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市場調查報告書

關節症性乾癬治療藥的價格·給付·通路

Psoriatic Arthritis Pricing, Reimbursement, and Access

出版商 Datamonitor Healthcare 商品編碼 365153
出版日期 內容資訊 英文 177 Pages
商品交期: 最快1-2個工作天內
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關節症性乾癬治療藥的價格·給付·通路 Psoriatic Arthritis Pricing, Reimbursement, and Access
出版日期: 2016年06月24日 內容資訊: 英文 177 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) 關節症性乾癬治療藥的價格·給付·通路趨勢,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,藥物的通路等方面全球保險業者的見解,並彙整各國藥價決策及給付趨勢還有藥物取得之相關趨勢。

摘要整理

市場背景

  • 漲價和得病率的擴大促使市場成長:預測將彌補生技仿製藥的進入市場
  • 已上市的關節症性乾癬產品:美國·日本·EU主要5個國家市場
  • 開發後期階段的開發平台關節症性乾癬治療藥
  • 參考文獻

全球保險者的見解

  • 考察·策略性建議
  • 乾癬·關節症性乾癬治療藥的支出額:中等但依患者人口不同也有變化可能性
  • 近幾年上市的藥物:與TNFAlpha抑制劑的競爭苦戰
  • 投藥頻率·途徑成為TNFAlpha抑制劑的差異化因素
  • 美國·EU的保險業者及醫生:有效性的檢驗和藥價決策用直接比較實驗期望
  • 就臨床性·統計性來看美國·EU的保險業者偏好長期的臨床試驗
  • 關節症性乾癬治療藥的開發平台:苦於缺乏有潛力的候補藥
  • 對患者而言重要的投藥方法
  • 參考文獻

美國的價格趨勢

美國的支付者分析

  • 考察·策略性建議
  • 多發性發炎性疾病症狀已批准藥物:偏好與保險業者契約
  • 乾癬通常可核准,關節症性乾癬的擴大對開發平台·已上市藥而言有益
  • Inflectra (最初的TNFAlpha生技仿製藥):FDA已批准但由於法律問題仍需要數年才可上市
  • 參考文獻

美國的報銷問題

  • 考察·策略性建議
  • 關節症性乾癬治療藥的支出趨勢
  • 參考文獻

日本

  • 效用加算·畫期性加算
  • 已上市關節症性乾癬治療藥的價格
  • 參考文獻

EU主要5個國家市場上價格

EU主要5個國家市場上保險者的考察

  • 考察·策略性建議
  • 生物製藥的通路:EU主要5個國家大部分受限

EU主要5個國家市場上生技仿製藥TNFAlpha抑制劑

  • 考察·策略性建議
  • 英國的生技仿製藥TNFAlpha抑制劑的利用情況不一:由於EMA未定義兼容性
  • 大部分的醫生·保險業者考量將互換性作為削減成本的機會,但在適應症方面仍有疑慮
  • 保險業者生技仿製藥的利用與首發品的價格壓力
  • 醫院的生技仿製藥·首發品的持續採購:動態的價格設定環境
  • 生技仿製藥:預測將作為開發平台藥物的價格基準
  • 保險業者預測將不導入強力推動生技仿製藥Infliximab引進的主張
  • 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: DMKC0161763

An absence of head-to-head trials, along with biosimilar launches, provide payers with leverage to demand favorable pricing for branded products in exchange for formulary access.

This report addresses the following questions:

  • What access controls are payers imposing on interleukins in psoriatic arthritis?
  • What discounts and market access levers will be required to drive uptake of interleukins and second-generation TNFalpha inhibitors?
  • How do US and European payers view the launch of oral small molecules in psoriatic arthritis?
  • What impact will biosimilar entry have on pricing and reimbursement of branded biologics?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

  • 1. Market growth due to price increases and rising prevalence will be offset by biosimilar entry
  • 2. Marketed psoriatic arthritis products in the US, Japan, and five major EU markets
  • 3. Pipeline psoriatic arthritis treatments in late-stage development
  • 4. Bibliography

GLOBAL PAYER INSIGHTS

  • 5. Insights and strategic recommendations
  • 6. Spend on psoriasis and psoriatic arthritis drugs is moderate, but may vary depending on the patient population
  • 7. Recently launched agents struggle to compete with TNF-alpha inhibitors
  • 8. Dosing frequency and route of administration act as differentiating factors for TNF-alpha inhibitors
  • 9. US and EU payers and physicians want head-to-head trials to assess efficacy directly and determine pricing
  • 10. Longer clinical trials with statistically and clinically significant results are favored by both US and EU payers
  • 11. The psoriatic arthritis pipeline suffers from a dearth of promising candidates
  • 12. Varying dosing and method of administration are important for patients, but oral formulation does not warrant a higher price
  • 13. Bibliography

