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市場調查報告書

氣喘治療藥的價格·給付·使用趨勢

Asthma Pricing, Reimbursement, and Access

出版商 Datamonitor Healthcare 商品編碼 365156
出版日期 內容資訊 英文 178 Pages
商品交期: 最快1-2個工作天內
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氣喘治療藥的價格·給付·使用趨勢 Asthma Pricing, Reimbursement, and Access
出版日期: 2016年05月05日 內容資訊: 英文 178 Pages
簡介

本報告調查美國·日本·歐盟5國 (法國·德國·義大利·西班牙·英國) 氣喘治療藥的價格·給付·使用趨勢,提供您主要國家已上市的主要產品,開發後期階段的開發平台,全球保險者的見解,並彙整各國藥價決策·給付·利用相關趨勢。

摘要整理

市場背景

  • 面臨專利到期的首發藥預測將造成氣喘市場規模縮小,但開發平台生技藥品預測將刺激市場
  • 已上市的氣喘治療藥:美國·日本·EU主要5個國家市場
  • 後期開發階段的開發平台氣喘治療藥
  • 參考文獻

全球保險者考察的考察

  • 考察·策略性建議
  • Nucala以及其他IL-5抑制劑雖然看來有正面效果但成本令人憂心
  • 首發吸入藥的產品差異化不明確,促進了價格競爭
  • 吸入藥治療的遵守服藥率低,對保險業者·醫生雙方而言是一大治療課題
  • 美國及歐洲的保險業者喜歡具有臨床性意義重大成果的長期臨床試驗

美國的價格趨勢

  • ICS/LABA 並用吸入藥年度的治療成本藥3,000美元
  • Nucala般生技藥品的價格高對保險業者而言是種隱憂
  • 參考文獻

美國的保險者考察

  • 考察·策略性建議
  • 利用IL-5抑制劑有嚴格的事前同意標準,但狀況均不同
  • 保險業者歡迎非專利ICS/LABA,可是醫生持懷疑態度
  • 參考文獻

美國的報銷問題

  • 考察·策略性建議
  • 氣喘治療藥支出趨勢
  • 氣喘治療指南GINA廣泛採用於美國,日本及EU主要5個國家
  • 處方集的配置
  • 參考文獻、其他

日本

EU主要5個國家市場上價格

EU主要5個國家市場保險者考察

EU主要5個國家市場非專利ICS/LABA吸入藥

法國

德國

義大利

西班牙

英國

附錄

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目錄
Product Code: DMKC0159959

Growth in the asthma market will be fueled by the introduction of new and expensive biologics, but companies will have to navigate access restrictions imposed by payers concerned about budget impact.

This report addresses the following questions:

  • What pricing benchmarks will European payers use in price negotiations for IL-5 inhibitors?
  • What access levers will be used for IL-5 inhibitors in each of the five major EU markets and how will they impact their uptake?
  • What attributes of future biologic entrants could secure a higher price and which ones are not valued by payers?
  • What are the EU and US payers' and physicians' opinions on generic ICS/LABA inhalers?
  • What discounts and market access levers will be required to drive uptake of generic ICS/LABA inhalers?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

  • 1. Traditional branded drugs facing patent expiry are expected to decrease the asthma market
  • size, but pipeline biologics will fuel growth
  • 2. Marketed asthma products in the US, Japan, and five major EU markets
  • 3. Pipeline asthma products in late-stage development
  • 4. Bibliography

GLOBAL PAYER INSIGHTS

  • 5. Insights and strategic recommendations
  • 6. Nucala and other IL-5 inhibitors are viewed positively, but cost is a worry
  • 7. Unclear product differentiation among branded inhaled products is driving price competition
  • 8. Low adherence to inhaler therapy is a major treatment challenge for both payers and Physicians
  • 9. Longer clinical trials with clinically significant results favored by both US and EU payers

US PRICING

  • 10. ICS/LABA combination inhalers have annual treatment costs of around $3,000
  • 11. Expensive price tags for biologics like Nucala are a worry for payers
  • 12. Bibliography

