BACKGROUND & AIMS:Chronic hepatitis B (CHB) remains a leading cause of cirrhosis and hepatocellular carcinoma (HCC) worldwide, yet treatment uptake is suboptimal even in high-resource settings. This pan-Canadian study aimed to quantify treatment gaps within the Canadian Hepatitis B Network (CanHepB) Registry, compare characteristics of treatment-eligible but untreated patients to those receiving therapy, and assess patient and specialist perspectives on barriers to treatment. METHODS:A cross-sectional, retrospective analysis of 1983 adults with CHB followed in 18 Canadian hepatitis B specialty clinics between January 2018 and November 2024. Treatment eligibility was determined using the 2018 Canadian Association for the Study of the Liver guidelines. An anonymous survey captured patient-reported barriers and perspectives (n = 191), while a separate survey evaluated specialist perceptions (n = 54). RESULTS:Among 881 untreated patients, 46.4% (n = 409) were treatment eligible. Compared with the treatment group (n = 1087), the treatment-eligible but untreated patients were younger (median 47.3 vs. 54.5 years), more frequently female (54.2% vs. 39.7%), and more likely to be of Black/African/Caribbean origin (18.2% vs. 9.7%). They had a lower prevalence of cirrhosis (2.4% vs. 20.3%), HCC (0.7% vs. 9.3%), and hypertension (17.1% vs. 22.9%), but a higher prevalence of steatotic liver disease (36.4% vs. 24.6%) and dyslipidemia (14.7% vs. 10.8%). Among untreated respondents, concerns included side effects, the need for long-term therapy, and lack of curative options. Conversely, specialists identified cost as the primary barrier and side effects as the least concerning. CONCLUSION:This nationwide study reveals a significant treatment gap in CHB care, driven by demographic disparities and a mismatch between patient concerns and clinician perceptions.

The introduction of elexacaftor/tezacaftor/ivacaftor (ETI) has led to improved outcomes and survival in patients living with cystic fibrosis (PwCF) although imposes a substantial economic burden. Despite the reduced healthcare utilization that follows ETI initiation, the economic impact on healthcare spending is not well understood. To try and better understand this, the estimated economic impact on healthcare spending of ETI was calculated in Canada. A treatment naïve cohort of PwCF receiving their first ETI prescription during the 2021-2022 fiscal year from 7 provinces had their healthcare utilization and costs collected one year prior and one year following the initiation of ETI for each patient. Data available included physician visits, emergency department presentations, hospitalizations, drug utilization and laboratory and other diagnostic charges. In the year prior to the first ETI prescription, there was an estimated direct health care cost of $17.6 million CDN. The spending decreased significantly in the year post ETI by $6.9 million with the majority attributed to a 75% reduction in hospitalization-associated costs. When the list price of ETI is accounted for, up to an additional $203 million was spent in the first year after ETI. Irrespective of improvements in life quality brought about by ETI, a price of approximately $10,000/year would be required for it to be cost neutral.

INTRODUCTION AND OBJECTIVES:Drug pricing is a major driver of healthcare spending in the United States (US) and the cost of medications in the US is up to three times higher than other countries. This cross-sectional study aims to investigate the current price differences between hepatitis B (HBV) and hepatitis C (HCV) antiviral therapies in the US as compared to peer high-income countries. MATERIALS AND METHODS:Publicly available drug formularies for Canada, UK, Japan, France, Germany, Italy, and Australia were used to collect 2024 prices for seven HBV medications (lamivudine, adefovir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate, entecavir, peginterferon alfa-2a, emtricitabine/TDF) and seven HCV medications (sofosbuvir/velpatasvir, sofosbuvir/ledipasvir, sofosbuvir, ribavirin, elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir). US prices were obtained from UpToDate®'s listed representative average wholesale price and Medicare Part D 2022 drug prices. RESULTS:US prices for HBV originator medications were on average 4.71x (range 1.99-6.17x) the prices in the peer countries. US generic HBV drug prices for TDF, entecavir, and emtricitabine/TDF were on average 45% cheaper or 0.55x less than the average generic prices in peer countries (range 0.48-0.66x). US originator prices for HCV medications were on average 1.83x the prices in peer countries (range 0.63-2.66x). CONCLUSIONS:HBV and HCV originator medications cost significantly more in the US compared to seven other major industrial countries. However, the introduction of HBV generic medications has lowered the cost of treatment for patients in the US. Future adoption of international reference pricing may help bridge remaining pricing disparities.

