A blueprint for health technology assessment capacity building: lessons learned from Malta.

OBJECTIVES: The development and strengthening of health technology assessment (HTA) capacity on the individual and organizational level and the wider environment is relevant for cooperation on HTAs. Based on the Maltese case, we provide a blueprint for building HTA capacity. METHODS: A set of activities were developed based on Pichler et al.'s framework and the starting HTA capacity in Malta. Individual level activities focused on strengthening epidemiological and health economic skills through online and in-person training. On the organizational level, a new HTA framework was developed which was subsequently utilized in a shadow assessment. Awareness campaign activities raised awareness and support in the wider environment where HTAs are conducted and utilized. RESULTS: The time needed to build HTA capacity exceeded the planned two years accommodating the learning progress of the assessors. In addition to the planned trainings, webinars supplemented the online courses, allowing for more knowledge exchange. The advanced online course was extended over time to facilitate learning next to the assessors' daily tasks. Training sessions were added to implement the new economic evaluation framework, which was utilized in a second shadow assessment. Awareness by decision-makers was achieved with reports, posters, and an article on the current and developing HTA capacity. CONCLUSIONS: It takes time and much (hands-on) training to build skills for conducting complex assessment such as HTAs. Facilitating exchange with knowledgeable parties is crucial for succeeding as well as the buy-in of local managers motivating staff. Decision-makers need to be on-boarded for the continued success of HTA capacity building.

Benefits of a digital health technology for older nursing home residents. A de-novo cost-effectiveness model for digital health technologies to aid in the assessment of toileting and containment care needs.

The aim of this study was first, to introduce a comprehensive, de-novo health economic (HE) model incorporating the full range of activities involved in toileting and containment care (T&CC) for people with incontinence, capturing all the potential benefits and costs of existing and future Digital Health Technologies (DHT) aimed at improving continence care, for both residential care and home care. Second, to use this novel model to evaluate the cost-effectiveness of the DHT TENA SmartCare Identifi in the implementation of person-centred continence care (PCCC), compared with conventional continence care for Canadian nursing home residents. The de-novo HE model was designed to evaluate technologies across different care settings from the perspective of several stakeholders. Health states were based on six care need profiles with increasing need for toileting assistance, three care stages with varying degrees of toileting success, and five levels of skin health. The main outcomes were incremental costs and quality-adjusted life years. The effectiveness of the TENA SmartCare Identifi was based primarily on trial data combined with literature and expert opinion where necessary. Costs were reported in CAD 2020. After 2 years, 21% of residents in the DHT group received mainly toileting as their continence care strategy compared with 12% in the conventional care group. Conversely, with the DHT 15% of residents rely mainly on absorbent products for incontinence care, compared with 40% with conventional care. On average, residents lived for 2.34 years, during which the DHT resulted in a small gain in quality-adjusted life years of 0.015 and overall cost-savings of $1,467 per resident compared with conventional care. Most cost-savings were achieved through reduced costs for absorbent products. Since most, if not all, stakeholders gain from use of the DHT-assisted PCCC, widespread use in Canadian residential care facilities should be considered, and similar assessments for other countries encouraged.

A SWOT analysis of the complex interdependencies of the Maltese reimbursement processes.

Background: The processes that operationalize the evaluation framework for new medicines are implemented to reach the system objectives of public health, financial sustainability, and equitability. However, when the activities and procedures of these processes are misaligned, the objectives of the system may be at risk. Objectives: To evaluate the supporting processes for introducing new medicines in public healthcare services in Malta. Methods: We first reviewed literature on the Maltese reimbursement system and subsequently conducted semi-structured interviews based on the Hutton Framework. Interviewees included policy makers, committee members, procurement staff, medical specialists, pharmacists, and pharmaceutical industry representatives. After validation, we analysed the data with a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis. Results: Most medicines are assessed for introduction on the Government Formulary List. Exceptional requests fall outside this policy and pass through the Exceptional Medicinal Treatment route. Efficiency, quality, and transparency are major weaknesses across the supporting processes. Taking up responsibility, however, is considered the most important factor in reaching system objectives. Stakeholders tend to shift responsibilities to other processes, start/stop activities that impact the activities of subsequent processes whilst dismissing any contribution to the weaknesses of the system. Consequently, system objectives cannot be reached in an optimum manner. Conclusions: The Maltese case showed that recommendations for introducing new medicines in the public healthcare setting are influenced beyond the choice of HTA tools and criteria. Earmarked budgets, political steering, delays, and uninformed applicants as well as HTA capacity are impeding on system goals of public health, equity, and sustainability.