-FSH. The mean pregnancy rate recorded in these studies is close to 26% with r-FSH, and to 23% if u-FSH is used. Ovulation rate is also slightly higher with r-FSH (95.6% compared to 93% with u-FSH). The cost per pregnancy is 609,599 Pta. with r-FSH, and 449,599 Pta, approximately, with u-FSH.

Authors' recommendations: As inferred from the studies reviewed in this report, r-FSH is more effective than the urinary origin equivalents in the two clinical circumstances studied. However, differences are relatively small, and are not statistically significant. The supposed excess of effectiveness of the recombinant drug, however, does not seem to compensate the difference in prices, since r-FSH is approximately 40% less cost-effectiveness than u-FSHs, taking into account the price of the drug as cost unit. The characteristics of the data analysed in this report do not allow to estimate the effectiveness and cost-effectiveness of these drugs in other contexts. It is important to value the degree of similarity of routine practice related to some other variables that influence the technique's effectiveness and efficiency - such as the patient's age, the inclusion criteria for assisted human reproduction techniques, drug schedules and doses, use of agonists or antagonists, follicle maturation criteria, etc., or even the effectiveness and efficiency of the different components of in vitro fertilization techniques. It is then necessary to establish mechanisms allowing to establish knowledge-based criteria on the convenience of one drug or other. At community level (from a public purchaser point of view) it is more favourable to use the urinary origin formulation, due to the small margin of effectiveness, and the large difference in costs between both drugs. However, other aspects could be taken into account, such as the need to maximise effectiveness in some special cases (older women, with prior failures, with limitations to repeat new attempts, etc.), or considerations on the negotiation capacity of the price of drugs. Social and economic trends do not favour the use of the simplest drug because, among other reasons, the availability of the raw material for the elaboration of urinary origin drugs is increasingly lower, at least in advanced societies. As long as new formulae to obtain and distribute the raw material from other countries is not developed, it will be difficult to adopt a massive use of the urinary origin substance at long term.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.gencat.net/salut/depsan/units/aatrm/html/en/dir393/doc7921.ht ml

Year Published: 2000

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Qualitat i Avaluacio Sanitries de Catalunya

Contact Address: Antoni Parada, CAHTA, Roc Boronat, 81-95 (2nd floor), 08005 Barcelona, Spain, Tel. +34 935 513 928, Fax: +34 935 517 510

Contact Name: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Contact Email: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Copyright: Catalan Agency for Health Technology Assessment and Research (CAHTA)