Short- and long-term impacts of the National Essential Medicines Policy on drug availability, price, and usage in a deprived rural county in southwestern China: an interrupted time series analysis across 8 years.

Background: China's National Essential Medicines Policy (NEMP) has been implemented for over 15 years; yet empirical evidence on its long-term impacts is lacking, particularly in remote and rural regions. This study aims to assess the short-and long-term effects of NEMP on the drug availability, price, and usage in a deprived rural county in southwestern China. Methods: A quasi-experimental design was employed, featuring a single-group pre-and-post comparison. We gathered 74,436 procurement records spanning from 2009 to 2016 from the drug warehouses of local medical institutions. Pharmaceutical data were analyzed quarterly, considering various policy and therapeutic attributes. Fisher's Drug Price Index (DPI-F) was calibrated for the retail and wholesale prices of a consistent collection of 405 medications. We conducted interrupted time-series analysis to examine the immediate and enduring impacts of NEMP's initial (commencing in January 2011) and second (starting from December 2015) stages. Results: After initiation of NEMP, the number of available essential medicines surged by 115 but subsequently faced a steady quarterly decline (-9.1) in township healthcare centers (THCs, primary care). Conversely, county hospitals (secondary care) initially saw a reduction of 40 in drug availability but later exhibited a steady increase (+4.2 per quarter) up to the second-stage NEMP. Regarding price, THCs encountered abrupt (-26.1%/-15.9% in retail/wholesale price) and sustained (-0.2%/-0.3% per quarter) price drops after NEMP. The immediate price change after NEMP in county hospitals were milder but significant in non-essential medicines, and long-term declines were also observed in all drugs. As for total sales, a significant long-term disparity emerged between THCs (+0.9% per quarter) and county hospitals (+3.3% per quarter). Following the second-stage NEMP, retail prices in county hospitals further decreased, although wholesale prices did not; however, following price upward trends were observed in both THCs and county hospitals. Lastly, the influences of NEMP varied across different therapeutical categories of medicines. Conclusion: NEMP has successfully regulated drug prices in primary and secondary healthcare facilities in remote and rural areas, both short-term and long-term. However, a remarkable disparity in medicine availability and utilization was observed between different levels of facilities over time. Continuous monitoring is essential, with increased attention needed on the uneven impacts of the policy on diverse drugs, facilities, regions, and demographics.

The cost of total hip arthroplasty: compare the hospitalization costs of national centralized procurement and national volume-based procurement.

Background: With the increasing demand for joint replacement surgery in China, the government has successively issued the policies of national centralized procurement (NCP) and national volume-based procurement (NVBP) of artificial joints. The purpose of this study is to evaluate the impact of NCP and NVBP policies on hospitalization cost, rehospitalization and reoperation rate of total hip arthroplasty (THA). Methods: In total, 347 patients who underwent THA from January 2019 to September 2022 were retrospectively analyzed. According to the implementation of NCP and NVBP, patients were divided into three groups: control group (n = 147), NCP group (n = 130), and NVBP group (n = 70). Patient-level data on the total hospitalization costs, rehospitalization rate, THA reoperation rate and inpatient component costs were collected before and after the implementation of the policies and Consumer Price Index was used to standardize the cost. Results: After the implementation of NCP and NVBP, the total cost of hospitalization decreased by $817.41 and $3950.60 (p < 0.01), respectively. The implantation costs decreased from $5264.29 to $4185.53 and then rapidly to $1143.49 (p < 0.01), contributing to increased total cost savings. However, the cost of surgery and rehabilitation increased after NCP and NVBP implementation (p < 0.01). The proportion of implants decreased from 66.76 to 59.22% and then to 29.07%, whereas that of drugs increased from 7.98 to 10.11% and then to 12.06%. The proportion of operating expenses rose from 4.86 to 8.01% and then to 18.47%. Univariate linear regression analysis showed that hospital stay, NCP and NVBP were correlated with total hospitalization cost (p < 0.01). Multivariate analysis showed that hospital stay, NCP and NVBP were independent predictors of total hospitalization cost (p < 0.01). Conclusion: In this study, hospital stay, NCP, and NVBP were independent predictors of total inpatient costs. After the implementation of NVBP policy, the cost of implants and hospitalization has decreased significantly, and the technical labor value of medical staff has increased, but a multifaceted method is still needed to solve the problem of increasing costs of other consumables. Limitations of the study suggest the need for further and more comprehensive evaluation in the future.

