Health Technology Management Research Articles

Utilising Health Technology Assessment to Develop Managed Access Protocols to Facilitate Drug Reimbursement in Ireland.

The Health Service Executive, responsible for operating the Irish health service, has introduced health technology management (HTM) initiatives to manage expenditure on medicines. One such approach is managed access protocols (MAPs) to support access to high-cost medicines, while providing oversight, governance and budgetary certainty to the payer. Herein we describe the development and operation of MAPs, using case studies of liraglutide (Saxenda®), dupilumab (Dupixent®) and calcitonin gene-related peptide monoclonal antibodies. A MAP imposes the eligibility criteria attached to reimbursement support of a medicine. Criteria applied include controls on prescribing authority, clinical diagnostic and severity criteria, previous lines of treatment, concomitant treatments, outcome data collection, and validations within the reimbursement claims system. The choice of criteria are specific to each medicine, dictated by the areas of uncertainty highlighted in the health technology assessment report, such as the place in treatment, population, duration of treatment, etc., the commercial arrangements reached with the marketing authorisation holder, and specific recommendations made by the decision maker. By December 2023, there were28 medicines reimbursed subject to a MAP in Ireland. Across the three case studies outlined, over 3000 patients were accessing novel treatments for chronic illnesses in September 2023. Managed access protocols can provide some cost certainty for the payer by aligning utilisation and expenditure with committed funds, while enabling access where unmet need is highest. Managed access protocols are now established in the drug reimbursement process in Ireland, meeting the needs of both payers, patients and industry, and are likely to remain a feature of the reimbursement landscape.

Utilization, Expenditure, and Treatment Patterns Associated With Calcitonin Gene-Related Peptide Monoclonal Antibodies Reimbursed Subject to a Managed Access Protocol in Ireland

ObjectivesCalcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are novel high-cost treatments for the prevention of migraine. This study presents data on utilization, expenditure, and treatment patterns with CGRP mAbs available under a managed access protocol in Ireland, to a cohort of treatment refractory patients (failed 3 or more previous treatments) with chronic migraine. MethodsData were extracted from the Primary Care Reimbursement Service High Tech claims database and special drug request online system and analyzed using Microsoft Excel and SAS. Treatment persistence was evaluated by refill patterns, and adherence was evaluated using the proportion of days covered method. Expenditure data were extracted directly from the database. ResultsBetween September 1, 2021 and April 30, 2023, 1517 applications for reimbursement approval for a CGRP mAb were received; 1458 (96.1%) were approved for reimbursement. Total expenditure on CGRP mAbs in year 1 (September 1, 2021 to August 31, 2022) was €3.2 million. The majority of patients initiated treatment with fremanezumab (60.8%) or erenumab (37.1%). Almost 90% of patients were considered adherent, and treatment persistence was high, with more than 75% of patients receiving more than 12 months of treatment in our 18-month study time frame. ConclusionsThis study demonstrates the importance of active health technology management, after reimbursement, in enabling cost-effective use of high-cost treatments while providing budget certainty for the healthcare payer. High levels of adherence and persistence suggest that treatment is successfully targeted in situations which unmet clinical need is greatest.

Application of Multi-Criteria Decision Analysis (MCDA) to Prioritize Real-World Evidence Studies for Health Technology Management: Outcomes and Lessons Learned by the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration.

Multi-criteria decision analysis (MCDA) is a value assessment tool designed to help support complex decision-making by incorporating multiple factors and perspectives in a transparent, structured approach. We developed an MCDA rating tool, consisting of seven criteria evaluating the importance and feasibility of conducting potential real-world evidence (RWE) studies aimed at addressing uncertainties stemming from initial cancer drug funding recommendations. In collaboration with the Canadian Agency for Drugs and Technologies in Health's Provincial Advisory Group, a validation exercise was conducted to further evaluate the application of the rating tool using RWE proposals varying in complexity. Through this exercise, we aimed to gain insight into consensus building and deliberation processes and to identify efficiencies in the application of the rating tool. An experienced facilitator led a multidisciplinary committee, consisting of 11 Canadian experts, through consensus building, deliberation, and prioritization. A total of nine RWE proposals were evaluated and prioritized as low (n = 4), medium (n = 3), or high (n = 2) priority. Through an iterative process, efficiencies and recommendations to improve the rating tool and associated procedures were identified. The refined MCDA rating tool can help decision-makers prioritize important and feasible RWE studies for research and can enable the use of RWE for the life-cycle evaluation of cancer drugs.

