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市場調査レポート

バイオシミラー:欧州における保険者の展望

Biosimilars: EU Payer Perspectives

発行 FirstWord 商品コード 326352
出版日 ページ情報 英文
納期: 即日から翌営業日
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バイオシミラー:欧州における保険者の展望 Biosimilars: EU Payer Perspectives
出版日: 2018年02月01日 ページ情報: 英文
概要

当レポートでは、欧州の主要5カ国の計15の保険者を対象にインタビューを行った結果から、欧州におけるバイオシミラーの展望を調査し、現在の承認・導入・利用状況、認知度および認識、関連法規制環境、将来の導入推進因子と各種課題をまとめています。

第1章 エグゼクティブサマリー

第2章 調査目的・調査手法

第3章 欧州のバイオシミラーの現状

  • バイオシミラーの承認状況
  • バイオシミラーの導入・利用

第4章 バイオシミラーの認知度・認識

  • 主要考察
  • 新たなバイオシミラーの承認による受容度の拡大
  • コスト削減の推進:主な利用推進因子
  • バイオシミラーの導入:医師の影響がもっとも大きいが患グループの声も拡大
  • バイオシミラーの複雑性が主な障壁に
  • バイオシミラーの教育:誰が率先すべきか保険者にとっても明確ではない

第5章 法規制環境

  • 主要考察
  • 保険者:切り替えにより充実したガイダンスが必要
  • 特に適応症の外挿における処方の決定において十分に整っている
  • 生物学的類似性に関する現在のガイダンスは曖昧だが生物学的医薬品の性質を反映している
  • 製造プロセスへの注目の拡大・実社会のデータが導入を推進
  • バイオシミラーを詳細に定義するガイダンス:保険者は歓迎
  • ECのバイオシミラー関連規制:大きな影響力を持たないと予測される
  • 保険者の提案:認証プロセスの所要時間の短縮

第6章 バイオシミラーの承認・利用・追跡

  • 主要考察
  • 現在のネーミング政策:保険者の期待を満たしていない
  • 疑問視されるネーミング戦略の有用性:区画化 (コンパートメンタリゼーション) の推進の可能性も
  • 非劣性:承認に十分では
  • 適応症の外挿の受容度:拡大しているが依然として分野により格差が
  • 保険者:一般的に互換性についてポジティブな考え
  • 切り替え:治療未経験患者では許容されているが既存患者層が成長エリア
  • 薬局レベルでの代替:依然として議論される課題
  • 教育が切り替えをサポートする鍵だが誰がデータを提供すべきかが不明確、など

第7章 商業化に関する課題

  • 主要考察
  • 処方の意思決定プロセス:昨年と比較し大きな変化はない
  • コスト削減:バイオシミラーの主な訴求因子
  • スカンジナビア諸国における前進とさらなるディスカウントの推進
  • 主要EU市場におけるディスカウント:近い将繰り返される可能性も
  • 主要EU加盟国:バイオシミラーの導入の足場を固める、など

第8章 将来の課題と市場機会

  • 主要考察
  • 切り替えのガイダンスの不足:バイオシミラー導入の大きな障壁
  • コスト削減の可能性:最大の市場機会
  • EU:ジェネリック薬ほど受容度には遠い
  • 将来の受容に関して医師がもっとも影響力を持つが他のステークホルダーも台頭している、など

第9章 付録

目次

Leading European payer experts reveal the real impact of biosimilars over the last 12 months

Keeping track of the dynamics and nuances of the biosimilars market is critical - not least because the $232 billion global biologics market is now seriously under threat. New biosimilar entrants have been taking on the European biologic brands for the last decade. The difference is: now they're winning.

Are you keeping up with the recent step change in the biologics marketplace?

Despite the best efforts of the doom-mongers, the clouds hanging over biosimilars have lifted. Payers, doctors and even patients are no longer wary. After nearly a decade, the positive experiences across Europe have multiplied; costs have plummeted; patients are switching; and treatment rates have steadily gone up. The penny has finally dropped: biosimilars are not a problem. So how will you respond?

What to expect from this report

Biosimilars: EU Payer Perspectives gives the inside track on the biosimilars market today, offering new information to help you stay ahead. For this report, we've spoken directly to 10 high-profile payer decision-makers and reimbursement influencers across Europe. These are the people who define and execute the formulary decisions and payer strategies that reverberate across the pharma landscape. What they think matters.

