Economic Evaluation of Three BRAF + MEK Inhibitors for the Treatment of Advanced Unresectable Melanoma With BRAF Mutation From a US Payer Perspective.

BACKGROUND: The combinations of BRAF + MEK inhibitors-encorafenib (ENC) + binimetinib (BIN), cobimetinib (COB) + vemurafenib (VEM), and dabrafenib (DAB) + trametinib (TRA)-are recommended for the treatment of BRAF-mutated advanced melanoma. OBJECTIVE: To assess the cost-effectiveness and cost-utility of ENC + BIN versus COB + VEM versus DAB + TRA from a US payer perspective. METHODS: A Markov model was constructed to simulate a hypothetical cohort over a time horizon of 10 years. The overall survival (OS) and progression-free survival (PFS) curves were independently digitized from a randomized controlled trial for ENC + BIN and fitted using R software. Published and indirectly estimated hazard ratios were used to fit OS and PFS curves for COB + VEM and DAB + TRA. Costs, life-year gains, and quality-adjusted life years (QALYs) associated with the 3 treatment combinations were estimated. A base case analysis and probabilistic sensitivity analysis (PSA) were conducted to estimate the incremental cost-utility ratio (ICUR). A discount rate of 3.5% was applied on cost and outcomes. RESULTS: The ENC + BIN versus COB + VEM comparison was associated with an ICUR of $656 233 per QALY gained. The ENC + BIN versus DAB + TRA comparison was associated with an ICUR of $3 135 269 per QALY gained. The DAB + TRA combination dominated COB + VEM. The base case analysis estimates were confirmed by the PSA estimates. ENC + BIN was the most cost-effective combination at a high willingness-to-pay (WTP) threshold of $573 000 per QALY and $1.5 million/QALY when compared to COB + VEM and DAB + TRA, respectively. CONCLUSION AND RELEVANCE: Given current prices and acceptable WTP thresholds, our study suggests that DAB + TRA is the optimum treatment. In this study, ENC + BIN was cost-effective only at a very high WTP per QALY threshold.

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.

Evaluating Six Commercially Available Closed-System Drug-Transfer Devices Against NIOSH's 2015 Draft Vapor Protocol.

Purpose: In 2015, the National Institute for Occupational Safety and Health (NIOSH) published a draft vapor containment protocol to quantitatively evaluate combined liquid, aerosol, and vapor containment performance of commercially available closed-system drug-transfer devices (CSTDs) that claim to be effective for gas/vapor containment within a controlled test environment. Until the release of this proposed protocol, no standard method for evaluating airtightness of CSTDs existed. The aim of this study was to evaluate six commercially available CSTDs utilizing NIOSH draft protocol methodology to evaluate vapor containment under a robust vapor challenge. Methods: In this study, six commercially available CSTDs were tested utilizing draft NIOSH vapor containment protocol methodology to simulate drug compounding and administration using 70% isopropyl alcohol (IPA) as the challenge agent. All device manipulations were carried out in an enclosed test chamber. A Miran sapphIRe gas analyzer was used to detect IPA vapor levels that escaped the device. Study test included the two tasks designated by the NIOSH protocol, with additional steps added to the evaluation. Tasks were repeated 10 times for each device. Results: Only three of the six tested CSTDs (Equashield®, HALO®, and PhaSealTM) had an average IPA vapor release below the quantifiable performance threshold (1.0 ppm) for all tasks performed. This value was selected by NIOSH to represent the performance threshold for successful containment. The remaining three CSTDs had vapor release above 1 ppm at various times during the IPA manipulation process. Conclusion: Equashield®, HALO®, and PhaSealTM devices tested met the 2015 NIOSH protocol quantifiable performance threshold, functioning as a truly closed system. Quantifiable effective data may be useful in product selection.

The economic impact of tobacco smoking and secondhand smoke exposure in Jordan: estimating the direct and indirect costs.

