Analysis of Lean Six Sigma Use in Pharmaceutical Production

Abstract Over the last years, pharmaceutical industries have adopted continuous improvement and operational excellence programs to optimize processes, improve quality and reduce operational costs. Worldwide, Lean Manufacturing (LM) and Six Sigma (SS), as well as the integration of the two methods: Lean Six Sigma (LSS) are the most used approaches in the continuous improvement of industries and services. This work aims to investigate the employment of the Lean Six Sigma methodology in the productive areas of pharmaceutical companies located in Brazil. Interviews were conducted with managers of pharmaceutical industries that apply the approach. The results indicated the greater use of Lean Manufacturing tools compared to Six Sigma and the influence of specific peculiarities of the pharmaceutical industry on the benefits that are achieved with the use of Lean Six Sigma. The approach is considered of great value as it provides substantial benefits to the pharmaceutical industry. It is concluded that the work corroborates to the theoretical and empirical knowledge about the methodology use in the context of Brazilian pharmaceutical industries, as well as contributes to the implementation, reformulation, and improvement of Lean Six Sigma programs in this industrial segment.

Trends in Reported Health Care Affordability for Men and Women With Employer-Sponsored Health Insurance Coverage in the US, 2000 to 2020.

This study uses National Health Interview Survey data from 2000 to 2020 to examine reported differences between US men and women aged 19 to 64 years with employer-sponsored insurance in obtaining affordable health care.

Elective versus nonelective brain tumor resections: a 5-year propensity score matching cost comparison analysis.

OBJECTIVE: Elective surgical cases generally have lower costs, higher profit margins, and better outcomes than nonelective cases. Investigating the differences in cost and profit between elective and nonelective cases would help hospitals in planning strategies to withstand financial losses due to potential pandemics. The authors sought to evaluate the exact cost and profit margin differences between elective and nonelective supratentorial tumor resections at a single institution. METHODS: The authors collected economic analysis data in all patients who underwent supratentorial tumor resection at their institution between January 2014 and December 2018. The patients were grouped into elective and nonelective cases. Propensity score matching was used to adjust for heterogeneity of baseline characteristics between the two groups. RESULTS: There were 143 elective cases and 232 nonelective cases over the 5 years. Patients in the majority of elective cases had private insurance and in the majority of nonelective cases the patients had Medicare/Medicaid (p < 0.01). The total charges were significantly lower for elective cases ($168,800.12) compared to nonelective cases ($254,839.30, p < 0.01). The profit margins were almost 6 times higher for elective than for nonelective cases ($13,025.28 vs $2,128.01, p = 0.04). After propensity score matching, there was still a significant difference between total charges and total cost. CONCLUSIONS: Elective supratentorial tumor resections were associated with significantly lower costs with shorter lengths of stay while also being roughly 6 times more profitable than nonelective cases. These findings may help future planning for hospital strategies to survive financial losses during future pandemics that require widespread cancellation of elective cases.

Comparative study between admission, orthopaedic surgery, and economic trends during Covid-19 and non-Covid-19 pandemic in an Italian tertiary hospital: a retrospective review.

BACKGROUND: The COVID-19 pandemic represents one of the most massive health emergencies in the last century and has caused millions of deaths worldwide and a massive economic and social burden. The aim of this study was to evaluate how the COVID-19 pandemic-during the Italian lockdown period between 8 March and 4 May 2020-influenced orthopaedic access for traumatic events to the Emergency Department (ER). METHODS: A retrospective review of the admission to the emergency room and the discharge of the trauma patients' records was performed during the period between 8 March and 4 May 2020 (block in Italy), compared to the same period of the previous year (2019). Patients accesses, admissions, days of hospitalisation, frequency, fracture site, number and type of surgery, the time between admission and surgery, days of hospitalisation, and treatment cost according to the diagnosis-related group were collected. Chi-Square and ANOVA test were used to compare the groups. RESULTS: No significant statistical difference was found for the number of emergency room visits and orthopaedic hospitalisations (p < 0.53) between the year 2019 (9.5%) and 2020 (10.81%). The total number of surgeries in 2019 was 119, while in 2020, this was just 48 (p < 0.48). A significant decrease in the mean cost of orthopaedic hospitalisations was detected in 2020 compared (261.431 euros, equal to - 52.07%) relative to the same period in 2019 (p = 0.005). Although all the surgical performances have suffered a major decline, the most frequent surgery in 2020 was intramedullary femoral nailing. CONCLUSION: We detected a decrease in traumatic occasions during the lockdown period, with a decrease in fractures in each district and a consequent decrease in the diagnosis-related group (DRG).

