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PP55 HTA And High Cost Innovative Therapies - Focus On Cancer Drugs
- Ralitsa Raycheva, Rumen Stefanov
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 88
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Introduction:
High-cost innovative therapies are considered as high-risk investments in the reality of limited health care budgets. Health technology assessment (HTA) facilitates evidence-based decision making that relies on robust assessment of the clinical cost-effectiveness of the technology that is often not available for expensive cancer therapies (CT).
Methods:The objective of the study is to undertake a systematic comparison between HTA agencies worldwide in order to identify similarities and differences in the methods and processes in HTA of CT. A cross-sectional web-based survey was conducted between September 2013 and May 2015. We received responses from 161 HTA organizations based in thirty-nine countries.
Results:HTA of CT is mainly performed by agencies in South America (38.46 percent), Australia (37.05 percent) and Europe (36.07 percent), followed by agencies in North America (20.00 percent) and Asia (16.67 percent). Logically, the agencies in high income countries produce more assessments of CT (40.23 percent), which in 34.43 percent they determine as innovative technologies compared with 10.00 percent of the units based in middle income countries and active in CT assessment (11.11 percent). We prove association (p < 0.05) between (i) the type of HTA and income per capita; the level at which the organization operates; its main activity; and the level of recommendation dissemination; (ii) the main target group and consumers of the final HTA product; the stage of evolution of the technology, on which it is likely to be assessed; and approaches to identify innovative technologies. The most active in the preparation of HTA reports are biomedical companies (50.00 percent), government agencies (42.11 percent) and professional organizations (40.00 percent). HTA bodies that assess CT distribute recommendations (37.50 percent) nationally and they are mainly addressed to private health care providers (66.67 percent).
Conclusions:Making coverage decisions based on HTA recommendations control the technologies introduction into the healthcare system that is why it's very important this tool to be properly adjusted to the specific needs of CT assessment.
PP071 Health Technology Assessment In Bulgaria: A Review Of The First Fifteen Reports Assessed
- Ralitsa Raycheva, Georgi Iskrov, Rumen Stefanov
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 103-104
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INTRODUCTION:
In Bulgaria, the regulatory body sets for the first time legal requirements for Health Technology Assessment (HTA) in Law on Medicinal Products in Human Medicine (LMPHM) on 27 June 2015. The next essential step for HTA capacity building was the promulgation of Ordinance 9 / December 1, 2015 on the conditions and procedures for conducting health technology assessment by the Ministry of Health (1). In the beginning of 2016, the Main Price and Reimbursement Committee was set and launched a process for establishing the small working groups with the task of reviewing the first applicants reports of pharmaceuticals for inclusion in the Positive Drug List (PDL).
METHODS:The objective of this study is to summarize the recommendations of the newly established HTA Committee in Bulgaria and to examine the characteristics of the technologies and the key considerations that led to those decisions. We systematically read all published by the Committee recommendations for 2016 and analyzed them under: type of recommendations (positive or negative for inclusion in PDL), population, specialization, type of service, type of justification and the impact on final conclusions.
RESULTS:For the first year of its work the HTA Committee was able to assess fifteen technologies (pharmaceuticals) and only one received a negative recommendation (6 percent) from the working group. All the rest (n = 14; 94 percent) were recommended for funding. The final recommendation from the Main Price and Reimbursement Committee is available for four (27 percent) technologies – all positive for inclusion in PDL. All recommendations were connected with adults and in oncology (n = 4; 27 percent); heart diseases (n = 4; 27 percent); Chronic Obstructive Pulmonary Disease, COPD (n = 2; 13 percent); diabetes (n = 2; 13 percent); psoriasis (n = 2; 13 percent); Hepatitis C (n = 1; 7 percent). The only negative recommendation was justified due to lack of robust evidence, safety issues and credibility of HTA analysis (2).
CONCLUSIONS:The information about the number of applications received from the Committee is not available and correct conclusions about the capability is not possible, but indirect circumstances, as the lack of well-trained HTA experts, certainly impede establishment of the small working groups and slow the assessment process (3). At this point it is clear that additional efforts are need to overcome the barriers and smooth adoption and implementation of HTA methods in Bulgaria.
