Updated trends in US brand-name and generic drug competition

Objective: To provide updated evidence on US trends in: market exclusivity periods (MEPs, time between brand-name drug launch and first generic competitors) for new molecular entities (NMEs); likelihood, timing and number of Hatch-Waxman Act Paragraph IV patent challenges; and generic drug penetration.

Methods: This study used IMS Health National Sales Perspectives^TM US data to calculate MEPs for the 288 NMEs experiencing initial generic entry between January 1995 and December 2014, the number of generic competitors for 12 months afterward (by level of annual sales prior to generic entry), and generic penetration rates. The likelihood, timing and number of Paragraph IV challengers were calculated using data from Abbreviated New Drug Approval (ANDA) letters, the FDA website, public information searches, and ParagraphFour.com.

Results: For drugs experiencing initial generic entry in 2013–2014, the MEP was 12.5 years for drugs with sales greater than $250 million (in 2008 dollars) in the year prior to generic entry ($250 million?+?NMEs), 13.6 years overall. After generic entry, brands rapidly lost sales, with their average unit share being 7% at 1 year for $250 million?+?NMEs, 12% overall. Ninety-four percent of $250 million?+?NMEs experiencing initial generic entry in 2013–2014 had faced at least one Paragraph IV challenge, an average of 5.2 years after brand launch (76% and 5.9 years for all NMEs). NMEs faced an average of 5.1 and 6.2 Paragraph IV challenges per NME, for all and $250 million?+?NMEs, respectively.

Limitations: Analyses, including Paragraph IV calculations, were restricted to NMEs where generic entry had occurred.

Conclusion: The average 2013–2014 MEP of 12.5 years for $250 million?+?NMEs, 13.6 overall remains consistent with prior research. MEPs are lower, and Paragraph IV challenges are more frequent and occur earlier for $250 million?+?drugs. Generic share erosion is also greater, and continues to intensify for both NME types.     

Economic impact of onabotulinumtoxinA for overactive bladder with urinary incontinence in Europe

Background: Overactive bladder (OAB) is a common condition that has a significant impact on patients’ health-related quality-of-life and is associated with a substantial economic burden to healthcare systems. OnabotulinumtoxinA has a well-established efficacy and safety profile as a treatment for OAB; however, the economic impact of using onabotulinumtoxinA has not been well described.

Methods: An economic model was developed to assess the budget impact associated with OAB treatment in France, Germany, Italy, Spain and the UK, using onabotulinumtoxinA alongside best supportive care (BSC)—comprising incontinence pads and/or anticholinergic use and/or clean intermittent catheterisation (CIC)—vs BSC alone. The model time horizon spanned 5 years, and included direct costs associated with treatment, BSC, and adverse events.

Results: Per 100,000 patients in each country, the use of onabotulinumtoxinA resulted in estimated cost savings of €97,200 (Italy), €71,580 (Spain), and €19,710 (UK), and cost increases of €23,840 in France and €284,760 in Germany, largely due to day-case and inpatient administration, respectively. Projecting these results to the population of individuals aged 18 years and above gave national budget saving estimates of €9,924,790, €27,458,290, and €48,270,760, for the UK, Spain, and Italy, respectively, compared to cost increases of €12,160,020 and €196,086,530 for France and Germany, respectively. Anticholinergic treatment and incontinence pads were the largest contributors to overall spending on OAB management when onabotulinumtoxinA use was not increased, and remained so in four of five scenarios where onabotulinumtoxinA use was increased. This decreased resource use was equivalent to cost offsets ranging from €106,110 to €176,600 per 100,000 population.

Conclusions: In three of five countries investigated, the use of onabotulinumtoxinA, in addition to BSC, was shown to result in healthcare budget cost savings over 5 years. Scenario analyses showed increased costs in Germany and France were largely attributable to the treatment setting rather than onabotulinumtoxinA acquisition costs.     

Economic burden of hypoglycemia: Utilization of emergency department and outpatient services in the United States (2005–2009)

Objective: To estimate the economic burden of hypoglycemia on the healthcare system at the national level in the US between the years of 2005–2009.

