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市場調査レポート

C型肝炎治療薬の価格設定・医療費償還

Hepatitis C Pricing and Reimbursement

発行 Datamonitor Healthcare 商品コード 342053
出版日 ページ情報 英文 85 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=106.12円で換算しております。
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C型肝炎治療薬の価格設定・医療費償還 Hepatitis C Pricing and Reimbursement
出版日: 2015年01月30日 ページ情報: 英文 85 Pages
概要

C型肝炎治療薬の価格設定・医療費償還は、2013年12月に米国で価格が1錠1,000米ドルのSavaldi (ソバルディ) が発売されて以来、注目を浴びています。

当レポートでは、米国、日本およびEUの主要5市場におけるC型肝炎治療薬の価格設定・医療費償還動向について、市場背景も含めて、調査しています。

図表

エグゼクティブサマリー

市場背景

  • 劇的な変化を迎えているC型肝炎市場
  • C型肝炎治療薬の予算の影響は保険者の抵抗を引き起こす
  • 米国、日本およびEU主要5市場における上市済みC型肝炎治療薬
  • 後期開発段階にあるC型肝炎治療薬のパイプライン
  • 価格設定の前提条件
  • 参考文献

米国

  • 価格決定
  • 医療費償還
  • 参考文献

日本

  • プレミアム価格は付加利益または革新に与えられる
  • 上市済みC型肝炎治療薬の価格設定
  • 近年の認可を踏まえた治療ガイドラインの変更
  • 参考文献

EUの主要5市場

  • 価格決定
  • 医療費償還・医療技術の評価
  • 参考文献

図表リスト

目次
Product Code: DMKC0131852

The pricing and reimbursement of hepatitis C therapies has been in the spotlight since the launch of Sovaldi in the US in December 2013 at the price of $1,000 per pill. While Sovaldi's and Harvoni's clinical effectiveness are undisputed, their high prices have prompted widespread criticism from payers, politicians, and patients due to the large budgetary impact of treating all eligible patients, which will exert a significant strain on healthcare systems.

With demand for treatment expected to be fueled further by the approval of Harvoni, many US payers will continue to restrict treatment to the more advanced patients, aided by the American Association for the Study of Liver Diseases guidelines that recommend the prioritization of patients with advanced fibrosis or compensated cirrhosis, along with other subgroups of patients associated with increased morbidity. However, some reprieve has been provided to payers through the launch of AbbVie's Viekira Pak, with increased competition resulting in contracting and associated discounts with a number of large payers.

In Europe, despite favorable health technology assessments recognizing the efficacy of Sovaldi, the challenge of the affordability of treating all eligible patients with the drug is presenting a significant barrier to fast uptake. Consequently, sizable discounts have been necessary to achieve market access.

Table of Contents

LIST OF TABLES

EXECUTIVE SUMMARY

MARKET CONTEXT

  • The hepatitis C market is undergoing a seismic shift
  • Budgetary impact of hepatitis C therapies is causing payer pushback
  • Marketed hepatitis C products in the US, Japan, and five major EU markets
  • Pipeline hepatitis C treatments in late-stage development
  • Price assumptions
  • Bibliography
  • US
  • Pricing
  • Reimbursement
  • Bibliography

JAPAN

  • Price premiums are awarded for added benefit or innovation
  • Pricing of launched hepatitis C treatments
  • Treatment guidelines have been changed in the light of recent approvals
  • Bibliography

FIVE MAJOR EU MARKETS

  • Pricing
  • Reimbursement and health technology assessment
  • Bibliography

List of Tables and Figures

  • Table 1: Marketed hepatitis C products and approved indications in the US, Japan, and five major EU markets
  • Table 2: Late-stage candidates in development for hepatitis C
  • Table 3: Price sources and calculations, by country
  • Table 4: Exchange rates used for calculating prices
  • Table 5: US pricing of key hepatitis C regimens using Harvoni, Incivek, Olysio, Sovaldi, Victrelis, and Viekira Pak
  • Table 6: Cost per sustained virologic response for Harvoni, Incivek, Olysio, Sovaldi, Victrelis, and Viekira Pak
  • Table 7: Number of diagnosed and undiagnosed HCV-infected individuals, by insurance coverage, 2014, 2017, and 2020
  • Table 8: Formulary placement of Harvoni, Olysio, Sovaldi, Victrelis, and Viekira Pak in selected commercial formularies
  • Table 9: Formulary placement of Harvoni, Olysio, Sovaldi, Victrelis, and Viekira Pak in top five 2015 Medicare Part D formularies
  • Table 10: Prior authorization criteria for Harvoni, Olysio, Sovaldi, Victrelis, and Viekira Pak in four major health plans
  • Table 11: Japan - pricing premiums given to medicines that can demonstrate benefit over comparators
  • Table 12: Pricing of key hepatitis C regimens using Daklinza/Sunvepra, Sovriad, Telavic, and Vanihep in Japan
  • Table 13: Pricing of key hepatitis C regimens using Daklinza, Incivek, Olysio, Sovaldi, and Victrelis in the five major EU markets
  • Table 14: Transparency Commission's ASMR ratings and pricing implications
  • Table 15: Transparency Commission's assessment of hepatitis C treatments
  • Table 16: G-BA assessment of key HCV therapies
  • Table 17: NICE assessments of key HCV therapies
  • Table 18: SMC decisions on key HCV therapies
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