Establishment and governance

The CDE, established in 1998 under the MOHW and formally commissioned to conduct HTA in 2008, comprises multidisciplinary experts in medicine, epidemiology, health economics, biostatistics, and public health. Its HTA activities cover new drug reimbursement, indication expansions, high-impact medical devices, and policy-level health and welfare programs (Reference Kao, Huang, Wu and Gau2). HTA reports led by the CDE HTA Division serve as key reference documents for deliberations of the Pharmaceutical Benefits and Reimbursement Scheme (PBRS) Joint Committee, the NHI’s principal advisory body for benefit listing and pricing (Reference Kao, Huang, Wu and Gau2;6).

Standardized HTA workflow and timelines

Taiwan implements a transparent timeline for HTA (7). Rapid HTA reports are typically completed within 42 days after receipt of the full submission dossier, followed by a 7-day period for manufacturers to provide comments, and an additional response period when needed (7). For broader policy-oriented HTA projects, which often involve population-level policy analysis or health system evaluation, the analytical timeline is ~6–12 months, with more complex studies occasionally requiring longer than 1 year. Clinical experts are regularly consulted during HTAs to provide insights into local clinical practice, treatment pathways, and the interpretation of clinical evidence. Their input helps ensure that HTAs appropriately reflect real-world clinical practice and patient needs in Taiwan. All finalized HTA reports are released simultaneously to the National Health Insurance Administration (NHIA) and manufacturers, supporting transparency, early dialogue, and consistent evidence use. Manufacturers are given the opportunity to review the reports and submit comments if they have concerns regarding the interpretation of evidence or other aspects of the assessment process (8–Reference Oortwijn, Husereau and Abelson10).

HTA reports are also publicly available on the NHIA and CDE webpage, where documentation – including assessment rationales and evidence summaries – is accessible, although largely in Mandarin. This disclosure mechanism enhances stakeholder engagement, increases accountability, and aligns Taiwan’s HTA system with international expectations for openness and transparency (8–Reference Oortwijn, Husereau and Abelson10).

Growth into policy-oriented HTA

In 2024, Taiwan’s HTA system conducted 196 rapid HTA reports covering new molecular entities, relative effectiveness and budget impact analyses, new formulations or routes of administration, and applications for expanded indications or reimbursement scope revisions. In addition, twelve HTA assessments were conducted for medical devices. Beyond these evaluations, the HTA system also informs broader health policy areas, including cancer screening, digital health and artificial intelligence (AI), NHI reimbursement and payment system reforms, and healthcare resource allocation. In the same year, the CDE HTA team completed five major policy evaluations commissioned by the MOHW and eight studies supporting reforms of NHI benefit mechanisms. HTA findings may inform policy planning, support policy development, or be directly adopted and implemented in policy.

Among the five commissioned evaluations, four have informed policy development or implementation, and the corresponding reports have been publicly released online (Table 1) (11).

Table 1.

Overview of policy-oriented HTA projects supporting health system reform in 2024 (11)

^* Note: B-to-C (Business-to-Consumer) refers to telemedicine services delivered directly from healthcare providers to patients via video consultation platforms.

Resource optimization and real-world effectiveness evaluation

In 2024, the CDE reassessed both pharmaceuticals and medical devices to optimize resource allocation. Drug-related evaluations included taxane and pyrimidine analog chemotherapies, immunoglobulin, and albumin, along with immune checkpoint inhibitors requiring RWE. Device and procedure reassessments included three-dimensional ablation catheters, ventricular assist devices, and rib fixation systems, examining clinical outcomes, safety, budget impacts, and patterns of use. Supported by RWD from the NHI database, these analyses refine benefit specifications, reduce low-value care, and ensure that coverage decisions align with contemporary clinical practice (13).

These system-level HTA applications extend impact beyond individual appraisals and reinforce their central role in Taiwan’s healthcare delivery, cost-effectiveness-informed reimbursement policies, and evidence-driven resource allocation.

