Search results for: reimbursement
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 16

Search results for: reimbursement

16 The Effect of a New Reimbursement Policy for Discharge Planning Service

Authors: Chueh Chi-An, Chan Hui-Ya

Abstract:

Background and Aim: National Health Insurance (NHI) Administration released a new reimbursement policy for hospital patients who received a superior discharge plan on April 1, 2016. Each case could be claimed 1,500 points for fee-of service with related documents. The policy is considered a solution to help reducing the crowding in the emergency department, the length of stay of hospital, unplanned readmission rate and unplanned ER visit. This study aim is to explore the effect of the new reimbursement policy for discharge planning service in a medical center. Methods: The discharge team explained to general wards the new policy and encouraged early assessment, communication and connecting to community care for patients. They stated the benefit from the policy and asked documenting for reimbursement claiming from April to May 2016. The imbursement fee of NHI declaration from June 2015 to October 2017 was collected. The indicators included hospital occupancy rate, hospital bed turnover rate, long-term hospitalization rate, and patients’ satisfaction were analyzed after the policy implemented. Results: The results showed that the amount of service declaration was increasing from 2 cases in February 2016 to 110 cases in October 2017, the application rate was increasing from 0.029% to 1.576% of all inpatient cases, and the average payment from NHI was around 148,500 NT dollars per month in 2017. There are no significant differences in the indicators among hospital occupancy rate, hospital bed turnover rate, long-term hospitalization rate, and patients’ satisfaction. Conclusion: To provide a good discharge plan require a specialized case manager, the new reimbursement policy is too complicated and the total fee-of-service hospital could claim is too limited to hiring one. The results suggest more strategies combine with the new reimbursement policy will be needed.

Keywords: discharge planning, reimbursement, unplanned ER visit, readmission rate

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15 Impact of U.S. Insurance Reimbursement Policy on Healthcare Business and Entrepreneurship

Authors: Iris Xiaohong Quan, Sharon Qi, Kelly Tianqin Shi

Abstract:

This study focuses on the critical role of insurance policies in a world grappling with increasing mental health challenges, as they significantly influence the dynamics of healthcare businesses and entrepreneurial ventures. The paper utilizes the mental health sector as a case to examine the impact of insurance policies on healthcare service providers, entrepreneurs, and individuals seeking mental health support. This paper addressed the following research questions: To what extent do changes in insurance reimbursement policies affect the accessibility and affordability of mental health services for patients, and how does this impact the overall demand for such services? What are the barriers and opportunities that mental health entrepreneurs face and what strategies and adaptations do mental health businesses employ when navigating the evolving landscape of insurance reimbursement policies? How do changes in insurance reimbursement policies, specifically related to mental health services, influence the financial viability and sustainability of mental health clinics and private practices? Employing a self-designed survey aimed at autism spectrum disorder (ASD) treatment companies, alongside two in-depth case studies and an analysis of pertinent insurance policies and documents, this research aims to elucidate the multifaceted influence of insurance policies on the mental health industry. The findings from this study reveal how insurance policies shape the landscape of mental health businesses and their operations. A total of 821 autism treatment organizations or offices were contacted by telephone between November 1, 2019, and January 31, 2020. About half of the offices (53.33%) were established in the past five years, and 80% were established in the past 15 years. There is a significant increase in the establishment of ABA service centers in the recent two decades as a result of autism insurance reform, the increasing social awareness of ASD, and the redefinition of autism. In addition, almost half of the ABA service providers we surveyed had a patient size ranging from 20 to 50 in the year when the residence state passed the legislation for autism insurance coverage. On average, an ABA service provider works with 5.3 insurance companies. This research find that insurance is the main source of revenue for most ABA service providers. However, our survey reveals that clients’ out of pocket payment has been the second main revenue sources. Despite the changes of regulations and insurance policies in all states, clients still have to pay a fraction of, if not all, the ABA treatment service fees out of pocket. This research shows that some ABA service providers seek federal and government funds and grants to support their services and businesses. Our further analysis with the in-depth case studies and other secondary data also indicate the rise of entrepreneurial startups in the mental health industry. Overall, this research sheds light on both the challenges and opportunities presented by insurance policies in the mental health sector, offering insights into the new industry landscape.

