The Challenge of Sustainability of High-Cost Oncological Drugs: A Budgeting Model in an Italian Cancer Center

In Italy, drug expenditure governance is achieved by setting caps based on the percentage increase in hospital spending compared to the previous year. This method is ineffective in identifying issues and opportunities as it does not consider an analysis of the number of treated cases and per capita consumption in local and regional settings. The IRCCS (Scientific hospitalization and treatment institute) Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” in Meldola, has developed and adopted an effective management model designed to oversee pharmaceutical expenditure, guarantee prescription appropriateness and quality of care to patients. The budget setting follows a structured process which evaluates determining factors of the expenditure such as expected patients calculated according to the epidemiology and to national and regional indications of appropriateness, mean cost per patient calculated on the average period of demonstrated efficacy of the drug and use of drugs with the best cost-effectiveness ratio. Strict monitoring and integrated purchasing processes allow for immediate corrective actions on expenditures, as well as a continuous dialogue with the region in order to guarantee consistent funding of IRST activities. The model, presented in this article is efficient and implements concepts beyond the conventional “silos” approach and national and regional governance tools, in terms of patient centricity.

Longitudinal Association of Salaries for Medical Staff With Medical Service Utilization and Expenditure in China, 2007–2016

Objectives: To test the hypothesis that higher salary levels of the medical staff are associated with lower medical service utilization and expenditure.Methods: Using longitudinal data from 31 Chinese provinces for the period 2007-2016, we constructed fixed effects models to analyze the association between the salary of medical staff and medical service utilization, medical expenditure, medication expenditure, and medication proportion.Results: A 10,000 CNY increase in medical staff's salaries was associated with a 0.89% decrease in the average number of annual inpatient admissions per person; 1.88 and 1.59% decreases in average expenditures per outpatient visit and inpatient admission, respectively; 3.05 and 2.66% decreases in drug expenditures per outpatient visit and inpatient admission, respectively; 0.58 percent point and 0.39 percent point decreases in the share of drug expenditure in outpatient and inpatient, respectively. When medical staff's salaries increased by 450,000 CNY, the turning point was reached when the maximum medical expenditure savings offset the medical staff salary increases, yielding a 634 billion CNY surplus from medical expenditure.Conclusions: Our results supported the hypothesis that higher salary levels of the medical staff are associated with lower medical service utilization and expenditure. Further studies are requested to test whether higher medical staff's salaries will attenuate over-treatment and that savings from reduced prescriptions and service charges will offset the increased salaries of medical staff.

The Effects of Cost Containment and Price Policies on Pharmaceutical Expenditure in South Korea

Background: Policymakers have proposed and implemented various cost-containment policies for drug prices and quantities to regulate rising pharmaceutical spending. Our study focused on a major change in pricing policy and several incentive schemes for curbing pharmaceutical expenditure growth during the 2010s in Korea. Methods: We constructed the longitudinal dataset from 2008-2017 for 11,849 clinics to track the prescriber behavior before and after the implemented policies. Applying an interrupted time series model, we analyzed changes in trends in overall monthly drug expenditure and antibiotic drug expenditure per prescription for outpatient claims diagnosed with three major diseases before and after the policies’ implementation. Results: Significant price reductions and incentives for more efficient drug prescriptions resulted in an immediate decrease in monthly drug expenditures in clinics. However, we found attenuated effects over the long run. The top-spending clinics showed the highest rate of increase in drug costs. Conclusion: Future policy interventions can maximize their effects by targeting high-spending providers.