VP81 Health Technology Assessment And Rare Disease Decision Making: Focus On Orphan Drugs
- Ralitsa Raycheva, Rumen Stefanov
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 186-187
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INTRODUCTION:
Health Technology Assessment (HTA) is applied to determine the value of innovative technologies. It usually relies on robust assessment of the clinical cost-effectiveness of the technology, while clinical and economic evidence required for this purpose are often not available for orphan drugs (OD) (1,2). The objective of the study is to undertake a systematic comparison between HTA agencies worldwide in order to identify similarities and differences in the methods and processes in HTA of OD.
METHODS:A cross-sectional web-based survey was conducted between September 2013 and May 2015. The data were obtained from a semi-structured questionnaire. We received responces from 161 HTA organizations based in 39 countries.
RESULTS:HTA of OD is performed by agencies in South America (38.5 percent), followed by agencies in Australia (37.5 percent) and Europe (36.1 percent). The agencies in high income countries produce more assessments of OD (36.8 percent), which in 31.2 percent they determine as innovative technologies compared with 11.8 percent of the units based in low income countries and active in OD assessment (11.1 percent). We prove association (p< .05) between (i) the type of HTA and income per capita; the level at which the organization operates; its main activity; and the level of recommendation dissemination; (ii) the main target group and consumers of the final HTA product; the stage of evolution of the technology, on which it is likely to be assessed; and approaches to identify innovative technologies. The most active in the preparation of HTA reports are biomedical companies or other organizations in the private sector (50.0 percent) and organizations in the pharmaceutical and/or medical industry (66.7 percent). HTA bodies that assess OD develop (36.0 percent) and distribute recommendations (35.9 percent) nationally; their main activity is to produce guidelines for good clinical practice (46.9 percent). Agencies that perform OD assessment are active in evaluation of innovative (37.2 percent) and emerging (35.9 percent) technologies, which are able to be identified by developing early warning systems (32.0 percent).
CONCLUSIONS:Making coverage decisions based on HTA recommendations control the technologies introduction into the healthcare system, that is why it's very important that this tool is properly adjusted to the specific needs of OD assessment (3).
VP94 Framework Of High-Quality Value Assessment Criteria In Health Care
- Ralitsa Raycheva, Rumen Stefanov
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 191-192
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INTRODUCTION:
No single assessment can evaluate the wide spectrum of health technologies pending access to healthcare systems. It is important to envision a complex systematic framework, in which different instruments are used for different purposes - all criteria should be used to ensure the transparency of the process, and should model good assessment and implementation practices (1,2).
METHODS:A cross-sectional web-based survey was conducted from September 2013 to May 2015 which was designed to gain information about the present status of Health Technology Assessment (HTA) activities; to examine its institutional contexts and the kind of application of its principles, logic, assessment methods, tools and best practices.
RESULTS:A total number of 161 questionnaires from 39 countries on 6 continents were received representing a 41.7 percent response rate. Based on analysis of the results, a complex systematic framework for value assessment was designed. Five major features define the framework that can fully measure the common and support the evaluation of more complex health technologies: (i) implementation of higher-order evaluation approaches that support complex multi-criteria assessment, rather than emphasizing only the use of basic evaluation procedures; (ii) precise evaluation of critical criteria, that measure technologies directly as they will be used in actual practical settings; (iii) assessment approaches, based on international best HTA practices that are accurate, in terms of the content and context of the evaluated technology, as well as the expected performance; (iv) high-fidelity priority-setting elements that are evaluation sensitive; and (v) assessments that are sound, unbiased, and transparent – in order to be truly valid for a wide range of technologies, assessments should evaluate them accurately and do so reliably across technology content and context. They should be unbiased and accessible and used in ways that support superior outcomes and higher quality for healthcare systems.
CONCLUSIONS:The healthcare systems that decide to use this framework should evaluate the set of assessments they select and develop them against the standards required, and should use them in ways for which they have been appropriately validated and in contexts that ensure a transparent evaluation process (3).