Pharmaceutical manufacturers, which in recent years have addressed social determinants of health (SDoH) via donations to community groups from their foundations, are taking new steps to address health inequities, including more direct partnerships with provider groups and payers, plus initiatives to make clinical trials more diverse.
These efforts have been sparked in part by the COVID-19 pandemic, which hit disadvantaged communities far harder than other groups. However, pharma manufacturers also are realizing that they potentially can improve patient access and adherence measures by targeting SDoH. This requires a data-driven approach that targets communities at a granular level, says Pratap Khedkar, managing principal at consulting firm ZS.
“Why do they need to care about SDoH?” Khedkar asks. “As you know, there are roughly three drivers of human health. About 11% is medical care. About 22% is your genome. And the remaining roughly two-thirds is social determinants of health — socioeconomics, lifestyle, education.”
Pharma costs are a small slice of overall health care costs, points out Khedkar. But even before the COVID-19 pandemic, payers (and, in some cases, providers) were demanding that pharma products show value for the money spent. “I think the problem was put to pharma that, in order to show your value, you have to open up your blinders and think broadly beyond your small slice of the pie,” he says.
“Pharma has been farther from the SDoH issue, but they’re now realizing that this is not just a need of the moment, but learning about SDoH properly actually will help the patients and help pharma,” says Khedkar. “It’s something that actually will have an impact in terms of the value of their medications and the outcomes of health.”
Source: Focus Has Been in Wrong Place
Khedkar describes the concept of a “patient funnel,” in which the patient presents with a symptom, is diagnosed, a pharmaceutical product is selected and fulfilled, and the patient is treated. The problem is, he says, “pharma has spent almost their entire energy and promotional budget at the top half of the funnel” to target the selection of the drug, while spending few resources on the bottom half of the funnel, which involves everything that happens after the product has been selected.
“It turns out that about 30% to 50% of patients fall off that part of the funnel — they either don’t fulfil the script, or they stay on the therapy for only two months when it’s supposed to be 10 months,” Khedkar says. “You’ve got the script started, and you lose half your value. In order to get to value, we have to look at the whole puzzle, including SDoH. And we have to focus on the second part of that funnel much more than we have so far.” In fact, pharma companies should analyze every step in the patient funnel and determine how SDoH drivers might impact them “rather than trying to treat it as one big problem,” he says.
The COVID-19 pandemic sparked a broader conversation about SDoH that has gotten the attention of many organizations, including pharmaceutical manufacturers, says Washington, D.C.-based advocacy group eHealth Initiative CEO Jennifer Covich. The entity has been talking about SDoH for around three years, she says, and for a long time, the organization “had such a hard time getting people’s attention. But then, COVID hit. And all of a sudden, I think it was readily apparent why there are certain vulnerable groups — it really just shone a light on the current disparities. I think it raised to the broader nation how important it is to address the whole person, all of these issues: food insecurity, housing insecurity, all the health equity issues that people have been talking about for years. Financially, payers and life sciences [companies] recognized immediately how important it is to address all of these different elements.”
To impact SDoH, pharma companies traditionally have given money to foundations, Khedkar says. “That’s great, but it doesn’t get to specifically solving the problem. It just assumes that somebody else has figured out the problem and spent the money wisely.” These donations are widespread. For example:
The Pfizer Foundation joined forces with the American Diabetes Association and local groups in March to address food insecurity and high rates of diabetes in communities in Montgomery, Ala.
Last September, the Novartis US Foundation announced a total commitment of $25 million to develop partnerships and fund community organizations and programs that address health inequities, with a focus on diversity in clinical trials. This support has included partnerships with New Jersey Primary Care Association, the CDC Foundation and the Institute for Healthcare Improvement, along with COVID-19 response efforts in 40 communities.
In November, Johnson & Johnson pledged $100 million over the next five years to invest in and promote health equity solutions. The grants will invest in and promote health equity solutions for Black people and other communities of color in the U.S.
The Merck Foundation announced in September 2019 that it had launched HIV Care Connect, a $7 million, five-year initiative to help reduce disparities in access to care and improve health outcomes for persons with HIV living in vulnerable and underserved Southeastern U.S. communities. The foundation partnered with community and provider groups on the project.
In 2021, GlaxoSmithKline plc is using its 25-year-old Impact Awards program to award grants to multiple nonprofits in greater Philadelphia and in the Triangle region of North Carolina. The 2020 grantees included local housing and food insecurity organizations, along with other population-targeted community groups.