AIM: To quantify the economic burden associated with tobacco smoking among smokers aged 30-69 years, and second-hand smokers (SHS) aged 15-69 years in Jordan. MATERIALS AND METHODS: A prevalence-based analysis was conducted in alignment with the Economics of Tobacco Toolkit developed by the WHO. The time-horizon of the analysis was one year (2019). Direct and indirect costs were estimated using data from the 2019 Global Burden of Diseases study. The analysis targeted the Jordanian population of smokers aged 30-69 years, and SHS aged 15-69 years. Adjustments were applied for age, gender, and smoking-related diseases. Direct costs were estimated using the smoking-attributable fraction (SAF) and national health expenditures. Indirect costs were divided into morbidity and mortality components. A discount rate of 3.0% and an annual productivity growth rate of 1.0% were assumed in modelling future economic losses. A sensitivity analysis was conducted on the lower and upper estimates of data used in this study. RESULTS: The cost of tobacco smoking and SHS exposure was estimated at US$2,108 million (95% confidence interval [CI] = US$2,003 million-US$2,245 million). This represents 4.7% (95%CI = 4.5%-5.0%) of national gross domestic product (GDP). Direct costs accounted for 3.1% of national GDP. Tobacco smoking accounted for 85.0% of total cost and SHS exposure accounted for 15.0% of total cost. Direct costs accounted for 67.0% of total cost, while indirect morbidity and mortality costs accounted for 9.0% and 24.0% of total cost, respectively. Non-communicable diseases accounted for 96.0% of total direct costs compared to communicable diseases (4.0% of total direct costs). CONCLUSIONS: Smoking cessation interventions such as raising taxes on cigarettes, protecting people from tobacco smoke, warning labels, plain packaging, and bans on advertising, are crucial for controlling national expenditures for treating smoking-related diseases and for averting future economic losses.

In this work, we aimed to calculate the annual economic impact of tobacco smoking in Jordan in 2019. We used the World Health Organization toolkit methodology to estimate both the direct and indirect costs associated with smoking nationally. Our focus was on Jordanian smokers aged 30-69 years and people exposed to second-hand smoke aged 15­69 years. Direct costs were calculated using epidemiological data on the proportion of health expenditures attributable to smoking and the national health expenditures. Indirect costs were divided into two components: morbidity and mortality. We also projected future economic losses, assuming a 3.0% discount rate and a 1.0% annual growth rate of productivity. Our study estimated that the cost of smoking and exposure to second-hand smoke was US$2,108 million (US$2,003 million-US$2,245 million), which accounted for 4.7% (4.5%-5.0) of Jordan's gross domestic product. The majority of the cost (85.0%) was due to direct smoking, while 15.0% was due to exposure to second-hand smoke. Direct costs made up 67.0% of the total cost, while the costs related to morbidity and mortality accounted for 9.0% and 24.0% of the total cost, respectively. In conclusion, our study emphasized that tobacco smoking has a significant economic impact on Jordan. Therefore, it is crucial to implement effective smoking cessation programs, such as enforcing existing anti-tobacco policies and raising taxes. These measures can help control national expenditures for treating smoking-related diseases and prevent future economic losses.

The status and preparation for the next decade of biosimilars in the Middle Eastern and North African region.

INTRODUCTION: Little is known about the status and the future potential of biosimilars in the Middle East and North Africa (MENA) region. AREAS COVERED: This perspective provides insights into the current regulatory landscape of some MENA countries, currently available biosimilars, the potential of biosimilars in the next decade, and challenges to overcome. EXPERT OPINION: Given the economic and demographic heterogeneity across the MENA countries, biosimilars could reduce significant economic unmet needs in these countries. In the next decade, biosimilars may witness higher approval rates and market share over their originators in the MENA countries. We argue that the regulatory bodies in the MENA countries should adopt the new policies of the FDA, the EMA, and the WHO, that aim to ease the biosimilar approval process. These policies are to adopt technology in the process of approval; engage health technology assessment bodies in price assessment; provide educational materials to increase awareness among providers, patients, and payers. Further, MENA countries should upgrade the external-reference pricing systems to more sophisticated ones that consider the heterogeneity in economics and needs.

Cost-efficiency analysis and expanded treatment access modeling of conversion to rituximab biosimilars from reference rituximab in Jordan.

