SAN FRANCISCO — A San Francisco-based pharmaceutical company is bringing a new contraceptive to the U.S. market. The product is Liletta, an intrauterine device (IUD), which, like any other IUD, is long-lasting and highly effective at preventing pregnancy when inserted properly.
However, the story here is not the product — it’s the company’s model as an all-in-one nonprofit, social enterprise and pharmaceutical company.
“We’re showing the pharmaceutical industry that there’s another model,” Pamela Weir, chief operating officer of Medicines360, told MintPress News.
That model is an affordable, accessible 340B Drug Discount Pricing Program model sustained not by donations, but by sales. Liletta is sold in the private sector through a distribution partner, Actavis, and Medicines360 receives a portion of the profits. Those profits directly support the company’s mission of expanding contraceptive access to women in the public sector.
“That’s the model we want to show and make it sustainable financially,” Weir said.
Medicines360 formed through an initial grant in 2009 to tackle one question: “What are the unmet needs in women’s health?” They quickly determined that a major issue were the hurdles standing between women and long-lasting contraceptives. To date, Liletta is the only branded drug that’s ever been developed specifically to expand access for women.
“We put women first by removing the barriers that prevent them from getting the best contraceptive choices, including awareness, education and cost,” Weir said. “Women everywhere deserve access to quality medicines, regardless of socioeconomic status, insurance coverage or geography.”
Other forms of contraceptives, like oral contraceptives or male condoms, are more affordable and easier to access than IUDs. Yet there’s room for error in the use of “The Pill” — a woman may forget to take it every day, thus reducing effectiveness — or male condoms — they could be improperly worn, defective, or simply not used at all “in the heat of the moment.”
IUDs, however, remain effective for a number of years and can be removed at anytime, with no effect on fertility. Women wear an IUD for 2.7 years, on average, though different IUDs have been approved for use for anywhere from three to 12 years. Once one is inserted, there’s nothing to remember and nothing to replace until the approved time period is up.
But these tiny t-shaped instruments can be prohibitively expensive due to up-front costs that can range from several hundred to one-thousand dollars. Further, a faulty IUD product, Dalkon Shield, caused injuries like infections and septic miscarriages among 200,000 women and led to 20 deaths in the U.S. in the 1970s, contributing to consumer mistrust about the birth control method that’s only recently waned.
Today, a number of factors are contributing to IUDs having a moment. According to the Centers for Disease Control and Prevention, 6.4 percent of women aged 15-44 used an IUD in 2011 to 2013 — nearly double the number of women using them from 2006 to 2010 and well above the estimated 1 percent of women using an IUD in the mid-1990s. But, as Weir notes, “This is still significantly lower than in other countries, like Europe.”
While new federal rules have eased some of the barriers for some women seeking an IUD, like high up-front costs, as Weir notes, these haven’t been a fix-all for everyone. High stocking costs, for example, were a barrier for 340B public clinics. The Affordable Care Act compels insurance companies to pay for FDA-approved contraceptives, with no co-pays or additional fees, but this, of course, doesn’t extend to uninsured women.
These are precisely the kinds of hurdles and barriers to access and information that Medicines360 is working to eliminate, not just by expanding access, but also by extensive outreach and education in both the private and public sectors.
“We want to expand access irrespective of wherever a woman is in the world — whether she’s in the U.S. or whether she’s in Vietnam,” Weir said.
She says the company hopes to keep the door open to more grants, but the goal is ultimately to use commercial sales in the private sector to generate profits. When MintPress asked exactly how much Liletta needs to be sold for this to work, Weir responded, “There is no minimum requirement to be sold in the private or public sectors, however, Actavis and Medicines360 feel that Liletta has a number unique programs to expand access and expects Liletta to be very successful in both sectors.”
After making sure the model is working, Medicines360 hopes to expand its reach abroad, starting next year in Kenya. The company will partner with a unannounced NGO, which will handle the marketing and distribution work and regulatory filing.
“We want to make sure the model is working, then replicate that in all other developing countries — but we want to do it in the U.S. first.”