Long-Acting Reversible Contraceptives Await “Obamacare” Boost
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Contraception coverage mandated by the Affordable Care Act could unlock demand for IUDs. Actavis aims to provide an alternative to Bayer’s hormone-eluting IUD in 2014; public sector rights to Levosert are assigned to nonprofit Medicines360.
The market for long-acting reversible contraceptive methods could see a growth spurt as the birth control coverage requirements of the Affordable Care Act take effect, making long-acting methods like intrauterine devices available at no cost to patients. Bayer HealthCare LLC and Allergan PLC are positioning themselves to take advantage.
High up-front costs for long-acting reversible contraceptives have been a major hurdle to their use, despite public endorsements from professional groups. Public health organizations have long favored LARCs for their reliability. The American College of Obstetricians and Gynecologists urges that LARC methods be first-line recommendations for all women and adolescents (Also see "Bayer IUD Could Get Boost From Revised ACOG Guidance On Adolescent Contraception" - Pink Sheet, 18 Jan, 2013.). The international Bellagio Consensus, the result of a May 2012 meeting hosted by the Population Council, the International Federation of Gynecology and Obstetrics and the Reproductive Health Supplies Coalition, recommends increased priority be given to LARC methods worldwide.
Demand for long-acting reversible contraception could be significant if cost is not an issue, as evidenced by data from Washington University’s Contraceptive CHOICE Project presented at the ACOG annual meeting in May. The CHOICE project offered free contraception of the patient’s choice to over 9,000 women in St. Louis between 2007 and 2011. Participants chose long-acting methods about 75% of the time. Over half of the women chose IUDs, compared to the 8.5% of U.S. women on contraception who use an IUD. The current level of IUD use itself marks an improvement: IUDs accounted for 2.4% of U.S. contraceptive use in 2002, according to ACOG.
IUDs are the most popular form of long-acting reversible contraceptives; contraceptive implants have failed to make significant commercial inroads. Traditional IUDs, like Teva’s copper IUD ParaGard, exert action physically, not pharmacologically. Bayer introduced the first hormone-eluting IUD to the U.S. with Mirena in 2001 and launched the second, Skyla, in early 2013. The firm is the current pharmaceutical market leader in IUDs. Actavis hopes to launch its Levosert IUD in 2014.
Design Improvements
In the IUD market, as in the oral contraception market, lowering hormone doses is a high priority. So are smaller devices designed to be more tolerable or easier to insert and remove. Both Bayer IUDs deliver the widely used second-generation progestin levonorgestrel, but Skyla is a smaller device that delivers a lower dose of the hormone than Mirena. IUDs delivering hormonal contraception may be associated with less menstrual blood loss than the copper IUD, ParaGard.
Skyla is effective for up to three years, less than the five years of contraception Mirena provides. Bayer’s next IUD project, LCS 16, is a small, low-dose device that is active up to five years. LCS 16, understood to contain levonorgestrel, is in Phase III.
Merck & Co. Inc. is also studying an “intrauterine system” for contraception in Phase II, according to a pipeline update from May. Merck’s contraceptive franchise is largely based on the progestin etonogestrel.
The level of levonorgestrel delivered by Actavis’ Levosert (LNG20), one of the fruits of the company’s January 2013 acquisition of Uteron, is comparable to Mirena: both IUDs initially deliver 20 mcg/day of hormone. Skyla provides 14 mcg/day initially. Levosert has been filed in the EU, and U.S. Phase III trials are complete. Actavis also has a next-generation, low-dose levonorgestrel IUD from Uteron, Alyssa, in preclinical development.
Actavis has been touting Levosert’s design as an advantage over Mirena. The Actavis IUD maintains “steadier, more controlled” release of levonorgestrel, the company said at an R&D day earlier this year. The device has a “smaller ring at bottom of stem,” which could “lower risk of infection,” and an “improved inserter in the U.S.”
Actavis, Medicines360 Split Private/Public Markets For Levosert
On June 11, Actavis announced a partnership that splits U.S. commercial rights to the IUD with the non-profit Medicines360, which had previously acquired rights to commercialize Levosert in the U.S. from Uteron.
Medicines360 will provide the IUD “at a very low price in U.S. public sector clinics,” the companies reported. Actavis gained rights to offer Levosert in private sector commercial markets in the U.S. and Canada for a payment of about $50 million to Medicines360, potentially followed by milestone payments of up to $125 million plus royalties.
“All monies received by Medicines360 from this partnership will go toward driving down the product’s cost in the public sector and future product development,” the companies said.