Payers, too, are stepping up. For example, Blue Cross and Blue Shield of North Carolina is focusing on food insecurity as part of its new long-term plan to address what it calls nonmedical drivers of health. Meanwhile, startup Cityblock Health began collaborating last year with Tufts Health Plan to provide care, including care that addresses SDoH, to dual-eligible Medicare-Medicaid members under age 65 in Worcester County, Mass. And Highmark Inc. and AllianceRx Walgreens Prime just started an SDoH pilot outreach program for Highmark members with a multiple sclerosis (MS) diagnosis who use AllianceRx Walgreens Prime as their specialty pharmacy.
Most of the programs and partnerships announced by pharma companies so far have not been targeted, Khedkar says: “They haven’t done detailed data analysis. But this is beginning to change.” In just the last 12 to 24 months, he says, pharma companies have started looking for specific gaps in care in their therapy areas; once they have identified a gap, they look for community partnerships. “Some companies are beginning to use data to be much more intentional and focused about these partnerships. However, it’s a trend that’s just starting.”
Over the next five years, Khedkar states, he expects targeting to accelerate, with pharma companies analyzing gaps in care and treatment, identifying drivers of those gaps and then looking for local partners to help address the gaps. That will shift funding from the “top of the funnel” — e.g., product promotion — to “the middle and bottom of the funnel,” where treatment and adherence are impacted, he says.
The COVID-19 pandemic has accelerated this process not only by illuminating health inequities but also by “delivering a hammer blow to the top few steps of the funnel” by pushing down demand for nonpandemic-related health care services, Khedkar says. “Now, of course, things are coming back slowly — the top of the funnel has gone back to basically 90% of pre-COVID levels, but it’s not 100% yet. So because of COVID and because pharma was now worrying about [demand], they got much more systemic and data-driven thinking about the funnel.” In addition, the pandemic forced companies to view trends more locally, he says,
because the surges happened in different places with different timing.
Payers have had population health programs for years, but prior to COVID-19, they typically did not involve making disproportionate investments in a disadvantaged community — they were more universal and by definition targeted people who had insurance, explains Khedkar.
Drill Down Through Gaps to Drivers
Pharma companies need to look at the problem in terms of therapy gaps, drivers and levers, Khedkar maintains. To do this, first pharma needs to “get specific about the therapy area,” he says. “Don’t just talk about health in general because no one pharma company has a monopoly on health in general.” Manufacturers that focus on their specific therapy areas of expertise will have the most success impacting more than the top of the patient funnel, he says. For example, he says, a hypothetical pharma company that specializes in breast cancer therapies may determine that patients in Las Vegas are not receiving care at optimal rates — diagnosis rates are very low. That’s the gap in care.
Next, pharma companies should analyze the drivers of those gaps in care, he says, noting, “this is where it becomes a bit analytical. Is it a socioeconomic issue where people are not showing up and the treatment rates are low? Is it a lifestyle issue? Is it an access-to-health-care issue? Is it a transportation issue? Is it that the smoking percentage is very high? What is the issue, really? The problem in Las Vegas is going to be very different from the problem in Camden County, N.J.”
Drilling down to this level of analysis requires county-level data that shows the different variables that might matter in treatment rates, Khedkar says. “Then you look across different counties to see what are the top three drivers because we can’t solve for all of them.”
Once a pharma company understands the care gaps and their drivers, it can attempt to find levers to move the drivers and fill the gaps, says Khedkar. Of course, it’s not always possible to do this, he adds. “So for instance in Nevada, we might find that unemployment is one of the bigger drivers, so if you moved unemployment, it would actually have an impact. But then you look at the unemployment figures and discover, yes, it’s important, it’s a driver, but it’s not moveable much.”
However, there are levers that can be impacted, he asserts: “Let’s say it’s something around smoking or something around transportation. Now you have to figure out how to affect it.” If it’s a transportation issue, a pharma company could partner with a local provider and other local entities and put together a program that addresses this issue, Khedkar says.
This fits with how some manufacturers are evolving their business models, he adds. “I would say about 30% of pharma companies are switching to a commercial model that is more locally focused, and when they do that, this becomes a very natural fit to the way that they are going to have to work,” says Khedkar.
Pharma Is Making Trials More Equitable
Multiple companies have announced efforts to improve racial equity and inclusion in clinical trials.
For example, last September, Roche announced a higher dose Phase III clinical trial for its multiple sclerosis medication Ocrevus (ocrelizumab) along with a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latinx-American patients with MS. The CHIMES trial (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) is the first prospective trial developed in collaboration with MS patients, patient advocacy groups and investigators to exclusively focus on meeting the needs of minority patients with MS, according to Roche, and the findings are expected to improve current understanding of MS disease biology and treatment response among minority groups with the condition. The goal, the company said, is to increase the standard of care to traditionally underserved communities and to enhance equality through clinical research.
