Associate Principal, Avalere Health
Richard Hughes IV
Managing Director, Avalere Health
Ensuring the highest possible vaccine uptake across the population of the US requires navigating the fragmented nature of the country’s healthcare coverage and delivery system.
“I’ve worked in vaccines for around 15 years,” says Richard Hughes, Managing Director and the Vaccines Leader at Avalere Health, a Washington DC-based advisory firm specialising in strategy, policy, and data analysis for life sciences, health plans, and providers.
“I’ve observed many opportunities to provide better vaccine access, and the COVID-19 pandemic really underscores their value in preventing major outbreaks and why access to them is so vital.”
US vaccine access challenges
One of the challenges for ensuring equitable vaccine access in the US, explains Hughes, is the fragmented nature of the country’s healthcare coverage and delivery system.
For instance, the Affordable Care Act (ACA), passed in 2010, requires that commercial health insurers cover recommended vaccines with zero cost-sharing. This means that nearly everyone with private health insurance in the US has better vaccine access.
Seniors in the US, aged 65-plus, have access to the flu and pneumococcal vaccines without cost sharing, under the Medicare physician benefit (Medicare Part B). However, other vaccines for seniors are covered under the Medicare drug benefit (Medicare Part D), which has variable cost-sharing levels across plans. “Absent supplemental coverage, seniors may pay an average of $50 out of pocket for vaccines under Part B,” says Hughes.
The traditional Medicaid programme, which covers those with limited income and resources who are often more vulnerable to health issues, has variable vaccine coverage and cost-sharing requirements across states.
Overcoming barriers to vaccination access
“Since the ACA passed, significant headway has been made to address financial barriers to vaccination, namely coverage and cost-sharing,” says Kelly Cappio, Associate Principal at Avalere Health.
“However, many Americans still experience coverage gaps and prohibitive out-of-pocket costs. Policymakers could consider ways to achieve parity across the private and public insurance markets – including covering vaccines the same, across sites of care, and eliminating patient cost sharing.”
These challenges require sophisticated solutions to overcome them – systems to connect patients to access or ensure providers are reimbursed – or, ultimately, policy reform to resolve the fragmentation of vaccine coverage and access
Additionally, “The US ACIP’s (Advisory Committee on Immunization Practices) increasingly complex recommendations have become more challenging for payers to implement and for providers to communicate, possibly leading to missed opportunities to protect a patient” says Hughes. “ACIP recommendations could be clearer. The vaccine pipeline is robust. And with new emerging non-vaccine technologies emerging, there’s also an opportunity for the ACIP to advise on the use of novel products that effectively play the same role as a vaccine.”
How COVID-19 will change the development of vaccines
With respect to a COVID-19 vaccine, “The ACIP will likely have a crucial role to play here,” says Cappio. “Given the urgent need, a vaccine may be deployed pre-licensure under an Emergency Use Authorisation by the Food and Drug Administration (FDA).
“Typically, the ACIP doesn’t make a recommendation for use of a vaccine before it receives FDA licensure; but, in extraordinary circumstances, the committee is able to provide guidance on the use of unlicensed vaccines and there is a likelihood they recommend that certain subgroups, like healthcare workers, receive the vaccine first. Later, when the vaccine is available for broader use, ACIP would need to determine whether to recommend it to the wider US population.”
The US Congress took legislative steps in March to ensure access to future COVID-19 vaccines, requiring the vaccine to be covered under the Medicare physician benefit with zero cost-sharing and providing enhanced federal funding for state Medicaid programmes that cover the vaccines at first dollar. Should the ACIP recommend the vaccine for use, commercial plans will also be required to cover it.
Hughes expects the COVID-19 crisis to have a long-lasting impact on vaccine development. “More broadly, this pandemic is likely to shape the long-term healthcare and public health outlook in many ways for good. If there’s any silver lining at all, it’s that.”