TABLE 5.

Enabler, barriers, and solutions to HBV elimination

Cascade of care	Enablers	Barriers	Proposed solutions
HBV screening
United States	CDC Universal Adult HBV screening recommendation40	• USPSTF (US Preventive Services Task Force) recommendation not universal, thus no guaranteed insurance coverage • Low awareness among providers • Need for blood draw, lack of point-of-care (POC) diagnostics	• Implementation of universal screening recommendations • USPSTF updated recommendation for universal adult HBV screening • National Coverage Determination from CMS should follow CDC universal HBV screening recommendation • Automated integration of screening panel into health system EMR (prompts and ordering sets, standing orders) • Expanded provider education (Extension for Community Health Care Outcomes, ECHO) • FDA Class 2 categorization for HBV diagnostic and licensing of point-of-care diagnostics • Electronic health record adult HBV screening prompts/care gaps • Quality metrics to include universal HBV screening (NCQA, NQF, Medicaid Core Set)
Canada	Recommendations for universal HBsAg screening of pregnant and HIV or HCV infected persons, otherwise risk-based screening suggested41	• Recommendations not widely circulated to all health care providers • Awareness of risk profile is narrow (drug use/sexual) such that persons at risk due to birth in an HBV endemic country may be missed • Late diagnoses- patients presenting first time with HCC and decompensated cirrhosis	• Improved education of frontline health care providers • Promotion of updated primary care guidelines/recommendations for Universal Screening and Vaccination of all Adults by the Canadian Task Force for Preventative Health Care (CTFPHC) • The College of Family Physicians of Canada should provide resources for practitioners • The Public Health Agency of Canada (PHAC) website and recommendations should be updated to Universal Screening instead of risk-based
Vaccination
United States	CDC/ACIP HBV vaccination recommendation for all children and adults < 60 y old42 Inflation coverage reduction act - no cost vaccine sharing with Medicaid	• Optional/risk-based vaccination for adults 60 y and older confusing for providers • No clear guidance on order of universal HBV vaccination and screening • Not all pharmacists can administer vaccine and vaccine not covered in all pharmacy settings • Many clinicians do not stock vaccine • Vaccine access/coverage challenges	• Automated integration into health system EMR with accompanied workflow and education • Education for providers and communities, focus on liver cancer prevention of vaccine • Programs to address vaccine hesitancy, partnering with trusted community organizations • Create vaccine demand among communities • Patient navigators to assist with vaccine completion • Updated state policies to allow pharmacy administration and reimbursement without prescription • NCQA’s proposal to add HBV adult vaccination to Measure Year 2025 as a quality metric
Canada	Covered under public health care plans for all childhood vaccines.	• Adult vaccination not covered and not recommended • Wide variation in timing of pediatric vaccination • Poor coverage of birth dose vaccination (discriminatory disadvantage for newcomer populations)	• Leverage engagement with Government decision makers (National Advisory Immunization Committee; Public Health Agency of Canada) and the general public by advocacy and stakeholder organizations to educate, promote awareness, and justify the implementation of universal birth dose vaccination • Leverage the updated national STBBI Action Plan (2024) recommending new innovation and uptake of vaccination (ie, universal birth dose vaccination)
Both countries		• Low awareness among providers and communities, vaccine hesitancy • Lack of National Vaccine registry	Wide dissemination of the recommendation through professional societies and awareness of newer vaccines
Treatment
Treaters
United States	• Any physician can write prescription for HBV antiviral • Primary care providers serving at risk communities are often HBV treaters (many at federally qualified health centers [FQHCs])	Barriers for nonspecialists treating • Primary care providers (PCP) with limited time per visit • Not familiar with hepatitis B management • Complex eligibility assessment by AASLD guidelines • PCPs not aware of simplified guidelines	Expand provider education on HBV care and treatment • Start in medical school • Include as core curriculum for family practice and internal medicine residency training • Expand ECHO and other professional training • AASLD partnership with family practice and internal medicine societies for training, training program for hepatitis B and C Create quality measures (National Quality Forum, HEDIS, Medicaid/Medicare) with payment incentives for HBV screening and treatment
Canada	Specialist can write prescription for HBV antiviral	• Nonspecialists cannot prescribe • Pharmacare reimbursement programs, lack of expertise, and shortage of primary care providers	Expand hepatitis B related services, including telehealth, in the provincial primary care and specialist pathways: Alberta: Specialist Link https://www.specialistlink.ca/ Ontario: Ontario eConsult https://otn.ca/patients/econsult/; VIRCAN - https://vircan.ca/ (Toronto area Viral Hepatitis network) Quebec: Réseau québécois de la télésanté HYPERLINK “https://telesantequebec.ca/”https://telesantequebec.ca British Columbia: RACE- http://www.raceconnect.ca/
Treatment Guidelines
