An Umbrella Review of the Cost Effectiveness of Human Papillomavirus Vaccines.

BACKGROUND AND OBJECTIVES: Although many systematic reviews for the human papillomavirus vaccines cost effectiveness have been published, they vary in perspectives, methods, and quality. We aimed to condense systematically such evidence to facilitate locating, processing, and learning, not only about the consensus of findings but also how models were built and their evolution over time and across settings. METHODS: We conducted an umbrella review of cost-effectiveness studies for human papillomavirus vaccines using three databases (PubMed, Embase, and Cochrane). Based on their objectives, we classified studies into three groups (human papillomavirus vaccines cost effectiveness, model characteristics, and all-type vaccines, including human papillomavirus vaccines). We used the AMTAR2 to assess the quality of the studies. Additionally, we provided a summary of study findings, discussions, and evidence gaps in the literature. RESULTS: Though most studies were critically low quality and had a low quality of reporting, the human papillomavirus vaccine was consistently cost effective in young girls and men who have sex with men. Stratified analyses by rated quality did not change the results. The quality assessment of the reviews did not necessarily reflect the quality assessment of underlying studies. The human papillomavirus vaccine models became more complex over time, capturing more realistic disease transmission with different human papillomavirus strains and herd immunities. CONCLUSIONS: Additional evidence is needed for vulnerable populations (e.g., childhood cancer survivors) who are at high risk for human papillomavirus vaccine-related cancers and, therefore, may be more cost effective when receiving human papillomavirus vaccines. Quantifying human papillomavirus vaccine cost effectiveness via meta-analyses is feasible if investigators can increase the homogeneity of their populations.

Comparative effectiveness and safety of eribulin in advanced or metastatic breast cancer: a systematic review and meta-analysis.

Eribulin is one of the few recommended chemotherapies for locally advanced breast cancer (LABC) or metastatic breast cancer (MBC). We systematically searched MEDLINE Ovid, Cochrane Library, IPA, CINAHL, Web of Science and ProQuest Dissertations for studies evaluating eribulin versus non-eribulin regimens in LABC/MBC till January 15, 2021. Primary effectiveness and safety outcomes were overall survival (OS) and adverse events (AE), respectively. Hazard ratios (HR) and relative risks (RR) with 95 % confidence intervals (CIs) were calculated using fixed or random-effects meta-analyses. Of 1183 publications identified, 13 studies were included in this review. Eribulin based therapy showed significantly increased OS [HR (95 % CI) = 0.77 (0.67-0.88)] compared to non-eribulin in both main and sensitivity analyses, as well as subgroup analyses according to receptor expression and line of therapy. Incidence of all-grade neutropenia was the only significant AE in eribulin than non-eribulin groups. Eribulin has a manageable toxicity profile and provides significant survival benefit in LABC/MBC patients.

Comparisons of adverse event reporting for colistin versus polymyxin B using the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Background: The polymyxins (colistin and polymyxin B) have recently reemerged in clinical practice. With the same antimicrobial activities, colistin has been more frequently prescribed in most countries, although available evidence on their nephrotoxicity is conflicting.Methods: The US Food and Drug Administration Adverse Event Reporting System (FAERS) data from Q1-2004 to Q1-2020 were used to identify adverse events (AE) reports. We described the reporting patterns and compare the reporting rates of serious AEs, acute kidney diseases (AKD), and death between colistin and polymyxin B using reporting odds ratios (RORs).Results: The annual number of AE reports increased over time for both drugs. Heterogeneity in reporting characteristics was observed in age and reporter region. RORs of serious, AKD, and death AEs were significantly higher for both drugs versus other drugs. RORs of serious and AKD AEs were higher for colistin compared to polymyxin B (p = 0.0479 and p = 0.0306, respectively), but no difference in death RORs was detected (p = 0.2211).Conclusions: This study showed higher reporting rates of serious AEs and AKD for colistin than polymyxin B, but no difference in death. The findings support future research with stronger study design and larger sample size for the safety comparison between colistin and polymyxin B.

Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

BACKGROUND: Since the approval and availability of the first biosimilar in 2015 in the United States (US), evidence regarding the post-marketing safety of cancer supportive care biosimilars remains limited. OBJECTIVE: The aim was to explore the adverse event (AE) reporting patterns and detect disproportionate reporting signals for cancer supportive care biosimilars in the US compared to their originator biologics. METHODS: The US Food and Drug Administration Adverse Event Reporting System database (January 1, 2004-March 31, 2020) was used to identify AE reports for filgrastim, pegfilgrastim, and epoetin alpha by type of product (originator biologics vs. biosimilars) and report characteristics. Plots of AE reports against years were used to reveal the reporting patterns. Disproportionality analyses using reporting odds ratios (RORs) were conducted to detect differences in serious and specific AEs between studied drugs and all other drugs. Breslow-Day tests were used to determine homogeneity between the originator biologic-biosimilar pair RORs for the same AE. RESULTS: Total numbers of AEs for all studied biosimilars increased after marketing. More AE reports were from female patients for all of the studied drugs. More AEs for originator biologics and filgrastim biosimilar were reported by health professionals, while the highest proportion of reports came from consumers for pegfilgrastim and epoetin alpha biosimilars (29% and 44.1%, respectively). Signals of disproportionate reporting in serious AEs were detected for a pegfilgrastim biosimilar (Fulphila®) compared to its originator biologic. CONCLUSION: Our findings support the similarity in the signals of disproportionate reporting between cancer supportive care originator biologics and biosimilars, except for Fulphila®.