市場調査レポート

米国における薬価と償還:比較効果研究(CER)と費用対効果分析の影響

Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis

発行 FirstWord 商品コード 229469
出版日 ページ情報 英文 85 Pages
納期: 即日から翌営業日
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米国における薬価と償還:比較効果研究(CER)と費用対効果分析の影響 Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis
出版日: 2012年01月23日 ページ情報: 英文 85 Pages
概要

当レポートでは、米国における薬価と償還について調査分析を行い、欧州モデルとの比較、米国におけるCERの利用、米国市場におけるバイオ医薬品とバイオシミラーの役割、今後の見通しなどについてまとめ、概略以下の構成でお届けいたします。

第1章 ハイライト

第2章 エグゼクティブサマリー

第3章 イントロダクション

第4章 世界のブランド医薬品売上における米国のシェア

  • 米国の影響の減少:ブランドバイオ医薬品の収益

第5章 米国におけるCERの利用

  • メディケア
  • メディケイド
  • 食品医薬品局(FDA)
    • 2型糖尿病薬Avandia(GSKA)へのFDAAの対応
  • バイオシミラー承認の新たな評価基準
  • マネージドケア・ツールが利用とコストを抑えている
    • マネージドケアの処方集
    • 事前承認
    • 非盲検自然的研究:PlavixとEffient
    • マネージドケア・ツールの影響
  • マネージドケアの影響を軽減する適応症
    • 癌治療薬
    • オーファンドラッグと代替治療の不足
  • 間接的にCEAを実施する政府機関:ケーススタディ
    • 加齢性黄斑変性症:AvastinとLucentis
    • 進行大腸癌/転移性結腸直腸癌:Erbitux
  • 直接比較臨床試験の長所と短所
  • 併用療法
    • 併用療法のブランド薬コストへの影響
    • 多剤混合薬
  • 今後の課題
    • 議論の多いCERの提案
    • 協力的なCERの提案
    • 潜在的な薬剤開発の再生
    • 薬剤開発の再生の影響

第6章 参考文献

第7章 謝辞

第8章 付録

目次
Product Code: 400200050

Abstract

Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis

Public healthcare costs are rising. Governments need to get them under control. In Europe, that means the systematic use of health technology assessments (HTA) and reference pricing. The US, on the other hand, focuses on comparative effectiveness research (CER) to identify drugs that maximise clinical efficacy, minimise clinical harm and are more in tune with individual needs. Vastly different solutions - but are they working?

Report Overview

In Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis, FirstWord Dossier lays bare the US model by defining comparative effectiveness research and exploring its limitations with regards to drug trials. The report expertly examines direct versus indirect cost effectiveness analysis, the role of key government institutions and managed care organisations and the impact such research is having on blockbuster drugs. Based on au courant research, expert interviews and several compelling case studies, the report takes a critical look at US policy decisions and trends and offers a clear, uncluttered view of the US drug reimbursement system.

Key Report Features

  • Wide-ranging analysis of US drug and reimbursement policies and how they differ from European models
  • Review of the use of CER in the US, with particular attention to Medicaid and Medicare
  • Up-to-date insight into the role of branded biologics and biosimilars in the US market
  • Insight into cost-containing managed care tools
  • Examination of the benefits and drawbacks of head-to-head trials and combination therapy
  • Analysis of future CER proposals and their implications

Key Benefits

  • Expert insight from ten industry voices on the effect of CER and CEA on the US system of drug reimbursement
  • In-depth examination of pertinent policy decisions and trends in the US pharmaceutical industry, explaining the utilisation of CER and direct versus indirect CEA
  • Multiple case studies and comprehensive references to key literature

Key Questions Asked

  • How does the US now control prescription drugs costs and what roles do reimbursement and pricing play?
  • How are US and European models similar and how do they differ?
  • How do branded pharmaceutical cost considerations influence reimbursement decisions and policy at the federal level in the US, as government costs outpace government revenue?
  • What are the implications of these trends for pharma and how will it respond?

