Standards and Procedures of HTA in China The Role of Economic Evaluation

Transcription

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

2 Outline 1 HTA Procedures- International Experiences 2 HTA Process in China 3 The Role and Adaption of HTA In China

3 HTA-Models Representatives REA France, Germany, Japan, Taiwan CEA United Kingdom, CANADA, Italy, Korea Core theory Clinical benefit/ appreciation value ( budget) cost/qaly Versus ICERs (Threshold) Varied by Countries Resources:Adrian Griffin, (2014), HTA Forum in Shanghai materials

4 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.

5 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.

6 HTA- United Kingdom Selecting Topics for Appraisal Scoping and Defining the Decision Problem Appraisal Committee meeting to develop the FAD or ACD Wk 21 First Appraisal Committee Meeting Second Appraisal Committee Meeting ACD Committee Deadline Application Deadline Wk 34 Wk- 7 Wk- 18 Wk 20 Wk 24 Wk 27 Wk 29 Wk 39 Selecting Topic, Scoping and Defining the Decision Problems Appraisal committee meeting materials ACD:Draft Figure1. Summary of the STA process FDA:Finalized Guidance published

7 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

8 HTA-Australia Figure 2. Summary of PBAC process

9 HTA-Australia Figure 3. Summary of PBAC process

10 Outline 1 HTA Procedures- International Experiences 2 HTA Process in China 3 The Role and Adaption of HTA In China

11 HTA-China Medical Technology Decision-Making Management Medical Service Items ;pay for service, Medical Services Reference Price Catalog, MOH, Health Insurance Department,Price Bureau Drug:eliminated Majority Government Price Setting Mechanism,health Insurance Payment Standards,centralized/local Bidding Procurement, Essential Drug List Guidelines Pricing Setting and Payment Guidelines payment Standards Medical Disposables Materials: Transparency Procurement Model, Hospital, Health Insurance Department, MOH(Shenkang), Price Bureau Hospital Purchasing Catalog, Purchasing Prices

12 HTA-Designing Procedures in China National and Local Organization Policy Makers and Payers(Users) Policy Makers and Payers(Initiator) Public And Hearth Insurance (Perspectives) Government(national/Local) (Funding/Pool) Hospital Hospital administrator and clinical administrator (Users) Physicians (Initiators) Hospitals (Perspectives) Other resources(funding)

13 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

14 HTA-Process in China Agency 厂商申请卫生 requires HTA 技术评估 Agency materials 否 厂商提供评估申请材料 反馈 审核 卫生技术评估研究机构 HTA organization Evaluate? 确定是否评估 是 Committed group 卫生技术评估专业组 修订 Drafted report 完成评估研究报告 Hearth insurance department, 医保办 卫计委 MOH Expertise 专家委员会 committee Clinical 临床疗效 benefits Cost 成本效果 effectiveness Evaluate and priority setting 评估纳入及优先秩序 Committed group review Committed group meeting 专家委员会会议 专家委员会专家审议 建议及修订 HTA policy report, and price suggestions 卫生技术评估政策简报及给付 价格建议 Price Bureau, health insurance department, MOH, 医保 物价及卫生计生委 Figure 4. The Process of HTA in China

15 HTA-the process of HTA at Shanghai 厂商申请技术及对比技术 Agency 的背景资料 Background FDA,indication, clinical 申请评估技术及对比技术的规格型号 pathway, FDA 准入情况 适应症 治疗路 treatment and 径 治疗疗程及疗程花费情况 cost Outcomes 疗效评价 Appraisal Outcomes, 效果证据 研究类型和质量 research type, quality Comparative analysis 疗效比较结论 ( 优于对照或非劣性结果 经济学评价 Economic Evaluation cost 治疗成本数据 CEA 成本效果分析结果 Budget 预算影响分析 Constraint Analysis 治疗疾病的流行病学 疾病负 Epidemiology 担状况 Marketing 市场影响分析 analysis Figure 5. Shanghai HTA Center---the process of HTA

16 HTA-HTA report template Abstract Agency provide abstract; HTA report abstract Background Outcomes Economic Evaluation Technical application impact assessment Conclusion/ Suggestions Disease Treatment; evaluation technic, regulations Literature review from international studies;cochrane Library, Medline literature review;evidence-based evaluation based on the materials provided by agency; outcomes and results population;evaluation the burden of disease;budget constraint analysis Conclusion;policy suggestion References Appendix

17 Outline 1 HTA Procedures- International Experiences 2 HTA Designing Process in China 3 The Role and Adaption of HTA In China

18 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):

19 HTA- 卫生经济评价应用思考 indicator s Disease Scientific standards The degree of severity Influenced population Informatio n needed Disease US Canada England Germany Australia Taiwan Intervent ion backgrou nd Intervent ion results Benefit type Economic evaluatio n Evidencebased Clinical guideline limits Improvement in outcomes Improvement in safety Effective treatment by patient feedback public health benefit Medical service type Budget constraint CEA Other costs adherence The completeness and consistency of the report Linkage and effectiveness of the evidences back ground Product informatio n Clinical benefits (including patient benefits PE evidence Comparati ve analysis Plan Optional specif ic

20 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

21 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

22 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

23 Thank you