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The hospital-based Health Technology Assessment (HB-HTA) Unit in the Hospital of the President’s Affairs Administration has been operating since 2015 and is the first example of the implementation of the HB-HTA system in Kazakhstani hospitals. In addition to assessing the feasibility of implementing new health technologies (HTs) into the hospital’s practice, the Unit also interacts with the National Regulatory Authority (NRA) to transfer new technologies into the National Reimbursement System (NRS). We report on the transformation of the HB-HTA Unit from a stand-alone entity to an integrated, specialized agency.
Methods
Data were drawn from reports of the HB-HTA Unit and internal NRA documents. Inclusion of new HTs into the NRS consists of the following sequential stages: (i) implementing the technology in at least one hospital; (ii) filing an application with the Ministry of Health Care (MoH) in the field of HTA to resolve the issue of reimbursement at the national level; (iii) in case of a positive decision, approval at the national level of the clinical protocol for using the medical intervention; (iv) agreement on the reimbursement price of the technology.
Results
Based on positive recommendations from the HB-HTA report in 2015, the hospital implemented 19 new nuclear medicine technologies. In 2016, the hospital initiated an application to the MoH to include these technologies in the NRS (previously, these technologies were carried out only for a fee or with private insurance). From 2016 to 2020, a positive decision from the MoH was received, protocols for medical interventions were published at the national level, and cost estimates were formulated. In 2021, 19 new medical services in nuclear imaging and scintigraphy were included in the NRS.
Conclusions
Despite the long and bureaucratic process of including new HTs in the NRS, the HB-HTA Unit managed to speed up this process. One of the main priorities of the integrated HB-HTA Unit is to promote the transfer of HTs into the health system at the national level.
Positron emission tomography combined with computed tomography (PET/CT) using 11C-methionine (11C-MET) is used to detect astrocytomas and low-grade brain tumors, in the primary detection of all malignant and benign neoplasms of the central nervous system (CNS), and in order to monitor staging and evaluate the results of treatment.
Methods
To assess the clinical and economic effectiveness of PET/CT with the use of radiopharmaceutical drugs (RFLP) based on 11C-MET in the diagnosis of CNS neoplasms, a systematic review of literature by keywords in the Pubmed/MEDLINE database was conducted. The search result was 218 publications. The analysis included 21 publications that met the search criteria, including three meta-analyses and six systematic literature reviews.
Results
Diagnostic efficacy in distinguishing gliomas of high and low malignancy has moderate diagnostic accuracy (combined sensitivity and specificity were 80% and 72%, respectively), but higher sensitivity compared to Fludeoxyglucose F18 (18F-FDG). PET/CT with 11C-MET demonstrated good diagnostic value in detecting brain tumor recurrence (combined sensitivity and specificity of 92% and 87%, respectively) compared with 18F-FDG.
Conclusions
PET/CT diagnostics of CNS neoplasms using the drug 11C-MET is an innovative technology with greater specificity and sensitivity than 18F-FDG, positively influences the subsequent surgery plan and identifies tumors previously undetermined by magnetic resonance imaging (MRI), CT or PET/CT with 18F-FDG.
Positron emission tomography combined with computed tomography (PET/CT) using 18F-sodium fluoride (18F-NaF) is used for functional imaging in diseases to detect abnormally altered osteogenic activity, such as benign and malignant bone diseases and inflammatory or traumatic changes in skeletal bones.
Methods
A systematic search of literature using keywords in the MEDLINE database was conducted to identify literature on the clinical and cost effectiveness of using PET/CT with 18F-NaF-based radiopharmaceuticals in the diagnosis of bone and cartilage cancer. The search retrieved 323 publications. The analysis included 11 publications that met the selection criteria, including one meta-analysis and ten literature reviews.
