Two Ways to Make Medicines More Affordable to Women

SHANOOR SEERVAI: Poor women in America have a really hard time accessing high-quality medicine and health care products, mostly because they’re so expensive. And then the result for many women is that they’re in this state of financial precariousness, and they’re forced to choose between rent and taking care of their health — or they just don’t. They skip care, and they put themselves and their families at risk.

And I could talk about this problem all day, but instead, I’ve invited two incredible women to join me on The Dose, because these women are trying really hard to solve this problem.

I’d like to welcome Jessica Grossman and Priti Krishtel to the show. Thanks for joining me today.

PRITI KRISHTEL: Thank you.

JESSICA GROSSMAN: Thanks.

SHANOOR SEERVAI: Jessica, let’s start with you. Could you tell me more about what you do?

JESSICA GROSSMAN: Sure. I’m the CEO of Medicines360, and we’re a global women’s health nonprofit pharmaceutical organization, focused on providing affordable medicines to women across the globe, regardless of their socioeconomic status, their geographic location, or insurance coverage.

Our first product is a hormonal IUD called LILETTA, and it’s available at a low cost to public health networks across the country. Making this option affordable to both clinics and patients is critical to expanding access for all women.

One of the other things that we’re hearing at the clinics that stock our product is because our product is available at such a reduced price, they now have more money to stretch their dollars and buy more products, fund more staff members. So we’re part of an ecosystem where providing an affordable product is helping the clinics more holistically and globally to do everything from stock more products on their shelves, hire more staff members to help them.

SHANOOR SEERVAI: And Priti, could you tell us a little bit more about what you do?

PRITI KRISHTEL: Sure. So in the early 2000s, I was running a legal aid unit, representing mostly women and children who weren’t getting access to life-saving medicines. And as we started to look into the reasons why there were barriers to access, we realized that companies were manipulating their ownership rights, also known as patents, so that they would hold market control for as long as possible.

So my cofounder Tahir and I decided to set up I-MAK in 2006. I-MAK stands for the Initiative for Medicines, Access, and Knowledge. We’re a team of lawyers, ex-pharmaceutical industry scientists and health experts who, for a decade, have served as what we call “patent detectives.” We unearth and unpack evidence to solve the drug patent problem that’s costing lives and disproportionately impacting women in particular.

SHANOOR SEERVAI: Priti, tell me more about how women are differently impacted than men when it comes to how much drugs or other medical products cost.

PRITI KRISHTEL: Women — and especially women of color — are poorer than men, make less money than their male counterparts, and use prescription drugs at a higher rate. So we’re more likely to be in low-wage or part-time jobs without benefits. We’re much less likely to have health insurance through work. And since we’re often covered as “dependents,” we’re more likely to lose coverage in the event of divorce.

And in fact, recent data shows that we have a serious gender gap in how high prescription drug costs are affecting women. A survey by Kaiser Health showed 22 percent of women are leaving prescriptions unfilled or are rationing doses — as compared to only 12 percent of men.

And our own data supports this. We at I-MAK looked at the top 12 highest-grossing drugs in America, and all of them affect women. But three out of 12 affect women disproportionately. Herceptin for breast cancer, Lyrica for fibromyalgia, and EYLEA for macular degeneration.

SHANOOR SEERVAI: I was looking into this a little bit, actually, and my understanding is that Lyrica is used to treat pain, including conditions like fibromyalgia, and 80 to 90 percent of people who get fibromyalgia are women. And this drug has seen the largest price increase over the last six years. And that burden is getting translated onto the part of the population that isn’t seeing its wages rise as much or as rapidly.

PRITI KRISHTEL: And we saw that across all of the top 12 highest-grossing drugs in the U.S.

SHANOOR SEERVAI: And Jessica the way that you’re getting at this is by setting up what you’ve described as a nonprofit drug company. Tell me a little bit about what that’s been like in this market of what I understand to be very competitive for-profit pharmaceutical companies.

