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Background: Breast cancer (BC) stands first with high incidence and mortality in India. Most of the oncologists are unaware of cost savings by utilising generic drugs., Aim: To perform a cost minimization analysis of generic versus branded chemotherapeutic regimen for treatment of BC., Methodology: CIMS (current index of medical stores) was referred for the cost of branded drugs and the generic cost was taken from Jan Aushadhi scheme. The percentage cost variation and potential cost-saving particular to BC regimens on substituting available generic drug was calculated using standard formula and costs were presented in Indian Rupees and US Dollars (as of 2019)., Results: Among the branded agents considered, a range of 25% to 606.11% cost variation was observed with cyclophosphamide and 5-Fluorouracil respectively. Gemcitabine proposed the highest cost variation (373.68%-990.78%) and cyclophosphamide (71.42%-114.28%) with the lowest variation when compared to generic drugs. The highest level of cost-saving (₹60,807.3 to ₹1,31,864.1) with TAC regimen and the lowest range (₹12,15.84 to ₹15,667.2) with AC regimen was observed among adjuvant therapy regimens., Conclusion: Our evaluation inferred that substituting generic chemotherapeutic drugs can bring potential cost savings. Healthcare professionals and patients should aware and opt generic drugs to achieve goals of BC therapy.

Objectives : The economic crisis in Greece has triggered an extensive public debate about the use of generic drugs (generics). Despite their cost-saving potential, generic market penetration remains very low. This raises questions on awareness of, perception on and preference for generics by health-care professionals and patients. This is a descriptive study on the level of knowledge and attitudes towards generics of final year pharmacy school students in Greece. Methods : An electronic questionnaire was distributed to 173 senior pharmacy school students in three Universities in Greece. Responses were submitted electronically. Results : The majority of students knew that generics contain the same active ingredient as the originator products and are cheaper. Students were somehow concerned with safety and efficacy of generics. The majority of students agreed that pharmacists should probably recommend the use of generics, and indicated that prescribing and dispensing practices would largely depend on the profit margin. Despite more than half of the students expressing a positive attitude towards generics, they were inadequately educated on their features. Conclusion : It is critical to improve knowledge of and preference for generics amongst health-care professionals from early on if to build the trust required to increase generic market penetration and achieve measurable savings in pharmaceutical expenditure.

Background: Discrepancies are seen between arguments in favor of and against prescribing generic versus brand-name drugs., Objective: To provide real-world evidence on treatment persistence, economic and clinical outcomes of pregabalin, generic versus brand-name (Lyrica®, Pfizer), routinely used to treat neuropathic pain (NP) or generalized anxiety disorder (GAD)., Methods: Electronic medical records from subjects' first starting treatment with pregabalin between January-2015 and June-2016 were analyzed. Persistence, resources utilization, and costs were assessed, along with remitter and responder rates., Results: A total of 4860 records were analyzed. Discontinuation was lower with brand-name than with generic in NP (adjusted hazard ratio [HR]: 0.70 [95% CI: 0.58-0.85], p < 0.001) and GAD patients (HR: 0.63 [0.45-0.84], p < 0.001). Adjusted mean total costs were lower with brand-name: €1500 [1428-1573] vs. €2003 [1864-2143] in NP and €1528 [1322-1734] vs. €2150 [1845-2454] in GAD (both p < 0.001). More patients were remitters/ responders with brand-name in NP (55.0% vs. 46.7% and 59.2% vs. 48.4%, respectively; p < 0.001) and GAD (58.6% vs. 48.7% and 64.6% vs. 47.2%, respectively; p < 0.001)., Conclusions: As a consequence of higher persistence in routine practice, patients who first started therapy with pregabalin brand-name versus generic showed better pain or anxiety outcomes at a lower cost to payers in Spain.

Background: Prescribing of lipid-lowering agents (LLAs) has increased worldwide including in Scotland with increasing prevalence of coronary heart disease, and higher dose statins have been advocated in recent years. There have also been initiatives to encourage prescribing of generic versus patented statins to save costs without compromising care. There is a need to document these initiatives and outcomes to provide future direction., Method: Assessment of utilization (items dispensed) and expenditure of key LLAs (mainly statins) between 2001 and 2015 in Scotland alongside initiatives., Results: Multiple interventions over the years have increased international nonproprietary name prescribing (99% for statins) and preferential prescribing of generic versus patented statins, and reduced inappropriate prescribing of ezetimibe. This resulted in a 50% reduction in expenditure of LLAs between 2001 and 2015 despite a 412% increase in utilization, increased prescribing of higher dose statins (71% in 2015) especially atorvastatin following generic availability, and reduced prescribing of ezetimibe (reduced by 72% between 2010 and 2015). As a result, the quality of prescribing has improved., Conclusion: Generic availability coupled with multiple measures has resulted in appreciable shifts in statin prescribing behavior and reduced ezetimibe prescribing, resulting in improvements in both the quality and efficiency of prescribing.