OBJECTIVES:Refugees in Canada are disproportionately affected by chronic hepatitis B (CHB) and its complications due to healthcare barriers and resettlement challenges. In 2011 the Mosaic Refugee Health Clinic (MRHC) in Calgary, Canada began a shared care model for CHB. Family physicians identify and monitor chronically infected patients, reviewing cases with hepatology. STUDY DESIGN:A cohort of all adult patients (≥18 years old) with a positive hepatitis B surface antigen result (HBsAg) between January 1, 2011 and December 31, 2020 was assessed through retrospective chart review. METHODS:Variables collected included basic demographics and disease characterization, monitoring parameters, and follow-up intervals. These were analyzed using descriptive statistics. RESULTS:A total of 171 cases were managed during the study time frame, representing 2.6 % of the total number of adult patients (6511) taken into the clinic. Of the cohort, 139 patients (81.0 %) were followed for more than a year. Nearly all patients (98 %) completed a full panel of recommended baseline lab testing, 88 % met ongoing ALT lab surveillance targets, and 70 % ultrasound surveillance. The majority (83 %) were reviewed by the hepatologist within 6 months. CONCLUSIONS:This unique model is the first example of a registry of CHB patients in a longitudinal program at a refugee primary care clinic. The observed high rates of adherence were likely achieved by empowering a primary health care interdisciplinary team with specialty support. No funding was utilized for this study.

Background. A major contributor to increased healthcare spending in the United States is drug pricing, as US drug prices are nearly 3× higher than those in other countries. This cross-sectional study aimed to investigate current global price differences in liver transplant medications and provide potential cost savings for Medicare Part D if international reference pricing was adopted. Methods. Publicly available drug formularies for Canada, the United Kingdom, Japan, France, Germany, Italy, and Australia were used to collect 2024 prices for 8 commonly used liver transplant medications (mycophenolate mofetil, mycophenolate sodium, sirolimus, tacrolimus, Advagraf, Envarsus, everolimus, and cyclosporine). US prices were obtained from UptoDate’s 2024 listed representative average wholesale prices and Medicare Part D’s drug prices from 2022. Results. The average US wholesale price and Medicare spend for originator liver transplant medications were 4.1× and 6.8×, respectively, the average originator prices in G7 countries and Australia. Adopting the average global originator drug price per dose may lead to an estimated $26 141 463 in cost savings per year to Medicare. The average US wholesale price and Medicare spend for generic liver transplant medications were 2.76× and 3.75×, respectively, the global average generic prices. Adopting the average global generic drug price per dose may lead to an estimated $363 538 474 in cost savings per year to Medicare. Conclusions. This study demonstrates the significantly greater financial burden that liver transplant patients in the United States face compared with liver transplant patients in 7 other major industrial countries. Future adoption of international reference pricing may help bridge this pricing disparity.

Hepatocellular carcinoma (HCC) is a leading cause of cancer morbidity and mortality worldwide. Common sites of metastases include the lungs, regional lymph nodes, bone, and adrenal glands. Although rare, distant metastases to the cervical lymph nodes have been reported. With better therapies for viral hepatitis, there has been a shift in the landscape of chronic liver disease and the development of HCC with rising prevalence of HCC attributable to metabolic dysfunction-associated steatotic liver disease. In this study, we describe a case of metastatic HCC presenting as cervical lymphadenopathy in a patient with metabolic dysfunction-associated steatotic liver disease in the absence of cirrhosis.