Parallel review: accelerating access without sacrificing rigor

Implemented in 2024, the parallel review system enables simultaneous assessment of regulatory documentation and reimbursement evidence by evaluation and insurance agencies. This coordinated approach shortens time-to-access for priority and high-impact therapies while maintaining the rigor of HTA. Previously, reimbursement evaluation generally began only after regulatory approval had been granted, which could result in delays of ~1 year or longer before reimbursement listing. Under the parallel review mechanism, regulatory and reimbursement evaluations can proceed concurrently, with the policy objective of enabling reimbursement implementation within ~6 months after marketing authorization.

Eligible products include priority review and accelerated approval therapies, high clinical impact treatments, pediatric rare-disease medicines, domestically developed novel ingredients, drugs sold internationally for at least 5 years but newly introduced or manufactured locally, and technologies that improve effectiveness or lower cost relative to NHI-covered alternatives (5).

In its first year, the parallel review system completed eighteen eligibility assessments for the parallel review pathway and contributed to reducing the time between regulatory approval and reimbursement listing for priority therapies. It has become a core mechanism aligning regulatory evaluation with reimbursement decisions, forming a key component of Taiwan’s strategy to enable timely, evidence-informed access to novel medical technologies. Its interaction with adaptive reimbursement tools, such as MEAs, supports a coherent, life cycle-based approach to market entry and coverage decisions (5).

Managed entry agreements

Since 2019, Taiwan has implemented a structured MEA framework to address clinical and economic uncertainties.

MEAs have become essential policy tools for managing uncertainties tied to novel or high-cost therapies. These agreements take various forms, including outcome-based arrangements (e.g., survival, response, or progression-linked payments), financial-based agreements (e.g., expenditure caps and price–volume arrangements), and hybrid models combining financial safeguards with clinical performance requirements. MEAs enable conditional access to therapies with uncertain benefits, incentivize manufacturers to generate RWE, and allow future price or coverage adjustments based on observed performance. They play a key role in facilitating timely access to oncological treatments, rare disease therapies, and high-cost biologics within Taiwan’s NHI system.

Temporary reimbursement and the Taiwan cancer drugs fund

To address rapidly growing cancer drug expenditure and urgent patient needs, and having learned from the NICE experience (14), Taiwan established the TCDF as a structured, multiphase, and temporary reimbursement policy (15). This design separates high-impact oncology spending from routine NHI financing while enabling conditional access under evidence development. The TCDF separates high-impact oncology expenditure from routine NHI financing and enables conditional access under evidence development. As of June 2025, twenty-four drugs were temporarily reimbursed. The scheme provides early access while generating RWE to inform final reimbursement decisions, supported by transparent governance, mandatory data submission, periodic reassessment, and financial safeguards such as expenditure caps and claw-backs. Its implementation relies on coordination among NHI, MOHW, CDE, and clinical networks, alongside the development of an integrated precision oncology RWD ecosystem linking next-generation sequencing (NGS), cancer registry, pathology, and claims data to support life cycle HTA.

Overall impact

The integration of parallel reviews, MEAs, and the TCDF represents a major reform in Taiwan’s reimbursement system. These pathways enable rapid, responsible access to high-cost and high-clinical impact therapies, link reimbursement to continuous evidence generation, and support the financial sustainability of NHI. They also enhance the national HTA system’s capacity to manage clinical and economic uncertainty, aligning Taiwan with international best practices for adaptive and life cycle-based reimbursements (5).

Building the evidence ecosystem

Taiwan’s HTA framework is evolving into a learning system, focusing on RWD, precision medicine evaluation methodologies, and systematic health technology reassessment (HTR). These components bridge evidence gaps, manage uncertainty, and optimize coverage decisions. To anticipate future budget pressures and support proactive policy planning, Taiwan has also strengthened its horizon scanning and forward-looking evaluation mechanisms. These activities identify emerging high-impact technologies, estimate timelines to market entry, project potential budget implications, and flag candidates that may require MEAs or temporary reimbursement. Enhanced horizon scanning enables the NHIA and CDE to better prepare for innovations such as CAR-T therapies, gene therapies, and advanced medical devices, ensuring that reimbursement strategies remain adaptive and aligned with rapid scientific and clinical advances. Temporary reimbursement mechanisms, including the TCDF and MEAs, play a central role in life cycle HTA. TCDF requires 2–3 years of RWD generation (extendable to 5 years), after which final reimbursement decisions are made. As highlighted in regional policy discussions, TCDF forms part of Taiwan’s broader strategy to reduce the cancer burden through integration with precision medicine and digital transformation. By linking evidence generation to funding conditions, Taiwan enables earlier access to high-need therapies while managing uncertainty and safeguarding the long-term sustainability of the NHI system (5).