JESSICA GROSSMAN: Yeah, it’s been really interesting, and there’s been a lot of challenges. In general, the health care system is not set up to provide low-priced drugs. There’s a way to provide drugs for free, and then there’s a way to provide high-priced drugs. But in general, not that many companies, as you can imagine, are working to provide low-priced drugs. The way that we do that today is working through the 340B program. The 340B program is a federal drug discount program that was enacted in 1992 that requires manufacturers to provide outpatient drugs to certain eligible health care organizations at significantly reduced prices. And what drug companies typically do is they offer drugs at about a 50 percent discount to these certain covered entities. What we do is we offer our product at a 90 percent discount for 340B-covered entities. The reason that we can do that is because of our nonprofit status.

SHANOOR SEERVAI: So a woman who is going to a 340B clinic — how much would it cost her?

JESSICA GROSSMAN: That’s a great question. We actually don’t control the price to the patient. What we do is control the price to the entity, so to the clinic. So we make sure our product is priced at $50 for these 340B-covered entities or public health entities. And to give a comparative sense, the competitive product is five times more expensive.

PRITI KRISHTEL: And if I can just add, what is so interesting about what Jessica is saying is this point that she made about how we see free drugs in the United States — and then we see the market price of the drugs. There are inherent incentives in the marketplace not to provide lower-priced drugs.

SHANOOR SEERVAI: What are the obstacles to offering lower-priced drugs in the marketplace?

PRITI KRISHTEL: In order to see meaningful price reductions on drug products in our market, we need competition. And there are so many laws, policies, regulations, designed to prevent that from happening. And I think that’s why there’s a real movement to re-examine policy right now.

SHANOOR SEERVAI: And what are the policies around, for example, giving a drug away for free?

JESSICA GROSSMAN: There are regulations on how drug companies and manufacturers can set up programs to give drugs away for free. And there’s quite a few regulations so that the drug companies don’t abuse the power to give their drugs away for free and have anything like kickbacks or any other incentives in the marketplace. One of the things that we’ve done is we’ve partnered with another nonprofit organization called Direct Relief. And we’ve set up with them a partnership to offer our IUD for free to certain free clinics and clinics that otherwise don’t have access to the 340B program.

SHANOOR SEERVAI: So between the free program and this 340B clinics that you provide your product to, how many women have you reached so far, Jessica?

JESSICA GROSSMAN: Thus far the product’s been on the market almost four years, and we’ve reached over 575,000 total women. About 180,000 of those women are low-income or access product through the safety-net clinics. So, almost 200,000 to date.

SHANOOR SEERVAI: That’s incredible. Priti, since a lot of your work has been in other parts of the world, I wonder if you can talk about whether there are similar obstacles to bringing low-cost products to the market in other countries the way there are here.

PRITI KRISHTEL: I think other countries do have similar barriers, but many — especially in the emerging markets — have been proactive in enacting policies that are designed to prevent abuse of the system by drug makers and encourage competition, which is different to what we have here.

SHANOOR SEERVAI: Could you give me an example?

PRITI KRISHTEL: Sure. India brought in health safeguards in 2005 into its patent law. So, patents are supposed to be for things that are new inventions. And what we see a lot is a lot of patenting by drug companies to just make small tweaks and really extend the product’s life cycle. It’s called “evergreening,” to keep the drug evergreen.

So what a country like India has done, is they’ve put in safeguards that really limit that type of follow-on patenting. And really what they’re trying to reward is breakthrough invention. So that then allows them to have competitors enter the market earlier, prices to come down, and the drugs to reach more people.

SHANOOR SEERVAI: Do you think that we would see changes like that in the U.S.?

PRITI KRISHTEL: I think that it’s starting to be discussed. But I think to do something like what India has done, which is to stop this type of patent practice to begin with, is what would actually save billions of dollars for our health care system. And I think we’re a few years away from that, at least.

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JESSICA GROSSMAN: When speaking with our clinics, many of them are telling us how they’ve been able to utilize our product and phase out the use of other IUDs for ours, specifically because of the cost benefit to both them and the patient. We find that when we decrease costs, the clinics are able to stock the product more readily and have it accessible for women the same day of their visit.

