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バイオシミラー:欧州における保険者の展望

Biosimilars: European Payer Perspectives

発行 FirstWord 商品コード 326352
出版日 ページ情報 英文
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バイオシミラー:欧州における保険者の展望 Biosimilars: European Payer Perspectives
出版日: 2017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

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目次

What is the future for biosimilars in the EU?

What issues do EU Payers think will impact adoption, pricing and reimbursement of biosimilars?

In January 2016 Samsung Bioepis launched Benepali, a biosimilar version of Enbrel marking a significant advance in biosimilar therapy options. With biosimilar versions of Avastin and Herceptin in the pipeline, the sector is on the verge of delivering lower cost yet equally effective medicines. Payers are enthusiastic about the savings biosimilars bring but warn that physician fear, stoked by a lack of data, clinical inexperience and misinformation, is limiting biosimilar uptake. As the market matures, expect wider clinical adoption and patient support, though questions around price discounting and substitution remain unresolved.

Report Features

  • In-depth interviews reveal unique and frank insights from 15 national and regional payers in Germany, France, Italy, Spain and the UK
  • Table summarising existing biosimilar approvals and current regulatory pipeline to the EMA
  • At-a-glance summaries of all the key insights

Key Benefits

  • Understand how the biosimilar market has grown in 2016 and what are the stand out developments
  • Investigate national trends driving adoption, pricing and reimbursement of biosimilars.
  • Examine how biosimilar cost savings are being reinvested in health and the positive impact this is having on payer perceptions
  • Gain insight into the role of patient groups whose voice is becoming increasingly heard in biosimilars discussions
  • Assess the current climate for price discounting and why a uniform price reduction is unlikely among EU member states
  • Review the ongoing arguments for switching from originator to biosimilar products and learn how they differ at the national level
  • Create communication strategies that challenge misinformation and instil confidence in clinicians and patients

Key Questions Answered By This Report

  • Market movements: What biosimilar products were approved in 2016 and which companies have been most active?
  • Discounts: 25%, 50% 70% - payers want significant discounts for biosimilars, but what is the right level and should it be available to everyone?
  • Switching: What are the national obstacles to switching from a brand to a biosimilar, and is there a role for developers in bringing about change?
  • Fear factor: Clinician and patient fear is limiting biosimilar adoption. Education can help, but who should be responsible for its creation and can industry have a role?
  • Misinformation: What can biosimilar developers do to defend their products from originator misinformation about the safety and efficacy of biosimilar products?
  • Italian job: What market and regulatory developments make Italy a biosimilar market to watch for biosimilar companies?

Expert Views

To ensure candid views were expressed, the names of payers have been kept anonymous. Each contributor has been carefully selected for their experience and detailed knowledge of the national and regional biosimilar market and their insights provide a unique front line perspective for industry.

United Kingdom Payers:

  • Herefordshire CCG
  • West Hampshire CCG
  • Wokingham CCG

French Payers:

  • AP-HP Villejuif
  • CHU Grenoble
  • CHU AP-HP Garches

German Payers:

  • G-BA/Physicians Association
  • Statutory Health Insurance (SHI)
  • G-BA/Physicians Association

Spanish Payers:

  • Regional Payer: Valencia
  • Regional Payer: Basque County
  • Regional Payer: Cataluna

Italian Payers:

  • National Payer: Piedmont
  • Regional Payer: Sicily
  • Regional Payer: Emilia-Romagna

4 Key Quotes

"Obviously biosimilars are giving us significant cost savings because they are cheaper than the originator molecules with all the same indications. So certainly in my area, we are very pro biosimilars. But for us locally, the reason that we've been able to switch [to biosimilars] is because we've shared savings with secondary care commissions. It's allowed us to develop the service and the feedback from patients is actually that it's better than it was before because they've got more time, they are being monitored more closely and they just feel there are getting more out of the service than they were when they were on a branded product, indirectly, because we have invested the money back into the service." UK Payer.

"It is my personal thinking that it would be better to have the possibility to distinguish [between originator biologics and biosimilars]. I do not understand why having another non-proprietary name is a problem. We have this already with several substances. So of course, it's not really a problem and they can do this in my opinion. It will improve the safety." German Payer.

"Formulary inclusion has been quite quick, once the product has been authorised. In fact, I think it has accelerated a bit and it will be accelerated in the future too because the market is growing. So at the regulatory level, AIFA and EMA, they have accepted this market, which they looked at with misgivings before. The process has accelerated, because all the verification processes are streamlined." Italian Payer.

"At this time it should be [the choice of physicians]. We need perhaps one or two more years to ensure that we don't have a problem with safety, that we don't have a problem in immunogenicity, for example. But after that, I think the pharmacists should be aware and should be able to switch like the generics." French Payer.

Who Would Benefit from This Report?

  • Commercial teams negotiating biosimilar prices and discounts with payers
  • Marketing teams communicating the benefits and safety of biosimilars
  • Medical affairs teams building the evidence case for biosimilars with physicians and payers
  • MSL teams engaging with physicians about biosimilar safety and efficacy
  • Market research and HEOR teams analysing long-term real world data on biosimilar use and outcomes

Content Highlights

Executive summary

Biosimilars in Europe: Where we currently stand

  • Biosimilar approvals in Europe to date
  • Uptake and usage of biosimilars in Europe
  • Awareness and perceptions of biosimilars
  • New biosimilar approvals, increased regulatory clarity, push for cost savings top changes over past 12 months
  • Promoting cost-savings remains most prominent way for countries to boost biosimilar use
  • Physicians remain key driver in biosimilar adoption; patient groups growing increasingly vocal
  • Complexity of biosimilars remains key barrier to uptake; manufacturer information also an issue
  • KOLs remain unsure who should head up biosimilar education efforts
  • Approval of Benepali viewed as turning point for biosimilar awareness

