Improving Care for Patients with Chronic Hepatitis B via Establishment of a Disease Registry.

In the United States, there is poor clinician adherence to the American Association for the Study of Liver Disease and other guidelines for chronic hepatitis B virus (CHB) management. This prospective cohort study evaluated whether a CHB registry improves CHB management. We included patients with CHB aged ≥ 18 years and who had a clinical encounter during September 1, 2016-August 31, 2019. We divided patients into three groups based on care received before September 1, 2019: 1) CIH: primary care clinician at HealthPartners Center for International Health, 2) GI: not CIH and seen by gastroenterology within previous 18 months, and 3) primary care (PC): not CIH and not seen by gastroenterology within previous 18 months. We created and implemented a CHB registry at CIH that allowed staff to identify and perform outreach to patients overdue for CHB management. Patients with laboratory testing (i.e., alanine transaminase and hepatitis B virus DNA) and hepatocellular carcinoma screening in the previous 12 months were considered up to date (UTD). We compared UTD rates between groups at baseline (September 1, 2019) and pilot CHB registry end (February 28, 2020). We evaluated 4,872 patients, 52% of whom were female: 213 CIH, 656 GI, and 4,003 PC. At baseline, GI patients were most UTD (69%) followed by CIH (51%) and PC (11%). At pilot end the percent of UTD patients at CIH increased by 11%, GI decreased by 10%, and PC was unchanged. CHB registry use standardized care and increased the percent of CHB patients with recent laboratory testing and HCC screening.

Characteristics and Price Increases Among Sole-Source, Off-Patent Drugs in the United States, 2008 to 2018.

Importance: Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy. Objectives: To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases. Design, Setting, and Participants: In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank. Main Outcomes and Measures: The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured. Results: Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013. Conclusions and Relevance: Price increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.