Are Global Trials Good Enough to Support the Reimbursement of a New Technology in Asia? A Review of Asian HTA Submissions

Author(s)

Liu Y1, Mol I2, Zhang L3, Hu Y4, Sarri G5, Heeg B2
1Cytel, Rotterdam, Netherlands, 2Cytel, Rotterdam, ZH, Netherlands, 3Cytel, Waltham, MA, USA, 4Cytel, Shanghai, China, 5Cytel, London, UK

Presentation Documents

OBJECTIVES:

An increasing number of Asian countries are implementing structured health technology assessment (HTA) models for reimbursement of new technologies. Literature showed that Asian origin is a potential effect modifier in relative treatment effect estimates (RTEs). Correspondingly, some Asian HTAs on local trials, or on international trials with considerable participation of Asian patients. However, local Asian trials are not always feasible, whereas limiting to Asian subpopulations from global trials might suffer small sample sizes. To understand HTA acceptance and considerations in including local populations to support Asian submissions, we conducted a review of the recent Asian technology appraisals (TAs).

METHODS:

A comprehensive review was conducted in June 2022 on the public summary documents of drug TAs published on Asian HTA websites since 2017. Data on the presence of country-adapted cost-utility analyses (CUA), population adjustments to reflect local population, critiques, and the final recommendations were extracted. Data were presented numerically.

RESULTS:

In total, 233 TAs were identified and reviewed, among which 137 TAs were from Taiwan, followed by Singapore (67), Malaysia (12), Japan (9), and Philippines (8). Most of the submissions were granted positive drug recommendations, and were relied on previously published CUAs or those submitted to other HTAs based on international trials, with no major critiques from the Asian HTAs. Local CUAs were found in Taiwan (19%), Singapore (10%), Malaysia (8%), and Japan (100%). Less than 2% of the submissions in Taiwan and 22% of those in Japan used local Asian data in population adjustment analyses.

CONCLUSIONS:

Previous published CUAs or submissions based on international trials remain as the primary source of evidence for Asian HTA submissions. Only a few submissions included local CUAs and population adjustment to ensure Asian representation in RTEs. Relying on international trials or local data seems not a decisive driver in reaching the final recommendation.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Code

HTA171

Topic

Clinical Outcomes, Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Clinical Outcomes Assessment, Cost-comparison, Effectiveness, Utility, Benefit Analysis, Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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