Who Would Benefit From This Report?

  • Global health economists
  • Global HTA directors
  • Managed care/market directors
  • Pricing and reimbursement managers
  • Marketing, brand and sales managers
  • Business development executives
  • Regulatory and government affairs professionals

Key Quotes

"Where is the risk/benefit quantitative standardised analysis that goes hand-in-hand with the CER analysis? It should never just be about avoiding a safety event in the absence of having a discussion of what is the married benefit. What's the right ratio we're looking for, not just the lack of a serious adverse event or the production of a clinically beneficial event? I think it's both." - John Doyle, Senior Vice-President and Practice Lead, Managed Markets at Quintiles

"There's a paradox of lots of CER data collected, but the companies don't know what to do with it. But they are getting better at finding the right data sources and understanding how to analyse it. There is going to be a tipping point, I believe, when the very purpose of comparative effectiveness will become clear. - Samuel Wagner, head of Health Economics, Oncology, for Bristol-Myers Squibb

"There are more similarities than differences, in terms of the US and Europe, regarding most of the key issues. Accordingly, it is time for cooperation between the industry, HTAs and payers. The adversarial tones that we can read about currently, do not lead to a good place - for anyone." - Alicia Granados, Senior Director Global HTA Strategy at Genzyme

Expert Views Include:

  • Leela Barham, MSc, Independent Health Economist
  • Marc Botteman, Managing Partner, PharMerit
  • John Doyle, DPH, Senior Vice President and Practice Lead Managed Markets, Quintiles
  • William Gerth, MBA, Principal, WC Gerth & Associates
  • Alicia Granados, MD, Senior Director Global HTA Strategy, GMA Genzyme
  • Larry Gorkin, PhD, President, Gorkin & Cheddar Consulting
  • Rob Nauman, Principal, BioPharma Advisors
  • Samuel Wager, PhD, Executive Director, Bristol-Myers Squibb
  • Jeff Waite, Pharmapricing.org
  • Leslie Williams, MBA, President and CEO, ImmusanT

Table of Contents

Content Highlights

Executive Summary

Introduction

US share of global branded pharmaceuticals sales

  • Diminishing impact of US: Revenue for branded biologics
    • Tumour Necrosis Factor-Alpha (TNF-a) Inhibitors

Use of CER in the US

  • Medicare
  • Medicaid
  • The Food and Drug Administration (FDA)
    • The FDAA's response to GSKA's Avandia in type 2 diabetes
  • New criteria for the approval of biosimilars
  • Managed care tools to restrain utilization and costs
    • The Managed Care Formulary
    • Prior Authorization
    • Open-label naturalistic studies: Focus on MedcoA's study of Plavix and Effient
    • Impact of the managed care tools
  • Disease indications that mitigate the impact of managed care
    • Oncology drugs
      • AmgenA's Xgeva
      • RocheA's Avastin
    • Orphan drugs and the lack of alternative treatments
      • Atypical antipsychotic agents via the Medicaid connection
  • Governmental agencies practicing CEA indirectly: Case studies
    • Age-related macular degeneration: Avastin versus Lucentis
    • Erbitux in advanced/metastatic colorectal cancer
      • FDA delays A"me-tooA" with a Novel Mechanism of Action
  • Pros and cons of conducting head-to-head clinical trials
  • The combination therapy compromise
    • Implications of combination therapy on branded drug costs
    • Fixed-combination drugs
  • Future considerations
    • Contentious CER proposals
    • Cooperative CER Proposals
    • Potential renaissance in drug development
    • Implications of the renaissance in drug development

References

Acknowledgements

Appendix 1

  • Use of CER by international governmental agencies
    • Health Technology Assessment: The UKA's NICE
      • Reference pricing
      • Risk-sharing strategies
      • Risk sharing in the US
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