Results
The pooled sensitivity, specificity, diagnostic odds ratio (DOR) and area under the receiver operating characteristic curve of 18F-NaF-based PET/CT for the detection of bone metastases were 0.98 (95% confidence interval [CI]: 0.95, 0.99), 0.90 (95% CI: 0.86, 0.93), 123.2, and 0.97, respectively. 18F-NaF-based PET/CT was highly effective in detecting bone metastases during staging and restaging of patients with high-risk prostate cancer. The effectiveness of 18F-NaF-based PET/CT was superior to bone scintigraphy with technetium-99m and single-photon emission computed tomography (SPECT) and was comparable to diffusion-weighted imaging.
Conclusions
PET/CT with 18F-NaF is a more accurate method of localizing and characterizing malignant bone lesions than SPECT. This method has improved clinical accuracy and provides greater convenience for patients and referring physicians. PET/CT with 18F-NaF in malignant neoplasms is a more specific, sensitive study than 18F-fluorodeoxyglucose PET/CT. These results were submitted to the Ministry of Health for a decision on the inclusion of 18F-NaF-based PET/CT in the state reimbursement system.
Major depressive disorder (MDD) severely limits a person’s psychosocial functioning and reduces quality of life. According to world statistics, about 3.8 percent of the population, or about 280 million people, suffer from depression. Approximately one-third of patients with MDD have treatment-resistant depression (TRD). Meanwhile, Vagus Nerve Stimulation (VNS) therapy was approved by the US Food and Drug Administration and received CE marking in Europe for the treatment of chronic or recurrent depression in the early 2000s. The aim of this analysis is to determine the impact of VNS use in the treatment of TRD.
Methods
A comprehensive literature search was performed in MEDLINE/PubMed and Google Scholar databases in order to estimate the clinical effectiveness of neurostimulator implantation for treatment of TRD. The main assessment methods were the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale and the Beck Depression Inventory.
Results
In total, 6 systematic reviews with meta-analyses on the effectiveness of VNS in TRD were studied. The identified meta-analyses did not report any statistically significant differences in treatment outcomes favoring VNS compared to placebo and treatment as usual (TAU). However, the results of two studies demonstrate its positive clinical effect in the form of additional treatment to the TAU with longer follow-up period. An improvement in the clinical response is observed on average after 12 months as a decrease of about 50 percent in the initial estimates of depression.
Conclusions
Despite the lack of clinical evidence of the benefits of treating depression, VNS therapy should be used as a standard adjunct treatment to antidepressants or other treatments for people with TRD. Many studies tend to suggest that the efficacy and safety of VNC in depression is still unclear, and additional further research is still needed to establish clinically significant effects.
Pelvic floor diseases (PFD) often affect the adult population, with approximately 50 percent of women aged 50 years and older suffering from PFD. The condition has complex symptoms that may lead to stress and a negative impact on the quality of life. The USA spends about USD 1 billion annually on inpatient costs as a result of more than 700,000 emergency department visits and 50,000 hospitalizations associated with PFD. Defecography is currently the most commonly used method of diagnostic imaging used to evaluate PFD. This technology is not available in the Republic of Kazakhstan, despite its high diagnostic value.
Methods
In order to assess the clinical effectiveness of defecography, we have conducted a literature search in the MEDLINE database. We selected articles with pairwise comparisons of defecography with other tests: anorectal manometry; balloon expulsion test; electromyography; magnetic resonance imaging (MRI); and, ultrasound.
Results
The findings are primarily based on two meta-analysis (91 studies representing 10,768 cases). The results have been evaluated according to the detection frequency and omission of the following signs: cystocele, middle compartment descent, rectocele, intussusception, rectal prolapse, enterocele, and perineal descent. The literature review did not reveal significant difference in diagnostic value between MR defecography and defecography based on X-ray. However, the imaging endpoints (detection rate of structural and functional abnormalities) for defecography based on X-ray were significantly better than plain radiography.
Conclusions
The defecography is currently considered the gold standard and the most commonly used tool of diagnosis. The implementation does not require an expensive equipment purchase (MR defecography) and is reproducible on conventional X-ray equipment if the necessary inventory is available.
Magnetic resonance imaging guided high-intensity focused ultrasound (MR-HIFU) is a non-invasive technique with a low risk of complications for the patient and few side effects. Integration with MRI allows monitoring of the temperature regime of thermal doses, which protects important structures from overheating, and at the same time directing a high thermal dose to the target tissue.
