Few PCPs implementing universal HBV vaccination guidance

It is finally possible to eliminate hepatitis B virus in the United States, as long as a multipronged strategy is used to fully implement new guidance that recommends universal vaccination for adults aged 19 to 59 years, experts said.

This multipronged strategy includes increasing clinician awareness of the guidance, which is currently low, according to Rita K. Kuwahara, MD, MIH, a primary care internal medicine physician and health policy fellow at Georgetown University.

The guidance was adopted by the CDC’s Advisory Committee on Immunization Practices (ACIP) in November. In addition to universal vaccination for adults aged 19 to 59 years, the guidance states that adults in this age group — plus adults aged 60 years or older with risk factors — “should” be vaccinated against HBV, while adults aged 60 years or older who do not have known risk factors “may” receive a vaccine.

“Now with the universal vaccination guidelines, we have an incredible opportunity to finally eliminate hepatitis B in the United States,” Kuwahara, who also serves on the Healio Primary Care Peer Perspective Board, said during the HHS National Vaccine Advisory Committee’s June 2022 Meeting. “However, we must be mindful about how we implement the new recommendations so that we can be most effective in expanding hepatitis B vaccination nationwide.”

Current HBV vaccination rates

During the committee meeting, Chari Cohen, DrPH, MPH, the senior vice president of the Hepatitis B Foundation, said that nearly 2.4 million people in the U.S. have chronic HBV, and acute infections are rising for the first time in 2 decades.

She further noted that HBV is the leading cause of liver cancer, which is also on the rise but could be prevented with HBV vaccination.

Although vaccination rates are higher among children, only about 25% to 30% of U.S. adults are vaccinated against HBV, Cohen said. The low coverage rates in adults are due to previous risk-based guidance, which led to challenges with reimbursement, she added.

Mark Weng, MD, an epidemiologist at the CDC and lead on the ACIP’s Hepatitis Vaccines Work Group, said that risk-based vaccination “has got us as far as it can take us.” It was first introduced in the early 1980s among adults and perinatally exposed infants, he said during the meeting. The recommendations evolved over time. Universal infant vaccination was introduced in 1991, followed by catch-up vaccination for adolescents in 1999 and a universal birth dose for newborns in 2005.

“All these steps toward routine hepatitis B vaccination resulted in large declines in new hepatitis B infections in children and adolescents,” Weng said. “However, hepatitis B incidence has plateaued over the past 10 years, with more than 20,000 new infections estimated to occur each year. Rates have actually increased among adults 40 years and older, indicating that we are losing ground. We cannot eliminate hepatitis B in the U.S. without a new approach.”

Multipronged implementation strategy

Cohen previously told Healio that it will likely take years before the ACIP’s universal vaccination guidance is fully implemented in clinical practice.

In a recent nationwide survey conducted by Kuwahara, 55% of 265 family medicine physicians said they were not aware of the new guidelines, and only 8% were implementing them.

“This represents a lot of opportunity where we really need to focus on increasing clinician awareness by partnering with medical societies to focus on clinician education but also working with academic centers and other training programs so that trainees are aware of this,” she said. “While we increase awareness of the universal guidelines, we also need to increase awareness of the different vaccine options available, including the two-dose Heplisav-B vaccine that has been available for a couple of years.”

In addition to increasing clinician awareness, Kuwahara said that a multipronged implementation strategy must include:

• adequate infrastructure and funding at all levels of government to support expanded adult HBV vaccination;

• establishment of effective clinic protocols, such as vaccine standing orders;

• partnerships with pharmacies to ensure that information on pharmacy-administered vaccines are transmitted back to patients’ primary care clinicians;

• efforts to address high-risk populations, including Asian American and Pacific Islanders, African immigrants and persons who inject drugs;

• effective public health messaging, including highlighting the HBV vaccine as the first anti-cancer vaccine; and

• messaging that aligns with anticipated updates to the CDC’s HBV screening recommendations, which are currently under review.

While funding is needed at the federal, state and local levels to fully implement the new guidelines, Kuwahara said there is a particular need to increase funding for Section 317 of the Public Health Service Act, which provides safety net funding for vaccines, so that the vaccines are available to patients without health insurance, as well as to establish and fund a new Vaccines for Adults Program that was included in President Joe Biden’s fiscal year 2023 budget.