AIM: To assess the cost-efficiency and expanded access of three rituximab biosimilars versus the reference rituximab from the perspective of the Jordanian national health payer. METHODS: A 1-year cost-efficiency and expanded access model of conversion from reference rituximab (Mabthera) to the approved biosimilars (Truxima, Rixathon, and Tromax) to assess five metrics: total annual cost to treat a hypothetical patient; head-to-head cost comparison; changes in patients' access to rituximab; number-needed-to-convert (NNC) to provide an additional 10 patients access to a rituximab treatment; and relative amount of Jordanian Dinar (JOD) spent on rituximab options. The model included rituximab doses at 100 mg/10 ml and 500 mg/50 ml and considered both cost-saving and cost-wastage scenarios. Costs of treatments were based on the fiscal year 2022 tender prices received by the Joint Procurement Department (JPD). RESULTS: Rixathon was associated with the lowest average annual cost per patient (JOD2,860) across all six indications among all rituximab comparators, followed by Truxima (JOD4,240), Tromax (JOD4,365) and reference Mabthera (JOD11,431). The highest percentage of patient access to rituximab treatment (321%) was achieved when switching patients from Mabthera to Rixathon in the RA and PV indications. At four patients, Rixathon was associated with the lowest NNC to provide an additional 10 patients access to rituximab treatment. For each JOD1 spent on Rixathon, an additional JOD3.21 must be spent on Mabthera, an additional JOD0.55 on Tromax, and an additional JOD0.53 on Truxima. CONCLUSION: Rituximab biosimilars were associated with cost savings in all approved indications in Jordan compared to reference rituximab. Rixathon was associated with the lowest annual cost, the highest percentage of expanded patient access for all six indications, and the lowest NNC providing 10 additional patients with access.

Gaps in pharmaceutical care for patients with mental health issues: A cross-sectional study.

BACKGROUND: Mental health issues such as depression and anxiety are often underdiagnosed and undertreated. Medications are a primary method of managing mental health problems, and pharmacists therefore have a vital role in supporting patients and providing them with information about the safety and efficacy of mental health medications. However, the potential role of pharmacists in managing mental health issues in Jordan has not been well established. AIM: This study aimed to assess Jordanian pharmacists' attitudes and actual practices related to the provision of mental health services. METHOD: This was an exploratory cross-sectional study that used a self-report questionnaire among a convenience sample of 347 pharmacists in Amman, the capital of Jordan. RESULTS: The participating pharmacists had positive attitudes towards providing care for patients with mental health problems. However, their actual practices did not resonate with their enthusiasm, particularly in terms of the long-term follow-up of disease symptoms and medication side effects and adherence. The participating pharmacists showed an eagerness to collaborate with their colleagues, but their level of actual cooperation was lower than desired. The most reported barrier to providing care for patients with mental health problems was the lack of education on mental health issues (71.5%), followed by the lack of privacy in pharmacy settings (53.9%). CONCLUSION: To be effectively involved in the provision of care to mental health patients, pharmacists should receive adequate education/training related to mental health issues, and pharmacies should be redesigned to provide private areas for patient counseling.

Cost-effectiveness of palonosetron and dexamethasone-based triple and quadruple regimens in preventing highly emetogenic chemotherapy-induced nausea and vomiting.

OBJECTIVE: Cost-effectiveness analyses that consider all currently used antiemetics in the case of emetogenic chemotherapy-induced nausea and vomiting (CINV) have not been performed yet. We aim to compare the cost-effectiveness of olanzapine (OLA), or/and neurokinin-1 receptor antagonists (NK-1-RAs), in combination with palonosetron (PAL) and dexamethasone (DEX) in preventing highly emetogenic CINV. METHODS: Two decision analytic models were constructed. The first model was based on overall complete response (CR); the second model was based on rate of absence of nausea. Four antiemetic regimens PAL + DEX, NK-1-RAs + PAL + DEX, OLA + PAL + DEX, and PAL + NK-1-RA + DEX + OLA were compared in terms of cost, overall CR and rate of absence of nausea. Base case incremental cost-effectiveness ratio (ICER) estimates were calculated. The study was from the US payer perspective. RESULTS: In terms of CR, the PAL + NK-1-RA + DEX + OLA was associated with the highest gains in the percentage of CR among all treatment regimens at base case ICERs of $4220 versus PAL + DEX, $4656 versus NK-1-RA + PAL + DEX, $16,471 versus OLA + PAL + DEX. In term of rate of absence of nausea, the PAL + NK-1-RA + DEX + OLA was associated with the highest rate of absence of nausea among all the treatment regimens at base case ICERs of $2291 versus PAL + DEX, $1304 versus NK-1-RA + PAL + DEX, $2657 versus OLA + PAL + DEX. CONCLUSION: from an economic perspective, our study revealed that whether to use overall CR or/and rate of absence of nausea as determinants in the antiemetic decision for the CINV patients, the CR-based-, and rate of absence of nausea-based cost-effectiveness analyses, showed negotiable ICER estimates for the treatment PAL + NK-1-RA + DEX + OLA over the combinations PAL + DEX, NK-1-RA + PAL + DEX, and OLA + PAL + DEX regimens.

