The Enterprisers: Life Science Leadership In Action
You might think a market made of half the human beings on this planet would attract any amount of investment. Why is it, then, that most women lack access to essential medicines? Why does it take a nonprofit model to even begin bringing access to such a large population in a systematic and durable way? Or on second look, have global health challenges simply outgrown the for-profit model? One company challenging the standard model is Medicines360, which has taken the practical step of using all its developed-world revenue to extend access to all women, regardless of the economic and healthcare circumstances in their part of the world.
This is not philanthropy, at least not in the traditional sense. It is more like a long-term construction project, with the delivered product, a contraceptive affordable for all women, the central focus of a related infrastructure. Medicines360 contains the concept in its name, an allusion to its global scope and mission. Through partnerships, the company aims to go beyond the temporary rescue mode of most relief organizations and build permanent systems for local healthcare delivery where they are now lacking in the United States and in the developing world. Its first non-U.S. locality-of-interest: Madagascar.
When CEO Jessica Grossman, M.D., came to Medicines360 in 2015, the company’s first product, the hormonal IUD Liletta, had just received FDA approval for three-year use and was later raised to five years. Liletta entered commercialization in a partnership with Actavis, now Allergan. “We were only at the beginning and finding our way,” Grossman says. “Since then, we have cemented a powerful relationship with Allergan, working together to comarket the product.”
Further development of Liletta has included upgrading the product from a two-handed to one-handed inserter through a supplemental FDA approval and updating the label from a three-year to a five-year contraceptive efficacy record as its Phase 3 trial continues. Last year, the company started an additional Phase 3 trial for Liletta in a second indication, treating heavy menstrual bleeding.
Meanwhile, in the interest of its larger mission, the company has established partnerships with leading nongovernmental organizations (NGOs) in women’s health, such as Population Services International and Marie Stopes International. Some of the groups help the company build channels and spread access for an alternative contraceptive product to women in developing nations.
“Liletta is five times less expensive than the competitive product in the public health clinic, but we realized that there were still women who did not have access, women seen at free clinics or unable to afford anything. So, we recently started a partnership with Direct Relief on an institutional patient assistance program, which furthers our mission of providing access in women’s health to all women, regardless of where they live, whether they have insurance, or whatever their socioeconomic status.”
Even with the discounted distribution, Liletta brings in a small milestone royalty income that flows back into the company’s continued development programs. “We use all of that income and reinvest it right back into our mission. Those payments are helping fuel our access agenda, and so we’re using it to win the approvals and launch our products in low- and middle-income countries as well as continuing to offer the product at an affordable price or even free in some instances where necessary,” Grossman says.
Medicines360 met perhaps its greatest challenge in 2009, trying to reach a market that still lacked a nationwide program promoting awareness and offering access to contraceptives for women. When I met and wrote about founder Victoria Hale in 2005, she had just moved on from her earlier nonprofit venture, The Institute for OneWorld Health, envisioning a broad line of medical products for women and children in developing countries. OneWorld Health subsequently merged into the nonprofit healthcare developer PATH, to become its drug development affiliate. Medicines360 remained active on its own, focused on women’s health, and at first it faced a lonely task getting attention for its chosen mission. Then came the Affordable Care Act.
“The ACA has really been incredibly beneficial to women,” Grossman says. “The ACA makes all contraceptives available to women with no cost-sharing, so it’s part of the essential health benefit. A huge unmet need for affordable contraception we saw in 2009 is now lessened because of the ACA. About 19 million women lacked coverage in 2009, but there’s still about 10 million women out there who don’t have coverage. They are making a little bit too much money to be qualified for Medicaid expansion, but still not making enough money to cover themselves.”
The original challenge of awareness remains in the physician community, according to Grossman. “There’s also the physician perception that birth control is ‘free’ because of the ACA. But it’s not free, it’s just covered — somebody is still paying for it. We try to drive that message home: birth control isn’t free.”
One must also pay attention to the vagaries of one’s health plan; some may cover a product but attach “cost-sharing” measures such as large co-pays or deductibles to the policy. Grossman also cites the “perverse incentives” for PBMs, insurers, and wholesalers to maximize prices for higher rebates. “It was shocking for us to see that, even though our mission is to provide an affordable product, sometimes the system is incentivized to choose a higher-priced product,” she says. “We needed to talk about the product to physicians and others along the supply chain to make them understand that our product is about access, not only here in the U.S., but also globally.”
More recent politics involving healthcare, including attacks on Planned Parenthood and cutbacks to the ACA, threaten to roll back some of the progress in contraceptive access. But Grossman says the company will continue to find ways around the hurdles women face in the area, starting with the economic ones.
SCALE & STRUCTURE
“Hormonal IUDs are virtually unheard of in the developing world because it’s generally quite expensive in those economies,” says Grossman. To match the scales of cost and economy in low- and middle-income countries, Medicines360 has introduced another product, Avibela, delivering the same hormone as Liletta and also an IUD, but with a different inserter. Revenues from Liletta go into development and access programs for Avibela.
The company is not, however, simply promoting a product or acting charitably by handing out some palletfuls of Avibela as a one-time gift to the local poor folks. “We don’t want to just donate product, drop off product, and say, ‘That’s it, we’re done.’ Our strategy in the developing world is to form partnerships with NGOs who have on-the-ground presence. We also want to make sure that we register the product in each country.”
Pharmaceutical companies often donate products as a relief effort, not actually thinking about long-term sustainability, Grossman observes. “It’s a one-time dropoff. We’ve been very thoughtful and conscientious to not do that. We want to make sure that the product has a sustainable life cycle in those countries.”