Keywords: entrepreneurship, healthcare policy, insurance policy, mental health industry

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14 The TarMed Reform of 2014: A Causal Analysis of the Effects on the Behavior of Swiss Physicians

Authors: Camila Plaza, Stefan Felder

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In October 2014, the TARMED reform was implemented in Switzerland. In an effort to even out the financial standing of general practitioners (including pediatricians) relative to that of specialists in the outpatient sector, the reform tackled two aspects: on the one hand, GPs would be able to bill an additional 9 CHF per patient, once per consult per day. This is referred to as the surcharge position. As a second measure, it reduced the fees for certain technical services targeted to specialists (e.g., imaging, surgical technical procedures, etc.). Given the fee-for-service reimbursement system in Switzerland, we predict that physicians reacted to the economic incentives of the reform by increasing the consults per patient and decreasing the average amount of time per consult. Within this framework, our treatment group is formed by GPs and our control group by those specialists who were not affected by the reform. Using monthly insurance claims panel data aggregated at the physician praxis level (provided by SASIS AG), for the period of January 2013-December 2015, we run difference in difference panel data models with physician and time fixed effects in order to test for the causal effects of the reform. We account for seasonality, and control for physician characteristics such as age, gender, specialty, and physician experience. Furthermore, we run the models on subgroups of physicians within our sample so as to account for heterogeneity and treatment intensities. Preliminary results support our hypothesis. We find evidence of an increase in consults per patients and a decrease in time per consult. Robustness checks do not significantly alter the results for our outcome variable of consults per patient. However, we do find a smaller effect of the reform for time per consult. Thus, the results of this paper could provide policymakers a better understanding of physician behavior and their sensitivity to financial incentives of reforms (both past and future) under the current reimbursement system.

Keywords: difference in differences, financial incentives, health reform, physician behavior

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13 Low Pertussis Vaccine Coverage Rates among Polish Nurses

Authors: Aneta Nitsch-Osuch, Sylwia Dyk, Izabela Gołebiak

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Background. Since 2014 the pertussis vaccine is recommended to Polish health care workers who have close contacts with infants. Although this recommendation is implemented into the National Immunization Programme, its realization has remained unknown. The Purpose: The aim of the study, conducted at the department of Social Medicine and Public Health (Medical University of Warsaw, Poland), was to describe a perception, knowledge and coverage rates regarding pertussis vaccination among nursing staff. According to the authors' knowledge, it was the first study related to this topic in our country. Material and Methods: A total number of 543 nurses who work at pediatric or neonatal wards was included into the study (501 women and 42 men), average age was 47 years. All nurses were asked to fulfill the anonymous survey, previously validated. Results: 1. Coverage rates: The analysis of results revealed that only 4% of responders reported they were vaccinated with Tdpa within past 10 years, while 8% declared they would plan the vaccine in the future. 35% of responders would consider the Tdpa vaccine whether there is some kind of the reimbursement. 2. Perception and knowledge of the disease and vaccination: The majority (82%) of nurses did not recognize pertussis as a re-emerging infectious disease. 54% of them believed that obligatory vaccinations in the childhood protect against the disease and the protection is a life-long one. Only 15% of nurses considered pertussis as a possible nosocomial infection. The current epidemiology of the disease was known to 6% of responders, while 24% of them were familiar with pertussis vaccination schedules for infants, children and adolescents, but only 9% of responders knew that adults older than 19 years are recommended to be vaccinated with Tdpa every 10 years. Many nurses (82%) would expect more educational activities related to pertussis and methods of its prophylaxis. Conclusions: The pertussis vaccine coverage rate among Polish nurses is extremely low. This is a result of not enough knowledge about the disease and its prevention. Educational activities addressed to health care workers and reimbursement of the pertussis vaccine are required to improve awareness and increase of vaccine coverage rates in the future.