MR-HIFU in the treatment of uterine fibroids, prostate cancer and the treatment of pain in bone metastases is compared with both traditional methods of treatment (uterine artery embolization, hysterectomy, prostatectomy, etc.).
Methods
To assess the clinical effectiveness and safety of non-invasive MR-HIFU, a literature search was performed in the MEDLINE database using the following keywords:“MRgFUS” “MR-HIFU”. The following filters were used: (i) article type: meta-analysis, systematic review, guidance; (ii) date of publication: no later than 5 years (from 2016).
Results
According to the search terms, 104 publications were submitted to MEDLINE for keywords. After using filters, 57 publications were identified to familiarize themselves with research abstracts. The analysis included six publications according to PICO criteria.
The use of non-invasive MR-HIFU therapy for the treatment of uterine fibroids, prostate cancer and various forms of metastatic bone lesions does not have convincing evidence of advantages over standard treatment methods (surgical resection, embolization, etc.) and may be used only as an alternative technique or in addition to standard therapy.
Conclusions
Despite some advantages of the MR-HIFU technology, it is experimental and should only be used as an alternative to surgical treatment. Convincing evidence of the efficacy of MR-HIFU treatment in meta-analyses, systematic reviews, and randomized controlled trials has not yet been published.
Osteoarthritis (OA) is a heterogeneous group of diseases of various etiologies based on the defeat of all components of the joint. OA is one of the main causes of disability in older people. To date, joint replacement is the most clinical and cost-effective method of the terminal stage treatment. The short and long-term success of total joint replacement is closely related to the accuracy of the prosthesis implantation. Published studies show that the accuracy of prosthesis implantation can be intraoperatively controlled by computed navigation and robotic systems better than by traditional methods.
Methods
In order to assess the clinical effectiveness of the technologies, we have conducted a literature search in the MEDLINE database. We included studies that reported a comparison of outcomes between conventional methods, computer navigation and robot-assisted surgery.
Results
The results of this literature review are based on six systematic reviews with meta-analyses (101 studies representing 482,367 cases) and one national joint replacement registry. The outcomes compared included Knee Society Score (KSS)-function, alignment correction, mechanical axis (varus and vagus deviance >3°), prosthesis positioning, soft tissues balancing and functional outcomes. Thus, the cumulative success rate in the computed navigation and robotic systems group was reported to be 86.7 percent, which is crucial considering its lowered rate of revision (3%), correct mechanical axis (≤3%) and functional status.
Conclusions
The literature review demonstrates a high potential of the computed navigation and robotics systems in the intraoperative monitoring of important surgical parameters for achieving the best intervention outcomes. All the clinical endpoints were significantly better by comparison with conventional method.
Contrast-induced nephropathy (CIN) is a common cause of hospital-acquired acute kidney injury (AKI) following the administration of contrast media for coronary interventions or procedures such as diagnostic coronary angiography. The optimal way of preventing CIN remains uncertain. However, preliminary intravenous hydration, minimizing the volume of contrast media, and avoiding the use of nephrotoxic drugs are recommended in current management guidelines. The aim of this analysis was to compare the RenalGuard® system with standard care.
Methods
A comprehensive literature search was conducted in PubMed and Google Scholar to identify evidence on the clinical and economic effectiveness of forced diuresis with matched hydration using the RenalGuard system for preventing CIN. Multiple criteria decision analysis (MCDA) was used to assess the performance of the method in hospital settings, compared with alternative options.
Results
Several systematic reviews with meta-analyses demonstrated that forced diuresis with matched hydration using the RenalGuard system was associated with a significantly lower relative risk of CIN among high-risk patients with chronic kidney disease. However, the evidence supporting the advantage of the proposed method over current forced diuresis techniques with manual calculation of the volumes for matched hydration in the hospital setting was limited.