Deregulation and pricing of medical services: a policy experiment based in China

Background Price regulation is a common constraint in Chinese hospitals. Based on a policy experiment conducted in China on the price deregulation of private nonprofit hospitals, this study empirically examines the impact of medical service price regulation on the pricing of medical services by hospitals. Methods Using the claim data of insured inpatients residing in a major Chinese city for the period 2010–2015, this study constructs a DID (difference-in-differences) model to compare the impact of price deregulation on medical expenditure and expenditure structure between public and private nonprofit hospitals. Results The empirical results based on micro data reveal that, price deregulated significantly increased the total expenditure per inpatient visit by 10.5%. In the itemized expenditure, the diagnostic test and drug expenditure per inpatient visit of private nonprofit hospitals decreased significantly, whereas the physician service expenditure per inpatient visit increased significantly. For expenditure structure, the proportions of drug expenditure and diagnostic test expenditure per inpatient visit significantly decreased by 5.7 and 3.1%, respectively. Furthermore, this paper also found that hospitals had larger price changes for dominant diseases than for non-dominant diseases. Conclusions Under price regulation, medical service prices generally become lower than their costs. Therefore, after price deregulation, private nonprofit hospitals increase medical service prices above their cost and achieve the service premium increasing physician medical services. Further, although price deregulation causes patient expenditure to increase to a certain level, it optimizes the expenditure structure, as well.

Vitamin D: Not Just Bone Metabolism but a Key Player in Cardiovascular Diseases

Vitamin D is the first item of drug expenditure for the treatment of osteoporosis. Its deficiency is a condition that affects not only older individuals but also young people. Recently, the scientific community has focused its attention on the possible role of vitamin D in the development of several chronic diseases such as cardiovascular and metabolic diseases. This review aims to highlight the possible role of vitamin D in cardiovascular and metabolic diseases. In particular, here we examine (1) the role of vitamin D in diabetes mellitus, metabolic syndrome, and obesity, and its influence on insulin secretion; (2) its role in atherosclerosis, in which chronic vitamin D deficiency, lower than 20 ng/mL (50 nmol/liter), has emerged among the new risk factors; (3) the role of vitamin D in essential hypertension, in which low plasma levels of vitamin D have been associated with both an increase in the prevalence of hypertension and diastolic hypertension; (4) the role of vitamin D in peripheral arteriopathies and aneurysmal pathology, reporting that patients with peripheral artery diseases had lower vitamin D values than non-suffering PAD controls; (5) the genetic and epigenetic role of vitamin D, highlighting its transcriptional regulation capacity; and (6) the role of vitamin D in cardiac remodeling and disease. Despite the many observational studies and meta-analyses supporting the critical role of vitamin D in cardiovascular physiopathology, clinical trials designed to evaluate the specific role of vitamin D in cardiovascular disease are scarce. The characterization of the importance of vitamin D as a marker of pathology should represent a future research challenge.

Agenda setting for essential medicines policy in sub-Saharan Africa: a retrospective policy analysis using Kingdon’s multiple streams model

Background Lack of access to essential medicines presents a significant threat to achieving universal health coverage (UHC) in sub-Saharan Africa. Although it is acknowledged that essential medicines policies do not rise and stay on the policy agenda solely through rational deliberation and consideration of technical merits, policy theory is rarely used to direct and guide analysis to inform future policy implementation. We used Kingdon’s model to analyse agenda setting for essential medicines policy in sub-Saharan Africa during the formative phase of the primary healthcare (PHC) concept. Methods We retrospectively analysed 49 published articles and 11 policy documents. We used selected search terms in EMBASE and MEDLINE electronic databases to identify relevant published studies. Policy documents were obtained through hand searching of selected websites. We also reviewed the timeline of essential medicines policy milestones contained in the Flagship Report, Medicines in Health Systems: Advancing access, affordability and appropriate use, released by WHO in 2014. Kingdon’s model was used as a lens to interpret the findings. Results We found that unsustainable rise in drug expenditure, inequitable access to drugs and irrational use of drugs were considered as problems in the mid-1970s. As a policy response, the essential drugs concept was introduced. A window of opportunity presented when provision of essential drugs was identified as one of the eight components of PHC. During implementation, policy contradictions emerged as political and policy actors framed the problems and perceived the effectiveness of policy responses in a manner that was amenable to their own interests and objectives. Conclusion We found that effective implementation of an essential medicines policy under PHC was constrained by prioritization of trade over public health in the politics stream, inadequate systems thinking in the policy stream and promotion of economic-oriented reforms in both the politics and policy streams. These lessons from the PHC era could prove useful in improving the approach to contemporary UHC policies.