The Impact of Centralized Procurement on Treatment Patterns for Myocardial Infarction and More Principled Utilization of Coronary Stents.

Reducing the price of expensive medical products through centralized procurement is generally considered an effective way to save public medical resources. Against this background, this paper presents an analysis of the impact of centralized procurement in China by comparing the treatment costs and patterns for acute myocardial infarction (AMI) patients before and after the introduction of this method of purchasing, with specific reference to the use of coronary stents. We found that, after the implementation of centralized procurement for coronary stents, the total expenditure of AMI cases receiving percutaneous coronary interventions with stent implantation (PCI with stents) dropped by 23.4%. The use rate of PCI with stents decreased by 32.5%, with the most significant decrease being evident in cases in which two stents were used simultaneously (32.9%). Meanwhile, percutaneous coronary interventions with balloon implantation (PCI with balloons) increased by 31.5% and coronary artery bypass grafting (CABG) increased by 80.3%. Based on these patterns, it can be observed that the use of centralized procurement significantly reduced the profits of the relevant medical manufacturers, forcing them to decrease their marketing investments, weakening their influence on providers, and ultimately resulting in a more principled use of coronary stents. We therefore conclude that, with reference to the data cited, the centralized procurement program led not only to a reduction in procurement prices but also to decreased overuse of these expensive medical products.

Analysis and discussion on the pharmaceutical centralized procurement implementation - a case study of a large provincial hospital in China.

Unaffordable medical treatment and inflated drug prices have become a challenging issue for lawmakers worldwide. To reduce the financial burden and standardize the pharmaceutical market, the Chinese government has issued several detailed regulations, including the measures of drug recruitment and procurement in one and volume purchasing to not only ensure the high quality of approved drugs but also lower the cost of the production and sell procedure. In this work, to have a thorough overview of the enforcement of these regulations, we attempted to critically analyze the data of our hospital's centralized procurement of drugs from 2019 to 2022. We identified some concerns, such as the difficulty in determining the "quantity" of drug procurement, out-of-stock of collectively procured drugs, difficulty in managing the preallocation of associated funds, incomplete centralized procurement systems, etc. Therefore, it is essential to promote a multidimensional strategy, including the combination of the medical insurance reform and drug centralized procurement policies, strict controlling of the forecast quantity of drugs to ensure stable drug supply, improvement of the relevant policies for retaining the surplus of centralized procurement drug medical insurance funds, secureness of the drug procurement system platform, and available reference and guidance for subsequent centralized quantity procurement of drugs.

The impact of centralized coronary stent procurement program on acute myocardial infarction treatments: evidence from China.

Background: The advent of coronary stents has resulted in many more many lives being saved from acute myocardial infarction (AMI). However, the high price associated with this method of treatment also imposes a heavy economic burden on healthcare systems. As a country making significant use of coronary stents, in 2021, China introduced a program around this method of treatment grounded in centralized procurement and it is the focus of this paper to assess the impact of this policy on AMI treatments. Methods: The patients with AMI are selected as the study group, and the patients with pre-cerebral vascular stenosis are selected as the control group, and individual-level medical insurance settlement data are collected from the years 2018, 2019, and 2021. Differences-in-differences methodology is used to analyze the impacts of this program on the probability changes in respect of AMI patients receiving stent therapy, as well as changes relating to cost, length of stay and 30-day readmission. Results: The results show that the reform has led to a reduction in the probability of AMI patients using stents to 51% of the original rate. Additionally, the average cost is shown to have decreased by 41%, and no significant changes can be found in respect of the length of stay and 30-day readmission. Conclusion: In sum, the centralized procurement program is shown to reduce not only the medical expenses incurred by treating patients with AMI, but also the use of coronary stents, resulting in changes to the treatment patterns of patients with AMI.

