The Biden administration cited health equity as one of its top 5 health priorities in a Health Affairs blog. The blog focused on what the administration can do within its Center for Medicare and Medicaid Services Innovation Center, an office that can implement wide-reaching demonstration programs without congressional authority. This follows a Day One executive order from the president directing resources to address historic inequalities. The announcement comes as the nation continues to grapple with health inequities brought to light during the COVID-19 pandemic, and government bodies take action in response to public concerns.

Environmental considerations

  • Advocacy stakeholders are putting pressure on the CDC to disclose data showing the uneven impact of COVID-19 on communities of color.
  • Increasing criticism over the lack of attention to race and ethnicity among contributors at leading scientific journals, insufficient diversity in clinical trials and concerns about equitable access and affordability are leading to new applications and initiatives to improve disparities across industry.
  • The momentum continues as House legislators introduced legislation to establish an interagency council on social determinants of health.
  • The COVID-19 health equity ripple effect was seen on the state level (CA, DE, IL, MA, MI, NY, PA, TN) and could have a similar impact as manufacturers and developers prepare for FDA guidance on the use of real-world evidence (RWE).  

Why this matters

  • The FDA is set to issue final guidance on the use of RWE as early as December 2021.
  • Beyond clinical trial designs and outcome assessments, RWE could be an opportunity to include reimbursement and disparities research.   
  • While CMS has started to incorporate RWE to design value-based models for Medicare and state Medicaid programs, the final guidance could prompt further reimbursement adjustments – especially with formulary coverage, patient care programs and care delivery.   
  • Understanding how a drug preforms across sub-populations – particularly when incidence of a disease may be higher in a particular sub-population – is increasingly being looked at as a key component of drug value, according to McKinsey & Company: 
    • “…the introduction of advanced RWE analytics could help companies identify new targets for molecules, accelerate time to market, improve formulary position and payer negotiations, and generate stronger evidence of differentiation and benefit/risk balance for in-market products. Our analysis suggests that applying these actions to key assets could generate top-line value of $200 million or more.”

What can life science companies do:

  • Companies should be prepared with reactive messaging if clinical trial data does not align with the addressable patient population.
  • Explain trial design to ensure stakeholders do not lose trust in the integrity of information. 
  • Engage key stakeholders (payers, policymakers, patient advocacy, HCPs, investors) to better understand how to contextualize RWE in order to positively shape value perception of a pipeline or on-market drug.
  • Develop proactive messaging to help demonstrate how patient support programs can help increase access among diverse patient populations.

The Syneos Health Reputation & Risk Management team will continue to monitor the policy landscape, provide insights and recommendations for clients with stakeholder engagement and value communications strategies. If you have questions, please reach out to [email protected]

About the Author:

Patrick Rigby joined Syneos from the private sector where he specialized in corporate communication, government relations, and public affairs across the healthcare industry. Patrick served as Director of Communications and later as Chief of Staff for the New Jersey Office of Homeland Security and Preparedness under two administrations. He also served as an Advisor to the Chairman of the U.S. Senate Foreign Relations Committee. Prior to government service, Patrick held positions with Bloomberg L.P., the Council on Foreign Relations, U.S. House of Representatives, and in the financial services industry. Patrick brings with him over 15 years of managing large teams and directing complex communications and reputation management programs for businesses and government.

Michelle Leeds is a healthcare communications and public affairs professional with 20 years of experience in healthcare policy, lobbying, marketing and communications. Michelle specializes in crafting strategic public affairs and communications strategies designed to resonate with a broad audience of stakeholders, including policymakers, patients and patient advocates, payers, and providers. Michelle also supports clients in developing and executing thought leadership and executive visibility strategies that promote organization/company priorities and values.