A Two-Year Outcome Evaluation of Government-Led Initiative to Upscale Hospital-Based Hepatitis C Treatment Using a Standard Two-Drug Regimen in Malaysia

Background: Malaysia has been fully committed to the global endeavor to eliminate hepatitis C virus (HCV) infection by 2030. In early 2018, the Ministry of Health (MOH) embarked on a “one-size-fits-all strategy” by introducing generic versions of sofosbuvir and daclatasvir as the standard treatment for HCV infection in public hospitals nationwide. Objectives: To evaluate the outcomes of such an initiative in multiple aspects, including the number and characteristics of patients treated, the extent of evidence-based drug use, the treatment completion status, individual responses to treatment, common side effects of treatment, and its economic implications. Methods: The findings were generated from the data compiled by the MOH, capturing the information regarding the treatment provided to adult HCV-infected patients in 16 selected hospitals between April 2018 and March 2020, along with the drug costs incurred. Results: A total of 1,797 patients were treated, nearly four times more than the patients receiving interferon-based treatment across the country in the preceding two years. Approximately one-third of them had liver cirrhosis, and the main HCV genotypes were 3 (46.9%) and 1a (20.0%). Dosing, treatment duration and the addition of ribavirin to the treatment generally agreed with the recommendations of the MOH. More than 90% of the patients completed the treatment course, and a sustained virologic response (SVR) rate of 95.4% (95% CI: 94.2, 96.7%) was recorded in those with a known treatment outcome (n = 1,163). The SVR achievement did not vary across HCV genotypes and cirrhosis status, but those ≥ 50 years of age (adjusted OR: 2.13; 95% CI: 1.16, 3.92) were more likely to fail the treatment. Side effects were rare. Anemia and fatigue caused treatment discontinuation in only 0.3% of the patients. The total drug expenditure reached US$678,258.20, and the mean cost of a 12-week treatment course of sofosbuvir and daclatasvir (US$235.16) was lower than the cost expected by the MOH (US$300). Conclusions: The findings demonstrate a high degree of real-world effectiveness, safety, and affordability of the standard treatment, suggesting that such a government-led initiative was reasonable and timely and could be extended to include more public health institutions.

Overuse or underuse? Use of healthcare services among irregular migrants in a north-eastern Spanish region

Background There is little verified information on global healthcare utilization by irregular migrants. Understanding how immigrants use healthcare services based on their needs is crucial to establish effective health policy. We compared healthcare utilization between irregular migrants, documented migrants, and Spanish nationals in a Spanish autonomous community. Methods This retrospective, observational study included the total adult population of Aragon, Spain: 930,131 Spanish nationals; 123,432 documented migrants; and 17,152 irregular migrants. Healthcare utilization data were compared between irregular migrants, documented migrants and Spanish nationals for the year 2011. Multivariable standard or zero-inflated negative binomial regression models were generated, adjusting for age, sex, length of stay, and morbidity burden. Results The average annual use of healthcare services was lower for irregular migrants than for documented migrants and Spanish nationals at all levels of care analyzed: primary care (0.5 vs 4 vs 6.7 visits); specialized care (0.2 vs 1.8 vs 2.9 visits); planned hospital admissions (0.3 vs 2 vs 4.23 per 100 individuals), unplanned hospital admissions (0.5 vs 3.5 vs 5.2 per 100 individuals), and emergency room visits (0.4 vs 2.8 vs 2.8 per 10 individuals). The average annual prescription drug expenditure was also lower for irregular migrants (€9) than for documented migrants (€77) and Spanish nationals (€367). These differences were only partially attenuated after adjusting for age, sex, and morbidity burden. Conclusions Under conditions of equal access, healthcare utilization is much lower among irregular migrants than Spanish nationals (and lower than that of documented migrants), regardless of country of origin or length of stay in Spain.