Making voluntary medical male circumcision services sustainable: Findings from Kenya's pilot models, baseline and year 1.

Voluntary medical male circumcision is a crucial HIV prevention program for men in sub-Saharan Africa. Kenya is one of the first countries to achieve high population coverage and seek to transition the program to a more sustainable structure designed to maintain coverage while making all aspects of service provision domestically owned and implemented. Using pre-defined metrics, we created and evaluated three models of circumcision service delivery (static, mobile and mixed) to identify which had potential for sustaining high circumcision coverage among 10-14-year-olds group, a historically high-demand and accessible age group, at the lowest possible cost. We implemented each model in two distinct geographic areas, one in Siaya and the other in Migori county, and assessed multiple aspects of each model's sustainability. These included numerical achievements against targets designed to reach 80% coverage over two years; quantitative expenditure outcomes including unit expenditure plus its primary drivers; and qualitative community perception of program quality and sustainability based on Likert scale. Outcome values at baseline were compared with those for year one of model implementation using bivariate linear regression, unpaired t-tests and Wilcoxon rank tests as appropriate. Across models, numerical target achievement ranged from 45-140%, with the mixed models performing best in both counties. Unit expenditures varied from approximately $57 in both countries at baseline to $44-$124 in year 1, with the lowest values in the mixed and static models. Mean key informant perception scores generally rose significantly from baseline to year 1, with a notable drop in the area of community engagement. Consistently low scores were in the aspects of domestic financing for service provision. Sustainability-focused circumcision service delivery models can successfully achieve target volumes at lower unit expenditures than existing models, but strategies for domestic financing remain a crucial challenge to address for long-term maintenance of the program.

Assessing the pricing and benefits of oncology products: an update.

Introduction: Oncology expenditure is outperforming all other health care sectors. In particular, the cost of oncology pharmaceuticals is soaring as it is fueled both by incremental costs and the introduction rate of new products. Due to the particularities of cancer as a disease, a significant multilayer of pressure is exerted toward the reimbursement of new treatments. Nevertheless, if the expenditure increase is left unattended, it may hamper the viability of any health care system worldwide.Areas covered: A literature review of the expenditure on oncology pharmaceuticals and the exploration of the root causes for the increase in expenditure was performed.Expert commentary: The surging oncology expenditure demonstrates a multi-layer causality that encompasses prices, the uncertainty of clinical trials, the specificities of cancer as a disease, and the artificial monopoly of oncology modalities. Moreover, laxity in the regulatory approval of new products was noted. In addition, the study design should be adequately justified. Finally, new reimbursement schemes, that explicitly reward and promote clinically meaningful and measurable outcomes, are also imperative.

Trends in access to anti-malarial treatment in the formal private sector in Uganda: an assessment of availability and affordability of first-line anti-malarials and diagnostics between 2007 and 2018.

BACKGROUND: Malaria is the single largest cause of illness in Uganda. Since the year 2008, the Global Fund has rolled out several funding streams for malaria control in Uganda. Among these are mechanisms aimed at increasing the availability and affordability of artemisinin-based combination therapy (ACT). This paper examines the availability and affordability of first-line malaria treatment and diagnostics in the private sector, which is the preferred first point of contact for 61% of households in Uganda between 2007 and 2018. METHODS: Cross-sectional surveys were conducted between 2007 and 2018, based on a standardized World Health Organization/Health Action International (WHO/HAI) methodology adapted to assess availability, patient prices, and affordability of ACT medicines in private retail outlets. A minimum of 30 outlets were surveyed per year as prescribed by the standardized methodology co-developed by the WHO and Health Action International. Availability, patient prices, and affordability of malaria rapid diagnostic tests (RDTs) was also tracked from 2012 following the rollout of the test and treat policy in 2010. The median patient prices for the artemisinin-based combinations and RDTs was calculated in US dollars (USD). Affordability was assessed by computing the number of days' wages the lowest-paid government worker (LPGW) had to pay to purchase a treatment course for acute malaria. RESULTS: Availability of artemether/lumefantrine (A/L), the first-line ACT medicine, increased from 85 to100% in the private sector facilities during the study period. However, there was low availability of diagnostic tests in private sector facilities ranging between 13% (2012) and 37% (2018). There was a large reduction in patient prices for an adult treatment course of A/L from USD 8.8 in 2007 to USD 1.1 in 2018, while the price of diagnostics remained mostly stagnant at USD 0.5. The affordability of ACT medicines and RDTs was below one day's wages for LPGW. CONCLUSIONS: Availability of ACT medicines in the private sector medicines retail outlets increased to 100% while the availability of diagnostics remained low. Although malaria treatment was affordable, the price of diagnostics remained stagnant and increased the cumulative cost of malaria management. Malaria stakeholders should consolidate the gains made and consider the inclusion of diagnostic kits in the subsidy programme.

