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.

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.

Germany finally rolling over EHC bump

Following the European Commission’s decision in January to switch HRA Pharma’s emergency contraceptive EllaOne (ulipristal acetate) to OTC status, the reaction of both government policymakers and healthcare professionals in pushing through the switch at national level has made for exciting viewing, particularly given the historically stubborn opposition to the free sale of EHCs, both among ruling politicians and GPs.

Regulatory authority BfArM, which makes regular switch proposals to the Health Ministry (BMG), had suggested the Rx-to-OTC switch of EHC levonorgestrel way back in 2003, with the recommendation last reviewed and updated in January 2014, only for Health Minister Hermann Gröhe and Jens Spahn – both CDU centre-right politicians – to resolutely reiterate the party’s age-old stance that the morning after pill would remain Rx. But the European Medicines Agency’s recommendation in November last year that ulipristal be made OTC prompted a sudden announcement by Gröhe that its classification would be reviewed, to the delight of centre-left coalition party the SPD, and the Greens.

Nevertheless, given the CDU’s resistance in the past, the speed with which the BMG initially planned to adopt the Commission’s centralised switch was surprising. Within a day of the announcement, a popular pharmacist publication quoted a BMG spokesperson as saying, “As far as we’re concerned, (the new classification)… is valid from today”, leading to a flurry of confused questions from pharmacist associations…Today? How… but… what?… Really? Manufacturer HRA Pharma even put in a request for pharmacists to be able to sell Rx packs without prescription as it had no packs ready for OTC sale, although this was refused by a local authority.

Things have slowed down a bit. As it stands, the Health Ministry has set out a decree, proposing both ulipristal and levonorgestrel be switched to OTC status, to be passed by the parliamentary Federal Council, with 15th March set as the date when consumers will actually be able to roll into a pharmacy and buy an EHC without a prescription.

Still to be decided on is whether consumer advertising should be restricted, what advice pharmacists will have to be provided alongside an EHC sale, and if a strict in-store protocol should be laid out, with GP associations extremely vocal about what they see as pharmacists’ lack of qualifications in advising on such a sensitive product, together with the frequent lack of an appropriate space for discussion between pharmacist and consumer. However, bespoke training programs and seminars led by female GPs are already underway in preparation, which should help to allay many of the safety concerns held by Health Minister Gröhe.

So despite initial confusion, the switch looks to be going ahead and it is undoubtedly a positive move, with around 60% of German consumers in favour according to a 2014 survey by research body Mingle. It is likely that the situation will be monitored for some time, to avoid the pills being dispensed “like smarties” as Mr Spahn feared they might be. German politicians need only look to responsible retailing in UK and France, where the birth rate is also markedly higher than in Germany, to see that pharmacists are unlikely to forget the “emergency” part of emergency contraception in a hurry.