From federal lawmakers to pharmaceutical companies, plans, providers and other health care stakeholders, efforts are coalescing to address social determinants of health (SDOH): the socioeconomic factors that create barriers to care and medications and risk worsening health outcomes. Initiatives are ramping up in response to COVID-19’s disparate impact on vulnerable populations and communities across the U.S. and include pharma collaborations with payers and health systems focusing on social determinants relevant to medication adherence and access.
As one pharma industry consultant puts it, the ongoing pandemic, now past the two-year mark, “has exposed and exacerbated the fractures in our health care and social delivery systems.”
“The time has never been more urgent for manufacturers to develop or evolve their strategic SDOH frameworks — supporting multistakeholder collaborations to mitigate social risk factors, integrate biopsychosocial care and advance population health — to better manage this pandemic and avoid the next one,” says Maureen Hennessey, Ph.D., senior vice president and director of value transformation at PRECISIONvalue, an agency focused on optimizing market access for life science companies.
Hennessey notes that her company has compiled proprietary information on pharma engagements with payers and health delivery systems, including collaborations to address SDOH. She points to a July 2021 survey of payers and health systems in which 100% of respondents were interested in collaborations with pharma to address SDOH relevant to medication adherence.
“In fact, about two-thirds [of the survey’s respondents] reported having initiatives in place with pharma, and the remaining third either had collaborations planned or were willing to consider them,” she says.
Nationwide, the U.S. pharmaceutical industry loses roughly $250 billion annually, for an estimated loss of 50% to 60% of total U.S. annual drug sales, due to medication nonadherence, Hennessey says. Moreover, this problem is associated with an estimated 125,000 deaths, 10% of hospitalizations, and $100 billion in health care services every year nationwide.
“Given that adverse SDOH have a negative impact on medication adherence, these are compelling reasons for pharma, health plans and health systems to collaborate to address adverse SDOH impacting adherence,” she says.
According to Hennessey, pharma companies are increasing their focus in this area and face “no lack of opportunities to further address” social determinants contributing to health disparities. She urges pharma to be proactive and “participate with plans, clinicians, health systems, integrated delivery networks (IDNs) and other private and public stakeholders to expand value, close disparity gaps and attain the quintuple aim” of better care, healthier people, smarter spending, care team well-being and health equity.
In Philadelphia, Novartis Pharmaceuticals Corp. recently teamed up with Thomas Jefferson University and Jefferson Health, a multistate, nonprofit health system. Citing growing evidence that suggests the COVID-19 pandemic has led to worsening cardiovascular disease outcomes in the U.S., they launched Closing the Gap, a three-year initiative, in September 2021 to address SDOH that contribute to adverse cardiovascular outcomes in underserved neighborhoods.
The program’s services include providing liaisons between the community and health care system to break down barriers to access to care; helping to secure housing assistance and food; educating people about cardiovascular risk factors; and offering wellness programs, including diabetes prevention and hypertension management.
Elsewhere, in efforts to address persistent HIV/AIDS treatment disparities, the Merck Foundation unveiled the HIV Care Connect program in 2019, committing $7 million over five years in collaboration with the University of Mississippi Medical Center, a community-based outreach organization in Alabama and other entities. Their goal is to expand chronic disease management services and improve health outcomes for people of color living with HIV in underserved communities in the southeastern U.S. Separately, Gilead Sciences, Inc. launched a 10-year, $100 million HIV/AIDS outreach program in the southern U.S. in 2017 known as the COMPASS (COMmitment to Partnership in Addressing HIV/AIDS in Southern States) Initiative.
Hennessey says Precision has been holding briefings for its life science clients and their customers about the impact of social determinants on health outcomes and helping to develop resources such as websites and other digital tools to support best practices for screening and addressing SDOH.
“Other clients have asked us to facilitate multistakeholder forums to support collaborations and value-based alliances to mitigate social risk factors,” she adds.
Hennessey says her firm recommends that life science companies “formulate a corporatewide, sustainable, strategic plan to address SDOH and health disparities” that may include:
- Building inclusive, patient-centric clinical trial processes to overcome obstacles to the participation of underrepresented populations in clinical trials;
- Developing social strategies for products, including approaches aligned with customers’ population health objectives;
- Packaging products with services, technology and analytics having an impact on population health, including resources supporting the identification and mitigation of SDOH adversely impacting medication access and adherence;
- Developing strategies to address misinformation and disinformation that impede adoption of therapies, including COVID-19 vaccines;
- Leveraging service hubs to address SDOH barriers to medication access; and
- Forging collaborations and value-based alliances with payers, health systems, patient advocacy groups and other community-based organizations to systematically target adverse SDOH.
PhRMA Urges Data Collection, Research
Spokesperson Andrew Powaleny of the Pharmaceutical Research and Manufacturers of America (PhRMA) frames the issue by stating that given “substantial disparities in health and access to care, including medicines, emphasis should be placed on adequately accounting for or addressing SDOH.”
