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市場調査レポート

前立腺癌治療薬の価格・償還・使用動向

Prostate Cancer Pricing, Reimbursement, and Access

発行 Datamonitor Healthcare 商品コード 365152
出版日 ページ情報 英文 161 Pages
納期: 即日から翌営業日
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前立腺癌治療薬の価格・償還・使用動向 Prostate Cancer Pricing, Reimbursement, and Access
出版日: 2016年07月05日 ページ情報: 英文 161 Pages
概要

当レポートでは、米国・日本・EU5カ国 (フランス・ドイツ・イタリア・スペイン・英国) における前立腺癌治療薬の価格・償還・利用動向を調査し、主要国で上市済みの主な製品、開発後期段階のパイプライン、世界の保険者およびKOL (キーオピニオンリーダー) による見解、各国における薬価決定・償還・利用に関する動向をまとめています。

エグゼクティブサマリー

市場背景

  • 上市済み前立腺癌治療薬:米国・日本・EU主要5カ国市場
  • 後期開発段階のパイプライン前立腺癌治療薬
  • 参考文献

世界の保険者・KOL (キーオピニオンリーダー) の考察

  • 考察・戦略的提言
  • 保険者の典型と利用動向
  • 非転移性去勢抵抗性前立腺癌
  • 転移性ホルモン感受性前立腺癌
  • 資源全体の使用における初期または併用療法の影響を示す証拠により保険者が勢いを増す
  • 特にXofigo (ゾフィーゴ) において、患者報告結果はますます重要に
  • 類似する新規の抗アンドロゲンは自身を他と区別
  • プロバイダーは治療薬の順次的な使用よりも併用薬がより長期間の転帰 (アウトカム) を提供するかどうかを解明
  • 包括払い制度の到来は、最適な治療経路に関するデータのニーズを促進
  • 新しい免疫療法・ワクチンは歓迎される代替薬、しかし前立腺癌治療用ワクチン「Provenge (プロベンジ)」と同様の課題に直面
  • 参考文献

米国の価格動向

  • 米国の価格動向:コスト制御への方向性
  • 参考文献

米国の保険者およびKOLの考察

  • 考察・戦略的提言
  • 参考文献、ほか

米国における償還

  • 考察・戦略的提言
  • NCCNガイドラインはFDAラベルを反映
  • 参考文献、ほか

日本

  • 付加利益または革新に対しての割増価格
  • 上市済み前立腺癌治療薬の価格
  • 参考文献

EU主要5カ国市場における価格

EU主要5カ国の保険者およびKOLの分析

  • 考察・戦略的提言
  • 主要動向
  • 参考文献

フランス

ドイツ

イタリア

スペイン

英国

付録

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目次
Product Code: DMKC0162106

Novel antiandrogens will need to present risk-sharing agreements in EU markets, while discussing contracting with US payers to ensure a competitive advantage. Vaccines suffer from inconclusive response measures and unattractive dosing.

This report addresses the following questions:

  • How do access restrictions for prostate cancer 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 drugs targeting non-metastatic CRPC or metastatic HSPC?
  • Which vaccines have a chance for uptake and reimbursement in US and EU markets?
  • What does the future hold for radiotherapy Xofigo?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

  • 1. Marketed prostate cancer products in the US, Japan, and five major EU markets
  • 2. Pipeline prostate cancer treatments in late-stage development
  • 3. Bibliography.

GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS

  • 4. Insights and strategic recommendations
  • 5. Payer archetypes and trends in access
  • 5. Non-metastatic castration-resistant prostate cancer
  • 6. Metastatic hormone-sensitive prostate cancer
  • 7. Evidence for the impact of earlier or combination treatment on overall resource use could gain traction with payers
  • 8. Patient-reported outcomes will become increasingly important, particularly for Xofigo
  • 9. Similar novel antiandrogens look to differentiate themselves from one another
  • 10. Providers grapple with whether or not combinations provide better long-term outcomes than sequential use of the drugs
  • 11. Advent of bundled payments will drive the need for data on optimal care pathways
  • 12. Novel immunotherapies and vaccines are welcomed alternatives, but will face similar challenges to Provenge
  • 13. Bibliography

US PRICING

  • 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 indications; obtaining a category 1 recommendation will become increasingly important
  • 18. If efficacy and safety data are not differentiated from other drugs, twice-daily dosing may hinder BAY-1841788's potential
  • 19. Jevtana will be restricted to use after docetaxel, unless a substantial benefit is shown in
  • FIRSTANA TRIAL
  • 20. Prescribing patterns differ between medical oncologists and urologists; payers consider management of CRPC by oncologists as ideal
  • 21. Cancer Drug Coverage Parity Act of 2015 could close gap in out-of-pocket costs between oral and inpatient drugs
  • 22. New drugs mean new opportunities for contracting
  • 23. Bibliography

US REIMBURSEMENT

  • 24. Insights and strategic recommendations
  • 25. NCCN guidelines reflect FDA labels
  • 26. NCCN Evidence Blocks
  • 27. Drug value frameworks will guide the formation of clinical pathways and reimbursement
  • criteria in the future
  • 28. Payers have limited utilization management options despite rising costs, but oncology pathways are making inroads
  • 29. Branded prostate cancer therapies are generally found on top tiers as specialty drugs
  • 30. Prior authorization and step therapy criteria from numerous payers restrict the use of Xtandi
  • 31. Bibliography

JAPAN

  • 32. Price premiums are awarded for added benefit or innovation
  • 33. Pricing of launched prostate cancer treatments
  • 34. Bibliography

PRICING IN THE FIVE MAJOR EU MARKETS FIVE MAJOR EU MARKETS PAYER AND KEY OPINION LEADER INSIGHTS

  • 35. Insights and strategic recommendations
  • 36. ESMO drug ratings praise Xofigo, but are uncertain about Xtandi's and Zytiga's role before Docetaxel
  • 37. Jevtana restricted in many European countries due to poor benefit-to-risk ratio
  • 38. Xofigo is restricted to use after docetaxel therapy in most European countries
  • 39. Real-world data are a priority for assessment bodies
  • 40. Bibliography

FRANCE

  • 41. Insights and strategic recommendations
  • 42. ASMR rating has an impact on pricing
  • 43. The majority of new market entrants will be compared to Zytiga
  • 44. While price is a concern, effective and tolerable vaccines will be a welcomed alternative
  • 45. Bibliography

GERMANY

  • 46. Insights and strategic recommendations
  • 47. Positive assessment from the G-BA will impact price negotiations
  • 48. Cell therapies will find entry into the German market at the hospital level through supplemental funding mechanisms
  • 49. Bibliography

ITALY

  • 51. Insights and strategic recommendations
  • 52. All established prostate cancer treatments are reimbursed by AIFA
  • 53. Regional health authorities perform thorough health technology assessments on new drugs
  • 54. Oral drugs subject to monitoring
  • 55. Bibliography

SPAIN

  • 56. Insights and strategic recommendations
  • 57. National reimbursement decisions are not a major access barrier in Spain
  • 58. Regional restrictions tend to align with adverse event profiles and clinical trial exclusion
  • Criteria
  • 59. Spanish Oncology Genitourinary Group recommendations
  • 60. Bibliography

UK

  • 61. Insights and strategic recommendations
  • 62. NICE and SMC assessments drive reimbursement decisions
  • 63. Cancer Drugs Fund
  • 64. Bibliography

APPENDIX

  • 65. Primary research
  • 66. Price assumptions
  • 67. Bibliography
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