Economic Opportunity: Brand Drugs vs. Generic Drugs

Outlines: * Pharmaceutical markets in the Middle East region are attractive *The high spending on branded drugs is unsustainable *Publicly funded health systems – increased pressure to reduce rising drug budgets *Originator (NDA) vs Generic (ANDA) review process requirements 20-90% cheaper generics * The generic drug industry is responsible for making more affordable and cost-saving medicine

Cost-Benefit Analysis of Genotype-Guided Interruption Days in Warfarin Pre-Procedural Management

Warfarin is commonly used in thromboembolic conditions. Warfarin interruption represents a significant challenge in pre-operative warfarin management as it is associated with major consequences. Genetics polymorphism demonstrated to be a significant predictor of the required days of warfarin interruption. This study sought to assess the economic benefit of implementing a pharmacogenetic-guided approach in the preprocedural warfarin management. From the hospital's perspective, a cost-benefit analysis was conducted based on a 1-year decision-analytic follow-up model of the economic implications of using a pharmacogenetic algorithm vs standard of care in pre-operative warfarin management in the Hamad Medical Corporation, Qatar. The benefit of the interventional algorithm was based on estimated reduction in the probabilities of clinical events and their cost, added to the avoided cost because of canceled procedures. The cost of the algorithm was the cost of the genotyping assay. The model event probability inputs were extracted from major literature clinical trials, and the setting-specifc and cost inputs were locally obtained. The model was based on a multivariate analysis at its base case. As per 10.3% prevalence of genetic variants, 82% bridging, and a calculated 20% optimization in the preparative period of warfarin management, the benefit to cost ratio was 4.0 in favor genotype-guided approach. This positive benefit to cost ratio was maintained in 100% of the simulated study cases. Sensitivity analyses confirmed the robustness and generalizability of the study conclusion. A pharmacogenetic- guided pre-operative warfarin interruption management is a cost-beneficial approach in the Qatari practice.This work was supported by Hamad Medical Corporation MRC [grant number 1698/2017 ]

Pharmacoeconomic Evaluations of Oral Anticancer Agents. Thematic Systematic Review

