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市場調查報告書

多發性骨髓瘤治療藥的價格·給付·存取處方集

Multiple Myeloma Pricing, Reimbursement, and Access

出版商 Datamonitor Healthcare 商品編碼 365155
出版日期 內容資訊 英文 159 Pages
商品交期: 最快1-2個工作天內
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多發性骨髓瘤治療藥的價格·給付·存取處方集 Multiple Myeloma Pricing, Reimbursement, and Access
出版日期: 2016年05月12日 內容資訊: 英文 159 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) 多發性骨髓瘤治療藥的價格·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

  • 新的治療藥·並用劑:預測將影響多發性骨髓瘤的預算性與延長患者壽命
    • 新限制和風險共享對策也推動發展
  • 市場已上市多發性骨髓瘤治療藥:美國·日本·EU主要5個國家
  • 開發後期階段的開發平台多發性骨髓瘤治療藥
  • 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
  • 保險業者的典型和處方集收載趨勢
  • 支出擴大:更加特定的收載契機
  • 新藥:適合增大的維持療法所扮演的角色之可能性
  • 非專利版Velcade的影響
  • 參考文獻等

美國的價格趨勢

  • 聯合治療的利用和長期治療增加多發性骨髓瘤的成本
  • 單株抗體:高成本但由於持續性效果而擴大了接受性
  • 美國的價格趨勢:成本控制的方向性
  • 參考文獻

美國的保險者及KOL分析

  • 考察·策略性建議
  • 參考文獻等

美國的報銷問題

  • 考察·策略性建議
  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻

日本

  • 效用加算·畫期性加算
  • 已上市多發性骨髓瘤治療藥的價格
  • 參考文獻

EU主要5個國家市場上價格

EU主要5個國家的保險者及KOL分析

  • 考察·策略性建議
  • 考察·策略性建議
  • 主要趨勢
  • 參考文獻等

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

調查手法

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目錄
Product Code: DMKC0160324

Growth in the multiple myeloma market will be spurred by the approval of novel drugs and the increasing role of combination therapy, but risk-sharing agreements will be key to entry into increasingly restrictive markets.

This report addresses the following questions:

  • How do access restrictions for multiple myeloma drugs differ across markets and why?
  • Which clinical trial comparators and outcomes are necessary for approval and uptake in each market?
  • What impact, if any, will value assessment tools have on US reimbursement patterns?
  • When and where are risk-sharing agreements useful in gaining market access?
  • What are US and EU payers' and physicians' opinions on monoclonal antibodies Darzalex and Empliciti?
  • What effect will generic bortezomib have on the pricing and reimbursement of multiple myeloma drugs in the US and EU markets?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

  • 1. Novel therapies and combinations will increase the budget impact of multiple myeloma and
  • the life expectancy of patients - spuring new restrictions and risk-sharing measures
  • 2. Marketed multiple myeloma products in the US, Japan, and five major EU markets
  • 3. Pipeline multiple myeloma treatments in late-stage development
  • 4. Bibliography

GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS

  • 5. Insights and strategic recommendations
  • 6. Payer archetypes and trends in access
  • 7. Growing expenditure may trigger more restrictive access
  • 8. Endpoints and magnitude effect
  • 9. New drugs may fit into the growing role of maintenance therapy
  • 10. The impact of generic Velcade
  • 11. Bibliography

US PRICING

  • 12. Use of combination therapy and longer treatment durations pushing up costs in multiple Myeloma
  • 13. Monoclonal antibodies prove costly, but affordability increases with sustained responses
  • 14. Pricing trends in the US look toward greater cost control
  • 15. Bibliography

US PAYER AND KEY OPINION LEADER INSIGHTS

  • 16. Insights and strategic recommendations
  • 17. Insurers commonly reimburse NCCN-backed off-label and payer-restricted indications
  • 18. Oncologists: heightened restrictions unlikely for multiple myeloma medicines in near future
  • 19. Bibliography

US REIMBURSEMENT

  • 20. Insights and strategic recommendations
  • 21. NCCN guidelines heavily feature Revlimid, Thalomid, and Velcade
  • 22. Drug value frameworks will guide the formation of clinical pathways and reimbursement criteria in the future
  • 23. Payers have limited utilization management options despite rising costs, but oncology pathways are making inroads
  • 24. Oral multiple myeloma therapies are found in the top tier of most commercial formularies and all Medicare formularies
  • 25. Prior authorization criteria follow FDA labels
  • 26. Revlimid dominates the multiple myeloma market, used in combination with most new agents
  • 27. Patient assistance programs look to improve access by relieving out-of-pocket costs, 28.Kyprolis gaining ground in earlier indications with enhanced efficacy
  • 29. Pomalyst is likely superior to Revlimid, but is set to be left for use in later lines of therapy
  • 30. New drugs must display superiority over future generic competition
  • 31. Numerous drugs are competing for use in relapsed and refractory disease
  • 32. Bibliography

JAPAN

  • 33. Price premiums are awarded for added benefit or innovation
  • 34. Pricing of launched multiple myeloma treatments
  • 35. Bibliography

PRICING IN THE FIVE MAJOR EU MARKETS

FIVE MAJOR EU MARKETS PAYER AND KEY OPINION LEADER INSIGHTS

  • 36. Insights and strategic recommendations
  • 37. Real-world data are a priority for assessment bodies
  • 38. Darzalex viewed as the more adaptable monoclonal antibody, but burden on hospitals could limit its potential
  • 39. Kyprolis is likely to become the standard of care for recurrent disease, but its high price may pose limitations
  • 40. Empliciti may face restrictions upon market entry
  • 41. The majority of multiple myeloma treatment is administered in an outpatient setting
  • 42. Ninlaro is an attractive oral option for elderly patients, reduces burden on ambulatory care
  • 43. Farydak will experience low usage due to poor risk-benefit ratio
  • 44. Pomalyst is reimbursed under a risk-sharing agreement in numerous European countries
  • 45. Bibliography

FRANCE

  • 46. Insights and strategic recommendations
  • 47. ASMR rating has an impact on pricing
  • 48. Majority of Transparency Committee assessments in multiple myeloma gave ASMR level of III or better
  • 49. Bibliography

GERMANY

  • 50. Insights and strategic recommendations
  • 51. Positive assessment from the G-BA will impact price negotiations
  • 52. No access barriers in Germany, but rising costs may trigger change
  • 53. Bibliography

ITALY

  • 54. Insights and strategic recommendations
  • 55. All established multiple myeloma treatments are reimbursed in Italy
  • 56. Cost-sharing differs among older and newer drugs
  • 57. The majority of drugs are subject to monitoring
  • 58. Bibliography

SPAIN

  • 59. Insights and strategic recommendations
  • 60. National reimbursement decision is not a major access barrier in Spain
  • 61. Pomalyst is recommended by the influential Spanish Myeloma Group in a new regimen
  • 62. Therapeutic positioning reports influence local and regional treatment guidelines
  • 63. Regional differences exist in drug reimbursement.
  • 64. Bibliography

UK

  • 65. Insights and strategic recommendations
  • 66. NICE and SMC decisions drive reimbursement decisions
  • 67. Four multiple myeloma medicines are reimbursed under risk-sharing, future entrants will need to offer discounts
  • 68. Cancer Drugs Fund
  • 69. Bibliography

APPENDIX

  • 70. Primary research
  • 71. Price assumptions, 72.Bibliography
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