One positive side effect of the fast rollout of the COVID vaccine might be that the FDA has learned to be more "agile" and have more "regulatory flexibility."
Health care leaders entered 2021 with increased anxiety, facing uncertainty brought on by the coronavirus pandemic and a new presidential administration. To help navigate some of most significant challenges, several high-ranking members of the Avalere Health team participated in a live webinar Jan. 7, "2021 Avalere Healthcare Industry Outlook: Clearing the Path."
Topics during the one-hour panel discussion ranged from the likely impact of a U.S. Congress with a Democratic majority to the emerging COVID-19 vaccines and therapeutics marketplace.
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Here are three key takeaways:
1. Joe Biden's administration and the new U.S. Congress will make some changes.
With the new Democrat-controlled Senate, some of the more controversial policy changes regarding health care "are likely off the table," according to Elizabeth Carpenter, head of advisory services for Avalere.
Instead, health-care-related accomplishments in 2021 might include enhancing Affordable Care Act subsidies to make them more affordable, finding incentives for states to expand Medicaid, and rolling back Trump Administration policies like the expansion of 1332 block grant waivers, suggested Chris Sloan, associate principal for policy at the health care consulting firm.
When it comes to ACA matters, he expects Congress to "clamp down" and try to return to 2016-era regulations. "The fact that Democrats control the Senate is a big deal," Sloan added. "Congress is the backstop; Congress has to put the thing back together, and that was going to be a lot harder in a divided Congress … than it will be – even with a slim majority – with the Democrats controlling the Senate."
2. Public education is critical in reducing hesitation over COVID-19 vaccines.
"The vaccine trials cut no corners," said John C. Neal, managing director of Avalere's commercialization and regulatory strategy, referring to the unprecedented speed with which coronavirus vaccines were produced and authorized for use. "What you saw was just a massive mobilization and investment by the pharmaceutical companies."
Hesitancy and speculation will dissipate as more individuals receive the vaccine, he added, recommending that vaccine manufacturers cooperate with both public and private stakeholders to channel health care personnel and patient vaccine advocacy groups to deliver consistent messaging on vaccine validity and safety.
One early challenge appears to be the "tiering structure" that prioritizes frontline healthcare workers and older adults as the first recipients of the vaccine, according to Avalere policy consultant Nick Diamond. He added that the way decisions are made regarding "sub-tiering" and when to move from one tier to the next will be critical. Complicating matters will be the need for existing state immunization registries to sync with internet technology structures that incorporate newly created systems.
That said, a positive side effect of the fast rollout might be that the U.S. Food and Drug Administration has learned to be more "agile" and have more "regulatory flexibility," according to Kelly L. George, a consultant for the firm's commercialization and regulatory strategy.
Regarding therapeutics, Neal noted that their long-term impact will be based on vaccine availability and efficacy, as well as the ability of new coronavirus strains to mutate and avoid the effectiveness of antibodies produced by the vaccines. He said he envisions a long-term need for therapeutics.
3. Telehealth is here to stay, which means new challenges to tackle.
The pandemic has pushed telehealth and virtual medicine to the forefront of health care, according to Kristi Mitchell, practice director for Avalere's Center for Healthcare Transformation. "Now that we've gotten a taste of it, there is tangible consumer demand pushing for it to stay," she said, citing research that indicates patients are increasingly comfortable using telehealth and view online tools as a mean to strengthen relationships with their providers.
With use of telehealth on the rise — and an opportunity for it to become more patient-centric — Mitchell noted that barriers to widespread adoption still exist. Not only do privacy concerns remain, but equity and access for underserved populations with a lack of broadband access, videoconferencing capabilities or overall digital literacy also stand in the way.
That speaks to the broader need to "tackle the root causes of longstanding health disparities to facilitate real change," Mitchell said. She suggested recruiting more people of color to participate in vaccine trials and investing in equity-driven analytics throughout the entire clinical development process.
"[We need to encourage] unique and, in some cases unprecedented, partnerships," she said. "Let's look to collaborations between local public health departments, historically Black colleges and universities, regional health plans, local providers, churches, community-based organizations, and life sciences. These groups will need to come together as we seek to improve education around vaccinations, for example, increase outreach, and ultimately build trust. Because that's the fundamental lynchpin in all of this: trust."
A video recording of the webinar, which also covered patient affordability, drug pricing, and other topics, can be viewed here.
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