Keywords: coverage, nurse, pertussis, vaccine

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12 Foreign Seeds on Chinese Soil: Public Bonds in Qing China, 1894-1911

Authors: Dan Li, Hao Tang

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The idea of “public bonds” was foreign to Qing China because it went against the traditional political ideology that supported that the emperor had absolute ownership over the nation. When a new fiscal crisis emerged out of the First Sino-Japanese War in 1894, the Qing rulers had no better option than to issue domestic bonds. This article documents the processes of issuance, distribution, and reimbursement for a total of three bonds issued by the Qing. These processes reveal how a well-established Western fiscal instrument could be extremely awkward and difficult to implant in China—a culturally, politically, and institutionally different society. Our paper sheds light on why Qing China failed to rise as a modern fiscal state.

Keywords: public bond, Qing China, fiscal crisis, fiscal state, the first Sino-Japanese war

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11 Economic Growth through Quality in Higher Education

Authors: Mohammad Mushir Khan, C. Satyanarayana

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Education is considered as one of the prime bottlenecks in the economic growth of India. The Ministry of Human Resource & Development, Government of India has, therefore, given special attention to this issue and the Gross Enrollment Ratio (GER) in Higher Education has increased marginally during last five years, with the efforts and various policy decisions like Right to Education (RTE) and other fee reimbursement schemes, initiated by the State Governments. But still this is one of the lowest, if assessed at the global level. It is true that the GER has improved but the survey reveals that the quality has been badly affected. This paper tries to assess the impact of lack of quality education in various sectors that affects Indian Economy and thereby signifies the need of immediate policy decision at the government level. It is to be noted that in higher education, science, management, engineering and technology plays vital role as far as shaping country’s economy is concerned and as such the quality needs to be addressed, particularly, in these streams. The paper, after carefully studying lots of survey reports and other government/ non-government documents recommends measures to be initiated by the Central Government, on priority, for improving quality of education. The quality up-gradation in higher education single handedly provides real fuel to the India’s growth Engine, as it has potential to touch each and every sector that strengthens country’s economy.

Keywords: higher education, economy, accreditation, industry, technology

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10 Fund Seekers’ Deception in Peer-to-Peer Lending in Times of COVID

Authors: Olivier Mesly

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This article examines the likelihood of deception on the part of borrowers wishing to obtain credit from institutional or private lenders. In our first study, we identify five explanatory variables that account for nearly forty percent of the propensity to act deceitfully: a poor credit history, debt, risky behavior, and to a much lesser degree, irrational behavior and disconnection from the bundle of needs, goals, and preferences. For the second study, we remodeled the initial questionnaire to adapt it to the needs of institutional bankers and borrowers, especially those that engage in money on-line peer-to-peer lending, a growing business fueled by the COVID pandemic. We find that the three key psychological variables that help to indirectly predict the likelihood of deceitful behaviors and possible default on loan reimbursement, i.e., risky behaviors, ir-rationality, and dis-connection, interact with each other to form a loop. This study presents two benefits: first, we provide evidence that it is to some degree possible to tighten control over lending practices. Second, we offer a pragmatic tool: a questionnaire, that lenders can use or adapt to gauge potential borrowers’ deceit, notably by combining their results with standard hard-data measures of risk.

Keywords: bundle of needs, default, debt, deception, risk, peer-to-peer lending

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9 Investigating the Effect of Refinancing on Financial Behaviour of Energy Efficiency Projects

Authors: Zohreh Soltani, Seyedmohammadhossein Hosseinian

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Reduction of energy consumption in built infrastructure, through the installation of energy-efficient technologies, is a major approach to achieving sustainability. In practice, the viability of energy efficiency projects strongly depends on the cost reimbursement and profitability. These projects are subject to failure if the actual cost savings do not reimburse the project cost in a timely manner. In such cases, refinancing could be a solution to benefit from the long-term returns of the project if implemented wisely. However, very little is still known about the effect of refinancing options on financial performance of energy efficiency projects. To fill this gap, the present study investigates the financial behavior of energy efficiency projects with focus on refinancing options, such as Leveraged Loans. A System Dynamics (SD) model is introduced, and the model application is presented using an actual case-study data. The case study results indicate that while high-interest start-ups make using Leveraged Loan inevitable, refinancing can rescue the project and bring about profitability. This paper also presents some managerial implications of refinancing energy efficiency projects based on the case-study analysis. Results of this study help implementing financially viable energy efficiency projects, so the community could benefit from their environmental advantages widely.