Does structural form matter? A comparative analysis of pooled procurement mechanisms for health commodities.

INTRODUCTION: Pooled procurement can be seen as a collaboration initiative of buyers. Such mechanisms have received increased attention during the Covid-19 pandemic to improve access to affordable and quality-assured health commodities. The structural form of pooled procurement mechanisms ranges from a third-party organization that procures on behalf of its buyers to a buyer's owned mechanism in which buyers operate more collaboratively. However, little is known about how these types of pooled procurement mechanisms differ in terms of characteristics, implementation and developmental process. To fill this gap, we compared four pooled procurement mechanisms. Two buyer's owned mechanisms: the Organisation of the Eastern Caribbean States (OECS) and the Pacific Island Countries (PIC). And two third-party mechanisms: the Global Drug Facility (GDF) and the Asthma Drug Facility (ADF). METHODS: For this qualitative study, we used a multiple case-study design. The cases were purposefully selected, based on a most-similar case study design. We used the Pooled Procurement Guidance to collect data on individual cases and compared our findings between the case studies. For our analysis, we drew upon peer-reviewed academic articles, grey literature documents and 9 semi-structured interviews with procurement experts. RESULTS: Buyers within a buyer's owned mechanisms differ in procurement systems, financing structures, product needs and regulatory and legal frameworks. Therefore, buyers within such mechanisms require relative alignment on motivations, goals and operations of the mechanism. Our study showed that buyers' relative homogeneity of characteristics and their perceived urgency of the problems was particularly relevant for achieving that alignment. Third-party organization mechanisms require less alignment and consensus-building between buyers. To participate, buyers need to align with the operations of the third-party organization, instead of other buyers. Elements that were essential for the successful implementation and operation of such mechanisms included the procurement secretariat's ability to create local and global awareness around the problem, to induce political will to act upon the problem, to mobilize sufficient funding and to attract qualified staff. CONCLUSION: To successfully sustain pooled procurement mechanisms over time, key actors should drive the mechanism through continuous and reflexive work on stakeholder engagement, mobilization of funding and alignment of interests and needs.

The impact of the national volume-based procurement policy on the use of policy-related drugs in Nanjing: an interrupted time-series analysis.

BACKGROUND: In September 2019, the "4 + 7" centralized procurement pilot program was expanded nationwide aiming at reducing drug prices by means of volume-based procurement and using accredited generic drugs for branded drug substitutes. Given the current uncertain effect of the policy outside pilot areas, this study was conducted to evaluate the impact of the National Volume-based Procurement policy on the use of policy-related drugs after expansion. METHOD: A single-group interrupted time series was applied using drug purchase data, covering 25 months from December 2018 to December 2020. Drugs related to the centralized procurement policy were selected as samples, including 25 first-batch policy-related drugs and 56 alternative drugs. Centralized procured drugs can be divided into bid-winning and non-winning products, where non-winning products were sorted into generic and branded drugs, and alternative products were classified according to different degrees of substitution. Purchase volume, expenditures, and daily costs were measured. RESULTS: After the implementation of the policy, a significant increase was associated with the volume of bid-winning drugs (p < 0.001) and the volume of generic and branded drugs decreased immediately. The DDDc of drugs under the same generic name significantly reduced (an instantaneous drop of bid-winning drugs by approximately 25%, 7.62 CNY for generics and 3.07 CNY for branded drugs), saving 48.2 million CNY of drug expenditures. The policy has a significant effect on the drug for the treatment of cardiovascular diseases and exerted little influence on the drug for the treatment of nervous diseases, and the substitution of generics for antitumor-branded drugs was not obvious. In addition, the procurement volume of alternative drugs appeared to be a "carry-over". CONCLUSIONS: These findings indicated that the policy demonstrated positive effects in terms of price reductions and cost savings and accelerated the substitution of generics against branded drugs. The "patent cliff" for branded drugs has gradually emerged. Besides, a short-term "spillover effect" of the volume of alternative drugs was observed, requiring special attention and vigilance.