Introduction: Multiple Criteria Decision Analysis (MCDA) is increasingly used in health care mainly because it moves decision-making from ad hoc to an evidence-based and comprehensive process. Developing countries with more restricted financial and human research capacities, however, should consider their own methods of MCDA development and implementation. Areas covered: An MCDA framework to improve procurement decisions of off-patent pharmaceuticals was developed for developing countries and adapted to Indonesia, Kazakhstan and Vietnam during three policy workshops. Based on the experience of these workshops and one joint workshop with international experts and decision makers from multiple developing countries, general recommendations were formulated on how to implement MCDA specifically in developing countries. We provide 17 practical MCDA implementation recommendations in four major areas, including (1) MCDA objectives; (2) technical considerations of MCDA tool; (3) development and customization of MCDA tool and (4) policy implementation of MCDA in decision-making. Expert commentary: These practical MCDA recommendations for developing countries contribute to feasible, transparent, stepwise, iterative and standardized decision-making in health care.

Aim: To give an overview of the pharmaceutical policy in the largest medical center in Morocco, a developing country in socio-economic transition., Methods: This is an analytical descriptive study of the drug formulary and the purchasing process carried out at the Ibn Sina University Medical Center., Results: Our formulary included 830 drugs belonging to 14 classes according to the Anatomical, Therapeutic and Chemical (ATC) Classification System. There was a respective predominance of class N (21.8%), class B (13.5%), and class J (12.6%). Injectable route was dominant (46%). Drugs had a significant actual benefit in 70% (according to the French Data), reimbursable in 42.8%, essential in 29.2% according to World Health Organization (WHO) list, and in 36.9% according to the Moroccan list. The calls for tenders included 542 drugs representing 65% of the formulary, and the attribution rate was 71%. The main reason for non-attribution was the lack of offers. Generics accounted for 45% by volume and 26.5% by value., Conclusion: With this first study, we were able to identify key indicators on drugs used in the largest medical center in Morocco. The current challenge is to introduce pharmacoeconomics in decision making concerning the updates of the drug formulary.

Background: The American College of Cardiology recommends considering initiation of cholesterol-lowering therapy in normal cholesterol adults aged 45-70, who are either diabetic or have a 10 year atherosclerotic cardiovascular disease risk higher than 7.5%. Although this policy was shown to be cost-effective, the multi-billion dollar budget impact may limit the adoption, diffusion and overall clinical impact of this therapy., Objectives: We examined whether using a substantially lower cost statin (Simvastatin) in a much wider population, while accepting almost-as-good per-patient outcomes can provide better outcomes for the entire intended use population (IUP) under a pre-specified budget constraint., Methods: We built a model to compare the outcomes on the entire IUP, and compared branded Rosuvastatin to Simvastatin. Outcomes measured were major adverse cardiovascular events (MACE): cardiovascular death, stroke, myocardial infarction, and hospitalization for revascularization or unstable angina., Results: The branded Rosuvastatin alternative resulted in the prevention of 6,571 MACE compared to 311,698 MACE with Simvastatin, and 83,120 MACE with generic Rosuvastatin., Conclusions: Under budget constraints, using Simvastatin instead of branded Rosuvastatin resulted in a 47 fold increase of prevention of MACE for the entire IUP. These results should be considered while initiating statin therapy in this target population.

Introduction: Since the introduction of tyrosine kinase inhibitors (TKIs), the treatment of patients with chronic myelogenous leukemia (CML) has resulted in significant improvement in patient survival but at a higher pharmaceutical cost to payers. The recent introduction of generic imatinib presents an opportunity to lower pharmacy costs within a population that is growing due to improved survival. Recent literature has focused on the likely benefits to payers of step therapy through generic imatinib. Areas covered: This review provides a perspective that is broader than the evaluation of financial savings or narrowly defined health economic metrics by incorporating factors such as CML patient heterogeneity, including varying levels of disease progression risk, comorbidities and genetic mutation status, differences in TKI product profiles, clinical guideline recommendations, and the importance of individualized patient care. A focused literature review evaluating the real-world impact of utilization management programs is presented. Expert commentary: The findings indicate that payers can achieve substantial savings without the need to implement utilization management policies. Compromises in the ability to provide individualized patient care and unwanted economic consequences resulting from increased costs of disease progression, adverse events, and lack of response to treatment due to utilization management are summarized.

