IBIS AND HRA AIM TO SWITCH THE PILL TO OTC

Ibis Reproductive Health and French-based HRA Pharma are working together to provide the research needed to submit an application to the US FDA to switch a progestin-only daily use oral contraceptive (OC) to OTC. For over a decade Ibis has worked with a broad coalition of healthcare providers, advocates and researchers in the Oral Contraceptives OTC Working group to build the evidence and make the case for the benefits of moving a birth control pill OTC.

Ibis highlights that too many people in the US face barriers to accessing the birth control they want and that a safe and effective OC would help people overcome some of those barriers. The coalition is committed to conducting the research and advocacy to ensure any OTC method is covered by health insurance and available to everyone who needs it.

HRA Pharma has already seen success in Rx-to-OTC switch in the EU, with its application to the European Medicines Agency to reclassify its emergency hormonal contraceptive ellaOne (ulipristal acetate 30mg) approved by the European Commission in early 2015 via the centralised procedure.

In an exclusive comment to the OTC.NewDirections team, Ibis Reproductive Health’s VP for Development & Public Affairs Britt Wahlin said: We are thrilled to be working with HRA Pharma in this effort that has been driven by demand from consumers and medical professionals. It’s past time we have an FDA approved OTC birth control pill, which would make it easier for women and men all across the country to determine how and when to have children and give them greater control over their lives and reproductive health. Currently, under the Affordable Care Act, most private insurance plans have to cover all types of FDA-approved birth control for women without any cost-sharing. This includes OTC methods used by women – though only if a healthcare provider prescribes them. We hope that women will be able to use their insurance for an OTC birth control pill without having to get a prescription.

A new law in Maryland is a promising direction. It will require coverage of OTC contraceptive medications without a prescription starting in 2018 and we hope more states will follow suit. Efforts are underway to dismantle the ACA and we have yet to learn what concrete plans there are to replace it. The birth control coverage provision is a crucial piece of the ACA. Millions of women have benefited from greater access to birth control and contraception is not one size fits all; insurance coverage of the full range of methods is critical so that women truly have a choice.

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Also, HRA Pharma’s US Portfolio Strategy Director Stéphanie Pradet told the OTC.NewDirections team: HRA Pharma is proud to partner with Ibis Reproductive Health and the OC OTC Working Group to bring to the US market a safe and effective over-the-counter contraceptive. At HRA, we are proud of our pioneering work to expand access to contraception for millions of women. We share the OC OTC Working Group’s commitment to increasing safe and effective options for preventing pregnancy and improving the reproductive health of women in the US.

Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts. The science is clear, and US experts including The American College of Obstetricians & Gynecologists, the American Medical Association and the American Academy of Family Physicians agree that oral contraceptives are appropriate as an over-the-counter option. We look forward to working together to build a future where each woman can get the safe and highly effective birth control method she prefers.

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.