From promise to practice: a guide to developing pooled procurement mechanisms for medicines and vaccines.

INTRODUCTION: Buyers of medicines and vaccines are increasingly interested in pooling their procurement to improve access to affordable and quality-assured health commodities. However, the academic literature has provided no detailed description of how pooled procurement mechanisms are set up and develop over time. These insights are valuable as it increases our understanding of implementing and operating pooled procurement mechanisms successfully. Therefore, the aim of this paper is twofold. First, to explore how such mechanisms evolve over time. Second, to clarify the work that is needed to set up and sustain a pooled procurement mechanism. These findings have been translated into our Pooled Procurement Guidance document. METHODS: This qualitative study draws upon theoretical insights from organizational life cycles, collaborative and network governance, semi-structured interviews with procurement experts and academic and grey literature documents on pooled procurement of medicines and vaccines. RESULTS: We identified four general developmental stages of pooled procurement mechanisms: promise, creation, early operational and mature. The promise stage is characterized by initiating engagement between participating actors, while they try to convert their perceived problem(s) or opportunities into a shared vision. The creation stage is where the participating actors formalize and design the mechanism through consensus-building, articulation of a shared plan, and mobilize resources to put the shared plan into action. The early operational stage is where the shared plan is being executed. The newly established or appointed procurement organization is required to learn fast from experience while showing flexibility to the changing needs of buyers and suppliers. Once operations are routinized, the mechanism enters the mature stage. During this stage, the pooled procurement organization develops into a trusted player that provides sufficient incentives for all actors involved. Importantly, pooled procurement mechanisms can stagnate or turn inactive at any time during the developmental process when alignment between actors is threatened. CONCLUSIONS: Pooled procurement mechanisms evolve over time. Setting up such mechanisms is a collaborative process that relies on intentional efforts by key actors involved. To increase the lifespan of pooled procurement mechanisms, key actors need to sustain a relative alignment of goals, needs, motivations and purpose of the mechanism throughout its entire life cycle.

Local causes of essential medicines shortages from the perspective of supply chain professionals in Saudi Arabia.

Background: The global supply chains of essential medicines faced frequent disruptions over the past five years, particularly during the COVID-19 pandemic. Different causes of prescription drug supply interruptions have been identified in Saudi Arabia. However, studies have yet to explore the views of pharmaceutical supply chain personnel regarding the causes of these interruptions. Therefore, this study aimed to survey individuals working in the pharmaceutical supply chains about their views on the observed interruptions in the supply of some essential drugs. Methods: This was a questionnaire-based cross-sectional study. The 10-item questionnaire was created based on the findings of previously published research that investigated the root causes of essential drug shortages and the impact of COVID-19 pandemic on the supply chains of essential drugs in Saudi Arabia. Purposive sampling was used to identify individuals with at least one year of experience in the area of the pharmaceutical supply chain, and the data collection occurred between April 19th, 2022 and October 23rd, 2022. In addition, descriptive statistics (e.g., frequencies and percentages) were conducted to present the views of the respondents. Results: Seventy-nine pharmaceutical supply chain specialists accepted the invitation and completed the questionnaire. About two-thirds (69.62%) of the respondents reported that centralized pharmaceutical procurement negatively affected the supply chain of essential drugs. Procurement of unregistered medications by the Saudi Food and Drug Authority (SFDA), as well as generic drugs with a history of recalls, and failure to supply requested quantities were the three most commonly reported reasons behind the observed interruptions in the supply of some essential drugs according to those respondents with a negative view of the centralized procurement. Furthermore, failure of pharmaceutical companies to inform SFDA of potential drug shortages, manufacturing issues, poor demand forecasting, unpredictable increase in demand, and low prices of essential drugs were also believed to be behind the observed interruptions in the supply of some essential medicines. Conclusion: The majority of surveyed pharmaceutical supply chain professionals held negative views about the role of centralized pharmaceutical procurement in exacerbating the issues with essential medicines supply chain. Future research should examine different strategies to improve purchasing and procurement practices in Saudi Arabia.