Methods: This study analyzed the National Hospital Ambulatory Medical Care Survey (NHAMCS), including emergency department (ED) and outpatient department (OPD) components, and the National Ambulatory Medical Care Survey (NAMCS). The annual rates of ED and OPD visits associated with hypoglycemia were reported. Subsequent medical services after disposition were studied. The unit cost of specific medical service was estimated from the Medical Expenditure Panel Survey (MEPS). All annualized costs were adjusted to US 2009 dollars. We also estimated the rates of injury and ambulance use incurring within a visit for hypoglycemia.

Results: The total direct medical cost of hypoglycemia was estimated as $3.49 billion in 2005 and decreased gradually to $1.84 billion in 2009. The declining trend was correlated with hospital admissions from ED, which decreased from 170 665 in 2005 to 71,751 in 2009. Consequently, the estimated annual expenditure of hospitalization for hypoglycemia from ED declined over time by more than half ($2.90 billion in 2005, $1.25 billion in 2009). Injury was reported among 9.5% of the ED visits for hypoglycemia. Ambulances were used among 58% of the ED visits for hypoglycemia.

Conclusion: Hypoglycemia poses a significant burden on the healthcare system; however, annual direct medical cost of severe hypoglycemia in the US decreased over the 5 years studied, which is attributable to tremendous decrease in need of hospitalization following an ED visit.     

Economic evaluation of nivolumab for the treatment of second-line advanced squamous NSCLC in Canada: a comparison of modeling approaches to estimate and extrapolate survival outcomes

Background Lung cancer is the most common type of cancer in the world and is associated with significant mortality. Nivolumab demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients with advanced squamous non-small cell lung cancer (NSCLC) who were previously treated. The cost-effectiveness of nivolumab has not been assessed in Canada. A contentious component of projecting long-term cost and outcomes in cancer relates to the modeling approach adopted, with the two most common approaches being partitioned survival (PS) and Markov models. The objectives of this analysis were to estimate the cost-utility of nivolumab and to compare the results using these alternative modeling approaches.

Methods Both PS and Markov models were developed using docetaxel and erlotinib as comparators. A three-health state model was used consisting of progression-free, progressed disease, and death. Disease progression and time to progression were estimated by identifying best-fitting survival curves from the clinical trial data for PFS and OS. Expected costs and health outcomes were calculated by combining health-state occupancy with medical resource use and quality-of-life assigned to each of the three health states. The health outcomes included in the model were survival and quality-adjusted-life-years (QALYs).

Results Nivolumab was found to have the highest expected per-patient cost, but also improved per-patient life years (LYs) and QALYs. Nivolumab cost an additional $151,560 and $140,601 per QALY gained compared to docetaxel and erlotinib, respectively, using a PS model approach. The cost-utility estimates using a Markov model were very similar ($152,229 and $141,838, respectively, per QALY gained).

Conclusions Nivolumab was found to involve a trade-off between improved patient survival and QALYs, and increased cost. It was found that the use of a PS or Markov model produced very similar estimates of expected cost, outcomes, and incremental cost-utility.     

Annual patient and caregiver burden of oncology clinic visits for granulocyte-colony stimulating factor therapy in the US

Objective:

Prophylactic treatment with granulocyte-colony stimulating factors (G-CSFs) is indicated for chemotherapy patients with a significant risk of febrile neutropenia. This study estimates the annual economic burden on patients and caregivers of clinic visits for prophylactic G-CSF injections in the US.

Methods:

Annual clinic visits for prophylactic G-CSF injections (all cancers) were estimated from national cancer incidence, chemotherapy treatment and G-CSF utilization data, and G-CSF sales and pricing information. Patient travel times, plus time spent in the clinic, were estimated from patient survey responses collected during a large prospective cohort study (the Prospective Study of the Relationship between Chemotherapy Dose Intensity and Mortality in Early-Stage (I–III) Breast Cancer Patients). Economic models were created to estimate travel costs, patient co-pays and the economic value of time spent by patients and caregivers in G-CSF clinic visits.