Keywords: energy efficiency projects, leveraged loan, refinancing, sustainability

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8 Role of a Physical Therapist in Rehabilitation

Authors: Andrew Anis Fakhrey Mosaad

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Objectives: Physiotherapy in the intensive care unit (ICU) improves patient outcomes. We aimed to determine the characteristics of physiotherapy practice and critical barriers to applying physiotherapy in ICUs. Materials and Methods: A 54-item survey for determining the characteristics physiotherapists and physiotherapy applications in the ICU was developed. The survey was electronically sent to potential participants through the Turkish Physiotherapy Association network. Sixty-five physiotherapists (47F and 18M; 23–52 years; ICU experience: 6.0±6.2 years) completed the survey. The data were analyzed using quantitative and qualitative methods. Results: The duration of ICU practice was 3.51±2.10 h/day. Positioning (90.8%), active exercises (90.8%), breathing exercises (89.2%), passive exercises (87.7%), and percussion (87.7%) were the most commonly used applications. The barriers were related to physiotherapists (low level of employment and practice, lack of shift); patients (unwillingness, instability, participation restriction); teamwork (lack of awareness and communication); equipment (inadequacy, non-priority to purchase); and legal (reimbursement, lack of direct physiotherapy access, non-recognition of autonomy) procedures. Conclusion: The most common interventions were positioning, active, passive, breathing exercises, and percussion. Critical barriers toward physiotherapy are multifactorial and related to physiotherapists, patients, teams, equipment, and legal procedures. Physiotherapist employment, service maintenance, and multidisciplinary teamwork should be considered for physiotherapy effectiveness in ICUs.

Keywords: intensive care units, physical therapy, physiotherapy, exercises

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7 Low Influenza Vaccine Coverage Rates among Polish Nurses

Authors: Aneta Nitsch-Osuch, Katarzyna Zycinska, Ewa Gyrczuk, Agnieszka Topczewska-Cabanek, Kazimierz Wardyn

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Introduction: Influenza is an important clinical and epidemiological problem and should be considered as a possible nosocomial infection. The aim of the study was to determine the influenza vaccine coverage rates among Polish nurses and to find out drivers and barriers for influenza vaccination among this group of health care workers (HCWs). Material and methods: The self- fulfilled survey with 26 questions about the knowledge, perception, and influenza coverage rates was distributed among 461 nurses. Results: Only 15% of nurses were vaccinated against influenza in the consecutive seasons. The majority (75%) of the regularly vaccinated nurses were ambulatory careworkers. The difference between the number of vaccinated hospitals and ambulatory care nurses was statistically significant (p < 0.05). The main motivating factors for an influenza vaccination were: a fear of the illness and its complications (97%) and a free of charge vaccine available at the workplace (87%). Ambulatory care nurses more often declared that they were vaccinated mainly to protect themselves while hospital care nurses more often declared the will to protect their patients, these differences in the perception and attitudes to an influenza vaccination among hospital and ambulatory care nurses were statistically significant (p < 0.05). The main barriers for an influenza vaccination among the nursing staff were: a lack of reimbursement of the vaccine (95%), a lack of insufficient knowledge about the effectiveness, and safety of the influenza vaccine (54%). The ambulatory care nurses more often found influenza vaccination as the ethical duty compared to hospital care nurses (p < 0.05). Conclusions: The influenza vaccine coverage rates among the Polish nurses are low and must be improved in the future. More educational activities dedicated to HCWs may result in the increased awareness of influenza vaccination benefits for both medical professionals and patients.