Changes in Drug List Prices and Amounts Paid by Patients and Insurers.

Importance: High out-of-pocket drug costs can cause patients to skip treatment and worsen outcomes, and high insurer drug payments could increase premiums. Drug wholesale list prices have doubled in recent years. However, because of manufacturer discounts and rebates, the extent to which increases in wholesale list prices are associated with amounts paid by patients and insurers is poorly characterized. Objective: To determine whether increases in wholesale list prices are associated with increases in amounts paid by patients and insurers for branded medications. Design, Setting, and Participants: Cross-sectional retrospective study analyzing pharmacy claims for patients younger than 65 years in the IBM MarketScan Commercial Database and pricing data from SSR Health, LLC, between January 1, 2010, and December 31, 2016. Pharmacy claims analyzed represent claims of employees and dependents participating in employer health benefit programs belonging to large employers. Rebate data were estimated from sales data from publicly traded companies. Analysis focused on the top 5 patent-protected specialty and 9 traditional brand-name medications with the highest total drug expenditures by commercial insurers nationwide in 2014. Data were analyzed from July 2017 to July 2020. Exposures: Calendar year. Main Outcomes and Measures: Changes in inflation-adjusted amounts paid by patients and insurers for branded medications. Results: In this analysis of 14.4 million pharmacy claims made by 1.8 million patients from 2010-2016, median drug wholesale list price increased by 129% (interquartile range [IQR], 78%-133%), while median insurance payments increased by 64% (IQR, 28%-120%) and out-of-pocket costs increased by 53% (IQR, 42%-82%). The mean percentage of wholesale list price accounted for by discounts increased from 17% in 2010 to 21% in 2016, and the mean percentage of wholesale list price accounted for by rebates increased from 22% in 2010 to 24% in 2016. For specialty medications, median patient out-of-pocket costs increased by 85% (IQR, 73%-88%) from 2010 to 2016 after adjustment for inflation and 42% (IQR, 25%-53%) for nonspecialty medications. During that same period, insurer payments increased by 116% for specialty medications (IQR, 100%-127%) and 28% for nonspecialty medications (IQR, 5%-34%). Conclusions and Relevance: This study's findings suggest that drug list prices more than doubled over a 7-year study period. Despite rising manufacturer discounts and rebates, these price increases were associated with large increases in patient out-of-pocket costs and insurer payments.

Capitated pricing model for stroke thrombectomies: a single center experience across three companies.

BACKGROUND: With a continued rise in healthcare expenditures, there is a demonstrable focus on curbing expenses. Mechanical thrombectomy (MT) is the standard of treatment for large vessel occlusions (LVOs); however, considerable costs are associated with devices utilized in each procedure. We report our institution's experience with capitation pricing models negotiated with three different companies. METHODS: We retrospectively reviewed a prospectively maintained database from February 2018 to August 2019 identifying cases performed under capitation models. We calculated the cost of equipment for each thrombectomy using the cost for individual devices utilized (virtual) and compared this sum to the total derived from cost-negotiated bundled equipment packages. This was compared with real-world cases that did not meet capitation criteria during this study period. RESULTS: 107 cases met the criteria for capitation; 39 cases used company A's models (28 with stentrievers), 44 cases used company B's models (3 with stentrievers), and 24 cases used company C's models (14 with stentrievers). Overall, there was a net savings of $202 370.50 utilizing the capitated model ($689 435 vs $891 805.50), amounting to $1891.31 savings per case. Mean capitation was lower ($6972±2774) compared with virtual ($8794±4614) and real-world non-capitation costs ($7176±3672). CONCLUSION: The negotiated capitated pricing model yielded total cost savings associated with equipment from each company. Overall mean capitation costs were lower than virtual and real-world cases. This may serve as a model for other centers in controlling costs for patients undergoing MT for LVO.