Analysis of Medical Device Reports That Contributed to a Class I Recall

The Food and Drug Administration (FDA) conducts postmarket review of medical devices as a part of its mission to protect patient safety and ensure product safety and effectiveness. Medical device reports (MDRs) are one way the FDA receives information on adverse events involving medical devices. Medical device reports can be submitted by manufacturers, importers, user facilities, and the public. User facilities are required to report device-related adverse events that resulted in a serious injury or death. In addition, user facilities are encouraged to submit voluntary medical reports where a device problem has the potential for patient harm. The FDA receives MDRs from user facilities through the MedWatch and Medical Product Safety Network programs. When reporters include detailed background information in their reports, they can directly contribute to meaningful action. Health technology management personnel, including clinical engineers, have unique insights into medical device problems and can provide valuable background information in MDRs. The highlighted examples hereinafter illustrate 2 cases where more detailed information included in MDRs was essential and contributed to a class I recall of a medical device.

Implementação de tecnologias em saúde no Brasil: análise de orientações federais para o sistema público de saúde

Abstract This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines. In 38.8% of the regulatory documents, citations to implementation related mainly to SUS clinical guidelines were identified; however, no document dedicated to guiding implementation actions was identified. Recommendations related to implementations were identified in 27.1% of the reports and 66.1% of the guidelines, although without standardization and, in general, in little detail, focusing on resources and actions needed for making technology available rather than on methods and interventions for its implementation. The results evidence a gap in formal guidelines to guide the implementation process in Brazil, representing an opportunity for the development of models aligned with the reality of the SUS.

Implementation of health technologies in Brazil: analysis of federal guidelines for the public health system.

This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines. In 38.8% of the regulatory documents, citations to implementation related mainly to SUS clinical guidelines were identified; however, no document dedicated to guiding implementation actions was identified. Recommendations related to implementations were identified in 27.1% of the reports and 66.1% of the guidelines, although without standardization and, in general, in little detail, focusing on resources and actions needed for making technology available rather than on methods and interventions for its implementation. The results evidence a gap in formal guidelines to guide the implementation process in Brazil, representing an opportunity for the development of models aligned with the reality of the SUS.

HSD23 Health Technology Management - The Future of the Post-Reimbursement Phase?

HSD23 Health Technology Management - The Future of the Post-Reimbursement Phase?

HPR24 Utilisation and Expenditure on Blood Glucose Test Strips in Ireland—The Impact of Health Technology Management in Reducing and Containing Expenditure

HPR24 Utilisation and Expenditure on Blood Glucose Test Strips in Ireland—The Impact of Health Technology Management in Reducing and Containing Expenditure

Evidence-based clinical engineering: Health information technology adverse events identification and classification with natural language processing

The primary goal of this project is to create a framework to extract Real-World Evidence to support Health Technology Assessment, Health Technology Management, Evidence-Based Maintenance, and Post Market Surveillance (as outlined in the EU Medical Device Regulation 2017/745) of medical devices using Natural Language Processing (NLP) and Artificial Intelligence. An initial literature review on Spontaneous Reporting System databases, Health Information Technologies (HIT) fault classification, and Natural Language Processing has been conducted, from which it clearly emerges that adverse events related to HIT are increasing over time. The proposed framework uses NLP techniques and Explainable Artificial Intelligence models to automatically identify HIT-related adverse event reports. The designed model employs a pre-trained version of ClinicalBERT that has been fine-tuned and tested on 3,075 adverse event reports extracted from the FDA MAUDE database and manually labelled by experts.

The Importance of Medical Device Reporting by Health Technology Managers Before and After Recalls Are Posted

The Food and Drug Administration (FDA) performs postmarket surveillance of medical devices as part of its mission to ensure that devices remain safe and effective while they are on the market. Medical device reporting by manufacturers, user facilities, and the public plays an important role in the agency identifying and resolving medical device safety signals. User facilities are defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility and do not include physician's offices. The Safe Medical Devices Act requires user facilities to report medical-device–related deaths to the FDA and the device manufacturer, to report device-related serious injuries to the manufacturer, and to submit an annual summary of all device reports to the FDA. If the manufacturer is unknown for a serious injury report, the user facility then submits the report to the FDA. Healthcare technology managers in user facilities use their expertise to recognize, communicate, and evaluate medical device concerns. This article highlights the importance of identifying and reporting medical device issues to the FDA to ensure continued safety and effectiveness of devices on the market.