Health technology reassessment: ensuring sustainability

HTR is a core component of Taiwan’s HTA strategy, designed to systematically reevaluate existing covered technologies, identify low-value or outdated interventions, adjust benefit coverage and payment levels, and respond to evolving clinical and economic evidence. In 2024, Taiwan implemented a comprehensive HTR program encompassing pharmaceuticals, high-cost medical devices, and medical services. Medical service reassessments covered areas such as high-flow oxygen therapy, stroke care, robot-assisted surgery, CT-based diagnostic imaging, and diabetes management under the Family Physician Program. Across these domains, HTR integrates structured evidence review, cost-effectiveness analysis, and the use of RWD – applied flexibly according to the specific characteristics and policy needs of each case – to inform adjustments to benefit specifications, payment mechanisms, and coverage scope. Reassessments included major oncology medicines – such as immune checkpoint inhibitors evaluated using national RWD – as well as targeted reviews of selected drugs and high-impact technologies, including transcatheter aortic valve implantation, cardiac ablation devices, and bariatric surgery technologies. Through standardized reassessment procedures combining clinical and economic evidence, the 2024 HTR program supported refinements in benefit design, cost-effectiveness-informed reimbursement policies, renegotiation of managed entry agreements, and decisions on the modification or continuation of temporary reimbursement. Collectively, these efforts strengthened the alignment of reimbursement policies with contemporary clinical value and reinforced the long-term sustainability and accountability of Taiwan’s NHI system.

Systematic integration of patient perspectives

Patient input is systematically collected and integrated into HTA through structured mechanisms, including a national submission platform and mandatory synthesis of patient perspectives within HTA reports for PBRS deliberation. Patient evidence is used to contextualize unmet needs, disease burden, and treatment goals – particularly for chronic, rare, and oncologic conditions – and is publicly disclosed to enhance transparency. These processes ensure that patient perspectives complement clinical and economic evidence in decision-making (Reference Chen, Huang and Gau16).

Pre-meeting mechanisms and stakeholder engagement

Since 2019, the CDE has convened twenty-nine pre-PBRS patient engagement meetings with patient groups, insured representatives, and caregivers. The insured representatives participating in these meetings are the formal representatives of the PBRS Joint Committee.

These efforts aim to clarify key uncertainties and unmet needs, consolidate patient input, prepare patient representatives for PBRS participation, and facilitate dialogue between HTA assessors and patient organizations to ensure accurate representation of patient evidence (Reference Chen, Huang and Gau16). During these meetings, the CDE HTA team also presents how patient submissions collected through the NHIA platform have been synthesized and incorporated into HTA reports and reimbursement deliberations, allowing patient groups to review the summaries and confirm whether any perspectives have been missed or whether additional input should be included.

From May 2015 to October 2024, seventy-five technologies (forty-five oncology, twenty-eight non-oncology, and two medical devices) incorporated patient input before the PBRS review. This cumulative figure spans multiple years and is not directly comparable to the number of HTA assessments conducted in 2024. These interactions show a process that is structured and adaptive, evolving from early patient submissions to more sophisticated inputs gathered by patient organizations through surveys, focus groups, and community networks.

International collaboration

International collaboration has been central to the evolution of Taiwan’s HTA system. With sustained support and exchange through global networks such as HTAi and the International Network of Agencies for Health Technology Assessment (INAHTA), Taiwan has strengthened its methodological capacity and policy impact. Over the past decade, Taiwan has actively contributed to international discussions by sharing practical experience and learning from peers. Through participation in HTAi activities, including the 2023 Asia Policy Forum, Taiwan presented its approaches to adaptive pathways and reimbursement of new medical technologies, contributing to regional dialogue on balancing timely access with evidentiary uncertainty. These collaborations have supported the maturation of Taiwan’s HTA system and enhanced its role in helping the government expand access to effective and sustainable healthcare for the population (17).