“While we have some resources available to those without insurance, many resources are not available to the underinsured, so we must ensure that resources are made available for those who are underinsured to access vaccines. We must also build upon existing COVID-19 vaccine infrastructure that we have already developed and invested heavily in to implement the updated HBV vaccination guidelines,” she said. “In addition, we need to develop a federal immunization information system, rather than the current state-based immunization information systems that do not communicate across state lines, so that we can effectively track all vaccines administered across a person’s lifespan, regardless of where a person might live, particularly if they move from state to state or receive vaccines while away from their home state.”

Clinic protocols must also be established to support implementation of universal HBV vaccination, Kuwahara said. For example, standing orders for vaccines must ensure eligible patients can receive the HBV vaccine, regardless of why they may be in the clinic. In addition, Kuwahara said it is important to stock HBV vaccines in clinics, develop electronic health record alerts to remind clinicians when patients are eligible for vaccination and ensure that HBV vaccine information for patients is available in multiple languages.

Kuwahara also said that checklists used in clinics to manage the care of patients with diabetes should be updated to include HBV vaccination “so that we include vaccination as a part of routine management for patients with diabetes, which was already recommended for several years prior to the recently updated universal vaccination guidelines.”

“Lastly, it is extremely important to create patient reminders to ensure patients return for subsequent doses of the vaccine,” she said. “Because hepatitis B is a multidose vaccine, it is critical that patients receive all required doses of the vaccine series, so they achieve immunity.

One of the key components to ensuring that patients complete their vaccine series is to create a system where any time a patient receives an HBV vaccine and needs to return for a subsequent dose, their next vaccine appointment is made before the patient leaves the facility where they received their vaccine, so they are more likely to return to complete their vaccine series, Kuwahara said.

“In addition, facilities administering vaccines should send patients reminder texts and phone calls to return for subsequent vaccines and develop other innovative ways to remind patients to complete their vaccine series,” she added.

There are additional financial considerations that Kuwahara said must be taken into account. For example, although ACIP-recommended vaccines are covered with no patient cost-sharing by Affordable Care Act-compliant private health insurance plans, Kuwahara said it will be important to ensure that HBV vaccines are covered with no cost-sharing for adults aged 60 years and older without risk factors who are not included in the universal vaccination cohort of those aged 19 to 59 years and those aged 60 years and older with known HBV risk factors.

In addition, Medicare often does not cover HBV vaccines administered in a pharmacy rather than in a clinical setting, despite many patients with Medicare meeting the criteria for HBV vaccination, Kuwahara said.

“It will be important for this issue to be addressed, so that Medicare beneficiaries needing HBV vaccination can receive this with no cost-sharing,” she added. “Medicaid coverage for adult vaccines also varies depending on the state, so it will be important to ensure that those with Medicaid have access to vaccines. We also need to make sure that if patients receive the vaccine in nonpharmacy and nonclinic settings, such as through community outreach programs that may reach higher risk communities who may not have regular access to health care, that they can be administered and reimbursed in those settings.”

Finally, according to Kuwahara, when the CDC releases its updated recommendations regarding HBV screening among adults, it will be important for the U.S. Preventive Services Task Force to readdress its HBV screening guidelines to align with the anticipated updated CDC guidelines, so that patients can receive HBV screening with no cost-sharing.

“This is particularly important as we develop messaging to raise awareness of ACIP’s recently updated universal HBV vaccination guidelines, which will need to be aligned with messaging for the anticipated updated CDC hepatitis B screening guidelines when they are released in the coming months,” Kuwahara said.

References:

Cohen C, et al. Help eliminating the silent epidemic in America: New adult hepatitis B immunization recommendations. Presented at: National Vaccine Advisory Committee Meeting; June 15-16, 2022; virtual.

Kuwahara RK, et al. Strategies to Implement Universal Hepatitis B Vaccination for Adults 19-59. Presented at: National Vaccine Advisory Committee Meeting; June 15-16, 2022; virtual.