Management of medical equipment in the Brazilian public health system (SUS), historical situation and the context of the pandemic COVID-19: a cut for lung ventilators

PurposeThe main objective of this paper is to analyze the Brazilian Ministry of Health (MoH) efforts in the management of medical equipment, with a specific approach for lung ventilators in the pandemic scenario of COVID-19.MethodsThe methodology included a review of the normative framework and literature on technological management and research on the database of the Ministry of Health.ResultsAs a promoter for acquiring medical equipment, the MoH role is highlighted and added to this competence; its function as the coordinator of the National Policy on Health Technology Management (PNGTS). According to the PNGTS the MoH has to support health managers in the implementing, monitoring, and maintaining health technologies. The scenario of lung ventilators in the pandemic was discussed, with research to verify demands, offers, installed capacity, and investments. In less than one year, the Ministry of Health acquired several pulmonary ventilators, 8.55 times greater than the annual averages of equipment acquired from 2016 to 2019. So far, there is still no maintenance plans or strategy of management for that equipment, especially in a post-pandemic scenario. Conclusion: It is possible to conclude that the Ministry of Health needs to improve health technology management systems. On the scale of the Policy, it is necessary to commit to permanent and long-term actions to ensure sustainability and reduce the technological vulnerabilities of the SUS.

Health technology management: the experience of a managed access approach to the reimbursement of dupilumab in Ireland

BackgroundDupilumab was the first biological medicine to receive marketing authorisation, in Ireland, for the treatment of atopic dermatitis (AD). In 2019, Ireland’s National Centre for Pharmacoeconomics recommended that dupilumab not be reimbursed at the submitted price; it was not cost effective. Following confidential price negotiations, the Health Service Executive (HSE) reimbursed dupilumab subject to a HSE-Managed Access Protocol (MAP). Patients with refractory, moderate-to-severe AD were deemed eligible to receive treatment under the MAP; the cohort for which dupilumab is expected to be most effective and most cost effective (versus standard of care). Approval, for treatment, is granted on an individual patient basis by the HSE-Medicines Management Programme.AimsApplications for approval of treatment with dupilumab were analysed to determine the percentage of patients deemed eligible. Key characteristics of this population were investigated.MethodsData from individual patient applications were analysed. Key characteristics of the approved population were investigated using IBM SPSS Statistics® version 27.Data were derived from the HSE-Primary Care Reimbursement Service pharmacy claims database. The number of patients who received dupilumab over the study period was determined.ResultsIn total, 96% of submitted applications were deemed eligible. Of these, 65% were male and 87% were adults. In the main, the approved patient population had severe refractory AD; the mean Eczema Area Severity Index score was 28.72.ConclusionThe majority of applications submitted were approved. This work highlights how a MAP can facilitate access to treatment in patients who are deemed eligible whilst containing overall expenditure.

Routine Supportive Supervision and Management of Medicines and Other Health Products and Technologies in Vihiga County, Kenya

Health Products and Technologies (HPTs) are pivotal for an efficient health system. Availability and accessibility to affordable health products are critical indicators towards achieving universal health coverage. Routine supportive supervision, performance monitoring, recognition of efforts and client feedback are vital activities toward health supply chain system strengthening. This is a descriptive paper that describes a model of integrated commodity supportive supervision, and mentorship and its impact on various outcomes of health commodity management. Data were abstracted from the standardized scored checklists used during integrated commodity supportive supervision and supply chain audit in public health facilities in Vihiga County. Scores for the period 2020 to 2022 were analyzed on the eight key areas of interest. The analysis was done using Statistical Package for Social Sciences (SPSS version 26). Results are interpreted at 95% Confidence interval. This paper also shares findings from both quantitative and qualitative data from client exit and facility managers’ interviews. Six complete rounds of supervisions, three clients and service providers’ interviews, and three annual award events have been conducted. We observed trends across six data collections points and compared the results at first point or baseline (January-June 2020) to the results at the last point or end line (April-June 2022). Findings show significant improvements on the eight parameters in terms of mean scores as follows: resolution of issues from previous visits by 35.06% (46.75% - 81.81%); storage of HPTs by 17.41% (68.72% - 86.13%); inventory management by 28.16% (42.67% - 70.83%); availability and use of commodity data management information systems (MIS) tools by 22.39% (74.40% - 96.79%); verification of commodity data by 25.61% (65.56% - 91.17%); availability of guidelines and job aids for commodity management by 46.28% (36.65% - 82.93%). There was an improvement on the mean score on accountability by 20.22% (58.58% - 83.51%). The composite (final) score improved by 28.33% (56.19% - 84.52%). There was progressive narrowing of the standard deviations on all the indicators across the study period. This demonstrates that there is standardization of practices and positive competition among all the public health facilities. There were significant improvements on all the eight indicators. Routine integrated commodity supportive supervision has proven to be an effective high impact intervention in improving management of health products and technologies in Vihiga County, Kenya.