SHANOOR SEERVAI: And so the women who get it on the shelves — and I think that’s really a huge, huge benefit for women who might be working part-time jobs or multiple jobs — jobs where they’re paid by the day or the hour, not having to go to see a doctor three or four times because the product that they need is not on the shelves. But what are they saying?

JESSICA GROSSMAN: I’ve had many women come up to me on the street or at conferences saying they would have never been able to get a hormonal IUD before our product was there, because it wasn’t affordable. It was literally out of reach for them.

SHANOOR SEERVAI: And as you’ve seen these changes, what are some of the challenges that you’ve encountered?

JESSICA GROSSMAN: One of the things that we were surprised to encounter is some resistance from physicians. A lot of the times physicians are incentivized perversely to provide the most expensive products, because they get reimbursed more — depending on the price of the product. So oftentimes a higher-priced product results in a physician making more money.

SHANOOR SEERVAI: Hmm.

JESSICA GROSSMAN: The other thing that we’ve been surprised about is the physicians’ perceptions that birth control is free under the Affordable Care Act. And what we’d like to say is it’s not free, it’s just covered by insurance. But somebody is still paying. Yes, there’s a lot more coverage, but it still makes sense to choose the most affordable option.

SHANOOR SEERVAI: And Priti, what about you? What challenges have you encountered as you’ve tried to get people to think differently about the way that drugs are priced and what they cost?

PRITI KRISHTEL: I think there are two things that are worth mentioning. The first is the information asymmetry that exists for Americans today around drug pricing. The polls are showing that overwhelmingly, Americans want to see change — that drug prices are too high. And we know that because prescription drug spending has tripled in the last decade, and it’s poised to double again.

Because the system is deliberately kept so complicated and so obtuse that on drug pricing specifically, we’re at the beginning of a very long journey to try to make a lot of technical laws and policies accessible and understandable for the general public.

The second challenge speaks to what Jessica was just talking about, which is that how much we lower drug prices actually matters.

You know, we have a new normal in this country, where a product can be launched for $100,000 for a 12-week course. And so when that product’s price comes down from $100,000 to, let’s say, $56,000, we’re asked to celebrate that. But when you look at the cost savings to the health system as a whole, we’re talking about hundreds of billions of dollars, if we could actually see competition in the marketplace, and prices come down even further.

And there’s a real cost to that. Those billions of dollars could be reinvested into health — into women’s health — into access to care, into other issues that we care about, like education for our children.

SHANOOR SEERVAI: I think that what you said about the new normal is so important, because once our threshold shifts, we celebrate something that might be an improvement from something that’s egregiously expensive — but it’s still egregiously expensive.

When policymakers are pushing for this, are they pushing for the $100,000 to $56,000, or are they really trying to change the way the system works?

PRITI KRISHTEL: My impression after spending the last couple of years really speaking with a lot of stakeholders on the Hill, is that I do believe there’s genuine intention to reduce prescription drug spending on both sides of the aisle. I think the intention is there. I think people understand that we’re in an untenable situation, and that the market is not going to be sustainable. That being said, I do think there’s a lot of fear around this idea that if we were somehow to curtail the industry in any way, that we wouldn’t get innovation — we wouldn’t get the next breakthrough cure. And that fear-mongering has been very successful, not just on policymakers, but on all of us. We’re all afraid that we’re not going to get the next breakthrough cure if somehow pharma is hindered in its work.

SHANOOR SEERVAI: One of the things that I’ve been thinking about a little bit, coming back to this idea where the public is and this information asymmetry around health care. I think our health care system is so complex that it’s very hard for people to wrap their heads around what’s going on, why their medicines cost so much. And I think historically, this has really impacted women, because women’s health concerns have been dismissed or misdiagnosed. They’ve been told that their pain is in their head. And we actually don’t know that much about how the most common medical conditions impact women. I didn’t know this myself, until I started looking into something called “the medical research gap.” And what I learned is that women have been historically excluded from clinical studies, and so we actually don’t know how heart disease affects women — because we’ve always treated heart disease as how it affects white men. Women have always been ignored and are now in this place where maybe they could or should be asking questions, but they don’t know how.