Conclusions
Although the effectiveness of the RenalGuard system has been demonstrated in meta-analyses, its clinical advantage over forced diuresis with manual hydration calculation is uncertain. It is also worth noting the lack of evidence to date on this technology, the fact that it is still at the research stage in some countries, and that it is not included in CIN management guidelines.
Interventional procedures often use iodinated contrast media (ICM) to visualize the area of interest. However, the use of ICM can cause contrast-induced nephropathy (CIN), which is a frequent complication after catheterization and is associated with morbidity and mortality. CIN is also a common complication in patients with pre-existing chronic kidney disease, diabetes, and heart failure. The purpose of this analysis was to compare carbon dioxide (CO2) with conventional contrast agents.
Methods
To assess the clinical effectiveness of CO2 in preventing CIN, a systematic review of relevant literature, including international guidelines, from the Medline database was conducted. Imaging of the chest, aorta, coronary arteries, and cerebral circulation with CO2 is limited, so effectiveness was determined in the field of renal and peripheral artery angioplasty. The effect on intervention cost was the main outcome.
Results
Use of CO2 generally reduced renal toxicity and anaphylactic reaction, but the benefits remain controversial. Angiography with CO2 is reasonable when image accuracy is not crucial due to its low informative value. Strategies for preventing acute kidney injury demonstrated the effectiveness of sodium chloride administration before and after the procedure. Additionally, the absence of risk factors for kidney disease significantly reduced the risk of impaired renal function.
Conclusions
Although CO2 is one of the alternative methods for visualization, it is not pivotal in preventing CIN, even though the manufacturers recommend CO2 as the preferred contrast agent in patients with renal insufficiency who are allergic to ICM. The economic indicators for the use of CO2 are similar to traditional visualization methods.
The experience of implementing a hospital-based health technology assessment (HB-HTA) system in Kazakhstan is currently represented by only one organization, an independent HB-HTA unit established in 2015 in the Medical Center Hospital of the President's Affairs Administration (the Hospital). Despite the demonstrated positive experience of the Hospital, the widespread implementation of the HB-HTA system in Kazakhstan has experienced some barriers that must be considered before further development can occur.
Methods
To determine the barriers to developing and implementing HB-HTA in Kazakhstani hospitals, data from the Hospital's experience were obtained through a survey of Kazakhstan hospitals, conducted on behalf of the Ministry of Health Care. An official response was received from 29 hospitals. During the survey and discussions with hospital staff using the “brainstorming” method, several barriers to the development of HB-HTA in Kazakhstan were identified.
Results
Barriers at the system level included the lack of monitoring of the HB-HTA system at the national and regional levels and a lack of methodological support. Organizational barriers included a critically small number of HTA experts and the need for additional logistical support and funding from hospitals. The subjective factors we attributed to the rejection of the HB-HTA system by hospital management were the underestimation of lost profits and that HTA is a tool for promoting a transparent and open system for making managerial decisions.
Conclusions
Despite some barriers, the development of HB-HTA in Kazakhstan is a promising area. The heads of key hospitals in Kazakhstan demonstrated a readiness and understanding of the need to use the principles of health technology assessment and clinical and economic analysis to promote the active transfer and implementation of innovative medical technologies.
According to international experience in the field of hospital-based health technology assessment (HB-HTA), most of the implemented new health technologies must undergo a clinical and economic assessment (CEA) of their viability by creating a mini-health technology assessment report. However, HB-HTA should not be limited only to the initial CEA; further monitoring of the effectiveness of implemented new health technologies is necessary.
Methods
We developed a special reporting form for creating a CEA of implemented new health technologies and integrated it into the hospital information system. Indicators of clinical effectiveness are determined individually for each implemented technology. The main indicators of economic effectiveness are financial results (or net profit) and profitability—high-cost and high-tech health technologies have priority for monitoring.
Results
In order to ensure a more detailed and complete CEA of implemented health technologies, the following measures were proposed: (i) before implementing the technology, determine the key clinical effectiveness criteria for further monitoring for each implemented health technology; (ii) if possible, determine comparative technologies (alternatives or analogs) for conducting comparative CEA of the implemented health technologies; and (iii) carry out a prospective CEA of the implemented health technologies with a view to publishing the results.
