scholarly journals Adjuvanted influenza vaccine for the Italian elderly in the 2018/19 season: an updated health technology assessment

2019 ◽  
Vol 29 (5) ◽  
pp. 900-905 ◽  
Author(s):  
Chiara de Waure ◽  
Sara Boccalini ◽  
Paolo Bonanni ◽  
Daniela Amicizia ◽  
Andrea Poscia ◽  
...  
Keyword(s):  
Influenza Vaccination ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cost Effective ◽  
The Elderly ◽  
Health Technology ◽  
Elderly Subjects ◽  
Ethical Implications ◽  
Inactivated Vaccines ◽  
Influenza Illness

Abstract Background The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for the elderly in Italy: trivalent inactivated vaccine (TIV), adjuvanted TIV (aTIV) and quadrivalent inactivated vaccines (QIV). No health technology assessment (HTA) of seasonal influenza vaccination in the elderly has previously been conducted in Italy. Methods An HTA was conducted in 2017 to analyze the burden of influenza illness, the characteristics, efficacy, safety and cost-effectiveness of available vaccines and the related organizational and ethical implications. This was then contextualized to the 2018/19 influenza season. Comprehensive literature reviews/analyses were performed and a static mathematical model developed in order to address the above issues. Results In Italy, influenza is usually less common in the elderly than in other age-classes, but the burden of disease is the highest; >10% of infected elderly subjects develop complications, and about 90% of all influenza-related deaths occur in this age-class. All available vaccines are effective, safe and acceptable from an ethical standpoint. However, aTIV has proved more immunogenic and effective in the elderly. Furthermore, from the third payer’s perspective, aTIV is highly cost-effective and cost-saving in comparison with TIV and QIV, respectively. Nevertheless, vaccination coverage needs to be improved. Conclusions According to this HTA, aTIV appeared the vaccine of choice in the elderly. HTA should be reapplied whenever new relevant data become available.

PERSPECTIVE: SOME CONCLUSIONS FROM MY LIFE IN HEALTH TECHNOLOGY ASSESSMENT

2018 ◽  
Vol 34 (2) ◽  
pp. 131-133 ◽  
Author(s):  
H. David Banta
Keyword(s):  
United States ◽  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
The United States ◽  
Main Concern ◽  
United States Congress ◽  
Healthcare Interventions

I have worked in health technology assessment (HTA) since 1975, beginning in the United States Congress Office of Technology Assessment (OTA), where we were charged with defining “medical technology assessment”. My main concern in HTA has always been efficacy of healthcare interventions. After years in OTA, I was invited to the Netherlands in 1985, where the Dutch government invited me to head a special commission concerning future healthcare technology and HTA. From there, I became involved in over forty countries, beginning in Europe and then throughout the world. My most intense involvements, outside the United States and Europe, have been in Brazil, China, and Malaysia. During these 40-plus years, I have seen HTA grow from its earliest beginnings to a worldwide force for better health care for everyone. I have also had some growing concerns, outlined in this Perspective article. Within HTA, I am most disappointed by a narrow perspective of cost-effective analysis, which tends to ignore considerations of culture, society, ethics, and organizational and legal issues. In the general environment affecting HTA and health care, I am most concerned about the need to protect the independence of HTA activities from influences of the healthcare industries.

OP07 Real World Evidence: How Can It Improve Health Technology Assessment?

2018 ◽  
Vol 34 (S1) ◽  
pp. 2-3
Author(s):  
John Gillespie ◽  
Sebnem Erdol ◽  
Chris Foteff ◽  
Liesl Strachan
Keyword(s):  
Health Economic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
New Technologies ◽  
Eligible Patient ◽  
Cost Effective ◽  
Health Technology ◽  
Economic Evaluations ◽  
Patient Pathways

