Pill-burden and its association with treatment burden among patients with advanced stages of chronic kidney disease.

Introduction: Chronic kidney disease (CKD) is associated with multimorbidity and high treatment burden. Pill-burden is one component of the overall treatment burden. However, little is known about its magnitude and contribution to the overall treatment burden among patients with advanced stages of CKD. This study aimed to quantify the magnitude of pill-burden in dialysis-dependent vs. non-dialysis-dependent advanced-stage CKD patients and its association with treatment burden. Methods: This was a cross-sectional study for the assessment of pill-burden and treatment burden among non-dialysis and hemodialysis (HD)-dependent CKD patients. Pill-burden was quantified as "number of pills/patient/week" through electronic medical record, while treatment burden was assessed using the "Treatment Burden Questionnaire (TBQ)". Furthermore, oral and parenteral medication burden was also quantified. Data were analyzed using both descriptive and inferential analysis, including Mann - Whitney U test and two-way between groups analysis of variance (ANOVA). Results: Among the 280 patients included in the analysis, the median (IQR) number of prescribed chronic medications was 12 (5.7) oral and 3 (2) parenteral medications. The median (IQR) pill-burden was 112 (55) pills/week. HD patients experienced higher pill-burden than non-dialysis patients [122 (61) vs. 109 (33) pills/week]; however, this difference did not reach statistical significance (p = 0.81). The most commonly prescribed oral medications were vitamin D (90.4%), sevelamer carbonate (65%), cinacalcet (67.5%), and statins (67.1%). Overall, patients who had high pill-burden (≥112 pills/week) had significantly higher perceived treatment burden compared to low pill-burden patients (<112 pills/week) [47(36.2) vs. 38.5(36.7); p = 0.0085]. However, two-way ANOVA showed that dialysis status is the significant contributor to the treatment-burden in the high overall pill-burden group (p < 0.01), the high oral-medication-burden group (p < 0.01), and the high parenteral-medication-burden group (p = 0.004). Conclusions: Patients with advanced CKD experienced a high pill-burden, which increases the treatment burden; however, the dialysis status of the patient is the main factor affecting the overall treatment burden. Future intervention studies should target this population with an aim to reduce polypharmacy, pill-burden, and treatment burden, which may ultimately improve CKD patients' quality of life.

Comparative cost-effectiveness analysis of CDK4/6 inhibitors in the first-line treatment of HR-positive and HER2-negative advanced breast cancer: a Markov's model-based evaluation.

Introduction: CDK4/6 inhibitors are the first-line treatment for HR+/HER2- advanced breast cancer. Despite their clinical benefit, they can increase healthcare expenditure. To date, there is no thorough comparison among the three approved CDK4/6 inhibitors in terms of their cost-effectiveness. Objective: To investigate and compare the cost-effectiveness of CDK4/6 inhibitors in combination with letrozole as a first-line treatment for advanced breast cancer with hormonal-receptor-positivity and HER-2-negativity versus one another and versus letrozole monotherapy. Methods: A 10-year within-cycle-corrected Markov's model was employed from the healthcare payer perspective. Costs were obtained from the National Center for Cancer Care and Research (NCCCR) in Qatar. Utilities and transition probabilities were calculated from published landmark trials of PALOMA-2, MONALEESA-2, MONARCH-3, PO25, and other relevant literature. Costs, measured in Qatari Riyal (QAR), and effectiveness, measured in quality-adjusted-life-years (QALYs), were incremented and the incremental cost-effectiveness ratio (ICER) was compared to a willingness-to-pay threshold (WTP) of 1.5 Qatari GDP (448,758 QAR). A deterministic sensitivity analysis was implemented to account for uncertainties. Results: Ribociclib was the most effective option, generating 4.420 QALYs, followed by palbociclib (4.406 QALYs), abemaciclib (4.220 QALYs), then letrozole monotherapy (2.093 QALYs). As for cost-effectiveness, ribociclib dominated palbociclib. However, it was not cost-effective compared to abemaciclib (ICER=1,588,545 QAR/QALY). Ribociclib remained dominant over palbociclib with all uncertainties. The base-case conclusion of ribociclib versus abemaciclib remained robust over all uncertainties. Conclusion: From the healthcare payer perspective in Qatar, ribociclib is the most effective CDK4/6 inhibitor. It was dominant over palbociclib in terms of cost-effectiveness; however, it was not cost-effective compared to abemaciclib at current prices.

The effectiveness and safety of palbociclib and ribociclib in stage IV HR+/HER-2 negative breast cancer: a nationwide real world comparative retrospective cohort study.