US PAYER INSIGHTS

  • 13. Insights and strategic recommendations
  • 14. Strict prior authorization criteria used for IL-5 inhibitors but conditions may vary
  • 15. Payers will welcome generic ICS/LABA inhalers, but physicians are more sceptical
  • 16. Bibliography

US REIMBURSEMENT

  • 17. Insights and strategic recommendations
  • 18. Trends in asthma drug expenditure
  • 19. Asthma treatment guideline GINA is widely used across the US, Japan, and five major EU Markets
  • 20. Formulary placement
  • 21. Prior authorization is reserved for asthma biologics
  • 22. Generic Advair entry to the US market is a real threat for GlaxoSmithKline
  • 23. Bibliography

JAPAN

  • 24. Price premiums are awarded for added benefit or innovation
  • 25. Pricing of launched asthma treatments
  • 26. Bibliography

FIVE MAJOR EU MARKETS PRICING

FIVE MAJOR EU MARKETS PAYER INSIGHTS

  • 27. Insights and strategic recommendations
  • 28. Inhaler spend is one of the top budget items for European payers with high visibility
  • 29. Access to asthma inhalers relatively unrestricted in the five major EU markets
  • 30. Breo Ellipta not well received by EU payers
  • 31. Entry of biologic IL-5 inhibitors is a key event in 2016

GENERIC ICS/LABA INHALERS IN THE FIVE MAJOR EU MARKETS

  • 32. Insights and strategic recommendations
  • 33. Generic versions of Advair and Symbicort struggle to gain market share
  • 34. Generic versions of Advair have received limited approval and continue to see low market penetration in the EU
  • 35. Generic Symbicort DuoResp gains traction in the EU
  • 36. Bibliography

FRANCE

  • 37. Insights and strategic recommendations
  • 38. ASMR rating has an impact on pricing
  • 39. Branded generic versions of Advair and Symbicort have been reviewed by the TC
  • 40. Bibliography

GERMANY

  • 41. Insights and strategic recommendations
  • 42. Positive assessment from the G-BA will impact price negotiations
  • 43. Sickness funds tender for branded combination ICS/LABAs; uptake of generics remain low
  • 44. Asthma medications are subject to indicative budget limits but relevance of this restriction may change under ongoing reforms
  • 45. Nucala's prospect remains unclear as Germany undergoes new regulatory changes
  • 46. Bibliography

ITALY

  • 47. Insights and strategic recommendations
  • 48. AIFA is responsible for pricing and reimbursement decisions
  • 49. Delays in inclusion on regional formularies hamper access to recently launched inhalers
  • 50. Access to Xolair is tightly controlled, with a price-volume agreement in place
  • 51. IL-5 inhibitors are likely to have stringent access criteria in place, with price-volume agreements or risk-sharing possible
  • 52. In the absence of restrictions from AIFA and regional decision-makers, the choice between branded vs generic combination inhaler is left to the physician
  • 53. Bibliography

SPAIN

  • 54. Insights and strategic recommendations
  • 55. National reimbursement decision is not a major access barrier in Spain, 56.Breo Ellipta is the only asthma product assessed by IPTs so far
  • 57. Regional assessments and formulary decisions
  • 58. Spanish payers place more importance on GENESIS regional reports than IPTs
  • 59. Regional therapeutic reports cause further delays after national product launches
  • 60. Access conditions for IL-5 inhibitors will be based on detailed analyses of clinical trial results
  • 61. Bibliography

UK

  • 62. Insights and strategic recommendations
  • 63. NICE approval is a key access barrier in the UK
  • 64. Xolair, the only asthma drug appraised by NICE, received a positive recommendation
  • 65. Access to IL-5 inhibitors will be determined by NICE, with additional restrictions likely
  • 66. NICE recommends the most economical option for ICS or ICS/LABA combinations, with the ultimate choice made by regional commissioners.
  • 67. UK physicians prefer using BTS/SIGN guidelines for asthma
  • 68. Bibliography

METHODOLOGY

  • 69. Primary research
  • 70. Price assumptions
  • 71. Exchange rates
  • 72. Bibliography
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