Background: Around 14.1 million new cancer cases and 8.2 million deaths caused by cancer were reported in 2012, expected to rise up to 22 million within the next 2 decades. The parenteral route (intravenous dosage form) has been the most common administration route for chemotherapeutic agents, which is associated with the need for hospitalization and a range of significant adverse drug reaction. A new generation of chemotherapies that is orally administered has been introduced to practices as a superior and more efficient therapeutic alternative. Oral anticancer drugs (OACDs) have shown to be eliminating the need for hospitalization, decreasing the rate of adverse drug reactions and, ultimately, improving patients' quality of life. Economically, this translates into reduction in inpatient hospitalization costs, including several of the associated costs, such as the cost of treating side effects. A disadvantage of OACDs however, is the increased acquisition costs as compared to those for the intravenously administered alternatives. This resulted into resistance to include OACDs by several international insurance schemes and drug formulary practices, including in Qatar. Objectives: The current project sought to analyze the medical literature in relation to published economic evaluations (pharmacoeconomics) of OACDs, especially as compared to the parenteral alternatives. This will identify the decision analytic modeling conducted as well as the variety of methods used. Strengths and weaknesses of study designs will be determined, including gaps in knowledge. Methodology: A thematic systematic review was conducted using the search engines: PubMed, Medline, EconLit, Embase and Economic Evaluation Database. The following 3 categories were considered: (i) therapy (chemotherapy [Mesh]); (ii) dosage form (oral [Mesh]); and (iii) research design (economics [Mesh] OR cost-benefit analysis [Mesh]). These included full-text, English articles incorporating comparative economic evaluations of oral chemotherapies. Excluded studies were: non-comparative, non-economic based models, of secondary indications (not cancer), and/or reviews. This process was followed by two stages of manual exclusion; based on title/abstract content and, then, the full-text article content. A data extraction form was developed and pilot tested for the purpose of data collection. Article inclusion and data collection was conducted twice, each by a different investigator. Included articles were finally summarized according to methodological themes of interest. Results: A total of 235 records were identified. After screening and removing duplicates, only 18 studies were deemed eligible study inclusion. It was found that the pharmacoeconomics evaluations were mostly of cost-utility analyses (13 out of 18), measuring cost per quality adjusted life years (QALY) gained, and from the payer perspective (15 out of 18). Primary sources of clinical and economic data were randomized clinical trials, expert panels and medical charts. Other sources included medicine databases, reimbursement schedules, drug policies and price lists, treatment guidelines, case reports and patient interviews. In 13 out of 18 cases, dominance status was reported in favor of OACDs, in relation to cost and/or clinical effect. Decision analytic modeling was used in the majority of studies, mostly constituting Markov modeling for the simulation of life long use of drugs. Sensitivity analyses were conducted in most studies, mostly constituting one-way sensitivity analysis to ensure robustness of study results. The types of cancers, where the effect of OACDs was studied, were the metastatic renal carcinoma, gastrointestinal tumors, colon cancer, chronic myeloid leukemia and non-small cell lung cancer. Most included articles were published during the last seven years. Most studies were conducted in the UK, US and Europe, while none were conducted in Australia or the Middle East. Conclusion: This is first systematic review of the economic methods used in the evaluation of OACDs. There seems to be a recent increasing interest of this type of research, whereby the QALYs measurement is of priority for the decision making in relation to the comparative value of OACDs in practices. Most important, is that despite the higher acquisition cost, OACDs were demonstrated to be mostly superior over the parenteral alternatives. Furthermore, the decision analytic modeling, mostly constituting Markov modeling, is valued and enables a structured decision analyses of therapies. The pharmacoeconomics research is difficult to generalize, whereby published economic evaluations are locally specific, especially for the purpose of practical interpretation. The current review of literature proposes valuable methods for the local Qatari implementation and guidance of decision makers. This is most relevant to National Center for Cancer Care & Research (NCCCR), which is the only tertiary service provider of cancer therapy in Qatar, where confusion in relation to the use of oral chemotherapies exists, particularly the therapies vinorelbine and capacitabine.qscienc

Cost-Effectiveness Analysis of Out-Of-Hospital versus In-Hospital Extracorporeal Cardiopulmonary Resuscitation for Out-Hospital Refractory Cardiac Arrest

It has been speculated that out-of-hospital cardiac arrest (OHCA) patients’ survival might be improved by implementing extracorporeal cardiopulmonary resuscitation (ECPR) before arrival to hospital. Therefore, we sought to assess the cost-effectiveness of OH-ECPR versus in-hospital (IH)-ECPR in OHCA patients in Qatar. From the hospital perspective, a conventional decision-analytic model was constructed to follow up the clinical and economic consequences of OH-ECPR versus IH-ECPR in a simulated OHCA population over one year. The primary outcome was the survival at discharge after arrest as well as the overall direct healthcare costs of managing OHCA patients. The robustness of this model was evaluated via sensitivity analyses. The OH-ECPR yielded 16% survival at discharge after arrest compared to 7% with IH-ECPR, [risk ratio (RR)=0.91; 95% CI 0.79 to 1.06; P = 0.26]. Incorporating the uncertainty associated with this survival rate, and based on the estimated willingness to pay threshold in Qatar, the OH-ECPR was cost-effective with an incremental cost-effectiveness ratio of QAR 464,589 (USD 127,634). Sensitivity and uncertainty analyses confirmed the robustness of the study outcome. This is the first cost-effectiveness evaluation of OH-ECPR versus IH-ECPR in OHCA patients. OH-ECPR is potentially an economically acceptable resuscitative strategy in Qatar.Open access funding was provided by the Qatar National Library

Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial

Background: It had been reported that up to 37% of the adult male population smokes cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is key to reducing smoking-related diseases and deaths. Healthcare providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible healthcare providers and are uniquely situated to initiate behavior change among patients. Many studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist-delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. Methods/Design: A prospective, randomized, controlled trial is conducted at eight ambulatory pharmacies in Qatar. Participants are randomly assigned to receive an at least four-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 min of unstructured brief smoking cessation advice (emulating current practice) given by the pharmacist. Both groups are offered nicotine replacement therapy if feasible. The primary outcome of smoking cessation will be confirmed by an exhaled carbon monoxide test at 12 months. Secondary outcomes constitute quality-of-life adjustment as well as cost analysis of program resources consumed, including per case and patient outcome. Discussion: If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease the smoking burden. Trial registration: Clinical Trials NCT02123329.Qatar National Research Fund under its National Priorities Research Program (NPRP)

Comparative efficacy and safety among high-intensity statins. Systematic Review and Meta-Analysis

Aim: To summarize the evidence in terms of efficacy and safety of head-to-head studies of high-intensity statins regardless of the underlying population. Materials & methods: A systematic review and meta-analysis was conducted to summarize the effect sizes in randomized controlled trials and cohort studies that compared high-intensity statins. Results: Based on 44 articles, similar effectiveness was observed across the statins in reducing LDL levels from baseline. All statins were observed to have similar adverse drug reactions (ADRs), although higher dosages were associated with more ADRs. Based on a pooled quantitative analysis of atorvastatin 80 mg versus rosuvastatin 40 mg, rosuvastatin was statistically more effective in reducing LDL. Conclusion: This review further confirms that high-intensity statins reduce LDL by ≥50%, favoring rosuvastatin over atorvastatin. Additional data are needed to confirm the clinical significance on cardiovascular outcomes using real-world studies

Cost-Effectiveness of Non-Statin Lipid-Modifying Agents for Primary and Secondary Prevention of Cardiovascular Disease among Patients with Type 2 diabetes mellitus: A Systematic Review

Background: Non-statin therapies (NSTs) have been shown to provide additional benefits for cardiovascular risk reduction among patients with type 2 diabetes mellitus (T2DM), but their economic merits have not been confirmed. The objective of this systematic review is to evaluate the cost-effectiveness of NSTs for primary and secondary prevention of cardiovascular disease (CVD) in T2DM patients. 1 Methods: A literature search was systematically performed using MeSH terms (Table 1) from January 1990 to January 2021 in ten databases (e.g. MEDLINE, PubMed, and EconLit). Two reviewers independently screened the included studies that evaluated the cost-effectiveness of NSTs versus any comparator. Quality of Health Economic Studies (QHES) checklist was used for quality assessment. 2 Cost outputs were adapted to 2019 United States dollars (USD) to facilitate comparisons between studies. 3 Results: The search identified 21,182 records. Of which, 10,781 records were screened based on the title and abstract, and 185 articles based on the full text (Figure 1). After a full-text review, 12 studies were included in this study, where eight studies evaluated ezetimibe, four evaluated Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors, two evaluated fenofibrate, one evaluated nicotinic acid, and one evaluated extended-release niacin/laropiprant (ER-ERN/LRPT). Six out of eight studies considered ezetimibe plus statin to be a cost-effective therapy for patients with T2DM and with or without CVD, three out of four studies suggested that PCSK9 inhibitors were not cost-effective. Fenofibrate, nicotinic acid, and ER- ERN/LRPT were cost-effective. Based on QHES, the majority of economic evaluations had good quality of reporting. The ICERs were consistent in the majority of studies after adaptation to 2019 USD values. 1-3 Conclusion: The systematic review demonstrated that most cost-effectiveness studies considered NSTs to be cost-effective compared with standard care but not PCSK9 inhibitors for primary and secondary prevention of CVD in T2DM patients.qscienc

Cost-effectiveness analysis of dapagliflozin in addition to standard therapy in heart failure with reduced ejection fraction: A Qatari healthcare perspective