Background: Fixed-dose combination (FDC) drugs are formulations of two or more active ingredients., Objectives: To assess the pricing structure and price difference of all US FDA-approved FDCs and single drugs included in the combination., Methods: Data were collected from the FDA Orange Book and Drugs@FDA. Average Wholesale Price (AWP) unit price data were derived from The Red Book., Results: The FDA approved 117 FDC. The average AWP difference percentage between the FDC and the sum of the single drugs in the FDC is 84.9 ± 26.2%, and varied by therapeutic class (p < 0.001). The FDC AWP averaged 83.3 ± 23.4% of the single drug AWP sum when there are no generics, and 95.1 ± 42.3% (p < 0.01) when there are two generic single active ingredients in the FDC., Conclusions: The price difference between FDC and single active ingredients in the combination is correlated with the therapeutic class, the year of FDC approval, and the number of single ingredients in the combination that have generics.

Introduction: Statins are recommended first-line treatment for hyperlipidemia, with published studies suggesting limited differences between them. However, there are reports of under-dosing. South Africa has introduced measures to enhance generic utilization. Part one documents prescribed doses of statins in 2011. Part two determines the extent of generics versus originator and single-sourced statins in 2011 and their costs., Results: Underdosing of simvastatin in 2011 with average prescribed dose of 23.7 mg; however, not for atorvastatin (20.91 mg) or rosuvastatin (15.02 mg). High utilization of generics versus originators at 93-99% for atorvastatin and simvastatin, with limited utilization of single-sourced statins (22% of total statins - defined daily dose basis), mirroring Netherlands, Sweden and UK. Generics priced 33-51% below originator prices., Discussion: Opportunity to increase simvastatin dosing through education, prescribing targets and incentives. Opportunity to lower generic prices with generic simvastatin 96-98% below single-sourced prices in some European countries.

Introduction: Prescribing restrictions for angiotensin receptor blockers (ARBs) limited their utilization in Austria. Recently, generic losartan became available with its prescribing restrictions lifted while still in place for patented ARBs., Objectives: The main aim of this study is to assess the impact of the lifting of the prescribing restriction on utilization of losartan in ambulatory care versus other single ARBs, expenditure per defined daily dose (DDD) of losartan as well as total ARB expenditure and utilization of ARB combinations. Finally, to suggest potential measures that could be introduced to further enhance ARB-prescribing efficiency., Methodology: A quasi-experimental study of the utilization of different ARBs alone or in fixed dose combinations using a segmented time series. Utilization measured in DDDs, defined as 'the average maintenance dose of a drug when used in its major indication in adults'. Costs measured as total expenditure for different ARBs as well as their expenditure/DDD., Results: Losartan utilization increased significantly following the withdrawal of prescribing restrictions (p > 0.001). Utilization of single-sourced ARBs also increased , but the growth rate was appreciably reduced once restrictions were lifted for losartan (p > 0.01). As a result, total expenditure of single ARBs increased but at an appreciably lower rate than utilization, helped by total expenditure/DDD for losartan declining by 78% over the study period. There was continuing appreciable utilization of fixed-dose combinations., Conclusion: Lifting of prescribing restrictions for losartan significantly enhanced its utilization, increasing ARB-prescribing efficiency, providing direction to other European authorities. Additional reforms are being considered to further switch utilization away from single-sourced ARBs to additionally improve prescribing efficiency as more multiple sourced ARBs become available.

A literature review was conducted to identify studies exploring the cost-effectiveness of intensive lipid-lowering regimens compared with a generic low-dose statin for individuals with acute coronary syndrome. Three papers matched the inclusion criteria. All used a Markov model to represent the long-term clinical pathway; two were set in the UK and one was in the USA. While there were substantial differences in the effectiveness data, the definitions of the health states and the numbers of events predicted, all authors found that the intensive regimen was a cost-effective alternative compared with a generic lower dose statin. If the cost of atorvastatin reduces from GBP 368 pounds to 90 pounds per annum when the patent expires in 2011, atorvastatin 80 mg/day would be the most optimal treatment for this patient group. Simvastatin 80 mg/day should not be considered an alternative owing to an adverse safety profile and limited additional benefits.