The rapid developments of innovative health technologies should mean more treatment options for patients. The information that can be kept track of and understood of developing or innovative health technologies to be introduced into the market, however, is relatively insufficient and they often involve enormous medical expenses. As such, the NHI reimbursement as well as policy planning of related technologies in countries around the world are caught in a stalemate and this gives rise to horizon scanning (HS). The HS assessment is an early awareness and alert system where existing information is collected for pre-determination of possible circumstances in the future. If related circumstances are determined to possibly impact the existing status, warnings will be given in advance in order to gain lead time for defining countermeasures. In light of the costly medical expenses following the adoption of innovative health technologies in NHI coverage and the low control over drugs whose coverage is to be proposed in the future, the NHIA finished configuring the “Horizon Scanning Platform” (HS Platform) in September 2020. Marketing authorization holders are encouraged to spontaneously register related information of drugs whose NHI coverage is to be applied for in two years and CDE HTA is authorized to develop the new drug budget planning model. The information from the HS platform and real-world drug cost filings are combined to estimate the budget for new drugs in the coming years.

       In order to expedite NHI coverage of drugs, NHIA has imposed parallel review mechanism for new drugs since January 2024. If parallel review is recommended, CDE, as authorized by NHIA, shall first review the qualifications. Qualified ones then go through the administrative review of coverage proposals, HTAs, and expert consultation meeting reviews, etc.
       In the past, NHI coverage for new drugs required that new drugs first be approved for indications by the competent authority before NHI coverage was applied for. The parallel review mechanism, on the other hand, targets new drugs meeting certain criteria and allows simultaneous applications for the drug permit and NHI coverage. Therefore, after parallel review is promoted, it is estimated that payments will be available 6 months after the drug permit is obtained. For common drugs, on the other hand, payments will be available 10 months versus originally about 12.5 months, after it is processed under NHI. For related questions and answers and informative data, visit the website of the NHIA (https://www.nhi.gov.tw/ch/lp-3531-1.html).

       HTA was introduced in the application for NHI coverage of new drugs in 2008. CDE HTA is responsible for preparing the HTA report of new drugs whose coverage is applied for. These reports are used as references by the Pharmaceutical Affairs Group of the NHIA in making decisions on new drug coverage. Since January 1, 2013, the National Health Insurance Act has been officially implemented. Article 42 of this Act stipulates that the NHI Fee Schedule and Reference List for Medical Services are to be established, and the insurer may conduct HTAs first and shall take into consideration human health, medical ethics, cost-effectiveness of healthcare and financing of this insurance. CDE researchers, reflective of the nature of each case, evaluate effectiveness evidence and perform economic evaluation or budget impact analysis. For timeliness, each case being evaluated needs to be completed within 42 calendar days and a rapid health technology assessment report is generated upon completion for NHIA’s reference. 
       An overview of the various assessments needed and outsourced to it, CDE provides NHIA with nearly 100 new drug evaluation reports for various types of new rugs, expansion or revision of indications, among others, each year. Related reports are released on the website of the NHIA (https://www.nhi.gov.tw/ch/np-2476-1.html. ) and also available on the website of CDE.

       According to Article 3 of the National Health Insurance Pharmaceutical Benefit and Reimbursement Scheme, special devices refer to additional items that may be declared than diagnosis and treatment items. For cases such as the addition or revision of requirements for special devices that may be advised to be included in NHI coverage or special devices and drugs with new functional, NHIA follows certain principles by authorizing CDE HTA to conduct HTAs, which will serve as a reference during review in the PBRS Joint committee.

       With the development of new health technologies, in order to meet actual clinical healthcare needs, NHI continuously introduces new medical technologies that are cost-effective and gradually reforms the National Health Insurance Fee Schedule and Reference List for Medical Services. It is highly complex to evaluate medical services and it is often required to also consider the technical impact of operators and clinical popularity during assessment and hence the assessment is relatively challenging. Over the past few years, innovative health technologies have also made it difficult for the insurer to only consider the value of new health technologies from the traditional perspective, such as innovative digital health technologies, which pose even greater challenges for the assessment in the future. CDE, as authorized by NHIA, conducts HTAs of special devices. Besides the aspects that will be taken into consideration during new drug or special devices assessments, the practical feasibility, capacity of each healthcare facility and physician learning curve will be evaluated reflective of the nature of the medical service, too, to hopefully further perfect considerations in the review of medical services.