Značaj biomedicinskih inženjera u zdravstvenom sistemu

In order for the Health Technology Management Policy at the state level to be successfully implemented, first of all, adequate personnel are necessary, and among these, biomedical engineers play an important role. Biomedical engineers (clinical engineers) work in a wide range of settings and disciplines in the health sector and play a key role in: innovation, design and development of new technologies in health care; testing, implementation and development of new diagnostic tools and medical equipment; defining safety standards for medical equipment; maintenance of (complex) medical equipment. The Ministry of Health of the Republic of Serbia labeled the biomedical engineering workforce as a "critical workforce". This critical workforce is defined as "a workforce that contributes to critical and essential elements of health technology management, especially in the domain of maintenance and replacement of (complex) medical equipment, now and in the future".

OP42 Increasing Access To Real-World Data To Move From Health Technology Assessment To Health Technology Management

IntroductionWhen assessing existing or emerging technologies using a one-off health technology assessment (HTA) we do not take into consideration the effects on people who will receive the technology once approved. Developments in real-world data (RWD) can help to address this by moving to ongoing health technology management (HTM).MethodsTo move to HTM, we first need to develop HTM data requirements. We undertook user interviews with National Institute for Health and Care Excellence (NICE) HTA developers to develop a list of requirements. We surveyed the types of data that NICE currently has access to and performed a gap analysis to understand where further data is needed. We then worked with external systems partners to identify and review available data sources that could support HTM.ResultsFrom our user interviews we established eight HTM data requirements. Data needed to be linked, cover full care pathways, contain data from new collections, be shareable, have direct access, be of high quality, have comprehensive coverage, and be responsive to technological developments (such as artificial intelligence). The review of data sources revealed a fragmented landscape of health data in the United Kingdom (UK). We identified National Health Service Digital’s (NHSD) Trusted Research Environment as the main data source that could address HTM requirements. This addresses challenges with fragmented data by providing approved researchers with timely and secure access to a range of linked health and care data. We also identified that a large national data collection would not capture all technologies, such as orphan technologies for rare conditions. We therefore established a process for accessing data from smaller data collections such as disease specific registries. To address how we can use this data, we developed the NICE Real-World Evidence (RWE) Framework that provides clear guidance on the expectations for the planning, conduct, reporting, and appraisal of RWE studies.ConclusionsWe have established requirements for the type of data that will help to deliver HTM as well as developed a process for accessing several suitable data sources that meet these requirements.

PD21 Data Sources And Real-World Data On Medical Devices In The Brazilian Scenario

IntroductionThe Brazilian government has made efforts in systems to generate data from medical devices (MD). This work explores the main systems and data sources in the perspective of contributing as a source to generate real world data (RDW).MethodsDocument review of relevant national data sources for MD. In addition, a structured search was carried out in EMBASE using key descriptors for RWD applied to the regulatory context and to the management of health technologies, without date or language restrictions.ResultsEighteen primary federal government data sources for MD were identified. Not all sources are publicly accessible. Of the articles, the search returned 1,185 results, of which 29 titles were selected and 8 met the protocol’s objective. Included articles were from Europe, the United States and Canada. As in other countries, Brazil initially systematized DM administrative data to meet commercial and financial demands. With the evolution of health technology assessment methods, the use of RDW has become imperative to assess the value of MD to society. Common examples from these countries are implantable MD databases. Current challenges focus on data linkage and quality, in addition to standardized naming. The adoption of the Unique Device Identification (UDI) is one of the promising initiatives to facilitate traceability throughout the lifecycle proposed in the International Medical Device Regulators Forum (IMDRF) of which Brazil is a member. Among the systems, the following stand out: i) ConectSUS, which intends to provide access to health information centered on the patient, anywhere and at any time; ii) National implant registry that generates data on implanted prostheses and stents, surgical techniques used, the profile of patients and the health services involved.ConclusionsThis work showed the similarities between Brazil and other countries in the management of MD data throughout its life cycle, as well as mapped the national primary data sources for MD.