This 87-page report covers how the European market has changed over the last 12 months as well as offering expert payer views on current practice and what is likely to happen next. Key issues discussed include regulatory policy and frameworks, commercial tactics and pipeline launches.

  • 20 current issues of most interest to pharma were uncovered during preliminary research
  • We used these to pose an average of 36 targeted questions of each expert
  • Their responses provided 37 unique new insights
  • Insights are supported by 242 directly quoted comments

Issues covered in this report

  • Key events in the European biosimilars market
  • The demand and need for biosimilars education
  • Delivering effective and tailored biosimilars education
  • The value of local-level educational initiatives
  • The European regulatory framework for biosimilars
  • The evolution, challenges and opportunities with biosimilar switching
  • Current views on the potential for pharmacy-level substitution
  • The impact of biosimilars on the European prescribing environment
  • European payer tactics used to drive biosimilar adoption
  • Local initiatives and their influence on biosimilar adoption rates
  • The evolution of payer and originator tactics in the future
  • The impact of complex biosimilar launches in Europe
  • Key challenges in the introduction of complex biosimilars
  • Insights into the commercial strategies of biosimilar companies
  • Uncovering the reasons behind the UK's success in introducing biosimilars
  • The success (or failure) of originator company biosimilar defence strategies
  • Future adoption drivers of Remicade, Enbrel and MabThera biosimilars in Europe
  • Opportunities and challenges in relation to Herceptin biosimilars
  • Opportunities and challenges in relation to Humira biosimilars
  • Future challenges and opportunities in the European biosimilars market

Example insight included in Biosimilars: EU Payer Perspectives

"Aligned with evolving national policies, the commercial tactics employed by payers are becoming increasingly aggressive toward biosimilars. Tenders have become the go-to strategy being used by payers in Europe to ensure rapid adoption of biosimilars. A direct consequence of this is that price has become the only commercial lever that companies can pull in order to differentiate themselves from other companies, with other offerings (e.g. devices, patient support services, etc.) seen as minimally influential. National initiatives which 'gamify' biosimilar adoption rates have also been hugely successful."

Example quote included in Biosimilars: EU Payer Perspectives

"There have been huge cost savings over the last two years, since infliximab, etanercept and MabThera biosimilars have reached the UK market. The rate of growth at the complex biologics end of the pharmaceuticals market has levelled off to a certain extent; we've gone from a 12-15 percent year-on-year increase in spending to a 2-3 percent increase in the last financial year and that's mainly due to the availability of biosimilars."

The expert panel interviewed for Biosimilars: EU Payer Perspectives

  • Former Vice-Chair of the Economic Affairs Committee of LEEM; currently working as an independent consultant, France
  • Former Research Director, scientific and technological institute within the French Ministry of Health; currently working as a consultant for a large regional payer, France
  • Former member of the Transparency Committee, HAS; currently working as a senior member of a regional clinical research centre, France
  • Head of Drug Reimbursement; large regional payer, Germany
  • Associate Member of the Drug Commission of the German Medical Association, Germany
  • Full Member of the Drug Commission of the German Medical Association, Germany
  • Chief Pharmacist; cancer specialist hospital, South East England, UK
  • Clinical Director, Pharmacy and Prescribing; pricing and reimbursement organisation, UK
  • Specialist Procurement Pharmacist; large NHS Trust, North East England, UK
  • Senior leadership team member, Spanish Association of Biosimilars (BioSim), Spain

Why buy now?

Branded drug manufacturers must work harder to deliver value in order to compete successfully against biosimilars-and understanding what lies behind changing payer opinion is a key part of any successful strategy.

Why FirstWord reports are different

Branded drug manufacturers must work harder to deliver value in order to compete successfully against biosimilars-and understanding what lies behind changing payer opinion is a key part of any successful strategy.

  • Hand-picked panel of experts: For every report, we take time to identify and approach those individuals with the most relevant experience at a senior level who can genuinely be regarded as experts in their field.
  • Entirely new information: Because our reports are based on interviews conducted in the last few weeks, the insights and analysis are fresh and new. This is a perspective you simply can't source anywhere else.
  • Driven by the needs of pharma: Our professional researchers and writers are industry specialists who are proficient at delving into the detail and discovering answers to the key questions pharma needs to ask.