Merck and Co., Inc. also is working to break down barriers to trial diversity, which include mistrust; fear; lack of comfort with the process; logistical restraints such as time, out-of-pocket expenses and transportation; and SDoH, said Luther Clark, M.D., deputy chief patient officer at Merck, in a Jan. 12 webinar sponsored by eHealth Initiative. Recognizing and addressing SDoH can increase trial diversity, he contended.
“Effective and meaningful community engagement, collaborations and partnerships are critically important for addressing all of the social determinants, particularly those that relate to education, increasing awareness and building trust,” Clark said. “We can leverage real-world data to improve site selection and participant and workforce diversity.”
Johnson & Johnson also is undertaking what it terms a “major initiative” to increase access and participation in clinical trials in diverse populations.
HIPAA, Anti-Kickback Rules Limit Efforts
Manufacturers cannot handle identified patient data unless they have explicit permission from the individual patients, so none of this activity is at the patient level, Khedkar says. Instead, it’s at the community level — the ZIP code, county or metropolitan statistical area level, he says.
In addition, manufacturers obviously cannot pay providers as part of these programs, he points out. However, manufacturers are allowed to form a partnership where the provider also is investing and the intent of the partnership is to benefit patients, not to benefit each other, he says. “Giving you a discount is off the table, but creating a value-added program that says, ‘In this patient community, if the outcome is X, you pay this price, but if the outcome is not X, you’ll pay a different price’ — that’s legitimate. But again, it has to be about some benefit or some outcome — not at the individual level necessarily, but at least in that population of patients in that community.”
Finally, drugmakers cannot create a program that’s centered around their product, says Khedkar. For example, a manufacturer can’t offer free Uber rides to an infusion clinic to patients who have been prescribed their product but not offer the free rides to patients on a competing product, he says. “So what pharma has to get comfortable with is that the best way to do this is an unbranded, therapy-area way agnostic of your product v. your competitor’s product. And that has been very hard for pharma to get its head around because you don’t want to spend money to help the competition.”
However, unbranded programs that address SDoH are better for the patient because they are not product specific, explains Khedkar. In addition, payers and providers — potential partners in these initiatives — prefer brand-agnostic programs, he says. Ultimately, expanding the market in a particular therapy area does help competitors, but it also helps the pharma company that developed the initiative, he says, adding, “I think pharma should be okay with that.”
Approach Program Design Carefully
Still, drugmakers need to be careful with program design, Khedkar cautions. “I think it is very possible to do this in a compliant, legal way, but if you’re not careful, it is also possible to make a mistake and not do it in a compliant way.” Unfortunately, he says, “a lot of pharma companies are overly cautious, and they don’t want to come anywhere near that line. They should be a little more courageous because they’re doing this for the right reasons.”
If companies don’t get closer to the line, they’re simply handing over a large check to another organization without any say over how that organization spends the money, he says. That’s unfortunate, he notes, because “pharma companies have the data and the budgets and the patience to do it.”
The best way to meet community needs and help patients, he says, is for pharma, payers and providers to team up on these programs, with pharma providing population-level data and analysis. Provider partners are critical, he says, since providers understand patients at the community level, but provider organizations don’t have the funding to do the necessary data analysis that underpins successful SDoH programs.
For example, during the pandemic, patients were reluctant to visit infusion centers, says Khedkar. In this instance, pharma could partner with a provider to create an at-home infusion service. The service would be product agnostic, but a particular pharma company might believe that it’s worth it, since patient outcomes at the community level would be worse if individual patients don’t receive necessary infusions, he argues.
COVID Has Prompted Changes
COVID-19 has been a catalyst for change by uncovering critical gaps in the health care system and huge disparities in health outcomes across minority populations. It’s also provided an impetus for organizations, including pharma, providers and payers, to address these disparities, Covich says. Drugmakers and payers are getting better at communicating with community groups, she maintains. However, she adds, “I don’t think this is ever going to be easy.” For example, different geographies will impact what’s possible, says Covich, noting that initiatives are more difficult in rural areas. “I think it’s going to continue to be really difficult and hard, because even if you have the funding to get a doctor to somebody or to get support to somebody, it doesn’t mean you have a person to do it.”
Wanneh Dixon, eHealth Initiative SDoH program director, says it’s important not to let up just because the health care system and society are moving past COVID-19. “Health systems are no longer separate — they’re working together, contributing to the ecosystem of health to improve health delivery and health access and remove health disparities,” she says. “I think that in one year or two years, it’s not going to be a big deal — it’s going to be the norm or business as usual, and it’s not going to be such a heavy lift to try to align social services with health services. And I think we’re going to look back and ask, ‘Why didn’t we do this earlier?’”
by Jane Anderson