This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.
Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
The article identifies the main problems of eliminating the reduction of environmental damage by improving the response systems to man-made accidents at hazardous production facilities of the oil and gas complex. Risk factors for ensuring safety at a hazardous production facility in the oil and gas industry are identified, the most significant risk factor is identified by the method of hierarchical analysis, and the problem of the engineering and technical factor in the system “man technical environment industrial environment environment” is revealed. “The solution to the problem is indicated the use of a developed mobile emergency response system, which makes it possible to halve the response time to an emergency. The developed response system can be applied at any hazardous production facility in the oil and gas industry due to its flexibility.
flows and the required cost of capital, can be used to validate the price of the new drug from a narrow investor's perspective. The free cash flow represent the sales from the pharmaceuticals, and cash necessary for capital expenditures represent the costs for research & development (R&D) and marketing. The cost of capital refers to the opportunity cost of making a specific investment, which is the rate of return required to persuade the investor to make a given investment. Conclusion: We propose a policy approach for the evaluation of innovative drugs by bridging concepts from health economics and business economic valuation. This approach may justify a drug price from an investor's perspective when the ICER exceeds the threshold and may be used in negotiations between governments and companies.
A173 95% CI: 0.54 to 0.86). However, the total cost of treatment was higher for carbetocin compared with oxytocin, approximately 25.7 times, from the position of the perspective of Kazakhstan healthcare payer. The probability for carbetocin being cost-effective did not exceed 50% for any value of willingness to pay for effect. ConClusions: Our analysis failed to detect a significant difference with respect to postpartum hemorrhage, severe postpartum hemorrhage, mean estimated blood loss and adverse effects between carbetocin and oxytocin. Carbetocin does not seem to be a cost-effective strategy as compared with oxytocin for postpartum haemorrhage. Additional, higher-volume studies examining the clinical effect would be valuable.
A647Objectives: Osteoarthritis (OA) is the most common and costly bone and joint disease in the elderly. Recently, viscosupplementation, an intra-articular injection of artificial joint fluid in order to restore rheological properties affecting lubrication and shock absorption, has introduced as an alternative conservative treatment. To assess the effectiveness and cost-effectiveness of Hylan G-F 20 (Hylan) as a substitute for existing treatments for pain due to OA of the knee, other viscosupplementation devices, and/or as an adjunct to conventional therapy. MethOds: A Markov microsimulation model was developed to define a treatment pathway for OA of the knee, illustrate the current costs of treating patients with the condition, and demonstrate the potential savings associated with introduction of Hylan. A hypothetical cohort of patients categorized as having 2-3 or 4 degree of OA of the knee was followed over a 30-month time period. Results: When comparing intra-articular administration of Hylan, the use of NSAIDs and intra-articular administration of corticosteroids (GCS), rirost costs compared with the strategy of NSAIDs amounted to $192 rate per 1 patient. This increase in efficiency of 20% in favor of Hylan. Accordingly, the ratio ICER was $979 per patient, which is much below the threshold of "society's willingness to pay." Markov cycle for patients with OA of the knee of 4 degrees showed that use of Hylan is more effective in the end point of modeling the effectiveness of this strategy was 12% (compared to 0% in the policies of NSAIDs and corticosteroids). We calculated the total cost of the budget in the application of NSAIDs, GCS, and Hylan, after calculations found that the use of Gilan can save significant budget funds -up to $954582 (for 1,000 patients). cOnclusiOns: Hylan may delay the need for joint replacement in patients with OA of 4 degrees, suggest its use is justified from a clinical and economic standpoint as compared to the consideration of other treatment strategies.
The need for innovative payment models for health technologies with high upfront costs has emerged due to affordability concerns across the world. Early technology adopter countries have been experimenting with delayed payment schemes. Our objective included listing potential barriers for implementing delayed payment models and recommendations on how to address these barriers in lower income countries of Central and Eastern Europe (CEE) and the Middle East (ME). We conducted a survey, an exploratory literature review and an iterative brainstorming about potential barriers and solutions to implement delayed payment models in these two regions. A draft list of recommendations was validated in a virtual workshop with payer experts from the two regions. Eight barriers were identified in 4 areas, including transaction costs and administrative burden, payment schedule, information technology and data infrastructure, and governance. Fifteen practical recommendations were prepared to address these barriers, including recommendations that are specific to lower income countries, and recommendations that can be applied more universally, but are more crucial in countries with severe budget constraints. Conclusions of this policy research can be considered as an initial step in a multistakeholder dialogue about implementing delayed payment schemes in CEE and ME countries.
Objectives: Italian recommendations for human papillomavirus (HPV) immunization currently consider females only. However, males can be vectors in viral transmission and at risk of infection. The BEST II study was designed to evaluate: the cost-effectiveness (CE) of different interventions targeting females as well as males; and the economic impact of vaccination on a wide range of HPV-induced diseases. MethOds: A dynamic Bayesian Markov model was developed to investigate the transmission between sexual partners and the cost-effectiveness of vaccination targeting female and male cohorts in comparison to screening and female cohorts only. A range of HPV-induced diseases was considered (cervical, vaginal, vulvar, anal, head and neck and penile cancer, the associated pre-cancerous stages and anogenital warts). The process of sexual mixing was calculated based on age, gender and sexual behavioural specific matrices to estimate th force of infection dynamically. Increased susceptibility to the virus, associated with early sexual début, a high number of partners, smoking and previous STDs, were included. We considered several scenarios; the baseline assumes universal vaccination to be implemented for 12-year-old females and males. The follow-up period was 55 years. Results: According to our preliminary analysis, universal vaccination resulted in incremental CE ratios (ICERs) corresponding to € 910 and € 5,770, when compared to screeningonly and female-only vaccination, respectively. We performed extensive sensitivity analysis, which confirmed the good CE profile of universal vaccination in Italy. cOnclusiOns: A universal HPV vaccination of male and female programme is more cost-effective than screening and female-only vaccination when accounting for all HPV-related diseases. Universal vaccination programme increase herd immunity and provide indirect protection to unvaccinated girls against HPV. The herd immunity plays a significant role in the economic evaluation of HPV immunization programmes. A universal vaccination may be further useful considering that males are both at risk of infection and vectors in viral transmission.
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