Results:

Estimated total clinic visits for prophylactic G-CSF injections in the US were 1.713 million for 2015. Mean (SD) travel time per visit was 62 (50) min; mean (SD) time in the clinic was 41 (68) min. Total annual time for travel to and from the clinic, plus time at the clinic, is estimated at 4.9 million hours, with patient and caregiver time valued at $91.8 million ($228 per patient). The estimated cumulative annual travel distance for G-CSF visits is 60.2 million miles, with a total transportation cost of $28.9 million ($72 per patient). Estimated patient co-pays were $61.1 million, ～$36 per visit, $152 per patient. The total yearly economic impact on patients and caregivers is $182 million, ～$450 per patient.

Limitations:

Data to support model parameters were limited. Study estimates are sensitive to the assumptions used.

Conclusions:

The burden of clinic visits for G-CSF therapy is a significant addition to the total economic burden borne by cancer patients and their families.     

Improving competitiveness in the member states of the Eurasian Economic Union: a blueprint for the next decade

The Eurasian Economic Union (EAEU) has made incredible strides in becoming an integrated body over the past 10 years, and is becoming part of a broader global process of economic regionalism that is shaping economic competitiveness. This paper applies a SWOT analysis to current and projected EAEU member states, and identifies where the difficulties and opportunities for the EAEU’s member countries will be in improving competitiveness in the coming years. The key conclusions are that the EAEU’s own institutional arrangements may foster competitiveness if it is able to remove some of the barriers to innovation that currently exist in the bloc’s member states.     

The effect of economic policy uncertainty on investor information asymmetry and management disclosures

Investor uncertainty about firm value drives investors’ information collection and trading activities, as well as managers’ disclosure choices. This study examines an important source of uncertainty that likely cannot be influenced by most managers and investors: uncertainty about government economic policy. We find that this uncertainty is associated with increased bid-ask spreads and decreased stock price reactions to earnings surprises. Managers respond to this uncertainty by increasing their voluntary disclosures, but these disclosures only partly mitigate the bid-ask spread increase. We conclude that government economic policy uncertainty is an important component of firms’ information environments and managers’ voluntary disclosure decisions.     

碳排放、绿色全要素生产率和经济增长

通过把资本存量、就业人数、能耗、时间等变量纳入超越对数生产函数,将碳排放总量、能源强度等变量以及区域虚拟变量作为生产无效率函数的解释变量构建随机前沿模型进行实证分析。结果显示：碳排放增长会扩大技术无效率项并降低绿色全要素生产率;技术进步降低了能源强度却引至了更多的碳排放,符合杰文斯悖论;减排技术较高的地区对应较高绿色全要素生产率增长水平;绿色全要素生产率增速比传统全要素生产率增速更快。     

新型城镇化发展与产业结构变迁的经济增长效应

利用全局主成分分析法和改进Moore指数,分别对新型城镇化水平和产业结构变迁指数进行测算,并在经济增长的空间相关性分析基础上,构建空间自回归模型、空间效应分解模型和面板门槛模型,实证检验了新型城镇化发展与产业结构变迁的经济增长效应。研究显示,新型城镇化通过发挥其“选择效应”优化产业结构、提升企业生产率,有效促进了经济增长;中国经济发展的“结构红利”因产业结构变迁而减弱,导致中国经济发展出现“结构性减速”现象,但产业结构变迁的经济增长效应仍存在;实现产城联动,发挥新型城镇化与产业结构变迁的“协同效应”,对于缓解经济发展过程中的“结构性减速”问题,促进中国经济增长具有积极作用;新型城镇化发展与产业结构变迁的经济增长效应因产城关系的阶段性不匹配而存在“门槛效应”。     

Europe's income convergence and the latest global financial crisis

This paper examines the effects of the 2008 financial crisis on economic growth and convergence across European countries from 1973 to 2012. Employing cross-sectional and dynamic panel data techniques, the results show that the global financial crisis has brought a greater absolute convergence rate rather than divergence, affected richer members more heavily and, presumably, allowed less developed members to recover more quickly. We find evidence that creating the European Union has contributed toward economic growth and convergence; meanwhile, no similar evidence is found concerning the European Monetary Union. Moreover, we present evidence that both the average output per capita and the rate of convergence during the financial crisis fell around 7%.