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市場調查報告書

COPD治療藥的價格·給付·存取處方集

COPD Pricing, Reimbursement, and Access

出版商 Datamonitor Healthcare 商品編碼 365154
出版日期 內容資訊 英文 202 Pages
商品交期: 最快1-2個工作天內
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COPD治療藥的價格·給付·存取處方集 COPD Pricing, Reimbursement, and Access
出版日期: 2016年05月11日 內容資訊: 英文 202 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) COPD治療藥的價格·給付·存取處方集趨勢,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,全球保險者及KOL (關鍵意見領袖) 的見解,並彙整各國藥價決策·給付·存取處方集相關趨勢。

摘要整理

市場背景

  • 傳統的第一選擇藥與學名藥競爭同時,3劑聯合治療的開發平台和LABA/LAMA刺激了COPD的緩慢成長
  • 已上市COPD治療藥:美國·日本·EU主要5個國家市場
  • 開發後期階段的開發平台COPD治療藥
  • 參考文獻

全球保險者·KOL (關鍵意見領袖)的見解

  • 考察·策略性建議
  • 醫生:期待對重度COPD患者使用3劑聯合治療的成果
  • 保險業者:3劑聯合治療的消極性·過度投藥可能性的疑慮
  • COPD非惡化患者中LABA/LAMA預計將超過ICS/LABA
  • KOL:IL-5生物製藥認為COPD未能扮演重要角色
  • 部分保險業者歡迎第二世代LAMA,但預測無法取代領導市場的Spiriva
  • 品牌ICS/LABA產品的差異化困難引起了價格競爭
  • 疾病過程的好轉:主要的未滿足需求之一
  • 美國·EU的保險業者及醫生:期待經濟性衝擊的易定量化成果
  • 臨床性具有重大成果的長期臨床試驗:美國·EU的保險業者較為偏好
  • 參考文獻

美國的價格趨勢

  • LABA/LAMA的藥價設定:和ICS/LABA同等
  • Spiriva Respimat和HandiHaler設備
  • 參考文獻

美國的保險者分析

  • 考察·策略性建議
  • 共同負擔:患者的治療選擇判斷標準
  • 保險業者雖然預測非專利版ICS/LABA吸入劑將受歡迎但醫生持懷疑態度
  • 呼吸系統的強力組合:拓展與部分保險業者的綁定套組契約可能性
  • 參考文獻

美國的報銷問題

  • 考察·策略性建議
  • COPD藥支出趨勢
  • 廣泛利用的GOLD指南
  • 處方集的階層地位:主要的利用管理工具
  • 非專利版Advair打入美國市場:對GlaxoSmithKline而言是嚴重威脅
  • 參考文獻

日本

  • 效用加算·畫期性加算
  • 已上市COPD治療藥的價格
  • LABA/LAMA的藥價設定:比起ICS/LABA相當高
  • 參考文獻

EU主要5個國家市場上價格

  • 第一次上市的Utibron:許多歐盟市場價格高

EU主要5個國家市場保險者分析

  • 考察·策略性建議
  • COPD吸入劑的通路:EU主要5個國家較無限制
  • 英國以外GOLD在EU各國是最常利用的指南
  • 參考文獻等

EU主要5個國家市場上非專利版ICS/LABA 吸入劑

  • 考察·策略性建議
  • 非專利版Advair·Symbicort:以市場佔有率為中心的競爭
  • 非專利版Advair:是限制性核准,EU市場普及率低
  • 非專利版Symbicort產品的DuoResp:EU有成長之勢
  • 非專利版chiotoropiumu的引進:單劑吸入劑LAMA的設備的替代性
  • 參考文獻

法國

  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻

德國

  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻

義大利

  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻

西班牙

  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻

英國

  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻

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目錄
Product Code: DMKC0160221

In-class competition and generic entry provide payers with leverage to demand favorable pricing for inhalers in exchange for formulary access.

This report addresses the following questions:

  • Which LABA/LAMAs have been most successful in securing national reimbursement and why?
  • How do US and European payers and physicians view the launch of once-daily Breo?
  • What discounts and market access levers will be required to drive uptake of generic ICS/LABA inhalers?
  • What impact will generic ICS/LABA inhalers have on pricing and reimbursement of triple combination ICS/LABA/LAMA therapies?
  • What role will biologics play in the treatment of COPD?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

  • 1. While traditional first-line medications face generic competition, pipeline triple combinations and LABA/LAMAs will fuel modest growth in COPD
  • 2. Marketed COPD products in the US, Japan, and five major EU markets
  • 3. Pipeline COPD treatments in late-stage development
  • 4. Bibliography

GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS

  • 5. Insights and strategic recommendations
  • 6. Physicians are looking forward to triple therapy combinations for severe COPD patients
  • 7. Payers are less impressed with triple therapy combinations, with potential for overprescribing a concern
  • 8. LABA/LAMAs set to overtake ICS/LABAs in non-exacerbating COPD patients
  • 9. Key opinion leaders believe IL-5 biologics are unlikely to play a major role in COPD
  • 10. Some payers welcome second-generation LAMAs, but they are unlikely to displace Spiriva as the market leader
  • 11. Unclear product differentiation among branded ICS/LABA products is driving price competition
  • 12. Reversal of disease progression is considered one of the main unmet needs in COPD
  • 13. Once-daily dosing matters less to physicians than having access to both once-daily and twice daily inhalers
  • 14. US and EU payers and physicians want more economically impactful, easily quantified outcomes
  • 15. Longer clinical trials with clinically significant results favored by both US and EU payers
  • 16. Bibliography

US PRICING

  • 17. Pricing of LABA/LAMAs is comparable to ICS/LABAs
  • 18. Spiriva Respimat is priced at a 50% discount over the HandiHaler device
  • 19. Bibliography

US PAYER INSIGHTS

  • 20. Insights and strategic recommendations
  • 21. Co-pays continue to determine patients' therapeutic choices
  • 22. Payers will welcome generic ICS/LABA inhalers, but physicians are more sceptical
  • 23. Strong respiratory portfolio opens possibility for bundled contracting with some payers
  • 24. Bibliography

US REIMBURSEMENT

  • 25. Insights and strategic recommendations
  • 26. Trends in COPD drug expenditure
  • 27. GOLD guidelines are widely used for COPD
  • 28. Formulary tier positioning is the key utilization management tool used in COPD
  • 29. Generic Advair entry to the US market is a real threat for GlaxoSmithKline
  • 30. Bibliography

JAPAN

  • 31. Price premiums are awarded for added benefit or innovation
  • 32. Pricing of launched COPD treatments
  • 33. Pricing of LABA/LAMAs in Japan is considerably higher than ICS/LABAs
  • 34. Bibliography

FIVE MAJOR EU MARKETS PRICING

  • 35. First-to-market Utibron enjoys high prices in most EU markets

FIVE MAJOR EU MARKETS PAYER INSIGHTS

  • 36. Insights and strategic recommendations
  • 37. Inhaler spend is one of the top budget items for European payers with high visibility
  • 38. Access to COPD inhalers relatively unrestricted in the five major EU markets
  • 39. With the exception of the UK, GOLD remains the most frequently used guideline in EU Countries
  • 40. Bibliography

GENERIC ICS/LABA INHALERS IN THE FIVE MAJOR EU MARKETS

  • 41. Insights and strategic recommendations
  • 42. Generic versions of Advair and Symbicort struggle to gain market share
  • 43. Generic versions of Advair have received limited approval and continue to see low market penetration in the EU
  • 44. Generic Symbicort product DuoResp gains traction in the EU
  • 45. Generic tiotropium uptake highly dependent on determination of device substitutability for single inhaler LAMAs
  • 46. Bibliography

FRANCE

  • 47. Insights and strategic recommendations
  • 48. ASMR rating has an impact on pricing
  • 49. Head-to-head trials of LABA/LAMAs vs ICS/LABAs likely to trigger a review by the TC and permit further education efforts
  • 50. ICS/LABA/LAMA combinations unlikely to receive ASMR higher than V
  • 51. Branded generic versions of Advair and Symbicort have been reviewed by the TC
  • 52. Bibliography

GERMANY

  • 53. Insights and strategic recommendations
  • 54. Positive assessment from the G-BA will impact price negotiations
  • 55. Sickness funds tender for branded combination ICS/LABAs; uptake of generics remain low
  • 56. COPD medications are subject to indicative budget limits but relevance of this restriction may change under ongoing reform
  • 57. Bibliography

ITALY

  • 58. Insights and strategic recommendations
  • 59. AIFA is responsible for pricing and reimbursement decisions
  • 60. Delays in inclusion on regional formularies hamper access for recently launched inhalers
  • 61. Approvals of LABA/LAMAs Anoro and Utibron with treatment plan provision will further restrict market uptake
  • 62. AIFA register is an access obstacle for Daliresp; prescription volumes remain low
  • 63. In the absence of restrictions from AIFA and regional decision-makers, the choice between branded vs generic combination inhaler is left to the physician
  • 64. Bibliography

SPAIN

  • 65. Insights and strategic recommendations
  • 66. National reimbursement decisions are not a barrier to access
  • 67. Some general physicians are subjected to prescribing limitations for COPD drugs
  • 68. None of the COPD drugs evaluated in IPTs offer additional therapeutic benefit
  • 69. Regional assessments are an additional market access step
  • 70. Bibliography

UK

  • 70. Insights and strategic recommendations
  • 71. NICE approval is a key access barrier in the UK
  • 72. Daliresp is restricted to patients with COPD currently undergoing clinical trials
  • 73. NICE recommends most economical option for LABA/LAMA combinations; choice down to regional commissioners
  • 74. NICE COPD treatment guidelines are used by NHS physicians
  • 75. SMC decisions
  • 76. Bibliography

METHODOLOGY

  • 77. Price assumptions
  • 78. Exchange rates
  • 79. Bibliography
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