加强马来西亚医疗器械评估：一种全面的价值导向方法

Enhancing theAssessment of MedicalDevices in Malaysia A comprehensive value-based approach AUTHORS: ANGELA TEOH XING YEE,Associate Consultant, Real World Insights, IQVIA Asia PacificDR. FOO CHEE YOONG,Associate Principal, Real World Insights, IQVIA Asia PacificDR. ALAN FONG,Consultant Cardiologist, Sarawak Heart CentrePROF. DR. ASRUL AKMAL SHAFIE,Professor of Pharmacoeconomic, Universiti Sains MalaysiaDR. IZZUNA MUDLA MOHAMED GHAZALI,Head, Malaysian Health Technology Assessment Section (MaHTAS) CONTRIBUTORS: ANDY LEE KUAN MIN,Chairman, Association of Malaysian Medical IndustryDATO’ DR. ASRI RANGA,Consultant Cardiologist, Hospital SerdangBRUCE LIM WEE DIONG,President, Persatuan Pesakit Imunodefisiensi Primer Malaysia (MYPOPI)CALLIX WONG,Head of Health Economics & Market Access, ASEAN, Boston ScientificDR. MURALITHARAN PARAMASUA,Chief Executive, Medical Device AuthorityDR. PINAKI GHOSH,Vice Chair, Market Access Committee, Asia Pacific Medical Technology AssociationDATIN DR. SHEAMINI SIVASAMPU,Director, Institute for Clinical ResearchDR. SIVANESWARAN LECHMIANNANDAN,Consultant Urologist, Hospital Raja Permaisuri BainunIR. DR. SASIKALA DEVI,Chief Executive Officer, MD Dev Sdn Bhd Disclaimer: The views and opinions expressed in this white paper are those of the author and contributors in their personal and professional capacity. Theseopinions do not represent or reflect the views of their respective institutions, organizations, or affiliations. The content is intended for informationalpurposes only and should not be construed as an official position of any entity. Table of contents Case study16 Recommendations for advancing value assessment of medical devices20Recommendation 1:Establish key value domains for comprehensive value assessment20Recommendation 2:Enhance evidence generation and development of research ecosystem20Recommendation 3:Foster transparent and consultative stakeholder engagement in21value assessment processesRecommendation 4:Implement strategies for framework adoption and progress evaluation22Recommendation 5:Address rapid technological advancements22Recommendation 6:Strengthen training and capacity building22Recommendation 7:Align with economic and regulatory policies22 Looking forward24 Conclusion24 25 Executive summary and patient outcomes. These assessments mustconsider clinical efficacy, cost-effectiveness, andbroader societal impacts. Through this approach, theyensure that medical devices contribute effectively topublic health goals. Introduction This white paper explores the critical role of medicaldevices in advancing Malaysia’s healthcare system.Through the integration of advanced technologies,Malaysia can address current health challenges,optimize healthcare delivery, and improve populationhealth outcomes. This paper aims to guide futurestrategies and policies for medical device valueassessment, fostering informed decision-making toensure their effective adoption and utilization withinthe healthcare system. Current assessment practice in Malaysia’shealth system In Malaysia, the evaluation of medical devices extendsbeyond regulatory oversight by the Medical DeviceAuthority (MDA) through the implementation ofHealth Technology Assessment (HTA), which is appliedto prioritized technologies upon request by relevantstakeholders. Health Technology Assessment (HTA) isa vital tool for evaluating medical devices in Malaysia.The Malaysian Health Technology Assessment Section(MaHTAS) conducts these assessments, focusingon clinical effectiveness, cost-effectiveness, andorganizational implications. Despite robust HTApractices, challenges remain in fully capturing themultifaceted value of medical devices, particularly inareas such as innovation, patient-centered outcomes,and long-term benefits. This necessitates enhancementsin evaluation processes and methodologies. Healthcare system and population healthsituation in Malaysia Malaysia aspires to provide comprehensive,accessible, and high-quality healthcare. However,the healthcare system faces considerable challenges,such as an aging population, rising rates of non-communicable diseases (NCDs), health disparities,and issues with healthcare affordability. Addressingthese challenges requires strategic efforts to improveinfrastructure, promote preventive care, and leveragetechnological advancements to realize the vision ofuniversalhealthcoverage. The role and innovation of medical devices Medical devices play a vital role in managing chronicdiseases, supporting an aging population, reducinghealth disparities, and addressing public healthemergencies. Their critical importance necessitatescontinuous innovation to meet the evolving needsof the healthcare system. Unlike pharmaceuticals,which follow a more standardized developmentpathway, medical device innovation is heavily drivenby advancements in engineering and technology. Thisdynamic and rapidly evolving nature demands flexibleassessment and integration strategies to ensure thesedev