HTA Procedures - iDSI

Standards and Procedures of HTA in China– The Role of Economic Evaluation Mr. Haiyin Wang Division Director Shanghai Health Development Research Center

Outline

1

HTA Procedures- International Experiences

2

HTA Process in China

3

The Role and Adaption of HTA In China

HTA-Models

Representatives

Core theory

REA

CEA

France, Germany, Japan, Taiwan

United Kingdom, CANADA, Italy, Korea

Clinical benefit/ appreciation value ( budget)

cost/QALY Versus ICERs （Threshold）

Varied by Countries

Resources：Adrian Griffin, (2014)， HTA Forum in Shanghai materials

HTA- International HTA Characteristics  Integrating HTA into Health and Social Act and relevant regulations  Developing HTA guidelines and procedures  Involving multi-stakeholders, and open to the public, in order to be transparency.

HTA-United Kingdom  The National Institute for Health and Care Excellence （NICE） integrates all relevant evidences for HTA, and plays an important role in designing clinical guideline and health insurance reimbursement Manual.  In 2009, NICE released Single technology appraisal (STA）and Multiple technology appraisal (MTA）procedure guidelines. In 2014, NICE published an updated guides to the methods of technology appraisal, including, health technology procedures guideline, health technology methodology guidelines, and health technology evaluation complaints etc.

HTA- United Kingdom

Selecting Topics for Appraisal

Scoping and Defining the Decision Problem

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Selecting Topic, Scoping and Defining the Decision Problems

Second Appraisal Committee Meeting

Appraisal Committee meeting to develop the FAD or ACD

ACD Committee Deadline Application Deadline

First Appraisal Committee Meeting

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ACD:Draft Appraisal committee meeting materials

Figure1. Summary of the STA process

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FDA:Finalized Guidance published

HTA-Australia  Australia mainly has Pharmaceutical Benefits Advisory Committee，(PBAC）and Medical Services Advisory Committee (MSAC），HTA are directly use in the adaption of Drug and Medical Services Reimbursement and Payment Policy Planning  Basically, procedures in Australia and NICE are the same, the applicants need to provide evidences to support their application, then the external experts will make a judgment for the project to be implemented.  Differences: Australia is mainly assessed by consultants organized b tone agency and got re-evaluated by an independent academic community

HTA-Australia

Figure 2. Summary of PBAC process

HTA-Australia

Figure 3. Summary of PBAC process

Outline

1

HTA Procedures- International Experiences

2

HTA Process in China

3

The Role and Adaption of HTA In China

HTA-China Medical Technology Decision-Making Management

Medical Service Items ；pay for service, Medical Services Reference Price Catalog, MOH, Health Insurance Department，Price Bureau

Guidelines、Pricing Setting and Payment

Drug：eliminated Majority Government Price

Setting Mechanism，health Insurance Payment Standards，centralized／local Bidding Procurement, Essential Drug List

Medical Disposables Materials:

Transparency

Procurement Model, Hospital, Health Insurance Department, MOH（Shenkang）, Price Bureau

Guidelines、payment Standards

Hospital Purchasing Catalog, Purchasing Prices

HTA-Designing Procedures in China National and Local Organization  Policy Makers and Payers（Users）  Policy Makers and Payers（Initiator）

Hospital

 Public And Hearth Insurance （Perspectives）  Government（national/Local） （Funding/Pool）

 Hospital administrator and clinical administrator （Users）  Physicians (Initiators）  Hospitals (Perspectives）  Other resources（Funding）

HTA-Designing Procedures in China （National or Local Organizations）

Four Steps

Two Pathway

 Applying And Scoping Appraisal Topic  Evidence Review Group  Appraisal Committee Meeting  Finalized and Adaption (Figure 4)

 Applicants needs HTA and submits reviewing materials to get the technology been reviewed and evaluated by Health Technology Evaluation Organizations (similar to STA)  Applicants providing materials, the Health Technology Evaluation Organization will evaluate the proposal (similar to MTA)

 Multi-stakeholders and transparency

Medical Technical Divison

From Pharmaceutical Company，HTA Research Center/ Organization and Relevant Health Regulators

