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市場調查報告書
商品編碼
858267

HR+/HER2 (荷爾蒙受體陽性/人表皮成長因素受體2陰性) - 乳癌治療藥的藥價·醫療費償付·使用

HR+/HER2- Breast Cancer Pricing, Reimbursement, and Access

出版日期: | 出版商: Datamonitor Healthcare | 英文 85 Pages | 商品交期: 最快1-2個工作天內

價格
  • 全貌
  • 簡介
  • 目錄
簡介

本報告提供全球HR+/HER2-乳癌治療藥市場相關調查,彙整市場概要,法規環境,使用促進因素,証據·評估帳單,各國市場考察·建議等資料。

概要

法規標籤

  • 美國,日本,及EU主要5個國家市場上市售的HR+/HER2-乳癌治療藥
  • 參考資料

全球使用促進因素

  • 乳腺癌支出是腫瘤藥物中最高的
  • HR+/HER2-乳癌治療藥的使用受到輕度限制
  • 契約·價格上限協議方式將在未來更廣泛使用

價值和證據

  • 美國及EU主要5個國家市場上乳癌臨床試驗end point的重要性
  • 全存活率 (OS)的中位數仍然是乳腺癌的黃金標準end point
  • 生活品質 (QoL) 對操作系統和PFS起著次要作用,但可以支持某些市場的額外效益評估、其他

最近核準的醫藥品·開發平台醫藥品的使用

  • CDK 4/6抑製劑成為HR + / HER2-乳腺癌的標誌性藥物
  • Kisqali和Verzenio的定價將參考Ibrance
  • 安全性和價格而非功效將推動CDK 4/6抑製劑的優先選擇

美國

加拿大

日本

法國

德國

義大利

西班牙

英國

調查手法

目錄
Product Code: DMKC0198792

Spend on breast cancer medicines is a high-level concern for payers, but few access restrictions are in place

Despite a high level of concern regarding spend on breast cancer medicines, access restrictions remain only mild to moderate. Spend in the indication is in the top three in oncology due to both medicines' cost and high disease prevalence; however, most payers have not implemented access restrictions. Some European payers have narrowed patient populations eligible for reimbursement, but most are in line with clinical trial inclusion and exclusion criteria, while US payers report an especially challenging environment to control access to breast cancer medicines. Payers also note cultural factors such as sensitivities and public image regarding this indication that limit their willingness to propose access restrictions, for fear of public backlash.

Selection of preferred CDK 4/6 inhibitors based on pricing may occur in the future

The selecting of preferred breast cancer medicines, including within the class of CDK 4/6 inhibitors, is not common, despite the high spend in the indication. Payers affirm that it is still too early to state preferences, and they have instead sought deeper discounts to reduce spending. German payers obtained a national rebate of 50% for the price of Ibrance, with an additional confidential discount. Meanwhile, Spanish payers have national cap agreements for Kisqali and for Ibrance, with additional caps and discounts at regional and local levels, respectively. With growing competition, some payers may begin to restrict access and select one or two preferred agents as a means of controlling expenditure.

Price and safety will be key determinants of preferred CDK 4/6 inhibitors

Without head-to-head trials, decisions as to the preferred CDK 4/6 inhibitors - Ibrance, Kisqali, or Verzenio - will be based on price and safety attributes. Ibrance's first-to-market status and greater familiarity among physicians, coupled with an acceptable safety profile, will give the drug an advantage over the later entrants. Meanwhile, Kisqali's cardiac testing requirements will reduce its chances of securing a preferred formulary position unless Novartis offers impressive discounts over its competitors. Payers may use soft control measures, such as advocating for the most inexpensive option after accounting for clinical needs, rather than blunt-force formulary exclusions.

Long survival times necessitate the use of intermediary endpoints such as PFS2, and time to subsequent therapy or chemotherapy

Long patient survival times in breast cancer present a further challenge to the collection of overall survival data, but intermediary endpoints could help support value propositions in the interim. Payers and regulators are increasingly more open to the use of PFS2 (the time from randomization to objective tumor progression on the next line of treatment or death from any cause) or time to subsequent therapy in both regulatory and reimbursement evaluations, especially due to the recent EMA guidance. Going forward, the endpoints will gain increasing importance with growing treatment complexity and products targeting early breast cancer. Manufacturers that invest in such evidence development could secure a better positioning in the treatment algorithm.