He explains that “one pillar” of PhRMA’s “patient-centered agenda” is a commitment to building a more just and equitable health care system. As a part of that commitment, the PhRMA Equity Initiative was launched in the summer of 2020, seeking to make progress in three core areas: diverse participation in clinical trials, health equity and a diverse workforce reflective of the U.S. population as a whole.
“To achieve these objectives, we’re working to improve affordability, access and data to better understand and measure the health disparities that we know communities of color consistently experience throughout the United States,” says PhRMA’s 2021 year-end report on its equity program.
“As PhRMA continues to engage in important issues around its health equity initiative, we support exploring ways to better understanding the impact of social determinants of health (SDOH),” Powaleny says. “SDOH play critical roles in improving access to care, including medicines and health outcomes. There are myriad and intersecting SDOH that create disparities in health and access to medicines in particular, including health insurance coverage, income, living in a medically underserved area, transportation, accessibility of health care providers and discrimination.”
To achieve the greatest impact, PhRMA decided to “include the voices of those most affected in our conversation,” he says, “which is why we decided to take a community-first approach.” This led to the creation of its Collaborative Actions to Reach Equity (CAREs) grant program in April 2020.
Recognizing that each community faces unique barriers, CAREs “aims to support community-centered solutions to address inequities in health and use of medicines and vaccines,” Powaleny explains. “To date, nearly $500,000 has been awarded to grantees nationwide who are driving meaningful change on the ground by addressing pressing SDOH issues, such as maternal mortality, access to COVID-19 treatments and vaccines, implicit bias in seeking health care and disparities in medication use/access.”
PhRMA says it supports solutions to SDOH that would:
- Encourage collection and public reporting of data to inform disparities in health care, including medicines and screening, while engaging the patient community, safeguarding patient privacy and ensuring that data is used to improve and provide the best care possible without stigmatization;
- Support research to improve understanding of how diseases and care regimens affect diverse communities in the real world;
- Pursue reforms to the health insurance system, “which too often fails to provide ready and affordable access to innovative medicines” because of “an endless web of high deductibles, expanded cost sharing, coverage exclusions and narrow formularies”; and
- Strengthen public programs and adoption of best practices to improve prevention and management of chronic disease, including through better adherence to medicines.
Congress Takes Aim at SDOH
Meanwhile, federal lawmakers are trying to keep an eye on the issue, which has gained bipartisan support despite little progress in moving legislation forward. Among dozens of SDOH-related bills introduced in 2021, one (S. 3039) would set up a federal interagency council to award state and local grants to address social determinants; another (H.R. 3894) would require CMS to periodically update guidance to help states address SDOH under Medicaid and the Children’s Health Insurance Program (CHIP).
In July 2021, the bipartisan Congressional Social Determinants of Health Caucus was launched to find ways to coordinate a federal response across multiple agencies and committees of jurisdiction. The panel tells AIS Health, a division of MMIT, that it received close to 400 responses to a request for information (RFI) issued shortly after its formation.
Among them was PhRMA’s response, describing its efforts to address treatment barriers by promoting policies to improve affordability and equitable access to medicines, such as capping annual patient out-of-pocket spending, lowering cost-sharing and making it more predictable, and sharing savings from negotiated rebates directly with patients at the pharmacy counter. And PhRMA cited its work to support community efforts to address inequities in underdiagnosis and undertreatment, particularly for COVID-19; build a diverse health care workforce; improve diversity in clinical trials; address underdiagnosis and undertreatment; and improve data collection and reporting.
In its RFI response, the pharma industry group also reiterated some of its longstanding positions, urging lawmakers to find ways to “reduce insurance barriers” to make medicines more accessible and affordable and describing drug pricing reforms as “a step backward.”
“From drug manufacturers to hospital systems and nonprofit organizations, it is clear that addressing the social determinants of health is a top priority of various industries,” the caucus’ four co-chairs — Reps. Cheri Bustos (D-Ill.), Tom Cole (R-Okla.), G.K. Butterfield (D-N.C.) and Markwayne Mullin (R-Okla.) — said in a joint statement Jan. 28 to AIS Health. “We know that many pharmaceutical companies have been focused on improving clinical trial diversity and medication adherence in all populations and as a caucus, we will continue to work with them to help where policy and regulatory changes are needed.”
“We are planning new briefings for this year and will continue to invite various stakeholders to discuss the main facets of health determinants,” the panel’s co-chairs added.
Pharma Must Tackle Misinformation
Hennessey, the life sciences industry consultant, says one area that requires “significantly more attention” is “identification and intervention of misinformation and disinformation.”
“Pharmaceutical manufacturers and their customers are operating in a landscape in which accurate, scientific truth competes against unintentionally misleading misinformation and against disinformation campaigns” typically based around a core of seemingly plausible information combined with half-truths and intentionally false information that often exploits consumers’ fears or biases, she says.