The change of drug utilization in China's public healthcare institutions under the "4 + 7" centralized drug procurement policy: Evidence from a natural experiment in China.

Background: Improving drug accessibility and rational drug use are major challenges for China's healthcare reform. In 2018, the Chinese government introduced a novel nationwide policy of centralized drug procurement for off-patent drugs, focusing on improving drug utilization patterns of public medical institutions. Objective: To estimate the impacts of the Chinese centralized drug procurement policy (the so-called "4 + 7" policy) on drug utilization in public medical institutions. Methods: A retrospective natural experimental design and difference-in-difference method were applied using cross-region data extracted from the national procurement database. Eleven "4 + 7" pilot cities (intervention group) and eleven non-pilot provinces (control group) were matched. In addition, "4 + 7" policy-related drugs (n = 116) were selected as study samples, including 25 drugs in the 4 + 7" procurement List ("4 + 7" List drugs) and their alternative drugs (n = 91) that have not yet been covered by centralized procurement policy. Then, the "4 + 7" List drugs were divided into bid-winning and non-winning drugs according to the bidding results, and they were sorted into generic and original drugs. Defined daily dose (DDD) was used to standardize the quantity of drugs used. Results: In the 1-year procurement period, the overall completion rate of agreed procurement volume reached 191.4% in pilot cities. Owing to policy impact, the consumption increased by 405.31% in bid-winning drugs (ß = 1.62, p < 0.001) and decreased by 62.28% (ß = -0.98, p < 0.001) in non-winning drugs. The overall use proportion of bid-winning drugs increased from 17.03% to 73.61% with statistical significance (ß = 1.48, p < 0.001), and increments were also detected in all healthcare settings, regions, and anatomical therapeutic chemical (ATC) categories (all p-values < 0.05). Generics and originators were detected with 67.53% increment (ß = 0.52, p < 0.001) and 26.88% drop (ß = -0.31, p = 0.006) in consume volume. The use proportion of generics increased from 59.23% to 78.44% with significance (ß = 0.24, p < 0.001), as well as in tertiary hospitals (ß = 0.31), secondary hospitals (ß = 0.23), and primary healthcare centers (ß = 0.11) (all p-values < 0.001). The use proportion of relatively quality-guaranteed drugs (i.e. bid-winning and original drugs) increased from 56.69% to 93.61% with significance (ß = 0.61, p < 0.001), and similar increments were also detected in all healthcare settings, regions, and ATC categories (all p-values < 0.05). Conclusion: Healthcare providers demonstrated good compliance with the "4 + 7" policy in completing contracted procurement volume. Centralized drug procurement policy promoted drug consumption gradually concentrated on bid-winning drugs, generic drugs, and more importantly, quality-guaranteed drugs.

Changing Characteristics of Pharmaceutical Prices in China Under Centralized Procurement Policy: A Multi-Intervention Interrupted Time Series.