Introduction:Health Technology Assessment (HTA) considers the question of whether evaluated technologies are cost-effective in real world settings. As observed in HTA conducted by the Australian Medical Services Advisory Committee (MSAC), questions regarding the validity of data inputs to economic analyses that reflect real-world practice is a common reason for uncertainty on the cost effectiveness of new technologies. In addition to resource use and costs, there may be other uncertainties regarding the eligible patient population, patient management pathways and comparator selection. Our objective in this study was to present case studies from Australia where real world linked datasets could be better utilized to inform HTA conducted by the MSAC.Methods:For selected therapy areas, assessment reports and public summary documents of HTA conducted by the MSAC published between January 2015 and November 2017 were reviewed. Our analysis identified HTAs where uncertainties around the inputs for health economic evaluations, as well as uncertainties in defining eligible patient numbers or current patient pathways of care were shown to exist. We then explored whether these uncertainties could have been addressed through real world linked datasets.Results:Our preliminary investigations identified two assessments: MSAC assessment of capsule endoscopy and transcatheter aortic valve implantation - where availability of real world linked data could have addressed uncertainties around the inputs required for the health economic evaluations.Conclusions:Australia has a range of real world datasets with the potential to be used to inform HTA conducted by the MSAC. This can only be achieved if the datasets could be better linked and accessible for use by key stakeholders in the MSAC HTA process (e.g. industry, clinician, patient societies). Use of these data sets in HTA will enable timelier patient access to cost-effective technologies and more effective implementation and review of technologies after adoption into clinical practice.

scholarly journals Interventions to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease: a cost-effective modelling review

2020 ◽  
Vol 24 (11) ◽  
pp. 1-150 ◽  
Author(s):  
Matt Stevenson ◽  
Lesley Uttley ◽  
Jeremy E Oakley ◽  
Christopher Carroll ◽  
Stephen E Chick ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
Quality Adjusted Life Year ◽  
Expert Elicitation ◽  
Jakob Disease ◽  
Single Use ◽  
Quality Adjusted Life

Background Creutzfeldt–Jakob disease is a fatal neurological disease caused by abnormal infectious proteins called prions. Prions that are present on surgical instruments cannot be completely deactivated; therefore, patients who are subsequently operated on using these instruments may become infected. This can result in surgically transmitted Creutzfeldt–Jakob disease. Objective To update literature reviews, consultation with experts and economic modelling published in 2006, and to provide the cost-effectiveness of strategies to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease. Methods Eight systematic reviews were undertaken for clinical parameters. One review of cost-effectiveness was undertaken. Electronic databases including MEDLINE and EMBASE were searched from 2005 to 2017. Expert elicitation sessions were undertaken. An advisory committee, convened by the National Institute for Health and Care Excellence to produce guidance, provided an additional source of information. A mathematical model was updated focusing on brain and posterior eye surgery and neuroendoscopy. The model simulated both patients and instrument sets. Assuming that there were potentially 15 cases of surgically transmitted Creutzfeldt–Jakob disease between 2005 and 2018, approximate Bayesian computation was used to obtain samples from the posterior distribution of the model parameters to generate results. Heuristics were used to improve computational efficiency. The modelling conformed to the National Institute for Health and Care Excellence reference case. The strategies evaluated included neither keeping instruments moist nor prohibiting set migration; ensuring that instruments were kept moist; prohibiting instrument migration between sets; and employing single-use instruments. Threshold analyses were undertaken to establish prices at which single-use sets or completely effective decontamination solutions would be cost-effective. Results A total of 169 papers were identified for the clinical review. The evidence from published literature was not deemed sufficiently strong to take precedence over the distributions obtained from expert elicitation. Forty-eight papers were identified in the review of cost-effectiveness. The previous modelling structure was revised to add the possibility of misclassifying surgically transmitted Creutzfeldt–Jakob disease as another neurodegenerative disease, and assuming that all patients were susceptible to infection. Keeping instruments moist was estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs. Based on probabilistic sensitivity analyses, keeping instruments moist was estimated to on average result in 2.36 (range 0–47) surgically transmitted Creutzfeldt–Jakob disease cases (across England) caused by infection occurring between 2019 and 2023. Prohibiting set migration or employing single-use instruments reduced the estimated risk of surgically transmitted Creutzfeldt–Jakob disease cases further, but at considerable cost. The estimated costs per quality-adjusted life-year gained of these strategies in addition to keeping instruments moist were in excess of £1M. It was estimated that single-use instrument sets (currently £350–500) or completely effective cleaning solutions would need to cost approximately £12 per patient to be cost-effective using a £30,000 per quality-adjusted life-year gained value. Limitations As no direct published evidence to implicate surgery as a cause of Creutzfeldt–Jakob disease has been found since 2005, the estimations of potential cases from elicitation are still speculative. A particular source of uncertainty was in the number of potential surgically transmitted Creutzfeldt–Jakob disease cases that may have occurred between 2005 and 2018. Conclusions Keeping instruments moist is estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs. Further surgical management strategies can reduce the risks of surgically transmitted Creutzfeldt–Jakob disease but have considerable associated costs. Study registration This study is registered as PROSPERO CRD42017071807. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 11. See the NIHR Journals Library website for further project information.

