App “as effective as the contraceptive pill”

A revolutionary form of contraception, especially available over-the-counter, has been long awaited. This year alone we have seen trials in male contraceptive injections and demands for numerous OTC contraceptive pills. Drastic change and action have long been in high demand.

What started out as a hobby project for Elina Berglund Scherwitzl has now become approved as the world’s first contraceptive app. The nuclear physicist, who had been working on the team that discovered the Higgs boson, felt finished with hormonal contraceptives and their physical and mental pitfalls, but was not yet ready to have a baby.

With a wealth of data skills, Elina was determined to find an alternative form of contraception. “Like many women I had tried many different contraception options since my teenage years and hadn’t really found a solution that fit me,” she explained. “It was in my quest for an effective natural alternative that I discovered that you can see when you’re fertile by your temperature, and for me that was really a revelation.”

Using complex mathematics and data analysis, Elina began developing an algorithm designed to be so accurate that it could identify exactly when in her cycle she would ovulate. This then enabled planning for when she would need to use protection, to a much higher degree of certainty than natural planning methods, which many women with timely periods are able to use.

These results proved to be so accurate that, together with her husband, fellow physicist, Raoul Scherwitzl, Elina set about founding her own business, Natural Cycles.

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Natural Cycles is an app designed to help women around the world with their fertility and contraception needs, allowing them to collect their own temperature datasets and closely monitor their cycle trends in the process.

Launched in 2014, the app now has some 300,000 users, who pay a monthly or annual fee for the service. Following several medical trials, the app became the first tech-based device on the planet to be formally certified for use as contraception, in February this year. It gained approval for use across the EU after getting the green light from the German inspection and certification organisation Tuv Sud.

The start-up now markets itself as being “as effective as the pill” following one of the largest clinical studies in contraception involving more than 4,000 women, published in the peer-reviewed European Journal of Contraception and Reproductive Health Care.

The researchers, which included the co-founding couple, found that 7% of women who used the app in a “typical” way (allowing for some human error) got pregnant, compared to 9% taking the pill and less than 1% using IUD coils. “Just like the pill we need some effort from the user on a daily basis. But we really hope to be the default alternative if you don’t want to use hormonal contraception or IUDs,” Elina commented.

While the product is only currently certified in the EU, where its users are concentrated in the UK and the Nordics, it is available worldwide and, despite its earlier controversies, has attracted users in some 160 countries.

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German women enjoying new dawn after EHC switches

It has been just over two months since the first Rx-to-OTC switch of an emergency contraceptive in Germany, the first results are in and they should make happy reading for EHC marketers. Industry sources indicate that week-on-week EHC sales are around 40% higher than before the switch, a just reward for HRA Pharma’s 5+ year struggle with regulatory agencies to get the switch pushed through. The mid-May 2015 figures show volume sales for all EHCs sitting between 13,000 and 13,500, with around three-quarters of these generated OTC.

Following years of living in one of only three EU countries without OTC access to EHCs – along with Poland and Italy – German women now have a choice between ulipristal acetate, found in ellaOne only, and levonorgestrel, switched to OTC a few weeks later, found in HRA Pharma’s PiDaNa, Gedeon Richter’s Postinor and Hexal’s Unofem. While HCPs and GP associations have generally spoken out in favour of ulipristal given the longer time period it allows to prevent pregnancy, levonorgestrel is said to be a strong alternative for women breastfeeding as well as those who suffer from heavy asthma.

Price may also be a significant factor for female consumers, with ellaOne’s recommended retail price set at €29.96 (€35.72 before the switch) compared to €18.31 for PiDaNa, €16.99 for Unofem and €15.97 for Postinor. Breaking down the spring sales geographically, the growth has come primarily in the major cities of Hamburg (+50% compared to before switch) and Berlin, although sales have been below average in the less affluent east German regions.

With only a year’s patent on ulipristal acetate, HRA Pharma, award winner of Nicholas Hall’s Most Innovative European New Product of the Year, will have to make hay while it can, with pharmacist and HCP backing crucial given that no consumer advertising is allowed.

For a more complete look at the issue of EHCs in Western markets, why not enquire about our recently published report Women’s Health: Obstacles & Opportunities. Contact nino.hunter@NicholasHall.com for more details.