Quantitative Assessment of Effectiveness and Utilization of Medical Equipment

The problem of operational efficiency assessment of medical equipment is becoming crucial, due to its increasing requirement in hospitals. It has been observed that a significant amount of medical equipment is out of service for several reasons such as lack of training, maintenance and health technology management. The unexpected failures, downtime associated with breakdown and make ready, loss of production and poor maintenance costs of medical equipment are the major drawback in any hospital. Quality of diagnostic and treatment care provided to patients largely depends on the reliability, availability and maintainability of sophisticated medical equipment. Aim of the present study is to determine quantitatively overall effectiveness and utilization of some medical equipment. Overall Equipment Effectiveness (OEE) and utilization coefficient is the metric measurement of Total Productive Maintenance (TPM) which specifies effective functioning of devices. The results of the effectiveness of the devices are found to be below the standard of 85%. The cause of low effectiveness value was due to poor performance and availability. Equipment utilization is also needed for the evaluation of medical equipment necessity, appropriateness and efficiency of the use in diagnosis and treating a patient. The proposed methodology may be able to increase the amount of working medical equipment by implementing preventive maintenance schedule. The methodology is also validated by failure probability and reliability of the machines.

Optimizing the delivery of genetic and advanced diagnostic testing in the province of Ontario: challenges and implications for laboratory technology assessment and management in decentralized healthcare systems

Aims The Canadian province of Ontario provides full coverage for its residents (pop.14.8 M) for hospital-based diagnostic testing. Historical governance of the healthcare system and a legacy scheme of health technology assessment (HTA) and financing has led to a suboptimal approach of adopting advanced diagnostic technology (i.e. protein expression, cytogenetic, and molecular/genetic) for guiding therapeutic decisions. The aim of this research is to explore systemic barriers and provide guidance to improve patient and care provider experiences by reducing delays and inequity of access to testing, while benefitting laboratory innovators and maximizing system efficiency. Materials and methods A mixed-methods approach including literature review, semi-structured interviews, and a multi-stakeholder forum involving patient representatives (n = 1), laboratory leaders (n = 6), physicians (n = 5), Ministry personnel (n = 4), administrators (n = 3), extra-provincial experts, and researchers (n = 7), as well as pharmaceutical (n = 5) and diagnostic companies (n = 2). The forum considered evidence of good practices in adoption, implementation, and financing laboratory services and identified barriers as well as feasible options for improving advanced diagnostic testing in Ontario. Results Overarching challenges identified included: barriers to define what is needed; need for a clear approach to adoption; and the need for more oversight and coordination. Recommendations to address these included a shift to an anticipatory system of test adoption, creating a fit-for-purpose system of health technology management that consolidates existing evaluation processes, and modernizing the governance and financing of testing so that it is managed at a care-delivery level. Conclusions The proposals for change in Ontario highlight the role that HTA, governance, and financing of health technology play along the continuum of a health technology life cycle within a healthcare system where decision-making is highly decentralized. Resource availability and capacity were not a concern – instead, solutions require higher levels of coordination and system integration along with innovative approaches to HTA.

Implementation of Health Technology Assessment and Management Course in Undergraduate Program in Biomedical Engineering ITB.

The Undergraduate Program in Biomedical Engineering ITB, Indonesia, introduce the Health Technology Assessment and Management as an elective course in 2021. This course is implemented to support the World Health Assembly that urges the member states to establish national strategies in health technology assessment and management, particularly medical devices. Furthermore, it is designed to give biomedical engineering students a broader insight into their career opportunities. Therefore, this course is delivered by the practitioner and guided by the main lecturer. The course syllabus is developed from the WHO Medical Devices Technical Series and European Network for Health Technology Assessment. It tries to implement HTA Core Model for Rapid Relative Effectiveness Assessments. A questionnaire is used to measure the students' perception of the course implementation. Moreover, it is used to obtain the students' comments and feedback. The course that is delivered by the practitioner not only gives the course content but also the context. After attending the course, students have a broader insight into the career opportunities as biomedical engineers in Indonesia.

Case Series

Health technology managers play a vital role in medical device safety for pediatric patients in the neonatal intensive care unit and the pediatric intensive care unit. Medical device malfunctions and failures can contribute to potential for harm and adverse events. These patients are especially vulnerable to harm when these incidents occur. When health technology managers provide their expertise on medical device malfunction reports, their valuable input can provide a more complete view of the safety concerns to the US Food and Drug Administration and the device manufacturer. The examples in this article are from medical device reports submitted to the US Food and Drug Administration's MedSun program and illustrate how health technology managers' input has advanced US Food and Drug Administration's understanding of medical device safety concerns and contributed to subsequent recalls and other safety actions for devices used in the neonatal intensive care unit and pediatric intensive care unit.