Sang-Soo Lee, PhD, MBA, Sr. Director, Government Affairs and Market Access (GAMA), Medtronic Korea, Seoul, South Korea and Head of Center of Expertise (COE), GAMA, Medtronic Asia Pacific

1) MoHW announced the reimbursement determination of digital health technology (AI and prescription digital therapeutics)

On December 13, 2023, the Ministry of Health and Welfare (MoHW) announced the coverage, coding and payment for procedures related to digital health technology through MoHW notice number 2023-244. (1) This notice contains determination of reimbursement and non-reimbursement for innovative medical technologies such as artificial intelligence and prescription digital therapeutics (PDT). The effective date of this notice is December 26, 2023.

The main contents are as follows.

Part 3. Innovative medical technology: artificial intelligence and prescription digital therapeutics reimbursement list

Chapter 1: Innovative medical technology: artificial intelligence reimbursement list

1 USD = 1,300 Korean won

Chapter 2: Innovative medical technology: prescription digital therapeutics (PDT) reimbursement list

Part 4. Innovative medical technology: artificial intelligence and prescription digital therapeutics non-reimbursement list

2) HIRA announced the recent ICER value for economic evaluation in drugs

On December 28, 2023, the Health Insurance Review and Assessment Service (HIRA) unveiled the 'Incremental Cost-Effectiveness Ratio (ICER),' a value of the examination of the cost-effectiveness evaluations of drugs submitted for economic evaluation spanning from 2018 to 2022. (2) The announcement encapsulates the evaluation outcomes of 20 novel drugs, subject to cost-effectiveness reviews conducted by the ‘Drug Reimbursement Evaluation Committee (DREC)’ within the mentioned timeframe. These drugs were scrutinized for reimbursement eligibility, and the conclusions derive from the ultimate deliberation criteria applied during the process.

• Number of Ingredients: The count of ingredients involved in the economic evaluation was determined by considering those assessed through Cost-Utility Analysis (CUA) and Cost-Effectiveness Analysis (CEA). However, ingredients evaluated through Cost Minimization Analysis (CMA) were excluded from the tally.
• ICER: The ICER for each ingredient was established based on the outcomes of the basic analysis. The sensitivity analysis results were not taken into account. In cases where the basic analysis results were presented as a range, the maximum value within that range was adopted as the standard. Additionally, if there were multiple ICER values for each indication, all of them were incorporated into the analysis.

Unit: thousand Korean won /QALY

3) HIRA unveiled the research plan, “"Study on the Revision of Indirect Comparison Guidelines for Assessing the Clinical Usefulness of New Drugs”

 On February 1, 2024, the Health Insurance Review and Assessment Service (HIRA) unveiled the research plan titled "Study on the Revision of Indirect Comparison Guidelines for Assessing the Clinical Usefulness of New Drugs." (3) Here's a breakdown of the comprehensive research plan.

1. Research Background and Purpose

• The primary data source for assessing the clinical usefulness, particularly in terms of improvements with new drugs, is direct comparative clinical studies. These studies involve random allocation between new drugs and alternative drugs. However, in cases where a clinical study involves a single-arm of the subject product or lacks direct comparison data with alternative drugs, it necessitates the use of evidence derived through a valid indirect comparison.
• In pursuit of this objective, document submission guidelines were formulated, drawing insights from the outcomes of the "Study on Indirect Comparison Guideline Development for Evaluating Clinical Usefulness of Drugs (2010)." These guidelines empower applicants to furnish evidence facilitating an objective effectiveness comparison of new drugs. While serving as the foundation for assessing reimbursement adequacy and conducting economic evaluations of new drugs, there is a need to revise domestic guidelines by incorporating advanced methodologies and considering revisions implemented in guidelines from foreign countries.
  • In recent times, there has been a surge in cancer drugs and treatments for rare diseases that rely on single-arm clinical studies, posing challenges in generating direct comparison clinical evidence. Anticipating a rise in such instances, the demand for employing indirect comparison is expected to grow, especially as improvements are made to the program for waiving the submission of drug economic evaluation data.
  • Reference: “Research on Measures to Enhance the Program for Waiving Drug Economic Evaluation Data” (2023)

2. Research Content

1) Scope of Guideline Revision

• Tracking the progress of the enactment and revision of guidelines pertaining to both domestic and foreign indirect comparisons
• A comprehensive review of advanced methodologies associated with indirect comparisons for evaluating the clinical usefulness of new drugs
• Delving into considerations crucial for enhancing the clinical usefulness of new drugs and estimating equivalent (or non-inferior) effects through indirect comparisons
• Scrutiny of indirect comparison reports to assess the clinical usefulness of previously submitted new drugs
• Gathering insights and opinions from stakeholders and relevant experts
• Clearly defining the scope and direction of revision (whether it involves revision, addition, deletion, etc., in comparison to existing guidelines
• Recommending areas for further research and exploration

2) Prepare Amendments for Each Item, Based on Current Guidelines and Subject to Change if Necessary

• Guidelines Overview
• Indirect Comparison Definition and Terminology
• Indirect Comparison Data Submission Guidelines

  －     Search Strategy

  －     Selection of Randomized Controlled Trials to be Included in Indirect Comparison

  －     Interchangeability Evaluation

  －     Presentation and Interpretation of Indirect Comparison Results

• Simple Comparison
• Mixed Comparison or Network Analysis
• Indirect Comparison of Continuous Data
• Data Preparation Checklist
• Presentation and Interpretation of Risk of Bias Assessment Tools and Indirect Comparison Evaluation Cases
• Instructions for Writing Indirect Comparison Data
• Items Added Compared to Existing Guidelines

3) Draft Revision of Indirect Comparison Guidelines for Evaluating Clinical Usefulness of New Drugs.

3. Expected Effect

• Timely Provision of Revised Guidelines: In response to the growing demand for indirect comparisons, timely delivery of revised guidelines is expected. This will simplify the preparation for applicants in establishing the necessary basis for evaluating the clinical usefulness of new drugs.
• Enhance Ease for Applicants: The revised guidelines aim to streamline the process for applicants, making it more straightforward to prepare the required foundation for indirect comparisons, addressing the increasing need for such assessments.
• Improved Market Access: Evaluators, utilizing standardized review criteria, are anticipated to contribute to the enhancement of market access for new drugs. The use of a consistent and transparent approach in the evaluation process benefits both applicants and the broader healthcare landscape.

References

1. https://mohw.go.kr/board.es?mid=a10409020000&bid=0026&act=view&list_no=1479285&tag=&nPage=1
2. https://www.hira.or.kr/bbsDummy.do?pgmid=HIRAA020002000100&brdScnBltNo=4&brdBltNo=10648&pageIndex=3&pageIndex2=3#none
3. https://www.hira.or.kr/bbsDummy.do?pgmid=HIRAA020004000000&brdScnBltNo=4&brdBltNo=11582&pageIndex=1&pageIndex2=1#none