       Patient involvement in the drug payment decision-making process began in 2013, when the second-generation NHI was enforced. Article 41 of the National Health Insurance Act stipulates that representatives of patient groups may be invited to attend the PBRS Joint Meeting and express their opinions about the Pharmaceutical Benefit and Reimbursement Scheme.
       In order for patients to provide opinions in the decision-making process over the reimbursement of new drugs and new special devices in the NHI coverage, NHIA, in 2015, created the “NHIA online submission platform” for official inclusion of patient opinions that will be referred to or be adopted in the new drugs and new medical devices for coverage. The platform features were further expanded on October 1, 2021, with the addition of the feature for sharing feedback on the expansion of the scope of coverage for drugs so that NHI-related decision-making truly reflects the needs of patients. Platform opinions, once summarized by CDE, are provided to the representative experts in PBRS Joint Meeting for their reference.
       Additionally, in 2016, NHIA announced the “Operational Guidelines for Patient organizations invited to present at PBRS Joint Committee meeting”. This guidelines stipulate that for cases of drugs recommended for reconsideration, NHIA must formally invite two designated representatives from patient groups who have provided specific opinions on the drug through the opinion sharing platform to attend and express their views at the drug joint drafting meetings. Thus, patients in Taiwan now have a formal channel to voice their perspectives and positions in drug coverage decisions.
       Besides compiling patient opinions and including them in the presentation during the PBRS Joint Meeting, CDE held the patient expert meeting in 2019 onwards where patient representatives, patient groups and related experts/scholars are invited to jointly discuss the current patient involvement mechanism in our country and bring forth modification advice, such as inclusion of patient opinions in the HTA report and holding the pre-meeting for patients to express their opinions prior to the PBRS Joint Meeting in order to reinforce patient representatives’ knowledge of the perspectives and experiences of patients in difference cases. Attendees in the patient opinion pre-meeting include patient representatives, representatives of the insured, representatives of patient groups having provided opinions and NHIA representatives, among others. The number of attendees has been increasing. Communications and conversations in the patient opinion pre-meeting help patient representatives express their opinions more precisely in the PBRS Joint Meeting. In addition, in order to enable more patients to share their medication experience through the “NHIA online submission platform” CDE is constantly building partnerships with different patient groups to hopefully boost the importance of patient voices while NHI apprisal are being reviewed, such as joint discussion with the Hope Foundation for Cancer Care about how to collect and sort out patient opinions, participation in workshops held by the Formosa Cancer Foundation on co-payment and multi-support cancer drugs fund, and sharing of the application of real-world data in HTA.
       The CDE routinely compiles patient opinions and includes them in the HTA report and presents them in the PBRS Joint Meeting and continues to hold patient opinion pre-meetings before the PBRS Joint Meeting so that patients’ opinions are conveyed through the consensus reached in the meeting to perfect the drug reimbursement decision-making mechanism. In the future, continuous efforts will be made to collect suggestions from all parties; the “NHIA online submission platform” will be optimized; and applicable educational training courses will be planned in order to reinforce the mechanism for patients to take part in the apprisal process.

        Continued population aging and constant advancement in health technologies as well as persistent increases in the domestic public demand for medical service are quickly driving up NHI expenses on healthcare to make it obviously urgent to reflect upon the efficiency in the configuration of NHI healthcare resources. The conventional HTA, however, only focuses on comparative effectiveness and economic analysis in the decision over whether or not to adopt a new health technology. This will serve as scientific evidence to be provided to decision-makers for their reference. Therefore, in order to boost the quality of healthcare and to enhance the legitimacy in the configuration of resources, conventional HTA can no longer satisfy the respective needs of policy-makers. This has also given rise to health technology management (HTM). Besides HTA prior to payment for a new health technology, health technology re-assessment (HTR) following the adoption of coverage is gradually gaining prominence, too, to hopefully accomplish re-allocation of healthcare resources and to free up resources consumed by low-value health technologies so that more higher-value new health technologies are covered and healthcare decision-makers are better supported to hopefully improve the quality of care for patients. Accordingly, CDE started to help plan the HTR of local health technologies in 2018 as authorized by NHIA and has been compiling the experiences in respective countries with re-assessment and providing advice on possible counter measures against challenges that may appear in the future through literature review and international collaboration. The current HTR steps and mechanism include: (1) identification, (2) preliminary screening, (3) prioritization, (4) re-assessment, (5) apprisal, etc.
        Since 2020, CDE has been helping evaluate and provide suggestions on effective distribution of NHI resources. The main scope of operations is focused on the re-assessment of drugs, special devices, and medical service-related items already covered by NHI. In the re-assessment of drugs and special devices, experiences in respective countries with re-assessment and advice on countermeasures against possible challenges that may appear in the future are compiled through literature review and international collaboration. In the re-assessment of medical services, on the other hand, besides referring to social insurance models in respective countries, the HTR system and standard operating procedure answering to the National Health Insurance in our country are planned. The re-assessment research reports and suggestions for respective items mainly serve as reference upon subsequent revision by NHIA of applicable payment policies.