Keywords: influenza, vaccination, nurses, ambulatory careworkers

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6 The Effects of the Introduction of a One-day Waiting Period on Absences for Ordinary Illness of Public Employees

Authors: Mohamed Ali Ben Halima, Malik Koubi, Joseph Lanfranchi, Yohan Wloczysiak

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This article assesses the consequences on the frequency and duration of ordinary sick leave of the January 2012 and 2018 reforms modifying the scope of sick leave reimbursement in the French civil service. These reforms introduce a one-day waiting period which removes the compensation for the first day of ordinary sick leave. In order to evaluate these reforms, we use an administrative database from the National Pension Fund for local public employees (FPT). The first important result of our data analysis is that the one-day waiting period was not introduced at the same time in the French Local Public Service establishments, or even never in some. This peculiarity allows for an identification strategy using a difference-in-differences method based on the definition at each date of groups of employees treated and not treated by the reform, since establishments that apply the one-day waiting period coexist with establishments that do not apply it. Two types of estimators are used for this evaluation: individual and time fixed effects estimators and DIDM estimators which correct for the biases of the Two Way Fixed Effects one. The results confirm that the change in the sick pay system decreases the probability of having at least one ordinary sick leave as well as the number and duration of these episodes. On the other hand, the estimates show that longer leave episodes are not less affected than shorter ones. Finally, the validity tests of the estimators support the results obtained for the second period of 2018-2019, but suggest estimation biases for the period 2012-2013. The extent to which the endogeneity of the choices of implementation of the reform at the local level impact these estimates needs to be further tested.

Keywords: sick leave, one-day waiting period, territorial civil service, public policy evaluation

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5 Cost-Effectiveness Analysis of the Use of COBLATION™ Knee Chondroplasty versus Mechanical Debridement in German Patients

Authors: Ayoade Adeyemi, Leo Nherera, Paul Trueman, Antje Emmermann

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Background and objectives: Radiofrequency (RF) generated plasma chondroplasty is considered a promising treatment alternative to mechanical debridement (MD) with a shaver. The aim of the study was to perform a cost-effectiveness analysis comparing costs and outcomes following COBLATION chondroplasty versus mechanical debridement in patients with knee pain associated with a medial meniscus tear and idiopathic ICRS grade III focal lesion of the medial femoral condyle from a payer perspective. Methods: A decision-analytic model was developed comparing economic and clinical outcomes between the two treatment options in German patients following knee chondroplasty. Revision rates based on the frequency of repeat arthroscopy, osteotomy and conversion to total knee replacement, reimbursement costs and outcomes data over a 4-year time horizon were extracted from published literature. One-way sensitivity analyses were conducted to assess uncertainties around model parameters. Threshold analysis determined the revision rate at which model results change. All costs were reported in 2016 euros, future costs were discounted at a 3% annual rate. Results: Over a 4 year period, COBLATION chondroplasty resulted in an overall net saving cost of €461 due to a lower revision rate of 14% compared to 48% with MD. Threshold analysis showed that both options were associated with comparable costs if COBLATION revision rate was assumed to increase up to 23%. The initial procedure costs for COBLATION were higher compared to MD and outcome scores were significantly improved at 1 and 4 years post-operation versus MD. Conclusion: The analysis shows that COBLATION chondroplasty is a cost-effective option compared to mechanical debridement in the treatment of patients with a medial meniscus tear and idiopathic ICRS grade III defect of the medial femoral condyle.

Keywords: COBLATION, cost-effectiveness, knee chondroplasty, mechanical debridement

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4 Comparison of Patient Satisfaction and Observer Rating of Outpatient Care among Public Hospitals in Shanghai