Regulations:

  • KOLs supportive of current regulatory oversight, but need greater guidance on switching
  • Regulations satisfactory for formulary decisions, particularly in indication extrapolation
  • Increased insight into manufacturing process, real world data could bolster confidence in market
  • Recent regulatory changes to further define biosimilars welcomed by KOLs
  • EC orphan drug legislation isn't expected to have significant impact

Biosimilar approval, use and tracking:

  • Current naming policies falling short of KOL expectations
  • Non-inferiority should be sufficient grounds for regulatory approval, except for indication extrapolation
  • Acceptance of indication extrapolation continues, but is siloed by specialty
  • KOLs remain generally positive about interchangeability
  • Switching permissible in treatment naive patients; existing patients represent a new growth area
  • Pharmacy-level substitution remains a hot button issue, but option may be on the horizon
  • Education key to switching support, but KOLs unsure of who should provide data
  • Physician fears, market turbulence and originator company misinformation remain barriers
  • EMA has significant role to play in biosimilar adoption, but may not be best for general oversight
  • Physicians should have final say on interchangeability for now, but times could be changing

Commercialisation issues:

  • Cost savings remain primary driver of biosimilar appeal
  • Fuelled by progress in Scandanavian countries, KOLs push for deeper discounts
  • Discounts in select EU markets could become replicable in near future
  • Scandanavian countries leading the way in biosimilar uptake, but select EU states gaining ground
  • Price-matching biosimilars to originator therapies remains unlikely

Future challenges/opportunities for biosimilars in Europe

  • Lack of guidance on switching remains primary barrier to greater biosimilar adoption
  • Potential for cost savings remains greatest opportunity for biosimilars
  • EU no closer to accepting biosimilars as 'generic' versions of reference products
  • Physicians remain most influential on future acceptance, but other stakeholders cannot be ignored
  • Opportunity to learn from US limited, as market dynamics too dissimilar to EU

Table of Contents

1.Executive Summary

2.Research objectives and methodology

3.Biosimilars in Europe: Where we currently stand

  • 3.1. Biosimilar approvals in Europe to date
  • 3.2. Uptake and usage of biosimilars in Europe

4. Awareness and perceptions of Biosimilars

  • 4.1. Key Insights
  • 4.2. New biosimilar approvals boosts acceptance over past 12 months
  • 4.3. Promoting cost savings key to boosting biosimilar use
  • 4.4. Physicians remain key driver in biosimilar adoption, although patient groups growing increasingly vocal
  • 4.5. Complexity of biosimilars remains key barrier, but manufacturer misinformation also an issue
  • 4.6. Payers remain unsure who should head up biosimilar education efforts

5. Regulatory environment

  • 5.1. Key insights
  • 5.2. Payers need greater guidance on switching
  • 5.3. Regulations satisfactory for formulary decisions, particularly for indication extrapolation
  • 5.4. Current guidance on biosimilarity ambiguous, but reflects nature of biological medicines
  • 5.5. Increased insight into manufacturing processes, real-world data could boost uptake
  • 5.6. Guidance to further define biosimilars welcomed by payers
  • 5.7. EC biosimilar legislation not expected to have significant impact
  • 5.8. Time for approval process to be expedited, payers suggest

6. Biosimilar approval, use and tracking

  • 6.1. Key insights
  • 6.2. Current naming policies falling short of payer expectations
  • 6.3. Utility of naming strategies questioned, may promote compartmentalisation
  • 6.4. Non-inferiority should be sufficient for approval
  • 6.5. Acceptance of indication extrapolation growing, but is siloed by specialty
  • 6.6. Payers remain generally positive about interchangeability 46
  • 6.7. Switching permissible in treatment-naive patients, but existing patients represent growth area
  • 6.8. Pharmacy-level substitution remains a hot button issue
  • 6.9. Education key to switching support, but payers unsure of who should provide data
  • 6.10. Physician fears, market turbulence and misinformation impede biosimilar acceptance
  • 6.11. Market location, clinical experience fuel biosimilar bias
  • 6.12. EMA has significant role in biosimilar adoption, but oversight may be limited
  • 6.13. Physicians should have final say on interchangeability for now

7.Commercialisation issues

  • 7.1. Key insights
  • 7.2. Formulary decision-making process largely unchanged versus last year
  • 7.3. Cost savings remain primary driver of biosimilar appeal
  • 7.4. Fuelled by progress in Scandinavian countries, payers push for deeper discounts
  • 7.5. Discounts in select EU markets could become replicable in near future
  • 7.6. Select EU states gaining ground in biosimilar uptake
  • 7.7. Price-matching biosimilars to originator therapies remains unlikely
  • 7.8. Increased prescription monitoring potentially a precursor to prescribing targets and penalties

8. Future challenges/opportunities for biosimilars in Europe

  • 8.1. Key insights
  • 8.2. Lack of guidance on switching remains significant barrier to greater biosimilar adoption
  • 8.3. Potential for cost savings remains greatest opportunity for biosimilars
  • 8.4. EU no closer to accepting biosimilars as 'generic' versions of reference products
  • 8.5. Physicians remain most influential on future acceptance, but other stakeholders emerging
  • 8.6. Critical Success Factors remain relevant, although priorities are shifting
  • 8.7. Opportunity to learn from US limited as market dynamics too dissimilar to EU

9. Appendix

  • 9.1. Definitions
  • 9.2. Experts interviewed for this report
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