To clarify the concept of disruptive technologies in health care, provide examples and consider implications of potentially disruptive technologies for health technology assessment (HTA).

We conducted a systematic review of conceptual and empirical papers on healthcare technologies that are described as “disruptive.” We searched MEDLINE and Embase from 2013 to April 2019 (updated in December 2021). Data extraction was done in duplicate by pairs of reviewers utilizing a data extraction form. A qualitative data analysis was undertaken based on an analytic framework for analysis of the concept and examples. Key arguments and a number of potential predictors of disruptive technologies were derived and implications for HTA organizations were discussed.

Of 4,107 records, 28 were included in the review. Most of the papers included conceptual discussions and business models for disruptive technologies; only few papers presented empirical evidence. The majority of the evidence is related to the US healthcare system. Key arguments for describing a technology as disruptive include improvement of outcomes for patients, improved access to health care, reduction of costs and better affordability, shift in responsibilities between providers, and change in the organization of health care. A number of possible predictors for disruption were identified to distinguish these from “sustaining” innovations.

Since truly disruptive technologies could radically change technology uptake and may modify provision of care patterns or treatment paths, they require a thorough evaluation of the consequences of using these technologies, including economic and organizational impact assessment and careful monitoring.

Breast cancer is the most frequent cancer among women globally, impacting 2.1 million women each year, causing the greatest number of cancer-related deaths among women. In Malaysia, the new cases of breast cancer comprised of 32.7 percent of all new cancer cases in women as reported by The International Agency for Research on Cancer (IARC). The recurrence rate was about 16.4 percent post-mastectomy. This early assessment is to evaluate the effectiveness and safety of a breast cancer vaccine.

A systematic review was conducted. Searches were done through PubMed, Medline and ClinicalTrial.gov. The articles were selected based on inclusion and exclusion criteria and appraised using Critical Appraisal Skills Programme (CASP) checklist. More than twenty cancer vaccines under development were identified.

The most advanced breast cancer vaccine is Nelipepimut-S (NPS). In a Phase 2b clinical trial, improvement disease-free survival (DFS) in the NPS group was 89.8 percent. The DFS rate in the NPS group was 92.6 percent for triple negative patients. Median DFS in the NPS group [hazard ratio (HR): 0.26 (95% confidence interval, Cl: 0.08–0.81)] showed a significant difference. A projection study showed the cost-effectiveness will be 90 percent success if the cost less than USD1,000 per patient. No safety issues were reported.

Early assessment showed potential benefit in patient with triple-negative breast cancer (TNBC). However, further research is required to ensure its efficacy, safety, and cost-effectiveness.

The aim of this study was to provide a comprehensive overview of the evolution of health technology assessment (HTA) in Malaysia over the past decade.

We described the evolution of HTA program in Malaysia based on review of administrative data, publicly available information and quantitative description of impact evaluation.

Health Technology Assessment HTA was formalized in Malaysia in 1995 as a central structure within the Ministry of Health, Malaysia in 1995. Expansion of activities demonstrated over the years including Horizon Scanning of health technologies and implementation of evidence-based Clinical Practice Guidelines. Improvement on the processes in terms of types of report, quality, monitoring, and impact evaluation as well as accessibility was also carried out. Examples of impact/influence of the reports have also been demonstrated.

HTA program in Malaysia has evolved over the past decades. Its role in policy formulation and decision making of health technologies has become more significant over the years and is foreseen to be bigger in the future. As a trusted source of evidence, HTA in Malaysia will continue to strengthen the health system by advocating informed decision making and value-based medicine. As other countries in this region is trying to establish their own HTA processes and procedures, this review on the evolution of the HTA program in Malaysia might give some insights on developing a sustainable HTA program.