How many alcohol-attributable deaths and hospital admissions could be prevented by alternative pricing and taxation policies? Modelling impacts on alcohol consumption, revenues and related harms in Canada. / Réduction des décès et des hospitalisations dus à l'alcool grâce à des politiques fiscales et d'établissement des prix différentes? Modélisation des effets sur la consommation d'alcool, les revenus et les méfaits liés à l'alcool au Canada.

INTRODUCTION: In 2017, Canada increased alcohol excise taxes for the first time in over three decades. In this article, we describe a model to estimate various effects of additional tax and price policies that are predicted to improve health outcomes. METHODS: We obtained alcohol sales and taxation data for 2016/17 for all Canadian jurisdictions from Statistics Canada and product-level sales data for British Columbia. We modelled effects of alternative price and tax policies - revenue-neutral taxes, inflation-adjusted taxes and minimum unit prices (MUPs) - on consumption, revenues and harms. We used published price elasticities to estimate impacts on consumption and revenue and the International Model for Alcohol Harms and Policies (InterMAHP) to estimate impacts on alcohol-attributable mortality and morbidity. RESULTS: Other things being equal, revenue-neutral alcohol volumetric taxes (AVT) would have minimal influence on overall alcohol consumption and related harms. Inflation-adjusted AVT would result in 3.83% less consumption, 329 fewer deaths and 3762 fewer hospital admissions. A MUP of $1.75 per standard drink (equal to 17.05mL ethanol) would have reduced consumption by 8.68% in 2016, which in turn would have reduced the number of deaths by 732 and the number of hospitalizations by 8329 that year. Indexing alcohol excise taxes between 1991/92 and 2016/17 would have resulted in the federal government gaining approximately $10.97 billion. We estimated this could have prevented 4000-5400 deaths and 43 000-56 000 hospitalizations. CONCLUSION: Improved public health outcomes would be made possible by (1) increasing alcohol excise tax rates across all beverages to compensate for past failures to index rates, and (2) setting a MUP of at least $1.75 per standard drink. While reducing alcohol-caused harms, these tax policies would have the added benefit of increasing federal government revenues.

Price Elasticity of cigarette smoking demand in the Philippines after the 2012 Sin Tax Reform Act.

The Philippine tobacco excise tax reform law passed in 2012 drastically increased cigarette prices which were historically low. A pack of 20 cigarettes costing nine cents (US Dollar) or less was taxed five cents in 2011. When the reform took effect in 2013, each pack was taxed 24 cents which is almost five times the 2011 rate. Alongside the increase in tax is a decline in the prevalence of tobacco use from 28.3% in 2009 to 23.8% in 2015. Seven years since the reform took effect, policymakers are still debating whether the tax introduced was high enough to significantly reduce smoking prevalence. This study estimated the total price elasticity of cigarette demand using regression analyses on the pooled Philippine 2009 and 2015 Global Adult Tobacco Survey data with the excise tax as an instrumental variable. Information from both tax regimes provided the variation in cigarette prices that allowed for the estimation of the price elasticity of smoking participation and intensity. Age, sex, urban residence, educational attainment, employment status, wealth quintile, and media exposure were used as control variables. Results confirm that cigarette demand is inelastic, given that total cigarette price elasticity of demand ranges from -0.56 to -1.10 which means that for every 10% price increase, total cigarette demand declines by 5.6% to 11.0%. This study also provides total price elasticities for different subpopulations. Future studies can use these elasticity estimates to forecast smoking prevalence and provide policy recommendations.

The Development of Health Technology Assessment in Asia: Current Status and Future Trends.

Health technology assessment (HTA) has long been employed by many countries around the world, but its adoption in Asia has been slower. Only recently have a growing number of Asian countries started to implement HTA for pricing and reimbursement decisions. The objective of this article is to provide an overview of how HTA has been or is being implemented in Asia within the context of a country's existing-and often complex-coverage, reimbursement, and pricing schemes. Three countries at different stages of HTA implementation were selected as case studies: South Korea, where there is a young yet established HTA program; Japan, where a 3-year HTA pilot program has just concluded; and China, where HTA efforts are underway but have not been formally implemented. Not only do the experiences of these 3 countries well exemplify how the organization and scope of HTA can be customized to meet a country's unique healthcare needs, but they also provide the opportunity to outline some common key challenges that must be overcome to implement and develop HTA competencies and capabilities.

Did Medicare Advantage payment cuts affect beneficiary access and affordability?