INTRODUCTION:Patient, clinician, and system-related barriers may affect adherence to hepatocellular carcinoma (HCC) surveillance programmes. The impact of a dedicated automated recall HCC surveillance programme on retention rates in patients eligible for screening is unknown. We aimed to describe and evaluate a large HCC surveillance programme in a publicly funded healthcare system. METHODS:Data were collected from January 1, 2013, to December 31, 2022, from a retrospective cohort of subjects enrolled in a publicly funded automated recall semi-annual surveillance programme as per the American Association for the Study of Liver Disease HCC guidance in the Calgary Health Zone (~1.6 million), Canada. Patients were excluded if there was incomplete data or did not meet indications for surveillance. Cox regression was used to identify predictors of non-retention to surveillance. RESULTS:A total of 7269 patients were included. The median was age 55.5 years (IQR: 45.5-63.8), 60% were male, 46% were of Asian descent, 51% had HBV infection, and 36% had cirrhosis (35% alcohol-related). Median follow-up was 4.9 years (IQR: 1.5-7.2). Overall, 52% (n = 3768) of patients were retained in the surveillance programme, while 8.3% (n = 603) left for potential medical reasons, and 40% (n = 2898) were lost in follow-up. The median time in the programme for those lost in follow-up was 0.81 years (IQR: 0.0-2.8) compared to 6.75 years if retained (IQR: 5.6-8.6; p < 0.001). In multivariable Cox regression analysis, HCV aetiology (HR 1.41; CI 1.23-1.62, p < 0.01), African ethnicity (HR 1.20, CI 1.02-1.42, p = 0.03), and cirrhosis (HR 1.16, CI 1.05-1.28, p < 0.01) increased risk of dropout. On interaction analysis, Hepatitis B amongst cirrhotic patients also increased risk of dropout (HR 1.48, CI 1.05-2.07, p = 0.02). CONCLUSION:A dedicated automated recall HCC surveillance programme has a high retention rate in a large multi-ethnic cohort of patients while identifying certain marginalised patient populations, such as those with viral liver disease, cirrhosis, or African ethnicity, as particularly vulnerable to loss to follow-up.

The introduction of cystic fibrosis transmembrane conductance regulator (CFTR) modulators has changed the landscape of therapy for persons with cystic fibrosis. However, the steep cost of targeted therapy poses significant financial burden for individuals and health systems. We aimed to determine the trends in Medicare and Medicaid spending on CFTR modulators between the years 2015 and 2022 through retrospective analysis of the Medicare and Medicaid claims data. The outcome measures included total dosage units prescribed, number of claims, spending per claim, and total spending on CFTR modulators for Medicare and Medicaid between 2015 to 2022. Average annual percentage changes (AAPC) were calculated for all outcome measures. Our results show that from 2015 to 2022, Medicaid consistently had higher total dosage units prescribed, number of claims, spending per claim, and overall spending on CFTR modulators compared to Medicare. Total spending for both Medicaid [AAPC 38.9, 95 % confidence interval [CI] 27.2-51.6, p < 0.01] and Medicare [AAPC 39.2, 95 % CI 30.2-55.1, p < 0.01] increased significantly during this period. Increases in CFTR spending was accelerated beginning in 2019, when the triple combination CFTR modulator therapy, elexacaftor/tezacaftor/ivacaftor, was introduced to the US market. This increase has been accompanied by a reduction in spending and use of other CFTR agents. This study evaluated the increases in spending for CFTR modulators over the years and the main drivers behind them, which may help inform future negotiations between healthcare systems and pharmaceutical companies, as well as policy makers and stakeholders.

Background: Individuals experiencing homelessness (IEH) tend to have increased length of stay (LOS) in acute care settings, which negatively impacts health care costs and resource utilization. It is unclear however, what specific factors account for this increased LOS. This study attempts to define which diagnoses most impact LOS for IEH and if there are differences based on their demographics. Methods: A retrospective cohort study was conducted looking at ICD-10 diagnosis codes and LOS for patients identified as IEH seen in Emergency Departments (ED) and also for those admitted to. Data were stratified based on diagnosis, gender and age. Statistical analysis was conducted to determine which ICD-10 diagnoses were significantly associated with increased ED and inpatient LOS for IEH compared to housed individuals.Results: Homelessness admissions were associated with increased LOS regardless of gender or age group. The absolute mean difference of LOS between IEH and housed individuals was 1.62 hours [95% CI 1.49 – 1.75] in the ED and 3.02 days [95% CI 2.42-3.62] for inpatients. Males age 18-24 years spent on average 7.12 more days in hospital, and females aged 25-34 spent 7.32 more days in hospital compared to their housed counterparts. Thirty-one diagnoses were associated with increased LOS in EDs for IEH compared to their housed counterparts; maternity concerns and coronary artery disease were associated with significantly increased inpatient LOS. Conclusion: Homelessness significantly increases the LOS of individuals within both ED and inpatient settings. We have identified numerous diagnoses that are associated with increased LOS in IE; these inform the prioritization and development of targeted interventions to improve the health of IEH.

