New emergency contraceptive method ellaOne[R] - is it worth the price?
POST-COITAL emergency contraception hasn't had a "new look" for some years. Indeed, research demonstrating that increased availability of post-coital contraception seems not to have reduced abortion rates has given it a distinctly passe feel. When discussion in expert groups began to shift the focus away from increasing its use to its role in "bridging" women to other methods, post-coital contraception seemed to have passed its prime.
However, news of the launch of ellaOne[R] by HRA Pharma, a young, private European pharmaceutical company, was welcomed enthusiastically by post-coital contraception supporters at the annual meeting of the International Consortium for Emergency Contraception in New York in September 2009.
The product seems to have exciting potential, not least because it is based on a compound that is new to emergency contraception, with the active ingredient ulipristal acetate (30mg), which acts by binding to the progesterone receptor. The primary mechanism of action, when taken up to 120 hours after unprotected sex, is thought to be delay or inhibition of ovulation, but it may also affect the endometrium.
Product characteristics literature distributed with launch materials on 1 October 2009 claimed comparable efficacy to levonorgestrel up to 72 hours after unprotected sex or contraceptive failure. Based on two comparative trials in women who presented for post-coital contraception between 0 and 72 hours alter unprotected intercourse or contraceptive failure, efficacy was "non-inferior to that of levonorgestrel. The observed pregnancy rate was 1.5% in both studies, thereby preventing 85% and 73% of expected pregnancies". The product characteristics literature claimed that clinical trial evidence supported an observed pregnancy rate of 2.1% in women using ellaOne[R] between 48 and 120 hours after unprotected sex or contraceptive failure, preventing 61% of expected pregnancies studied, according to HRA Pharma.
The main advantage of ulipristal acetate over levonorgestrel seems to be its established efficacy of up to 120 hours (five days), and its licence for this period.
Currently, statisticians and epidemiologists are pouring over the HRA Pharma efficacy data, and much debate can be anticipated. However, even as things stand ellaOne[R], which is now registered in the UK, France, Netherlands, Germany and Belgium, is burdened by two major, related problems: it is only available on prescription and it is expensive. In the UK, the current public sector price for ellaOne[R] is UK16.95 [pounds sterling] (Personal correspondence 1 October 2009), compared to UK5.05 [pounds sterling] for Levonelle, the licensed levonorgestrel product. This price differential raises the question of whether the added value of an extra 50 hours efficacy is worth the increased price, particularly at a time of economic recession when health services are facing pressure to ensure the cost-effectiveness of every intervention.
HRA Pharma is a company that is worthy of support. Its chairman, Andre Ullman, was one of the pioneers who developed mifepristone into Mifegyne, the first "abortion pill". He established HRA Pharma with the aim of designing products to fill therapeutic gaps. The company invests in niche specialist areas and commits 20% of its turnover to research and development. But, with ellaOne[R], it faces a crucial challenge that confronts any small company without the capacity to absorb research and development costs. Levonorgestrel is an old compound that has been used in contraception, including post-coital methods, for decades. There are those of us who would argue that even the current UK public sector price of Levonelle is scandalously high--given the minimal R&D commitment and costs incurred when Schering Health Care Ltd (now BayerScheringPharma) acquired the product from Gideon Richter in Hungary. But compared with ellaOne, Levonelle is cheap. For ellaOne[R] to succeed in the marketplace, HRA Pharma will need to demonstrate that its value is worth its price. It will encourage future innovation if Ullman is able to succeed.