Medicines360 launched Avibela in Madagascar in May 2018, and Grossman says the market has already yielded some useful early signals. “Women are saying that, without Avibela, about a third of them would use either no method or a less-effective method. That is really great data.”
At the same time, because the company recognizes parts of a prosperous country such as the United States can share some access challenges with the developing world, it is using the partnering approach in those areas as well. One of the company’s key partnerships is with Power to Decide, based in Washington, D.C., and formerly named The Campaign to End Teenage Pregnancy. Power to Decide is a nonprofit that conducts related programs and manages a contraceptive access fund. The group’s current moniker has an advantage not only in greater brevity but also, in Grossman’s words: “The name Power to Decide conveys the notion that all women should have their own power to decide what kind of birth control they use. The group is trying to put power in teenagers’ hands to decrease the rate of unintended pregnancy in teens, which has decreased dramatically over the years. Power to Decide was formed in a bipartisan fashion more than 20 years ago, and we love what they are doing. They have a very positive, empowering message for teens and young women.”
Nineteen million women in the United States live in so-called contraceptive deserts, where they lack full access to the 18 different contraceptive methods the FDA has approved. “Some of the most effective methods, like hormonal IUDs, implants, and the copper IUD require a healthcare practitioner to administer them, and a lot of the clinics don’t have that capability. We’re trying to reach those clinics to ensure they can provide all methods, and that women have a choice,” Grossman says.
In truth, the United States harbors incredible disparities in accessibility to contraception, from the most complete inventory of choices in prosperous areas to the contraceptive deserts in rural and urban areas. “As a mission- driven pharmaceutical company, we want to make sure that all women have the same access,” says Grossman. “It should never be that a rich woman in a major metropolitan city has access to the most effective methods, but a poor woman in rural Mississippi doesn’t.”
Unlike some companies, Medicines360 does not post a pipeline chart with a long list of development programs; in fact, it currently mentions only one project, the Avibela program. But it is also factual to note the company has taken one product through a Phase 3 trial and on to the market in the United States, made supplemental improvements to the product, and developed the product for an entirely different market in other countries. Add to that an ongoing Phase 3 trial for the heavy menstrual bleeding indication. All of those programs and more have amounted to a great deal of experience for the company in drug development, which Grossman says will pay off with future products.
“We certainly are looking to add products to our portfolio,” she says. “The perfect product for us would be in women’s health, meet an unmet access need, and be Phase 3-ready because what we did with Liletta is the full Phase 3 clinical trial. We have done two large-scale Phase 3 clinical trials, and that’s something we definitely know how to do. We’ve looked at quite a few products, but we haven’t found anything that’s perfectly in our sweet spot.”
One principle the company has learned to employ in its drug development is to design clinical trials with a broad range of patients. A recent Phase 3 trial for Liletta enrolled 1,751 women in a broad spectrum of races, ethnicities, and ages. “We also had quite a few obese women in our trial, women with a high BMI, because we wanted to make sure that we were fully representing the U.S.-based population. With the product competitive to ours, the company did a study in Northern Europe, and so it studied a very specific patient type. But to give clinicians in the U.S. the right data and the tools to counsel their patients, we wanted to make sure we had a full set of representative patients in our trial.”
Considering the company’s mission, pricing is also an element incorporated into its drug development. It starts with the principle of putting patients first — making their interests the highest priority, starting with access and affordability. Grossman says it’s important to think about access to drugs from multiple angles. “Even though our product is affordable to most, we’ve had to also contemplate how it is still not affordable to everyone. We always keep access at the forefront of our mind.”
Does the experience of Medicines360 have any guidance to offer the almost absolute majority of companies in the industry — the profit-driven kind? All too many examples exist of companies intending to go the opposite way, pushing prices as high as possible knowing the many “middlemen” will go along for the ride to get their added shares.
“Pharmaceutical industry executives are fighting to maintain their position. They really don’t want to talk about price transparencies. But I believe they are getting a bit of a bad rap,” says Grossman. “There are also lots of players along the supply chain who are getting their palms greased and have an active interest in keeping prices high. With many of the other pharm execs I meet, their hearts are in the right place most of the time; they are motivated by helping patients by developing innovative new drugs. It is true that the cost to develop products is very high. Our Phase 3 trial cost about $80 million, a number that includes all operations of the company, design of the inserter, and two additional studies. It is a balancing act of providing affordable products, but also continuing R&D and continuing to keep the lights on. I don’t have all the answers, but I can tell you what we’ve been doing at Medicines360 is working so far.”
Based on her work with other women founders and CEOs, Grossman has some advice for executives just entering or still new to the process of building a company. “Think through your long-term strategy and work closely with your board to get alignment — that’s really important as you’re starting out. Especially think about your long-term clinical strategy. A lot of times, people want to get the product out as soon as possible, but that can be shortsighted. You need to plan a good clinical trial that will potentially support the claims that you want by yielding the kinds of data you need. It might take a long time, but that’s okay.”
There are two ways in which women play a particular role in guiding this company’s strategy — management and market reach. Again, the unique mission and experience of Medicines360 sends some messages to the industry as a whole.
“All of us women executives need to be committed, which I am, to mentoring, paying it forward, being active on boards, and so on,” Grossman says. “The rest of the pharma industry needs to open its eyes and look for qualified women candidates, because they are definitely out there. People have to make an effort to embrace and recruit diversity.”
Whether you follow this company’s example or not, Grossman is correct in asserting its value to patients and to the rest of the industry. “I just want to make sure that people know there is a different business model available. For a nonprofit but self-sustaining pharma, doing good work and helping patients is all possible, and I would encourage others to think outside the box. I would also say women’s health is a very important part of the pharma industry, but it doesn’t always get enough attention. We must continue to innovate in the women’s health arena.” It would be illogical to find fault with either point.