United States	• Management and treatment guidelines published by AASLD (American Association for the Study of Liver Disease)43 • Simplified HBV management guidance for primary care providers available online44	• Largely specialist prescribing, specialty guidelines have high complexity • Simplified HBV management guidance not widely adopted	• Create and promote simplified management and treatment guidelines • Creation of HBV guidelines from internal medicine or family medicine societies or wider dissemination of already published simplified guidelines
Canada	Management and treatment guidelines published by CASL (Canadian Association for the Study of the Liver)45	Largely specialist prescribing	-Development of primary care version of CASL guidelines. -Work with primary care networks to create a shared care model with specialists.
Drug Access and Coverage
US	2 oral generics are available (entecavir, tenofovir disoproxil fumarate), can go through nonprofit pharmacies	• Inconsistent health insurance coverage of HBV drugs • HBV drugs are often high-tiered on formulary and require prior authorization • Can be very costly for patients • Pharmacy benefit managers have dropped tenofovir alafenamide (Vemlidy) coverage	HBV meds should be universally covered and generics should be in low tier formulary to reduce patient cost for insurance company (Single government leverage negotiation bulk pricing with pharmaceutical company)
Canada	2 oral generics are available (entecavir, tenofovir disoproxil fumarate)	• >100 public prescription drug plans and over 100,000 private plans—with a variety of premiums, copayments, deductibles and annual limits • Pharmacy coverage of entecavir and tenofovir as first-line therapies (remove current recommendations in some plans to use lamuvidine and adefovir)	National, universal, single-payer, public pharmacare program. First phase of Legislation introduced in Spring 2024
Patient engagement and representation Stigma and Discrimination Quality of life measures
US	Advocacy groups and patient-serving groups foster patient engagement and document quality of life impact Hepatitis B discrimination protected under Americans with Disabilities Act (ADA)46	• Little or no formal patient engagement/patient preference in treatment guidelines and national hepatitis efforts • Quality of life indicators not included in management and treatment guidelines • Discrimination continues to occur despite ADA47	• Enhanced medical society engagement with patients, create formal inclusion of patient perspective into guidelines • Develop PROs to assess quality of life on and off treatment, and integrate into clinical care/guidelines • Culturally appropriate messaging to reduce stigma • Continued efforts to decrease discrimination (Hepatitis B Foundation Discrimination Registry) • Patient/advocacy/community organizations and programming (Hepatitis B Foundation, Hep B United)
Canada	Advocacy groups and patient-serving groups foster patient engagement and document quality of life impact	• No formal patient engagement/patient preference in treatment guidelines • Quality of life indicators not included in management/treatment guidelines	• Recent studies to investigate barriers and quality of life outcome measures for Canadian patients48,49 • Canadian Charter of Rights and Freedoms provides equality rights and protection against discrimination • Patient/advocacy/community organizations (CATIE Canadian Liver Foundation, Action Hepatitis Canada)
HCC Surveillance Opportunities to address gaps in early detection and improve outcomes of liver cancer Other50
US and Canada	Tools for HCC surveillance are available (Imaging, AFP) Specialty recommendations for HCC surveillance	• Low implementation and adherence to HCC surveillance • Less than ideal sensitivity and specificity of currently available screening tools • Non-universal terminology and criteria for HCC screening methodologies • Limited data on effective strategies to improve implementation and adherence	• Increase use of current surveillance tools • Wider adoption of Ultrasound Liver Imaging Reporting and Data Systems (US LI-RADS) for HCC surveillance • Study and validate new screening strategies, including noninvasive biomarkers • Implement provider and patient education • Integrate automated algorithms and reminders into health systems EMR • Create quality metric for HCC screening • Support national coverage recommendations for HCC surveillance (Canadian Task Force on Preventive Healthcare, US Preventive Services Task Force)

Abbreviations: AASLD, American Association for the Study of Liver Diseases; ACIP, Advisory Committee on Immunization Practices; ADA, Americans with Disabilities Act; AFP, alpha fetoprotein; CASL, Canadian Association for the Study of the Liver; CDC, Centers for Disease Control and Prevention; CMS, Center for Medicare and Medicaid Services; CTFPHC, Canadian Task Force for Preventative Health Care; ECHO, Extension for Community Healthcare Outcomes; EMR, Electronic Medical Record; FDA, Food and Drug Administration; FQHC, federally qualified health centers; HEDIS, Healthcare Effectiveness Data and Information Set; NCQF, National Community for Quality Assurance; NQF, National Quality Forum; PCP, primary care providers; PHAC, Public Health Agency of Canada; POC, point of care; PRO, Patient Reported Outcomes; STBBI, Sexually Transmitted and Bloodborne Infection; US LI-RADS, Ultrasound Liver Imaging Reporting and Data Systems; USPSTF, US Preventative Services Task Force.