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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: European Payer Perspectives

出版商 FirstWord 商品編碼 326352
出版日期 內容資訊 英文
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生物相似物:歐洲的保險人展望 Biosimilars: European Payer Perspectives
出版日期: 2017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

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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