TABLE OF CONTENTS

OVERVIEW

REGULATORY LABELS

  • Marketed HR+/HER2- breast cancer products in the US, Japan, and five major EU markets
  • Bibliography

GLOBAL ACCESS LEVERS

  • Breast cancer spend is among the highest for oncology medicines
  • Access to HR+/HER2- breast cancer medicines is subject to mild restrictions
  • Contracting and price cap agreements are expected to be used more widely in the future

VALUE AND EVIDENCE

  • Importance of breast cancer clinical trial endpoints in the US and five major EU markets
  • Median OS remains the gold-standard endpoint for breast cancer, but PFS is typically accepted
  • Quality of life plays a secondary role to OS and PFS, but can support added benefit assessments in some markets
  • Intermediary endpoints such as PFS2 and time to second subsequent therapy or chemotherapy are valued as proxies
  • Launch of CDK 4/6 inhibitors in the first line has raised the bar for pipeline agents
  • Bibliography

ACCESS TO RECENTLY APPROVED AND PIPELINE PRODUCTS

  • CDK 4/6 inhibitors to become hallmark drugs for HR+/HER2- breast cancer
  • Pricing for Kisqali and Verzenio will be referenced to Ibrance
  • Safety and price, rather than efficacy, will drive preference among the CDK 4/6 inhibitors
  • Tablet strength differences and linear versus flat pricing are not major differentiators for the CDK 4/6 inhibitors
  • Continuous dosing is an asset for most clinicians for adherence purposes, but has a limited impact on payer perception
  • Discounting at the local or regional level may drive CDK 4/6 inhibitor preference
  • Lackluster results may affect Lynparza's reimbursement prospects in the EU
  • Talazoparib shows early sign

US

  • Insights and strategic recommendations

CANADA

  • Insights and strategic recommendations

JAPAN

  • Insights and strategic recommendations
  • Japan's pricing strategy is reliant on premiums for innovative medicines
  • Bibliography

FRANCE

  • Insights and strategic recommendations
  • ASMR rating has an impact on pricing
  • Bibliography

GERMANY

  • Insights and strategic recommendations
  • Positive assessment from the G-BA will impact price negotiations
  • Bibliography

ITALY

  • Insights and strategic recommendations
  • Bibliography

SPAIN

  • Insights and strategic recommendations
  • National reimbursement decisions are not a major access barrier in Spain
  • Regional access to breast cancer treatments varies in Spain

UK

  • Insights and strategic recommendations
  • NICE approval is a key market access barrier
  • Bibliography

METHODOLOGY

  • Primary research
  • Price assumptions
  • Exchange rates
  • Bibliography

LIST OF FIGURES

  • Figure 1: Price sources and calculations, by country

LIST OF TABLES

  • Table 1: Marketed products and approved indications for HR+/HER2-breast cancer in the US, Japan, and five major EU markets
  • Table 2: Levers impacting access to breast cancer drugs in the US and five major EU markets, by country
  • Table 3: Summary of important key endpoints in breast cancer clinical trial design, by country
  • Table 4: Differentiating factors among the CDK 4/6 inhibitors, by country
  • Table 5: Contracting and other financial agreements for the CDK 4/6 inhibitors
  • Table 6: Pricing of key HR+/HER2- breast cancer drugs in the US, Japan, and five major EU markets, by country
  • Table 7: Japan - pricing premiums given to medicines that can demonstrate benefit over comparators
  • Table 8: Transparency Committee's ASMR ratings and pricing implications
  • Table 9: Transparency Committee's SMR ratings and pricing implications
  • Table 10: AIFA web registry and managed entry agreements for HR+/HER2- breast cancer drugs
  • Table 11: Exchange rates used for calculating drug prices