Introduction: Palbociclib and ribociclib are indicated in the first-line treatment of hormonal receptor-positive HER-2 negative (HR+/HER2- negative) advanced breast cancer. Although randomized-controlled trials (RCTs) proved their clinical efficacy, there are no observational studies yet to validate the clinical findings in the real-world. Therefore, this study aimed to evaluate and compare the clinical effectiveness and safety profiles of palbociclib and ribociclib in Qatar. Materials and methods: A retrospective observational study was conducted on HR+/HER-2-negative stage-IV breast cancer patients receiving palbociclib or ribociclib in the state of Qatar. Clinical data were collected from the National Center for Cancer Care and Research (NCCCR) in Qatar using Cerner®. Primary outcomes were progression-free-survival (PFS) and overall-survival (OS) generated by Kaplan-Meier curves. Moreover, safety profiles of both two treatments were evaluated. Results: The data from 108 patients were included in the final analysis. There was no statistically significant difference in PFS between the palbociclib and ribociclib groups; PFS was 17.85 versus 13.55 months, respectively(p> 0.05). Similarly, there was no statistically significant difference in OS between the two medications, 29.82 versus 31.72 months, respectively(p>0.05). Adverse events were similar between the two groups. Neutropenia was the most common side effect in the study population accounting for 59.3% of the patients. Conclusions: Therefore, both treatments have similar efficacy and safety profiles. Further research on a larger-scale population and longer follow-up period is recommeneded.

Cost-Effectiveness and Cost-Utility of Palbociclib versus Ribociclib in Women with Stage IV Breast Cancer: A Real-World Data Evaluation.

Palbociclib and ribociclib are indicated in the first-line treatment of hormonal-receptor-positive HER-2 negative (HR+/HER-2 negative) advanced breast cancer. Despite their clinical benefit, they can increase healthcare expenditure. Yet, there are no comparative pharmacoeconomic evaluations for them in developing countries, the Middle East, or Gulf countries. This study compared the cost-effectiveness of palbociclib and ribociclib in Qatar. A 10-year within-cycle-corrected Markov's model was developed using TreeAge Pro® software. The model consisted of three main health states: progression-free (PFS), progressed-disease (PD), and death. Costs were obtained from the actual hospital settings, transition probabilities were calculated from individual-patient data, and utilities were summarized from the published literature. The incremental cost-effectiveness ratio (ICER) and the incremental cost-utility ratio (ICUR) were calculated and compared to three gross-domestic-products per capita. Deterministic and probabilistic sensitivity analyses were performed. Ribociclib dominated palbociclib in terms of costs, life-years gained, and quality-adjusted life-years gained. The conclusions remained robust in the different cases of the deterministic sensitivity analyses. Taking all combined uncertainties into account, the confidence in the base-case conclusion was approximately 60%. Therefore, in HR+/HER-2 negative stage IV breast cancer patients, the use of ribociclib is considered cost-saving compared to palbociclib.

Assessment of Knowledge, Attitudes, and Readiness to Practice Regarding Disaster Medicine and Preparedness Among University Health Students.

OBJECTIVES: The aim of this study is to assess the knowledge (K), attitude (A), and readiness to practice (rP) levels regarding disaster medicine and preparedness among health profession students at Qatar University. METHODS: A survey-based study was carried out to assess medical, pharmacy, and health sciences students' KArP levels using pretested and validated questionnaire. Student's t-test, analysis of variance, correlation, and linear regression were used with an alpha level of 0.05. RESULTS: The difference in the mean KArP level between genders was not significant (P > 0.05). Students from the College of Health Sciences had significantly higher KArP levels than those from the College of Pharmacy (101.5 vs 90.0; P = 0.033). Overall, Qatari students had better knowledge, attitude, and readiness to practice scores and total KArP scores than non-Qatari students. Moreover, students who were born in Qatar also had better knowledge, attitude, and readiness to practice scores and total KArP scores than students who were born outside Qatar. Significant direct moderate correlations were found among the 3 KArP parameters (P < 0.001). Knowledge and attitudes were indicated to be significant predictors of readiness to practice (P < 0.001). CONCLUSIONS: Students from the health colleges at Qatar University have moderate disaster medicine preparedness.

Cost-effectiveness analyses of breast cancer medications use in developing countries: a systematic review.

BACKGROUND: Pharmacoeconomic evaluation is important for breast-cancer medications due to their high costs. To our knowledge, no systematic literature reviews of pharmacoeconomic studies for breast-cancer medication use are present in developing-countries. OBJECTIVES: To systematically review the existing cost-effectiveness evaluations of breast-cancer medication in developing-countries. METHODOLOGY: A systematic literature search was performed in PubMed, EMBASE, SCOPUS, and EconLit. Two researchers determined the final articles, extracted data, and evaluated their quality using the Quality of Health-Economic Studies (QHES) tool. The interclass-correlation-coefficient (ICC) was calculated to assess interrater-reliability. Data were summarized descriptively. RESULTS: Fourteen pharmacoeconomic studies published from 2009 to 2019 were included. Thirteen used patient-life-years as their effectiveness unit, of which 10 used quality-adjusted life-years. Most of the evaluations focused on trastuzumab as a single agent or on regimens containing trastuzumab (n = 10). The conclusion of cost-effectiveness analysis varied among the studies. All the studies were of high quality (QHES score >75). Interrater reliability between the two reviewers was high (ICC = 0.76). CONCLUSION: In many studies included in the review, the use of breast-cancer drugs in developing countries was not cost-effective. Yet, more pharmacoeconomic evaluations for the use of recently approved agents in different disease stages are needed in developing countries.