Background: Dapagliflozin has been shown to reduce the risk of heart failure hospitalization and cardiovascular mortality in patients with heart failure with reduced ejection fraction (HFrEF). 1,2 This work aims to determine the cost-effectiveness of dapagliflozin added to standard therapy versus standard therapy alone in patients with HFrEF, regardless of the presence or absence of type 2 diabetes mellitus (T2DM). Methods: A lifetime Markov model was constructed to compare the health outcomes and costs of dapagliflozin added to standard therapy versus standard therapy alone from a Qatari public healthcare perspective (Figure 1). 2 The cohort is comprised of HFrEF patients with left ventricular ejection fraction (LVEF) ? 40%, and New York Heart Association (NYHA) class II-IV with an average age of 65 years, based on Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure (DAPA-HF) trial (Table 1). 1,2 The model consisted of three health states: 'stable', 'hospitalization for heart failure', and 'dead'. Clinical inputs were derived from the results of DAPA-HF trial and costs, and utilities were estimated from published sources as well as publicly available sources in Qatar. 3 The main outcome was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year gained (QALY). All outcomes and costs were discounted at a rate of 3% annually. Sensitivity analyses were conducted to confirm the robustness of the results. The study was based on published data; therefore ethics approval was not required. Results: Dapagliflozin added to standard care prevented 112 heart failure hospitalization and resulted in an additional cost of QAR 33,890 (USD 9,309). This equated to an ICER of QAR 101,763 (USD 27,951) per QALY gained, below the US willingness-to-pay threshold of USD 150,000 per QALY gained. Sensitivity analyses showed the findings to be robust. Conclusion: Dapagliflozin in addition to standard care appears to be a cost-effective strategy for patients with HFrEF, regardless of the presence or absence of T2DM.qscienc

The design and implementation of an undergraduate health professional degree elective course on scientific writing, peer assessment, and critical appraisal

Background and purpose: Strong writing skills are critical to the pharmacy profession. This paper describes the design, delivery, and impact of a course intended to develop pharmacy students' scientific writing, peer assessment, and critical appraisal skills. Educational activity and setting: The course was offered in the final year of an undergraduate pharmacy program with students whose first language is not English. In this course, students write two structured pharmacy review articles (PRA) based on assigned scientific research articles and peer assess each others' written PRAs. Students also critically appraise scientific research articles on a weekly basis, complete one pre-journal club written reflective critique based on a assigned scientific research article, and moderate one journal club session. Findings: Course rubrics were developed and validated by the course coordinators. A survey administered to students enrolled in the course identified that 85% of the students perceived that they gained adequate writing skills in the course. More than 70% of the students indicated they had the necessary skills to evaluate their peers' written assessments, and 93% felt comfortable providing and receiving feedback from peers. More than 90% of the students indicated that writing PRAs and the peer assessment improved their critical and analytical skills. This course improved students' scientific writing, peer assessment, and critical appraisal skills. Further practice is required to reinforce the skills learned and to strengthen the writing skills of students

Bridging vs Non-Bridging with Warfarin Peri-Procedural Management: Cost and Cost-Effectiveness Analyses

The warfarin peri-procedural management in Qatar is predominantly based on bridging (63%), compared to non-bridging. This study sought to perform a first-time cost analysis of current warfarin peri-procedural management practices, including a cost-effectiveness analysis (CEA) of predominant bridging vs predominant non-bridging practices. From the hospital perspective, a one-year decision-analytic model followed the cost and success consequences of the peri-procedural warfarin in a hypothetical cohort of 10,000 atrial fibrillation patients. Success was defined as survival with no adverse events. Outcome measures were the cost and success consequences of the 63% bridging (vs not-bridging) practice in the study setting, ie, Hamad Medical Corporation, Qatar, and the incremental cost-effectiveness ratio (ICER, cost/success) of the warfarin therapy when predominantly bridging based vs when predominantly non-bridging based. The model was based on Monte Carlo simulation, and sensitivity analyses were performed to confirm the robustness of the study conclusions. As per 63% bridging practices, the mean overall cost of peri-procedural warfarin management per patient was USD 3,260 (QAR 11,900), associated with an overall success rate of 0.752. Based on the CEA, predominant bridging was dominant (lower cost, higher effect) over the predominant non-bridging practice in 62.2% of simulated cases, with a cost-saving of up to USD 2,001 (QAR 7,303) at an average of USD 272 (QAR 993) and was cost-effective in 36.9% of cases. Being between cost-saving and cost-effective, compared to predominant non-bridging practices, the predominant use of bridging with warfarin seems to be a favorable strategy in atrial fibrillation patients