But pharma companies “have an armamentarium of marketing strategies and tactics at their disposal” to combat misinformation and disinformation that includes expanding public and private collaborations to build trust in science, using “a broad network of leaders and messengers” and employing “fresh narratives,” Hennessey says. She cites the use of “psychographic research” to study consumers’ attitudes and behaviors for more customized messaging, as well as humorous advertising and “gamification (e.g., CoronaChampion 1.0 and 2.0, aimed at debunking COVID-19 myths).”
Hennessey adds that drugmakers must recognize the impact that health literacy has on medication adherence “and the importance of writing in plain language about conditions and medications, using positive psychology to suggest actionable next steps.” She notes that manufacturers are collaborating with health plans and systems to overcome health literacy obstacles to care access and medication adherence, with Precision’s survey data suggesting an openness on the part of payers and health systems to engage in additional joint efforts.
Specifically, nearly four in 10 of the payers and health systems responding to Precision’s July 2021 survey indicated that they need “significant to moderate support” on health literacy, she said. Fully 97% said they were open to collaborating with life science companies on such efforts: 27% were collaborating, another 23% planned to collaborate within 18 months, and nearly half (47%) said they were willing to consider such collaborations.
Payers and health systems also have a broadening interest in access to digital therapeutics and emerging technologies, says Hennessey. The survey found only 13% had such collaborations in place with pharmaceutical manufacturers at that time, but roughly 25% planned collaborations in the next 18 months, and most of the remaining respondents were willing to consider such collaborations, “suggesting opportunities are ripening” for working with pharma in these areas.
CQI Programs, Telehealth Are Part of Mix
Hennessey describes continuous quality improvement (CQI) as “imperative to developing sustainable models to impact SDOH.” She says Precision advises its clients and their customers to integrate a process within their models to review clinical and financial outcomes; recalibrate processes and interventions as needed; and reach resolution on pilots and initiatives by modifying, expanding or sunsetting them.
Another potential tool is telehealth. “Early in my career, in the 1980s, I led teams that developed processes and prioritization protocols for telehealth outreach with ‘at-risk’ patients,” she says. “This led to identification and expansion of networks for transportation and in-home care to overcome obstacles to patients accessing and adhering with care and medication. Subsequently, I led teams to support patients and their networks (families and caregivers) to promote patient safety.”
Hennessey explains that these initiatives, which spanned several decades and began “before we used terms like ‘telehealth’ and ‘social determinants of health,’” ultimately gained recognition from entities including the National Committee for Quality Assurance (NCQA), became recognized as best practices and been more widely adopted today.
Precision’s July 2021 survey of payers and health systems indicated that half of respondents were collaborating with pharmaceutical and device manufacturers on telehealth initiatives at that time, and another 37% said they were willing to consider future collaborations. “Given pharmaceutical and device manufacturers’ analytics and data resources, collaborations in this area could bring additional value to customers and consumers,” she says.
“Patient outreach has since evolved in some intriguing directions,” states Hennessey, “leveraging, for example, avatars and gamification concepts to expand scalability, affordability and engagement with multiple generations, including millennials — a large, influential population cohort recognized for high levels of digital technology use.”
Hennessey notes that the use of algorithms to better identify patient risk factors and the need for outreach has been receiving more scrutiny during the pandemic. She says she has participated in webinars, one sponsored by Precision and another by the Pharmacy Quality Alliance, on the use of “conversational artificial intelligence technology and AI analytics to meet the needs of surging numbers of patients during COVID-19” by Northwell Health, a large nonprofit, integrated health network in New York.
But she cautions that the National Academy of Medicine, after exploring AI in health care, urged “population-representative,” inclusive datasets so that AI doesn’t “further exacerbate the considerable existing inequities in health outcomes at a monumental scale.”
Will Hubs Aggregate SDOH Data?
As for what comes next, Hennessey says the concept of using the pharmaceutical hub — the point of contact connecting patients, prescribers, manufacturers, pharmacies and insurers, long used for such services as prior authorization, copay assistance, patient education and data collection — to aggregate data on SDOH is “an area of emerging interest.”
Drug companies “frequently offer patient support programs to identify and address patient barriers to medication access and adherence,” she says. “Screening and providing assistance or referrals for patients with social risk factors offers additional support for patients seeking help with medication access and adherence and promotes patient engagement and loyalty.”
Hennessey points to a 2021 report by the Patient Access Network (PAN) Foundation, which offers dozens of patient assistance programs, summarizing its survey of the SDOH concerns among 7,500-odd patients receiving copay and premium assistance. The foundation recommends that patient support organizations use screening questions to identify concerns about social determinants, “regardless of resource constraints”; determine whether to focus on providing financial or nonfinancial assistance to patients; and use screening questions to determine patient needs and referral recommendations.
By Judy Packer-Tursman