Revitalizing oncology medications access in Saudi Arabia: Current challenges and recommendations by the Saudi Oncology Pharmacy Assembly.

BACKGROUND: Cancer care is posing immense challenges to healthcare systems globally. Advances in screening, monitoring, and treating cancer improved patient outcomes and survival rates yet amplified the disease burden. Multiple barriers might impede early access to innovative therapies. We thoroughly examined the current challenges in oncology medication access in Saudi Arabia and provided consensus recommendations to revitalize the process. METHODS: A focus group discussion was conducted. Expert healthcare providers (pharmacists and physicians) were invited to participate based on prespecified criteria. The research team conducted a qualitative analysis of the discussion to identify themes and formulate recommendations. RESULTS: Fourteen experts were equally distributed into two groups, limiting the number in each group to 7. Pharmacists were 12 (∼86%), and physicians were 2 (∼14%). Ten were practicing in governmental hospitals, four representing different sectors; regulatory bodies, including Ministry of Health, National Unified Procurement Company, and Saudi Food and Drug Authority. Five themes were identified: national cancer burden, local data availability, pharmacoeconomic evaluation, patients reported outcomes, administration, and procurement. Consensus recommendations were formulated to optimize the formulary management process, enabling informed decision-making and facilitating early medication access for cancer patients. CONCLUSIONS: The formulary management process can be enhanced by addressing the national cancer burden, promoting local data availability, conducting pharmacoeconomic evaluations, focusing on patient outcomes, and improving administration and procurement procedures. Implementing these recommendations can improve access to oncology medications and improve patient care outcomes in Saudi Arabia.

Cost-effectiveness of Favipiravir in moderately to severely ill COVID-19 patients in the real-world setting of Saudi arabian pandemic referral hospitals.

Purpose: We aimed to evaluate the cost effectiveness of Favipiravir treatment versus standard of care (SC) in moderately to severely ill COVID-19 patients from the Saudi healthcare payer perspective. Methods: We used the patient-level simulation method to simulate a cohort of 415 patients with moderate to severe COVID-19 disease who were admitted to two Saudi COVID-19 referral hospitals: 220 patients on Favipiravir and 195 patients on SC. We estimated the incremental cost-effectiveness ratio (ICER) of Favipiravir versus SC in terms of the probability to be discharged alive from hospital and the mean time in days to discharge one patient alive. The model was performed twice: first, using unweighted, and second, using weighted clinical and economic data. Weighting using the inverse weight probability method was performed to achieve balance in baseline characteristics. Results: In the unweighted model, base case (probabilistic) ICER estimates favored Favipiravir at savings of Saudi Riyal (SAR)1,611,511 (SAR1,998,948) per 1% increase in the probability of being discharged alive. As to mean time to discharging one patient alive, ICERs favored Favipiravir at savings of SAR11,498 (SAR11,125). Similar results were observed in the weighted model with savings using Favipiravir of SAR1,514,893 (SAR2,453,551) per 1% increase in the probability of being discharged alive, and savings of SAR11,989 (SAR11,277) for each day a patient is discharged alive. Conclusion: From the payer perspective, the addition of Favipiravir in moderately to severely ill COVID-19 patients was cost-savings over SC. Favipiravir was associated with a higher probability of discharging patients alive and lower daily spending on hospitalization than SC.

Health-related quality of life of breast and colorectal cancer patients undergoing active chemotherapy treatment: Patient-reported outcomes.