Objective: National centralized drug procurement organized by the Chinese government currently represents the largest group purchasing organization worldwide, to establish a reasonable price formation mechanism. This study aimed to evaluate the effects of centralized procurement policy on drug price and price ratio in China. Method: Monthly drug procurement data of public medical institutions were extracted from the national procurement database, including 11 pilot cities and 36 months from January 2018 to December 2020. Centralized procured INNs (International Nonproprietary Names) (n = 25) and their alternative INNs (n = 96) were selected as study samples. Centralized procured INNs were divided into bid-winning and non-winning products according to the bidding results. Drug price, price distribution, and price ratio were measured. Multi-intervention interrupted time series analysis was performed to estimate the policy impacts in two centralized procurement periods. Results: The price of centralized procured INNs showed an immediate drop of 44.57% (ß = -0.59, p < 0.001) at the policy implementation, among which bid-winning drugs decreased by 61.71% (ß = -0.96, p < 0.001). No significant change in the price level or trends was found for non-winning products and alternative drugs in the first-year procurement period (all p-values > 0.05). During the second-year procurement period, alternative drugs in four therapeutic categories detected significant increases in the price level (all p-values < 0.05). The overall coefficient of variation of price distribution exhibited upward trends after policy implementation. Among the most centralized procured INNs, the price ratio between certificated generics (generics that have passed the consistency evaluation) and original drugs declined significantly after policy intervention (p < 0.05), whereas the price ratio between uncertificated and certificated generics increased significantly (p < 0.05). Conclusion: Chinese government-organized group purchasing resulted in prominent price reduction of bid-winning drugs. The policy observed a short-term "spillover" effect of synergistic price reduction, while the effect wore off after 1-year procurement period. The extremely dispersed price distribution, as well as unreasonable price ratios, requires further effective price regulation means.

A systematic review of pooled procurement of medicines and vaccines: identifying elements of success.

INTRODUCTION: Pooled procurement of health commodities has increasingly been promoted as a solution to reduce prices, increase availability, and achieve more efficient procurement processes. However, little is known about what is required to implement pooled procurement mechanisms successfully and how they function under specific circumstances. Therefore, the aim of this systematic review is to synthesize empirically grounded insights by identifying the elements that are essential for setting up and operating pooled procurement mechanisms of medicines and vaccines. METHODS: Our review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed, Scopus and Web of Science for empirical studies on pooled procurement of medicines and vaccines using various search terms. Publications were assessed based on predetermined eligibility criteria. RESULTS: Our initial search yielded 1596 publications, of which 44 were eventually included in our review. Most of the included articles focused on pooled procurement mechanisms that operated on a sub-national level (43%), procured a variety of products (38%), and were set up with the goal to contain costs (64%). The review identified several elements that are essential for pooled procurement mechanisms to function. We organized these elements around three key actors in the mechanism: buyers, the pooled procurement organization, and suppliers. To participate in pooled procurement, buyers need a sufficient level of technical capacity, financial capacity and compatible laws and regulations. To carry out pooled procurement, the pooled procurement organization needs sufficient financial capacity, technical capacity, and independent operations. To supply the mechanism with health commodities, suppliers need sufficient incentives, such as a sufficient market size and a prompt payment mechanism. CONCLUSION: Pooled procurement mechanisms are very diverse. They differ in characteristics and organizational structures and are set up to achieve a variety of goals. While certain essential elements are more likely to increase successful implementation and functioning of pooled procurement mechanisms, the organizational structure must be aligned with the goals of the mechanism, and adapted to the local contextual environment.

The effects of pricing policy on the prices and supply of low-cost medicines in Shandong, China: evidence from an interrupted time series analysis.