US PRICING

US PAYER INSIGHTS

  • 14. Insights and strategic recommendations
  • 15. Drugs with approvals in multiple inflammatory indications are favored in payer contracting
  • 16. Psoriasis is usually approved first, but expanding to psoriatic arthritis is beneficial for pipeline and marketed drugs
  • 17. Inflectra, the first TNF-alpha biosimilar, is approved by the FDA, but launch could take years due to legal battles
  • 18. Bibliography

US REIMBURSEMENT

  • 19. Insights and strategic recommendations
  • 20. Trends in psoriatic arthritis drug expenditure
  • 21. Bibliography

JAPAN

  • 22. Price premiums are awarded for added benefit or innovation
  • 23. Pricing of launched psoriatic arthritis treatments
  • 24. Bibliography

FIVE MAJOR EU MARKETS PRICING

FIVE MAJOR EU MARKETS PAYER INSIGHTS

  • 25. Insights and strategic recommendations
  • 26. Access to biologics is mostly restricted in the five major EU markets, with a variety of tools used to curb access

BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS

  • 27. Insights and strategic recommendations
  • 28. Uptake of biosimilar TNF-alpha inhibitors varies across UK markets as the EMA does not determine interchangeability
  • 29. Most physicians and payers consider biosimilars to be interchangeable, and an opportunity to reduce costs, but worries around indication extrapolation remain
  • 30. Payers use biosimilars to pressure originators on pricing
  • 31. Hospitals continue to procure both biosimilars and originators; dynamic pricing environment observed
  • 32. Biosimilars will be used as price benchmarks for pipeline agents
  • 33. Payers are unlikely to implement strong incentives to drive uptake of biosimilar infliximab due to limited use of the drug
  • 34. Bibliography

FRANCE

  • 35. Insights and strategic recommendations
  • 36. ASMR rating has an impact on pricing
  • 37. Access restrictions for biologics are minimal, and are largely determined by national Transparency Committee guidelines
  • 38. Both IL-17s Cosentyx and Taltz are likely to get ASMR V from the TC
  • 39. Bibliography

GERMANY

  • 40. Insights and strategic recommendations
  • 41. Positive assessment from the G-BA will impact price negotiations
  • 42. Certain sickness funds subject TNF-alpha inhibitors to indicative budget limits, but the relevance of this restriction may change under ongoing reforms
  • 43. The G-BA follows IQWiG recommendation, and Otezla receives evaluation of no added benefit for psoriatic arthritis
  • 44. IQWiG determines Cosentyx to offer no added benefit in psoriatic arthritis
  • 45. Taltz is unlikely to get an added benefit assessment in psoriatic arthritis from the G-BA
  • 46. Bibliography

ITALY

  • 47. Insights and strategic recommendations
  • 48. Delays in AIFA decisions for newly launched biologics hamper regional and local access
  • 49. Access to psoriatic arthritis medications is controlled for specialist use, but a more restrictive barrier is limited budget allocation
  • 50. Emilia-Romagna outlines therapeutic strategy for biologics in psoriatic arthritis
  • 51. Taltz will be placed in later lines of therapy in psoriatic arthritis
  • 52. Bibliography

SPAIN

  • 53. Insights and strategic recommendations
  • 54. National reimbursement decisions are not a barrier to access
  • 55. Regional access to psoriatic arthritis drug treatments varies in Spain
  • 56. Budget limitations and formulary restrictions are quoted as access barriers, with differences between hospitals
  • 57. Risk-sharing agreements and local negotiations are used to control expenditure for biologics
  • 58. Taltz's positioning in psoriatic arthritis remains speculative
  • 59. Bibliography

UK

  • 60. Insights and strategic recommendations
  • 61. NICE approval is a key market access barrier
  • 62. Patient population restrictions and brand preference in regional formularies are the main access levers in psoriatic arthritis
  • 63. UK physicians reserve the use of biologics as a last resort for psoriatic arthritis patients
  • 64. Use of Stelara in psoriatic arthritis is reserved for after failure with TNF-alpha inhibitors
  • 65. Later biologic entrants require patient access schemes to have an acceptable ICER
  • 66. NICE does not recommend Otezla for psoriatic arthritis due to lower effectiveness than TNFalpha Inhibitors
  • 67. Biosimilars present the greatest threat to Cosentyx's chances of NICE recommendation for first-line biologic use
  • 68. Taltz is likely to receive a similar NICE recommendation to Cosentyx
  • 69. Regional formulary decisions
  • 70. SMC approves Otezla for psoriatic arthritis contrary to NICE decision due to differences in treatment sequencing
  • 71. SMC supports use of lower dose of Simponi, but higher dose is not deemed to be cost effective
  • 72. Bibliography
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