Conclusions
The organization of a continuous monitoring process that analyzes the effectiveness and usage of new health technologies in hospital practice will allow assessment of the following: the clinical effectiveness and safety of the implemented technologies in comparison with world data; the economic effectiveness of the technology, including an accurate calculation of the payback period for investments; and the “real” data on the effectiveness of implemented health technologies in comparison with the initial request for implementation.
Hospital-based health technology assessment (HB-HTA) in Kazakhstan is currently at the initial stage of development. The Medical Center Hospital of the President's Affairs Administration, Nur-Sultan is one of the first examples of implementing and using an HB-HTA system in practice, having included in its structure an HB-HTA unit in 2015.
Methods
In order to evaluate the current situation of using the principles of HB-HTA in Kazakhstan hospitals, a special questionnaire was developed. The questionnaire was sent in the form of an official request on behalf of the Ministry of Health Care. An official response was received from twenty-nine hospitals, of which nine were at the federal level, thirteen at the regional level, and seven at the city level.
Results
Of the twenty-nine hospitals that participated in the survey, only half (52%) indicated that they were aware of the principles of using the HB-HTA system and of the structure and functions of mini-health technology assessment reports (55%). Nonetheless, most hospitals (90%) noted that the results of HB-HTA may affect the final decision on implementing new technologies in practice, and that using the systematic approach of technology assessment is necessary.
Conclusions
In assessing the clinical and economic effectiveness of new health technologies in hospitals, and the viability of implementing them, there is a lack of standardized processes in managerial decision making. The assessment of clinical effectiveness and safety when implementing technologies is carried out mainly by technology applicants or by the main specialists who are responsible for the profile of evaluating technology. This can be regarded as a conflict of interest, since the applicant's wish to introduce the new technology may bias the evaluation process.
Worldwide, more than 50 million people suffer from epilepsy, and there are 16–51 new cases per 100,000 population each year. Up to 30 percent of patients with epilepsy are pharmacoresistant, who are candidates for surgical treatment. Invasive electroencephalography (iEEG) is a mandatory method in the arsenal of epileptic centers, and is gradually becoming the gold standard for invasive determination of boundaries between the affected and functional zones of the cortex and subcortical brain. Treatment costs correlate with the severity of the disease, with patients having uncontrolled seizures incurring eight times the costs compared to those with controlled epilepsy.
Methods
To assess the clinical and cost-effectiveness of the iEEG in the pre-surgical diagnosis of pharmacoresistant epilepsy, a systematic search of literature by keywords in the MEDLINE database was conducted. The search resulted in sixty-six articles. The analysis included twenty studies that met the search criteria.
Results
Most studies including meta-analysis show very low rates of complications of iEEG. Literature data demonstrate cost-effectiveness of the method in patients with pharmacoresistant epilepsy in comparison with continued antiepileptic drug therapy. As an integrated method, rather than a simple method, it takes maximum account of clinical, neurophysiological and anatomical-functional data to achieve accurate localization of the epileptogenic zone. Currently, iEEG is a clinically effective method to improve the safety and specificity of resective surgery.
Conclusions
With the use of iEEG, mortality and disability of patients with pharmacoresistant epilepsy will be significantly reduced. It has also been proven that epilepsy surgery leads to significant financial savings in the treatment of pharmacoresistant epilepsy. The results of the clinical and economic evaluation (mini-HTA report) have been submitted to the Ministry of Healthcare for decision-making on including iEEG in government reimbursement system.
ABC-VEN analysis is an easy method of clinical and economic analysis on the costs of drug coverage and an important tool for monitoring and ensuring the rational use of medicines. However, this methodology is difficult to apply in assessing the viability of medical equipment procurement (MEP) in hospital. Using a combined model of ABC analysis and Multiple criteria decision analysis (MCDA) may be more appropriate to apply to MEP.