JESSICA GROSSMAN: Even if you look at the animal studies that are done, most of the animal studies are in male animals. And then if we fast-forward into the clinical trials that are done, as you said, Shanoor, most of the clinical trials are done on men, so there is very little known about how the medicines may affect women differently.

Even in women’s health, a lot of the clinical trials to date have been done in only certain kinds of women — mostly white women, as well as thin women. We wanted to make sure that we represented all women in our trial. So we had women of all ethnicities. We really tried to mirror the U.S. census population. We also wanted to make sure that we had women of all body habitus, as well — and not just thin women. So we had obese women, women with high BMIs. And so that was really out-of-the-box thinking when we started our trial in 2009. But we thought it was really important to create data of all different types of women and how our product affects them — and not just a single type of woman.

PRITI KRISHTEL: You know what’s so important about what Jessica’s saying is that this discussion about inclusion in medicine is not really happening. The other side of it, on the access to medicine side, the conversation that’s happening around drug pricing today isn’t actually inclusive. The conversation is happening about governments, companies, payers — it’s all centered around money. And we’re not talking about the human cost of drug prices or what this means for real people, and women in particular, trying to stay healthy and alive.

So I-MAK, my organization, is part of something called the Global Access to Medicines movement. And a lot of the work our movement has done over the last 20 years is to introduce this concept of treatment literacy, which is the very basic idea that women deserve access to information — not just about the specific medicines that they’re taking, but the research that went into them — how those medicines can be taken, access to care, and ultimately the systems within which this works — and that includes the patent issue.

SHANOOR SEERVAI: This makes me think again of what you said about that “new normal,” Priti, because if the new normal is just that, you know, drugs and medical treatment cost a lot of money, then it must mean that women who have higher incomes and are able to pay for their care just have a totally different experience of the health care system. What do you think about that, Jessica?

JESSICA GROSSMAN: I think in some ways that’s true, that there is a two-tiered system where women of a higher socioeconomic status who access their care in private physicians’ offices are offered a higher level of care than women who are disadvantaged and access care in the public health clinics.

Before our product came on the market, we were really seeing this two-tiered system where the hormonal IUD is the number one choice of female Ob-Gyns for their own reproductive health. But women who were poor, who were of color, were not being offered this method.

SHANOOR SEERVAI: What’s next for Medicines360, Jessica? What other products are you looking at moving into?

JESSICA GROSSMAN: Yeah, we’re looking at any product that’s in women’s health that addresses an access need.

SHANOOR SEERVAI: And what about you, Priti? As you keep on chipping away at this really large and complex problem that is our drug pricing system?

PRITI KRISHTEL: I think our focus is really going to be on addressing the information asymmetry that I talked about. People deserve information about how the legal system is working to protect companies and not necessarily protecting patients.

SHANOOR SEERVAI: it’s been great to have both of you on the show today, but we really shouldn’t be having a conversation about why poor women in the richest country in the world have to struggle so hard to get the care that they need.

PRITI KRISHTEL: I agree completely, Shanoor, and I would just add that as we start discussing more seriously as a country how we are going to improve access to medicines for women, I think as we advance this work, we really need to think about the fact that women aren’t necessarily a monolithic population.

We have spoken with grandmothers in Kentucky and trans women in New York and young, single mothers in Maine. I mean, the spectrum of what it means to be or to identify as female in America today is really complex, and it’s intersectional. And I think we really need to make sure policy solutions are taking all of those realities into account.

JESSICA GROSSMAN: I couldn’t agree more, Priti. And you know, at Medicines360, we’re fueled by our nonprofit mission to close these critical gaps in women’s health care. We believe that women should have access to the medicines they need to live their best and fullest lives. And that’s why we’re putting our nonprofit model out there to show that we’re different from traditional pharmaceutical companies.

SHANOOR SEERVAI: It’s been so great to have both of you on the show.

PRITI KRISHTEL: Thank you.

JESSICA GROSSMAN: Thanks.

SHANOOR SEERVAI: And thank you all for listening to today’s show. If you have ideas that you want to hear more about, or if you’re a woman and you want to tell us about your experience using health care in the U.S., please get in touch. You can send us an email. Our address is [email protected].