Authors: Tian Yi Du, Guan Rong Fan, Dong Dong Zou, Di Xue

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Background: The patient satisfaction survey is becoming of increasing importance for hospitals or other providers to get more reimbursement and/or more governmental subsidies. However, when the results of patient satisfaction survey are compared among medical institutions, there are some concerns. The primary objectives of this study were to evaluate patient satisfaction in tertiary hospitals of Shanghai and to compare the satisfaction rating on physician services between patients and observers. Methods: Two hundred outpatients were randomly selected for patient satisfaction survey in each of 28 public tertiary hospitals of Shanghai. Four or five volunteers were selected to observe 5 physicians’ practice in each of above hospitals and rated observed physicians’ practice. The outpatients that the volunteers observed their physician practice also filled in the satisfaction questionnaires. The rating scale for outpatient survey and volunteers’ observation was: 1 (very dissatisfied) to 6 (very satisfied). If the rating was equal to or greater than 5, we considered the outpatients and volunteers were satisfied with the services. The validity and reliability of the measure were assessed. Multivariate regressions for each of the 4 dimensions and overall of patient satisfaction were used in analyses. Paired t tests were applied to analyze the rating agreement on physician services between outpatients and volunteers. Results: Overall, 90% of surveyed outpatients were satisfied with outpatient care in the tertiary public hospitals of Shanghai. The lowest three satisfaction rates were seen in the items of ‘Restrooms were sanitary and not crowded’ (81%), ‘It was convenient for the patient to pay medical bills’ (82%), and ‘Medical cost in the hospital was reasonable’ (84%). After adjusting the characteristics of patients, the patient satisfaction in general hospitals was higher than that in specialty hospitals. In addition, after controlling the patient characteristics and number of hospital visits, the hospitals with higher outpatient cost per visit had lower patient satisfaction. Paired t tests showed that the rating on 6 items in the dimension of physician services (total 14 items) was significantly different between outpatients and observers, in which 5 were rated lower by the observers than by the outpatients. Conclusions: The hospital managers and physicians should use patient satisfaction and observers’ evaluation to detect the room for improvement in areas such as social skills cost control, and medical ethics.

Keywords: patient satisfaction, observation, quality, hospital

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3 Resolving Problems Experienced by Involving Patients in the Development of Pharmaceutical Products at Post-Launch Stage of Pharmaceutical Product Development

Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

Abstract:

Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL

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2 Scientific and Regulatory Challenges of Advanced Therapy Medicinal Products

Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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1 Operational Characteristics of the Road Surface Improvement

Authors: Iuri Salukvadze

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Construction takes importance role in the history of mankind, there is not a single thing-product in our lives in which the builder’s work was not to be materialized, because to create all of it requires setting up factories, roads, and bridges, etc. The function of the Republic of Georgia, as part of the connecting Europe-Asia transport corridor, is significantly increased. In the context of transit function a large part of the cargo traffic belongs to motor transport, hence the improvement of motor roads transport infrastructure is rather important and rise the new, increased operational demands for existing as well as new motor roads. Construction of the durable road surface is related to rather large values, but because of high transport-operational properties, such as high-speed, less fuel consumption, less depreciation of tires, etc. If the traffic intensity is high, therefore the reimbursement of expenses occurs rapidly and accordingly is increasing income. If the traffic intensity is relatively small, it is recommended to use lightened structures of road carpet in order to pay for capital investments amounted to no more than normative one. The road carpet is divided into the following basic types: asphaltic concrete and cement concrete. Asphaltic concrete is the most perfect type of road carpet. It is arranged in two or three layers on rigid foundation and will be compacted. Asphaltic concrete is artificial building material, which due stratum will be selected and measured from stone skeleton and sand, interconnected by bitumen and a mixture of mineral powder. Less strictly selected similar material is called as bitumen-mineral mixture. Asphaltic concrete is non-rigid building material and well durable on vertical loadings; it is less resistant to the impact of horizontal forces. The cement concrete is monolithic and durable material, it is well durable the horizontal loads and is less resistant related to vertical loads. The cement concrete consists from strictly selected, measured stone material and sand, the binder is cement. The cement concrete road carpet represents separate slabs of sizes from 3 ÷ 5 op to 6 ÷ 8 meters. The slabs are reinforced by a rather complex system. Between the slabs are arranged seams that are designed for avoiding of additional stresses due temperature fluctuations on the length of slabs. For the joint behavior of separate slabs, they are connected by metal rods. Rods provide the changes in the length of slabs and distribute to the slab vertical forces and bending moments. The foundation layers will be extremely durable, for that is required high-quality stone material, cement, and metal. The qualification work aims to: in order for improvement of traffic conditions on motor roads to prolong operational conditions and improving their characteristics. The work consists from three chapters, 80 pages, 5 tables and 5 figures. In the work are stated general concepts as well as carried out by various companies using modern methods tests and their results. In the chapter III are stated carried by us tests related to this issue and specific examples to improving the operational characteristics.

Keywords: asphalt, cement, cylindrikal sample of asphalt, building

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