ObjectivesIn high-income countries hepatitis E virus (HEV) is an uncommonly diagnosed porcine-derived zoonoses. After identifying disproportionate chronic HEV infections in persons with cystic fibrosis (pwCF) postlung transplant, we sought to understand its epidemiology and potential drivers.DesignAll pwCF post-transplant attending our regional CF centre were screened for HEV. HEV prevalence was compared against non-transplanted pwCF and with all persons screened for suspected HEV infection from 2016 to 2022 in Alberta, Canada. Those with chronic HEV infection underwent genomic sequencing and phylogenetic analysis. Owing to their swine derivation, independently sourced pancreatic enzyme replacement therapy (PERT) capsules were screened for HEV.ResultsHEV seropositivity was similar between transplanted and non-transplanted pwCF (6/29 (21%) vs 16/83 (19%); p=0.89). Relative to all other Albertans investigated for HEV as a cause of hepatitis (n=115/1079, 10.7%), pwCF had a twofold higher seropositivity relative risk and this was four times higher than the Canadian average. Only three chronic HEV infection cases were identified in all of Alberta, all in CF lung transplant recipients (n=3/29, 10.3%). Phylogenetics confirmed cases were unrelated porcine-derived HEV genotype 3a. Ninety-one per cent of pwCF were taking PERT (median 8760 capsules/person/year). HEV RNA was detected by RT-qPCR in 44% (47/107) of PERT capsules, and sequences clustered with chronic HEV cases.ConclusionPwCF had disproportionate rates of HEV seropositivity, regardless of transplant status. Chronic HEV infection was evident only in CF transplant recipients. HEV may represent a significant risk for pwCF, particularly post-transplant. Studies to assess HEV incidence and prevalence in pwCF, and potential role of PERT are required.

Introduction and ObjectivesTreatment of chronic hepatitis B (CHB) with nucelos(t)ide analogues (NA) can improve outcomes, but NA treatment is expensive for insurance plans.Materials and MethodsThe Centers for Medicare & Medicaid Services database was assessed from 2012 to 2021 to assess the use of NA for CHB in patients on Medicaid. Data extracted included the number of claims, units, and costs of each agent stratified by originator and generic.ResultsOver the study period, 1.9 billion USD was spent on NA, with spending peaking in 2016 at $289 million US, which has subsequently decreased. Lower expenditures since 2016 have been associated with increased use of generics. The use of generic tenofovir or entecavir led to savings of $669 million US over the study period.Conclusions: Increased generic use has significantly reduced expenditures for NA drugs; policy shifts towards generic drug use may help with sustainability.

ABSTRACTChronic hepatitis B (CHB) is the leading cause of hepatocellular carcinoma (HCC) globally. We described and evaluated the outcomes of patients with CHB‐HCC in Canada. In this retrospective cross‐sectional cohort study, data were analysed from CHB mono‐infected subjects seen between 1 January 2012 and 31 December 2022, and entered the Canadian Hepatitis B Network Registry. Descriptive analysis and chi‐squared modelling were used to compare cohorts, followed by multivariable survival analysis regarding survival post‐diagnosis. Statistical analyses were completed in R version 2.2. Of the 6711 patients with CHB who met inclusion criteria, 232 (3.5%) developed HCC. Compared with the CHB cohort, the majority of CHB‐HCC cohort were male, SEA and HBeAg negative and born in endemic area (80% vs. 56%, 73% vs. 55%, 84% vs. 54%, 64% vs. 40% and all p < 0001). Overall, median HBV DNA level was log 2.54 (IQR: 0–4.04). Advanced liver disease, defined as minimum Fibrosis stage F3, was seen in 9.4% of overall cohort, but 92% of HCC cohort. At diagnosis, median tumour size was 2.5 cm (IQR: 1.7–4.0) and mean tumour number was 1.33 (SD: 1.33), with 81% of patients BCLC 0‐A. Fifty‐three per cent of patients were diagnosed with HCC as part of surveillance protocols. The survival rate after HCC diagnosis was 78.7%, during the median follow‐up of 52.9 months (IQR: 17–90). In multivariable analysis, survival was significantly correlated with diagnosis through the screening programme. In this large cohort of patients with CHB‐HCC, the majority of patients were detected with early‐stage HCC and received treatment with curative intent, resulting in strong survival rates.