OBJECTIVES: To explore whether the Affordable Care Act (ACA)'s Medicare Advantage (MA) payment cuts were associated with changes in enrollees' access to and affordability of healthcare relative to traditional Medicare (TM). STUDY DESIGN: Descriptive analyses of changes in access and affordability in MA relative to TM between 2009 and 2017 and between 2011 and 2017. METHODS: Respondents who reported Medicare coverage on the National Health Interview Survey were divided into MA and TM enrollees. Using multivariate regression to adjust for demographic, economic, and health status changes over time, we compared changes in healthcare access and affordability for the 2 groups between 2009 and 2017, as the ACA payment cuts were implemented. For some measures, the analysis covers 2011 to 2017. RESULTS: Between 2009 and 2017, MA respondents did not report statistically significant changes in healthcare access or affordability after adjusting for demographic, socioeconomic, and health status changes in the MA population. There were no statistically significant differences between changes in access and affordability for beneficiaries in MA relative to those in TM over this period. CONCLUSIONS: Although MA payment cuts were expected to reduce the attractiveness of the MA program to both plans and enrollees, the program's enrollment grew steadily from 2009 to 2017. Over this period, plans reduced their costs for providing Part A and Part B benefits to their enrollees, thereby preserving room for rebates. Our findings show that plans made such cost reductions without significantly affecting enrollees' access to or affordability of care compared with TM beneficiaries.

Number of manufacturers and generic drug pricing from 2005 to 2017.

OBJECTIVES: To evaluate how changes in generic drug prices and the incidence of abrupt price increases varied with the number of manufacturers supplying each drug. STUDY DESIGN: Analysis of 2005 to 2016 monthly wholesale acquisition costs (WACs) and University of Pittsburgh Medical Center Health Plan counts of pharmacy claims for National Drug Codes (NDCs) for generic drugs. METHODS: Each year, NDCs were categorized according to the number of manufacturers offering each combination of active ingredient and dosage form: 1 to 3, 4 to 7, and more than 7. For every month from January 2006 to January 2017, we estimated the 12-month change in WAC (eg, 12-month change in January 2006 was calculated as the difference in WAC between January 2006 and January 2005, divided by the WAC in January 2005), before and after weighting each NDC by counts of pharmacy claims. We evaluated the proportion of NDCs that had large price increases, greater than 20%, 50%, 100%, and 500% within a year. RESULTS: Before 2010, price changes were higher for drugs supplied by a lower number of manufacturers; however, after 2010, prices increased sharply, and drugs supplied by 4 to 7 manufacturers showed increases similar to or higher than those supplied by 1 to 3. In 2013, prices increased by an average of 29% for drugs supplied by 1 to 3 and 4 to 7 manufacturers, and 10% for more than 7. Price changes increased after weighting by counts of pharmacy claims, demonstrating that price increases disproportionately affected widely used drugs. The proportion of NDCs from drugs supplied by 1 to 3 manufacturers that doubled in price within a year was 3.6 times higher in 2012 to 2015 than in 2005 to 2009 (4.6% vs 1.3%, respectively). CONCLUSIONS: Increases in generic drug prices are concerning because they affected widely used drugs and suggest that generic drug prices may be increasingly insensitive to competition.

Historical overview of regulatory framework development on pricing and reimbursement of medicines in Bulgaria.

Objectives: The current study aims to analyze, from a historical perspective, the regulatory framework of prices and reimbursement in Bulgaria with emphasis on the introduction of economic evaluation.Methods: The study explores all regulatory changes during the period 1995-2016 combining the macroeconomic and regulatory analysis on medicines pricing and reimbursement. A roadmap summarizing the current regulatory requirements for the medicinal product entrance on national market and access to public funding was elaborated.Results: Demographic processes in the country have been negative for the past decade. On the other hand, health care and pharmaceutical expenditures experienced a growth up to 8.6% and 3% of total GDP, respectively. The total pharmaceutical market permanently grew from 309 to 1409 million of Euro. During the last 20 years, the pricing and reimbursement legislation of medicines in Bulgaria was changed extensively.Conclusion: Pricing policy remains oriented toward the lowest European prices and reimbursement policy impose cost containment measures. Appraisal of the obligatory Health Technology Assessment Dossiers and pharmacoeconomic analysis is in accordance with world recommendations. Main regulatory issues that still remain to be tackled are the slower entrance of medicines on the national market and lower national prices that often lead to parallel import.