Methods
We created five standardized criteria, which present the main results of assessment of the viability of MEP for implementing new health technologies (HTs). These criteria address the following: 1) Novelty/innovation; 2) Comparative clinical effectiveness and safety; 3) Relevance (demand); 4) Economic effectiveness; and 5) Payback period. Based on these criteria we determine the threshold values of priority for MEP: 1) High priority; 2) Medium priority; 3) Low priority.
Results
Using the ABC model and five standardized criteria, we analyzed all proposals from the Hospital units for implementing new HTs connected with MEP for 2018. In total, proposals contained 11 items of ME, among them three items were in group A (27%), two items were in group B (18%), and six items were in group C (55%). All items were high priority for procurement with the exception of one item from group B with medium priority. Items with low priority were not revealed which can be considered as a direct indicator of the operational effectiveness of Hospital-based HTA Unit. Excluding ME with a medium priority from the procurement plan would reduce Hospital costs by 13.5 percent.
Conclusions
Combined ABC and MCDA analysis in the process of assessment the viability of MEP can give the opportunity to make comparative assessment of different types of ME based on standardized criteria; determine the priority for procurement of new ME; and avoid the influence of subjective factors of the managerial decision-making process in hospital.
The aim of this study was to describe the development and activities of the Hospital-Based Health Technology Assessment (HB-HTA) Unit in the Hospital of the President's Affairs Administration, one of the first examples of the implementation of HB-HTA into the practice of Kazakhstani hospitals.
Methods
Details of the development of the Unit were obtained from the hospital's administrative records. The Unit's own records were used to describe the reports prepared and the clinical areas that were covered. Responses to recommendations in the Unit's reports were obtained from hospital administration and individual departments. Estimates of savings and payback periods were based on data from the hospital information system, and data submitted by manufacturers and distributors of medical equipment.
Results
Fifty-one rapid- and mini-HTA reports were prepared by the Unit from 2015 to 2017. Seventeen health technologies (33 percent) were not recommended for implementation in hospital practice. Refusal to implement sixteen of these technologies saved approximately 1,053,500 USD. Of the thirty-four recommended health technologies, twenty-four were implemented to treat or diagnose 1,376 patients, and eight others were included in plans for 2018–20. Of the twenty-four implemented health technologies, twelve did not require additional investments. The payback period of investments for the other twelve implemented technologies is not more than 3 years for six, less than 5 years for four, and more than 10 years for two technologies.
Conclusions
Establishment of the HB-HTA Unit in the hospital created the basis for making informed managerial decisions; identifying key directions for strategic development; and improving hospital management.
One of the main tools for Hospital-Based Health Technology Assessment (HB HTA) is the preparation of a mini-health technology assessment (HTA) report. Despite the high value of the results of mini-HTA reports for hospital decision-makers, the classical mini-HTA report does not allow a direct comparison of several health technologies among themselves.
Methods:
Based on the analysis of international experience of using the principles of multiple-criteria decision analysis (MCDA) in the field of HB HTA, we created and approved our own managerial decision-making model which includes five standardized multiple criteria. The value (weight) of each criterion was defined as the arithmetic mean obtained as a result of interviewing hospital decision-makers and an HTA expert group.
Results:
Five standardized multiple criteria were included in the structure of our mini-HTA report. These criteria presented the main results of assessment of the viability of implementing new health technologies (HTs) in hospital practice and contain the following: i) Novelty/innovation; ii) Comparative clinical effectiveness and safety; iii) Relevance (demand); iv) Economic effectiveness; and, v) Payback period. We conducted the modeling of various options of HTA results by using multiple criteria, which allowed us to determine the threshold values of the evaluated HTs corresponding to their priority for implementation: i) High priority - HTs are recommended for implementation; ii) Medium priority - HTs can be recommended only if there are sufficient financial resources in hospital; and, iii) Low priority - HTs may be recommended only if there are strong reasons for their need.
Conclusions:
Integration of the principles of MCDA in the structure of mini-HTA reports gives the opportunity to i) make comparative assessments of implementing new health technologies based on standardized criteria; ii) determine the priority for implementation of newly evaluated health technologies; iii) avoid the influence of subjective factors on the managerial decision-making in hospitals.
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