PURPOSE: We sought to explore the Health-Related Quality of Life (HRQoL) of Breast Cancer (BC) and Colorectal Cancer (CRC) patients receiving active chemotherapy. METHODS: A cross-sectional study was conducted among a convenient sample of BC and CRC patients between May 2018 and June 2019. HRQoL was measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B; 36 items, score range 0-144)) and the Functional Assessment of Cancer Therapy-Colon (FACT-C; 34 items, score range 0-136) scales. Both scales measured Physical Well-Being (PWB), Social Well-Being (SWB), emotional well-being, Functional Well-Being (FWB), and an additional disease-specific HRQoL items. RESULTS: A total of 209 BC and 159 CRC patients were included, with a mean age 49.73 ± 10.41 and 55.38 ± 11.35 years, respectively. 110 (52.6%) of BC and 86 (54.1%) CRC patients were dependent on caregivers, and 115 (55%) of BC and 92 (57.9%) CRC patients slept > 7 h/night. Reported HRQoL mean scores of BC (FACT-B) and CRC (FACT-C) were 85.53 ± 14.81 and 87.69 ± 20.21, respectively. For BC, the PWB score of patients aged >49 years (postmenopausal) was statistically significantly (p = 0.013) worse than those aged ≤49 years (premenopausal). Patients dependent on caregivers had statistically significant better PWB and worse EWB (p = 0.041; p = 0.027, respectively). CRC patients' dependent on caregivers had better statistically significant differences scoring in FACT-C (p = <0.001), PWB (p = 0.001), EWB (p = <0.001), and FWB (p = 0.001). CONCLUSION: In this study, BC and CRC patients who received active chemotherapy were more likely to have poor HRQoL. BC and CRC HRQoL should be addressed early and continuously, to limit their effects on treatment plan.

Use of Thrombopoietin Receptor Agonists in Pregnancy: A Review of the Literature.

The management of immune thrombocytopenic purpura (ITP) involves several lines of therapy such as corticosteroids and intravenous immunoglobulin. With the emergence of novel therapies such as thrombopoietin receptor agonists (TPO-RAs), there has been a shift in treatment modalities. Eltrombopag and romiplostim have proven to be effective in the management of ITP through clinical studies, but their safety in pregnancy remains uncertain. The purpose of the study is to review the literature to evaluate the safety of TPO-RAs in pregnant women. Ten case reports and a cohort study pertaining to the use of TPO-RAs in pregnancy were obtained. According to the reported cases and prospective study, the use of eltrombopag and romiplostim appears to be relatively safe in the first, second, and third trimesters, as there were no reported congenital malformations. Low fetal birth weight has been observed following the administration of eltrombopag during the second trimester, whereas preterm birth has occurred following the administration of eltrombopag in the third trimester. Eltrombopag and romiplostim seem relatively safe. Further studies are necessary to clarify their safety during pregnancy.

Effectiveness and safety of favipiravir compared to supportive care in moderately to critically ill COVID-19 patients: a retrospective study with propensity score matching sensitivity analysis.

INTRODUCTION: Favipiravir is a repurposed drug to treat coronavirus 2019 (COVID-19). Due to a lack of available real-world data, we assessed its effectiveness and safety in moderately to critically ill COVID-19 patients. METHODS: This retrospective study was conducted in two public/specialty hospitals in Saudi Arabia. We included patients ≥18 years) admitted April-August 2020 with confirmed SARS-CoV-2 diagnosed by real-time polymerase chain reaction (RT-PCR) from nasopharyngeal swab. Patients received either favipiravir (1800 mg or 1600 mg twice daily loading dose, followed by 800 mg or 600 mg twice daily) or supportive-care treatment. Patients were excluded if they were outside the study period, classified as having a mild form of the disease per WHO criteria, or had an incomplete patient file. Kaplan-Meier (KM) models were used to estimate median time to discharge. Discharge ratios, progression to mechanical ventilation, and mortality outcomes were estimated across the severity spectrum using Cox proportional-hazards models. As a sensitivity analysis, we performed propensity score-matching (PSM) analysis. RESULTS: Overall, median time to discharge was 10 days (95%CI = 9-10) in the favipiravir arm versus 15 days (95%CI = 14-16) in the supportive-care arm. The accelerated discharge benefit was seen across the COVID-19 spectrum of severity. The adjusted discharge ratio was 1.96 (95%CI = 1.56-2.46). Progression to mechanical ventilation was slower with favipiravir (HRadj = 0.10, 95%CI = 0.04-0.29). There was no significant effect on mortality (HRadj = 1.56, 95%CI = 0.73-3.36). There was a statistically non-significant trend toward worse outcomes in the critical category (HRadj = 2.80, 95%CI = 0.99-7.89). Age was an independent risk factor for mortality in mechanically ventilated patients. PSM analyses confirmed these findings. CONCLUSION: Favipiravir was associated with clinical benefits, including accelerated discharge rate and less progression to mechanical ventilation; however, no overall mortality benefits were seen across the severity spectrum.