BACKGROUND: In China, some medicines had a supply problem. In 2015, to address this problem, the Chinese government issued a policy to raise the price cap for some shorted low-cost medicines (LCMs). The objective was to assess the effects on medicine prices and supply of medicines from a medicine pricing policy reform point of view. METHODS: This study was conducted in Shandong, an eastern province of China with a population of 99.4 million. We collected procurement data of all (n = 1494) LCM medicines available between April 2014 and February 2017 from the web-based Provincial Drug Centralized Bidding Procurement System. This study used the Drug Price index and the average price to reveal the price change of LCMs and used the interrupted time series to evaluate the effects of LCM policy on medicine supply by measuring the change of monthly procurement volume, the number of products, and the average delivery time of LCMs. RESULTS: After the policy implementation in October 2015, the quarterly average price of all LCM products, especially traditional Chinese medicines, showed a sudden growth trend. Then after two-quarter implementation of policy, the price recovered to the same trend before policy intervention, which is consistent with the trend of the Drug price index. There were 466 of LCM products available in October 2015. After the policy intervention, the number of products available increased by 109.87% (n = 978) in February 2017, at a growth rate of 6.44% per month (Value = 30.02, P < 0.001). Besides after the intervention in October 2015, the monthly procurement volumes of LCMs increased rapidly, on average, at a rate of 28.93% per month (Value = 474,000, P < 0.001) for all LCMs. The average delivery time of LCMs kept on decreasing from 33.37 days to 10.69 days at a reduced rate of 3.63% (Value = - 1.21, P < 0.001) per month before the policy, while no significant changes were noted. Also, average monthly delivery time was stable at 9 days after the intervention. CONCLUSIONS: The policy promoted the supply of low-cost medicines, which is beneficial for the Universal Health Coverage. However, future policies should focus on monitoring price change and reducing the delivery time of generic medicines.

Distribution of essential medicines to primary care institutions in Hubei of China: effects of centralized procurement arrangements.

BACKGROUND: Poor distribution of essential medicines to primary care institutions has attracted criticism since China adopted provincial centralized regional tendering and procurement systems. This study evaluated the impact of new procurement arrangements that limit the number of distributors at the county level in Hubei province, China. METHODS: Procurement ordering and distribution data were collected from four counties that pioneered a new distribution arrangement (commencing September 2012) compared with six counties that continued the existing arrangement over the period from August 2011 to September 2013. The new arrangement allowed primary care institutions and/or suppliers to select a local distributor from a limited panel (from 3 to 5) of government nominated distributors. Difference-in-differences analyses were performed to assess the impact of the new arrangements on delivery and receipt of essential medicines. RESULTS: Overall, the new distribution arrangement has not improved distribution of essential medicines to primary care institutions. On the contrary, we found a 7.78-19.85 percentage point (p < 0.01) decrease in distribution rates to rural primary care institutions. Similar results were demonstrated using the indicator of received rates, with a 7.89-19.65 percentage point (p < 0.01) decrease. CONCLUSIONS: Simply limiting the number of distributors does not offer a solution to the poor performance of delivery of essential medicines for primary care institutions, especially those located in rural areas. Procurement arrangements need to consider the special characteristics of rural facilities. In a county, there are more rural primary care institutions than urban ones. On average, rural primary care institutions demand more and are more geographically dispersed compared to their urban counterparts, which may impose increased distribution costs.

The impact of HTA and procurement practices on the selection and prices of medical devices.

Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices. This paper focuses on medical devices (MDs) and investigates the combined effect of various HTA governance models and procurement practices on the two steps of the MD purchasing process (i.e., selecting the product and setting the unit price). Our analyses are based on primary data collected through a national survey of Italian public hospitals. The Italian National Health Service is an ideal case study because it is highly decentralized and because regions have adopted different HTA governance models (i.e., regional, hospital-based, double-level or no HTA), often in combination with centralized regional procurement programs. Hence, the Italian case allows us to test the impact of different combinations of HTA models and procurement programs in the various regions. The results show that regional HTA increases the probability of purchasing the costliest devices, whereas hospital-based HTA functions more like a cost-containment unit. Centralized regional procurement does not significantly affect MD selection and is associated with a reduction in the MD unit price: on average, hospitals located in regions with centralized procurement pay 10.1% less for the same product. Hospitals located in regions with active regional HTA programs pay higher prices for the same device (+23.2% for inexpensive products), whereas hospitals that have developed internal HTA programs pay 8.3% on average more for the same product.