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No.R07C0009

医療技術評価の動向(英語版)

Trends in Health Technology Assessment

出版日 2011年5月
価格
Single User License(PDFタイプ) US$3835
Multi- User License(PDFタイプ) US$14381
ページ数 120ページ
発行<調査・編集> Business Insights
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<Introduction>
The report explores approaches to HTA, profiles HTA organizations in six countries (Australia, Canada, France, Germany, the UK, and the US) and examines how their results are used to inform pricing and reimbursement decisions. The focus is on pharmaceuticals, medical devices, and diagnostics and how the rapidly evolving HTA environment will influence future market access of these technologies.

<Features and benefits>
・Analyze what evidence is required for HTA evaluations to show that a particular drug/medtech product represents an improvement on current practice.

・Gain an insight into HTA programs & identify common trends in assessment practices and areas where there are differences in processes and procedures.

・Evaluate how P&R policies are influenced by HTA outcomes and what impact HTA advice has on payors and providers, supported by case studies.

・Assess industry’s role in providing evidence that meets diverse HTA demands.

・Evaluate how interaction between regulators and payors could pave the way for greater synergies between regulatory and HTA requirements.

<Highlights>
Clinical and cost effectiveness are assessed for pharmaceuticals in Australia, Canada and the UK, while clinical benefit is the main focus in France and Germany for new drugs. CER is rapidly gaining momentum in the US to inform federal funding decisions, while commercial US payors use clinical and economic evidence in formulary listings.

Patient input is gaining greater significance in HTA, helping to provide a broader perspective of a product’s value in the real world setting. By February 2011, 22 drugs had benefited from the new process for patient group input during the Canadian Common Drug Review since it was introduced in May 2010.

From January 2011, the clinical benefit of all new pharmaceuticals launched in Germany must be assessed on the basis on manufacturers’ dossiers. The introduction of value-based pricing in the UK in 2014 will require all new brand medicines to demonstrate value, replacing the current system of selective appraisals by NICE.

-CONTENTS-
1.EXECUTIVE SUMMARY
Overview of health technology assessment
National HTA organizations profiled
HTA in practice
Influence of HTA on pricing and reimbursement
Industry’s role in HTA
Future perspectives

2.Overview of health technology assessment
Summary
Introduction
Definition of HTA
HTA processes
Evolution of HTA
Collaborative initiatives
INAHTA
HTAi
EuroScan
EUnetHTA
Key HTA principles
Influence of HTA on pharma/medtech

3.National HTA organizations profiled
Summary
Introduction
Australia
PBAC
MSAC
PLAC
Canada
CADTH
Provincial HTA organizations
France
Pharmaceutical HTA
Medical device HTA
MTAs
Germany
G-BA
IQWiG
DAHTA@DIMDI
UK
NICE technology appraisals
Evaluation Pathway Program
NIHR HTA
US
CMS
AHRQ
PCORI
DERP
Private sector

4.HTA in practice
Summary
Introduction
Transparency
Stakeholder involvement
Patient input
Canada’s new process for CDR
Calculating cost-effectiveness
NICE threshold
Theoretical thresholds
Cost minimization
Efficiency frontier
Cost-consequence analysis
Timeliness of HTA

5.Influence of HTA on pricing and reimbursement
Summary
Introduction
Uptake of HTA advice by payors
Australian government overrides PBAC advice
Listing of drugs assessed centrally in Canada
Dual recommendations in France
Pharmaceuticals
Medical devices
Reassessment
Germany’s new early assessment procedure
HTA of older products
Implementation of advice by providers
Future role of NICE
Changing US landscape
CMS coverage of Provenge
Tackling uncertainty
US CED
Ontario’s cancer drug scheme
UK patient access schemes
Managed entry in Australia

6.Industry’s role in HTA
Summary
Introduction
European Tapestry Network
Swiss HTA consensus
Industry case study
Industry relationship with payors/policy-makers
Regulator/HTA/payor interaction
UK pilot parallel scientific advice process
Sweden’s experience with parallel advice
US collaboration

7.Future perspectives
Summary
Introduction
Increased scope of HTA
Orphan drugs
HTA as part of product development
HTA and market access schemes
Convergence of HTA programs
EU HTA co-operation
Relative effectiveness/comparative effectiveness
Summary of conclusions

Appendix
Scope
Methodology
Secondary research
Glossary/Abbreviations

<TABLES>
Table: Key milestones in HTA development
Table: WellPoint HTA grading scale
Table: Comparison of public input into HTA processes in various countries
Table: MSAC appraisals, 2006-10

<FIGURES>
Figure: Relationships of evidence processes
Figure: HTA processes
Figure: Key HTA principles
Figure: Understand where and how value can be demonstrated
Figure: HTA processes in Australia
Figure: CDR process in Canada
Figure: HAS committees involved in HTA in France
Figure: IQWiG process
Figure: Role of IQWiG in pharmaceutical clinical and economic assessments
Figure: Development of HTA reports by DAHTA in Germany
Figure: French ASMR ratings for pharmaceuticals, 2009
Figure: French ASA ratings for medical devices, 2009
Figure: Core elements in Roche’s drug development strategy
Figure: Key stakeholders in Roche’s drug development strategy
Figure: Key challenges posed by HTA

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