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市場調查報告書

生物相似物:歐洲的保險人展望

Biosimilars: EU Payer Perspectives

出版商 FirstWord 商品編碼 326352
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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生物相似物:歐洲的保險人展望 Biosimilars: EU Payer Perspectives
出版日期: 2018年02月01日 內容資訊: 英文
簡介

本報告針對歐洲主要5國共計15種保險人訪談結果,提供歐洲生物相似物的未來調查,彙整現在的認可導入及使用狀況、認知度與認識、相關法規環境、未來導入促進因子與各種課題。

第1章 執行摘要

第2章 調查目的及方法

第3章 歐洲生物相似物的現狀

  • 生物相似物的核准狀況
  • 生物相似物的的導入與使用

第4章 生物相似物的的認知度與認識

  • 主要觀察
  • 過去12個月由於新的生物相似物核可而促進接受度的提升
  • 促進節約成本:主要促進利用因素
  • 生物相似物的導入:醫生仍為主要推動者,但病患團體的意見也逐漸增加
  • 生物相似物的複雜度是主要障礙
  • 生物相似物的教育:保險人們仍未決定誰應該首先發難

第5章 法律環境

  • 主要觀察
  • 保險人:需要更多的轉換指導方針
  • 處方決策的法規滿足,特別是適用症外推的部份
  • 生物相似性的現存規定仍然模糊不清,但也反應了生物藥劑的本質
  • 對於製造過程的關注增加,可促進真實數據的導入
  • 詳細定義生物相似物的指導方針:受到保險人歡迎
  • EC的生物相似物相關規定:預期不具有多大影響力
  • 保險人提案:認證流程所需時間的縮減

第6章 生物相似物的核可、使用與追蹤

  • 主要觀察
  • 目前的命名政策:無法滿足保險人的期待
  • 備受質疑的命名策略可用性:可能促進分隔化
  • 非劣性:應該已經足夠
  • 適用症外推的接受度:雖然逐漸成長但根據領域不同仍有差異
  • 保險人:對於互換性一般保持樂觀
  • 切換:未使用過藥物患者可允許但現有患者則代表了成長領域
  • 藥局層級的替代:依然是爭論焦點
  • 教育是支援轉換的關鍵,但保險人仍不確定應該由誰提供數據、其他

第7章 商業化相關課題

  • 主要觀察
  • 處方的決策過程:與去年相比無特別變化
  • 成本削減:生物相似物的主要訴求
  • 斯堪的納維亞各國流程的快速推動,保險人力促更多折扣
  • 主要EU市場的折扣:在不遠的將來可望複製
  • 主要EU加盟國:鞏固生物相似物導入的基礎、其他

第8章 未來課題與市場機會

  • 主要觀察
  • 轉換指導方真的闕如:生物相似物導入的巨大障礙
  • 成本削減的可能性:最大市場機會
  • EU:一般性藥物的接受度仍然遙遠
  • 關於未來接受度,醫師仍最具影響力,但其他利害關係人也將興起、其他

第9章 附錄

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目錄

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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