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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 (2016年)

Biosimilars: European Payer Perspectives (2016)

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
価格
本日の銀行送金レート: 1USD=102.12円で換算しております。
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バイオシミラー:欧州における保険者の展望 (2016年) Biosimilars: European Payer Perspectives (2016)
出版日: 2016年01月01日 ページ情報: 英文
概要

欧州のバイオシミラー市場は、新たな治療薬が利用可能となり、多くの保険者の対応が変化するなど、変化と進化の渦中にあります。差し迫ったコスト管理のニーズから、保険者は「互換性」や「適応症の外挿」といったエリアに位置付けを定めています。

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、バイオシミラーの継続的成長と導入拡大のために保険者が重要と考える主要課題について、各種見解・考察をまとめています。

主な調査項目

  • 高価値のパイプライン
    • バイオシミラーの開発が行われているブランド薬
    • それらが利用可能となることで、どのように変化が推進されるか?
  • 互換性
    • いつ、どのような環境でバイオシミラーとブランド薬の互換性は可能となるか?
  • 適応症の外挿
    • 承認された適応症間の境界での利用に影響を及ぼす長引く不安への対応
  • 実世界のデータ
    • 臨床上の自信は経験により拡大するが、実世界のデータはすべての治療エリアでの広い導入を奨励できるか?
  • よりより教育
    • 医師の教育の不足 (特に適応症の外挿などの分野) が導入を阻害
    • バイオシミラー産業はどのように対応できるか?
  • 処方集への追加
    • 処方集への追加の基準とは?
    • 価格の重要度は?
    • 上市されるすべてのバイオシミラーのための余地はあるか
  • 薬価設定
    • その程度のバイオシミラーのディスカウントが最適か?
    • 将来ブランド薬とバイオシミラーの価格のマッチングが見られるか?
  • 目標・割り当て
    • 処方の目標・割り当てがどれほど欧州諸国においてバイオシミラーの利用推進となってきたか?
    • 常に成功を収めてきたか?

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目次
Product Code: 596200479

What's driving the uptake of biosimilars in Europe and what still needs to be done?

The European market for biosimilars has seen a year of progress and change , with more therapies available and changing attitudes from many payers . Driven by the pressing need to control drug costs, payers have notably moved their position in key areas such as interchangeabilty and indication extrapolation. But where are the sticking points? What are the critical factors for success? What more could the biosimilar industry do to help its cause?

This report identifies the issues that payers identify as critical to the continued growth and adoption of biosimilars. Biosimilars: European Payer Perspectives is informed with candid insights of 15 European payers from the five leading European markets and packed with actionable information. It is essential reading for all commercial and research planners in branded and biosimilar manufacturers .

"The key reimbursement challenge at the moment comes down to the four-letter word of cost: every healthcare organisation is really struggling to contain cost."

Answering Key Questions

  • High value pipeline : What are the leading branded therapies that are in biosimilar development and how will their availability continue to drive change?
  • Interchangeability : When, and in what circumstances, could a biosimilar be interchangeable with the branded product?
  • Indication extrapolation : What can be done to challenge the lingering anxieties that are impacting the broader use of biosimilars across all approved indications?
  • Real world data : Clinical confidence is growing with experience but can real world data encourage wider adoption across all therapy areas and who should collect/disseminate it?
  • Better education : A lack of physician education, especially in areas such indication extrapolation, is limiting uptake - how can the biosimilar industry positively respond?
  • Formulary inclusion : What are the differing criteria for formulary inclusion, to what extent does price play a role and is there room for every biosimilar that comes to market?
  • Pricing : What level of biosimilar discounting is optimal and will we ever see price matching between branded and biosimilar products?
  • Targets and Quotas : To what extent have prescribing targets and quotas driven biosimilar usage in European countries and are they always successful?

With this report you will be able to:

  • Learn from the experiences of EU payers and the critical factors they identify as essential for biosimilar market progress
  • Understand how issues and questions around interchangeability, switching and indication extrapolation are limiting broader biosimilar usage
  • Identify the key areas where better physician education could have real benefits and formulate appropriate communication strategies
  • Examine how clinical and real world data can help build prescriber and payer confidence
  • Understand current EU biosimilar regulation and guidance and know where payers feel improvements could be made
  • Know the key elements for successful biosimilar formulary inclusion
  • Explore payer thinking on pricing, discounts, reimbursement and prescribing targets/quotas

Key Topics explored

  • How confidence in the sector is growing as a result of more biosimilar products now being on the market, and the increasing number of blockbuster therapies becoming the subject of biosimilar research
  • The challenge of convincing physicians, especially those with limited experience, to prescribe biosimilars
  • The EU regulation of biosimilars is seen by many as the best system, but there is still room for improvement
  • Biosimilars benefit from an abridged regulatory process, but that can lead to questions about safety in all patient populations - is it time for a rethink and how might real world data fill the knowledge gap?
  • It is alleged that mis information from branded industry and other stakeholders is feeding physician anxiety. True or false?
  • Why are patient advocacy groups less than enthusiastic about biosimilars and what impact is this having on biosimilar uptake?
  • The naming of biosimilars in the EU is causing confusion: is there a viable and universally agreeable alternative on the horizon?

Expert Contributors

For this report FirstWord has interviewed 15 payers, 3 from each EU5 country. Payers interviewed have direct experience of assessing biosimilars for inclusion on formulary, either as part of a committee or as the lead decision-maker.

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