Perspectives of the community in the developing countries toward telemedicine and pharmaceutical care during the COVID-19 pandemic.

Background: Pharmaceutical care (PC) services have expanded in recent years, resulting in improved patient outcomes. However, such PC services are currently available for free in the majority of Arabic countries. During the coronavirus disease (COVID-19) pandemic, telemedicine is especially beneficial since it allows for continuity of care while allowing for social distancing and minimizing the risk of infection. Objective: To assess the community's attitude, opinion, and willingness to pay for telemedicine and PC services during COVID-19 pandemic, as well as to create a website provision for telemedicine and PC services. Methods: This cross-sectional study was conducted, over five months (December 2020- April 2021), among the general population in Arabic countries, excluding pharmacists, physicians, and pharmacy students. Results: A total of 1717 participants were involved, most of them were from Jordan (52.2%) and Iraq (24.8%). Sixty two percent of participants seek pharmacists' advice whenever they have any medication changes and 45.1% of the participants agreed with the idea of paying pharmacists to decrease medication errors. Interestingly, 89.5% of participants encouraged the idea of creating a website that provides a PC, and 35.5% of them would pay for it. The failure to document the medical information of the patients had most applicants' agreement as a reason of medical errors (M=4.17/5, SD=0.787). More than three-quarters of participants agreed that creating a database containing the patients' medical information will reduce medical errors. Conclusion: From a patients' perspective, this study suggests a large patient need for expanding PC services in Arabic countries and introduces a direct estimate of the monetary value for the PC services to contribute to higher savings. The majority of participants supported the idea of creating a website provision of telemedicine and PC services, and a considerable proportion of them agreed to pay for it.

Perspectives of the community in the developing countries toward telemedicine and pharmaceutical care during the COVID-19 pandemic

Background: Pharmaceutical care (PC) services have expanded in recent years, resulting in improved patient outcomes. However, such PC services are currently available for free in the majority of Arabic countries. During the coronavirus disease (COVID-19) pandemic, telemedicine is especially beneficial since it allows for continuity of care while allowing for social distancing and minimizing the risk of infection. Objective: To assess the community’s attitude, opinion, and willingness to pay for telemedicine and PC services during COVID-19 pandemic, as well as to create a website provision for telemedicine and PC services. Methods: This cross-sectional study was conducted, over five months (December 2020– April 2021), among the general population in Arabic countries, excluding pharmacists, physicians, and pharmacy students. Results: A total of 1717 participants were involved, most of them were from Jordan (52.2%) and Iraq (24.8%). Sixty two percent of participants seek pharmacists’ advice whenever they have any medication changes and 45.1% of the participants agreed with the idea of paying pharmacists to decrease medication errors. Interestingly, 89.5% of participants encouraged the idea of creating a website that provides a PC, and 35.5% of them would pay for it. The failure to document the medical information of the patients had most applicants’ agreement as a reason of medical errors (M=4.17/5, SD=0.787). More than three-quarters of participants agreed that creating a database containing the patients’ medical information will reduce medical errors. Conclusion: From a patients’ perspective, this study suggests a large patient need for expanding PC services in Arabic countries and introduces a direct estimate of the monetary value for the PC services to contribute to higher savings. The majority of participants supported the idea of creating a website provision of telemedicine and PC services, and a considerable proportion of them agreed to pay for it. (AU)