Table of Contents

1. Subject synopsis

  • 1.1. Sources

2. Research methodology and objectives

  • 2.1. Methodology
  • 2.2. Objectives

2. Key insights summary

3. Issues and insights

  • 3.1. Key events in the European biosimilars market
    • 3.1.1. Issue summary
    • 3.1.2. Questions
    • 3.1.3. Key insights
    • 3.1.4. Supporting quotes
    • 3.1.5. Intelligence exhibits
    • 3.1.6. Sources

4. The demand and need for biosimilars education

  • 4.1. Issue summary
  • 4.2. Questions
  • 4.3. Key insights
  • 4.4. Supporting quotes
  • 4.5. Sources

5. Delivering effective and tailored biosimilars education

  • 5.1. Issue summary
  • 5.2. Questions
  • 5.3. Key insights
  • 5.4. Supporting quotes
  • 5.5. Sources

6. The value of local-level educational initiatives

  • 6.1. Issue summary
  • 6.2. Questions
  • 6.3. Key insights
  • 6.4. Supporting quotes
  • 6.5. Intelligence exhibits
  • 6.6. Sources

7. The European regulatory framework for biosimilars

  • 7.1. Issue summary
  • 7.2. Questions
  • 7.3. Key insights
  • 7.4. Supporting quotes
  • 7.5. Sources

8. The evolution, challenges and opportunities with biosimilar switching

  • 8.1. Issue summary
  • 8.2. Questions
  • 8.3. Key insights
  • 8.4. Supporting quotes
  • 8.5. Sources

9. Current views on the potential for pharmacy-level substitution

  • 9.1. Issue summary
  • 9.2. Questions
  • 9.3. Key insights
  • 9.4. Supporting quotes
  • 9.5. Sources

10. The impact of biosimilars on the European prescribing environment

  • 10.1. Issue summary
  • 10.2. Questions
  • 10.3. Key insights
  • 10.4. Support quote
  • 10.5. Sources

11. European payer tactics used to drive biosimilar adoption

  • 11.1. Issue summary
  • 11.2. Questions
  • 11.3. Key insights
  • 11.4. Supporting quotes
  • 11.5. Sources

12. Local initiatives and their influence on biosimilar adoption rates

  • 12.1. Issue summary
  • 12.2. Questions
  • 12.3. Key insights
  • 12.4. Supporting quotes
  • 12.5. Sources

13. The evolution of payer and originator tactics in the future

  • 13.1. Issue summary
  • 13.2. Questions
  • 13.3. Key insights
  • 13.4. Supporting quotes
  • 13.5. Sources

14. The impact of complex biosimilar launches in Europe

  • 14.1. Issue summary
  • 14.2. Questions
  • 14.3. Key insights
  • 14.4. Supporting quotes
  • 14.5. Sources

15. Key challenges in the introduction of complex biosimilars

  • 15.1. Issue summary
  • 15.2. Questions
  • 15.3. Key insights
  • 15.4. Supporting quotes
  • 15.5. Sources

16. Insights into the commercial strategies of biosimilar companies

  • 16.1. Issue summary
  • 16.2. Questions
  • 16.3. Key insights
  • 16.4. Supporting quotes
  • 16.5. Sources

17. Uncovering the reasons behind the UK's success in introducing biosimilars

  • 17.1. Issue summary
  • 17.2. Questions
  • 17.3. Key insights
  • 17.4. Supporting quotes
  • 17.5. Sources

18. The success (or failure) of originator company biosimilar defence strategies

  • 18.1. Issue summary
  • 18.2. Questions
  • 18.3. Key insights
  • 18.4. Supporting quotes
  • 18.5. Sources

19. Future adoption drivers of Remicade, Enbrel and MabThera biosimilars in Europe

  • 19.1. Issue summary
  • 19.2. Questions
  • 19.3. Key insights
  • 19.4. Supporting quotes
  • 19.5. Sources

20. Opportunities and challenges in relation to Herceptin biosimilars

  • 20.1. Issue summary
  • 20.2. Questions
  • 20.3. Key insights
  • 20.4. Support quotes
  • 20.5. Sources

21. Opportunities and challenges in relation to Humira biosimilars

  • 21.1. Summary
  • 21.2. Questions
  • 21.3. Key insights.
  • 21.4. Supporting quotes
  • 21.5. Sources

22. Future challenges and opportunities in the European biosimilars market

1. Summary

2. Questions

3. Key insights

4. Supporting quotes

5. Sources

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