scholarly journals Health Technology Assessment of Belimumab: A New Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Maria Lucia Specchia ◽  
Chiara de Waure ◽  
Maria Rosaria Gualano ◽  
Andrea Doria ◽  
Giuseppe Turchetti ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Lupus Erythematosus ◽  
Clinical Pathways ◽  
Active Form ◽  
Health Technology ◽  
Systemic Lupus ◽  
Ethical Implications

Objective.Systemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy.Methods.SLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed.Results.Literature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2–5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental cost-effectiveness ratio of €32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial.Conclusions.The assessment supports the use of belimumab into the SLE treatment paradigm in Italy.

scholarly journals Tackling ethical issues in health technology assessment: A proposed framework

2011 ◽  
Vol 27 (3) ◽  
pp. 230-237 ◽  
Author(s):  
Amanda Burls ◽  
Lorraine Caron ◽  
Ghislaine Cleret de Langavant ◽  
Wybo Dondorp ◽  
Christa Harstall ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Development Process ◽  
Ethical Issues ◽  
Health Technology ◽  
Face To Face ◽  
Context Sensitive ◽  
Ethical Implications ◽  
Starting Point ◽  
Methodological Approaches

Objectives: Values are intrinsic to the use of health technology assessments (HTAs) in health policy, but neglecting value assumptions in HTA makes their results appear more robust or normatively neutral than may be the case. Results of a 2003 survey by the International Network of Agencies for Health Technology Assessment (INAHTA) revealed the existence of disparate methods for making values and ethical issues explicit when conducting HTA.Methods: An Ethics Working Group, with representation from sixteen agencies, was established to develop a framework for addressing ethical issues in HTA. Using an iterative approach, with email exchanges and face-to-face workshops, a report on Handling Ethical Issues was produced.Results: This study describes the development process and the agreed upon framework for reflexive ethical analysis that aims to uncover and explore the ethical implications of technologies through an integrated, context-sensitive approach and situates the proposed framework within previous work in the development of ethics analysis in HTA.Conclusions: It is important that methodological approaches to address ethical reflection in HTA be integrative and context sensitive. The question-based approach described and recommended here is meant to elicit this type of reflection in a way that can be used by HTA agencies. The questions proposed are considered only as a starting point for handling ethics issues, but their use would represent a significant improvement over much of the existing practice.

scholarly journals Vaccine effectiveness of live attenuated and trivalent inactivated influenza vaccination in 2010/11 to 2015/16: the SIVE II record linkage study

2020 ◽  
Vol 24 (67) ◽  
pp. 1-66
Author(s):  
Colin R Simpson ◽  
Nazir I Lone ◽  
Kim Kavanagh ◽  
Tanya Englishby ◽  
Chris Robertson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Vaccine Effectiveness ◽  
Rt Pcr ◽  
Trivalent Influenza Vaccine ◽  
The Uk

