Pharma’s pivotal role in social determinants of health

By Maureen Hennessey, PhD, CPCC, CPHQ, Senior Vice President and Director of Value Transformation, Precision for Value

The World Health Organization has defined social determinants of health (SDOH) as: "conditions in which people are born, grow, live, work and age,” and has asserted that SDOH “are mostly responsible for health inequities." This year has seen significant milestones in the advancement of multi-stakeholder initiatives to address SDOH, suggesting that the healthcare ecosystem has reached a “tipping point” in recognizing the vital role of SDOH in population health management. Among the 2019 milestones:

• The Pharmacy Quality Alliance (PQA) published its framework, “Medication Access Framework for Quality Measurement,” to address SDOH impeding patient access to medication
• The National Quality Forum issued a Call to Action to address SDOH through quality and innovation
• Although not yet passed, the Social Determinants Accelerator Act of 2019 (H.R. 4004) was introduced in the US House of Representatives to establish an interagency council on SDOH
• The Centers for Medicare & Medicaid (CMS) published its 2020 Rate Announcement and Call Letter; the move permits Medicare Advantage plans greater flexibility to offer supplemental benefits for chronically ill beneficiaries to address factors such as nutrition and transportation with the goal of improving their chronic conditions
• CMS issued a proposed rule seeking comments by December 31, 2019 regarding value-based arrangements, safe harbors, and safeguards to promote innovation and limit abuses by stakeholders (including pharmaceutical manufacturers); it is aimed at expanding value-based care and appropriately addressing SDOH within federal programs

Through addressing SDOH, pharmaceutical manufacturers have an opportunity to play an essential role in advancing precision population health and promoting health equity. Forward-thinking manufacturers will gain market distinction with strategic initiatives aimed at ameliorating social risk factors, from clinical trials through FDA approval and beyond.

Building and sustaining an inclusive clinical trial process

Manufacturers have opportunities during the clinical trial process to address social factors that may inhibit participation by diverse populations. Clinical trials are the “first portal to standards of care and innovative care,” and a lack of diversity in clinical trials thwarts the goal of precision medicine to provide therapies that account for factors like ethnicity, gender, genetics, race, and SDOH. Advancing patient-centric clinical trials through identifying and circumventing participation barriers has the potential to increase trial enrollment rates of diverse participants and aligns with FDA efforts to work with stakeholders to encourage diversity within clinical trials.

Notable practices for building and sustaining an inclusive clinical trial process include the following steps:

• Commit organizational leadership to diversity in hiring, development, and training, including cultural competency training
• Establish trust within diverse communities, to nurture development and recruitment infrastructure for clinical trials
• Promote clinical trial designs that better assess and address participation barriers, gaining input from diverse populations
• Support participatory discussions by healthcare providers with patients about clinical trials and other options; discussions should be supplemented by informational materials and strategies relevant to patients’ ethnicity, culture, language, and cognitive functioning
• Offer engagement programs to bridge continuation, when appropriate, with beneficial therapies
• Communicate results to inform communities of outcomes and benefits gained from clinical trials
• Analyze data and messaging strategies to advance diverse recruitment and the science of precision medicine

Beyond clinical trials

Pharmaceutical manufacturers’ opportunities to impact social determinants of health extend well beyond clinical trials. A 2019 Precision for Value survey of IDNs, plans, and similar stakeholders found those entities are actively engaging in, planning or willing to consider future collaborations with manufacturers to address SDOH. Participation by pharma in population health management must be guided by innovative practices that address social determinants and disparities of health. Opportunities for pharmaceutical manufacturers to reduce the adverse impact of SDOH include the following:

• Formulate a strategic plan to address SDOH, integrating SDOH within a precision population health strategy
• Collect, analyze, and develop data obtained on SDOH to drive preventive and predictive biopsychosocial strategies and algorithmic interventions
• Engage in policy development that reduces unnecessary government restrictions and proposes structures and safeguards to advance innovation and scientific research to address social determinants and promote population health
• Facilitate access to therapies within existing hubs by addressing barriers to appropriate medication access
• Bundle products with services and technology to optimize adherence and create unique value
• Develop resources to support healthcare providers, patients, and caregivers in advancing health literacy
• Sponsor and participate with national, state, and local collaborations, galvanizing payers, patients, and providers to systemically impact social risk factors
• Publicize “lessons learned” to accelerate best practices in precision population health for global attainment of better outcomes

Pharmaceutical manufacturers have a pivotal role to play in precision population health through strategic data collection, analysis, and biopsychosocial and algorithmic interventions to address SDOH. Further, they have opportunities, through innovative products and services designed to facilitate appropriate access and adherence,to grow revenues forfeited to medication nonadherence. Collaborations with patients, providers, and payers, beginning with clinical trials and continuing throughout the patient journey, pave a pathway for manufacturers to market differentiation through adroit intervention with SDOH, delivering distinctive value for key stakeholders.