HTA-Process in China Agency requires 厂商申请卫生

卫生技术评估研 HTA organization 究机构

技术评估 HTA

确定是否评估 Evaluate？

否

Hearth insurance 医保办、卫计委 department, MOH

Evaluate and priority setting

评估纳入及优先秩序

Expertise committee 专家委员会

是 厂商提供评估申请材料 Agency materials

审核

Committed 卫生技术评估专 业组 group 修订

反馈

Clinical benefits Cost 成本效果 effectiveness 临床疗效

Drafted 完成评估研究报告 report

Committed group 专家委员会专家审议 review Committed group 专家委员会会议 meeting

建议及修订

卫生技术评估政策简报 HTA policy report, and price 及给付、价格建议 suggestions

Price Bureau, health insurance department, MOH,

医保、物价及卫生计生委

Figure 4. The Process of HTA in China

HTA-the process of HTA at Shanghai 厂商申请技术及对比技术 厂商申请技术及对比技术 的背景资料 的背景资料

Agency Background

疗效评价 疗效评价 Outcomes Appraisal

FDA，indication, clinical pathway, treatment and cost

申请评估技术及对比技术的规格型 申请评估技术及对比技术的规格型 号、FDA准入情况、适应症、治疗路 号、FDA准入情况、适应症、治疗路 径、治疗疗程及疗程花费情况 径、治疗疗程及疗程花费情况

效果证据、研究类型和质量 效果证据、研究类型和质量 Outcomes, research type, quality

Comparative analysis

疗效比较结论（优于对照或非劣性结果 疗效比较结论（优于对照或非劣性结果

经济学评价 经济学评价 Economic Evaluation

cost

治疗成本数据 治疗成本数据

CEA

成本效果分析结果 成本效果分析结果

Budget Constraint 预算影响分析 预算影响分析 Analysis

治疗疾病的流行病学、疾病负 治疗疾病的流行病学、疾病负 担状况 担状况

Epidemiology

市场影响分析 市场影响分析 Marketing analysis

Figure 5. Shanghai HTA Center---the process of HTA

HTA-HTA report template Abstract

Agency provide abstract； HTA report abstract

Background

Disease Treatment； evaluation technic, regulations

Literature review from international studies；Cochrane Outcomes Library, Medline literature review；evidence-based evaluation based on the materials provided by agency； Economic Evaluation outcomes and results population；evaluation the burden of Technical application impact assessment

Conclusion/ Suggestions References

disease；budget constraint analysis Conclusion；policy suggestion Appendix

Outline

1

HTA Procedures- International Experiences

2

HTA Designing Process in China

3

The Role and Adaption of HTA In China

HTA,EBM,CER?

Resource: Luce B R, Drummond M, Jönsson B, et al. EBM, HTA, and CER: clearing the confusion[J]. Milbank Quarterly, 2010, 88(2): 256-276.

HTA-卫生经济评价应用思考 indicator s Disease Intervent ion backgrou nd Intervent ion results Benefit type Economic evaluatio n Evidencebased

Scientific standards Informatio

The degree of severity

n needed

Influenced population

Disease

Clinical guideline

back

limits

ground Product

Improvement in outcomes

informatio

Improvement in safety

n

Effective treatment by patient feedback

Clinical

public health benefit Medical service type Budget constraint

US

Canada

England

Germany

Australia

Taiwan

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Optional

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benefits (including patient benefits

CEA

PE

Plan

Other costs

evidence

specif

adherence

ic

The completeness and consistency of the report

Comparati

Linkage and effectiveness of the evidences

ve analysis

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HTA-Reflection For the same functional（class）drugs, we set cost-effectiveness analysis outcomes as priorities prerequisite based on the principle of the pharmaceutical economics. Based on the results of the HTA, we can get rid of the high cost and less effectiveness drugs from the drug lists。 In the Centralized procurement bidding system, the drugs with relative better outcomes and less cost, will be more attractive and getting a relative higher bidding price than the less effectiveness one. At the same time, we are highly encourage the development of innovative drugs. We have developed one reimbursement payment system for the innovative drugs which were lacking of competitors, based on the results of HTA and

HTA-Reflection Medical Services Price Catalog，DRG；Price of Services Items。 The Selection of Technology, Evaluation and Adaptation The Development of Clinical Practices Guidelines。 Re-evaluation and Adjustment on a regular basis for the limitations of Clinical Health Technology Application

HTA-Medical Disposable Materials  Procurement(purchase of Hospital High Value Disposable Materials and Price Negotiation Mechanism Low-value and One-time Used Disposable Materials Packaging Selection

Thank you