Background There is good evidence of vaccine effectiveness in healthy individuals but less robust evidence for vaccine effectiveness in the populations targeted for influenza vaccination. The live attenuated influenza vaccine (LAIV) has recently been recommended for children in the UK. The trivalent influenza vaccine (TIV) is recommended for all people aged ≥ 65 years and for those aged < 65 years who are at an increased risk of complications from influenza infection (e.g. people with asthma). Objective To examine the vaccine effectiveness of LAIV and TIV. Design Cohort study and test-negative designs to estimate vaccine effectiveness. A self-case series study to ascertain adverse events associated with vaccination. Setting A national linkage of patient-level general practice (GP) data from 230 Scottish GPs to the Scottish Immunisation & Recall Service, Health Protection Scotland virology database, admissions to Scottish hospitals and the Scottish death register. Participants A total of 1,250,000 people. Interventions LAIV for 2- to 11-year-olds and TIV for older people (aged ≥ 65 years) and those aged < 65 years who are at risk of diseases, from 2010/11 to 2015/16. Main outcome measures The main outcome measures include vaccine effectiveness against laboratory-confirmed influenza using real-time reverse-transcription polymerase chain reaction (RT-PCR), influenza-related morbidity and mortality, and adverse events associated with vaccination. Results Two-fifths (40%) of preschool-aged children and three-fifths (60%) of primary school-aged children registered in study practices were vaccinated. Uptake varied among groups [e.g. most affluent vs. most deprived in 2- to 4-year-olds, odds ratio 1.76, 95% confidence interval (CI) 1.70 to 1.82]. LAIV-adjusted vaccine effectiveness among children (aged 2–11 years) for preventing RT-PCR laboratory-confirmed influenza was 21% (95% CI –19% to 47%) in 2014/15 and 58% (95% CI 39% to 71%) in 2015/16. No significant adverse events were associated with LAIV. Among at-risk 18- to 64-year-olds, significant trivalent influenza vaccine effectiveness was found for four of the six seasons, with the highest vaccine effectiveness in 2010/11 (53%, 95% CI 21% to 72%). The seasons with non-significant vaccine effectiveness had low levels of circulating influenza virus (2011/12, 5%; 2013/14, 9%). Among those people aged ≥ 65 years, TIV effectiveness was positive in all six seasons, but in only one of the six seasons (2013/14) was significance achieved (57%, 95% CI 20% to 76%). Conclusions The study found that LAIV was safe and effective in decreasing RT-PCR-confirmed influenza in children. TIV was safe and significantly effective in most seasons for 18- to 64-year-olds, with positive vaccine effectiveness in most seasons for those people aged ≥ 65 years (although this was significant in only one season). Future work The UK Joint Committee on Vaccination and Immunisation has recommended the use of adjuvanted injectable vaccine for those people aged ≥ 65 years from season 2018/19 onwards. A future study will be required to evaluate this vaccine. Trial registration Current Controlled Trials ISRCTN88072400. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 67. See the NIHR Journals Library website for further project information.

scholarly journals Sustainability of Endovenous Iron Deficiency Anaemia Treatment: Hospital-Based Health Technology Assessment in IBD Patients

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
A. Poscia ◽  
J. Stojanovic ◽  
F. Kheiraoui ◽  
E. M. Proli ◽  
F. Scaldaferri ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Iron Deficiency Anaemia ◽  
Health Technology ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Deficiency Anaemia ◽  
Ethical Implications ◽  
Iv Iron

Iron deficiency anaemia (IDA) is the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD). The Health Technology Assessment approach was applied to evaluate the sustainability of intravenous (IV) iron formulations in the Italian hospital setting, with particular focus on ferric carboxymaltose. Data on the epidemiology of IBD and associated IDA, in addition to the efficacy and safety of IV iron formulations currently used in Italy, were retrieved from scientific literature. A hospital-based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed. IDA prevalence in IBD patients varies markedly from 9 to 73%. IV iron preparations were proven to have good efficacy and safety profiles, and ferric carboxymaltose provided a fast correction of haemoglobin and serum ferritin levels in iron-deficient patients. Despite a higher price, ferric carboxymaltose would confer a beneficial effect to the hospital, in terms of reduced cost related to individual patient management and additionally to the patient by reducing the number of infusions and admissions to healthcare facilities. Ethically, the evaluation is appropriate due to its efficacy and compliance. This assessment supports the introduction of ferric carboxymaltose in the Italian outpatient setting.

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