C型肝炎治療薬の価格設定・医療費償還

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

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.

This report addresses the following questions:

• What reimbursement restrictions have been imposed by US payers and how do they differ between major brands?

• Which payers have imposed patient prioritization and how do the strategies differ between countries?

• How are European payers controlling expenditure on hepatitis C drugs?

• In which markets did Sovaldi have the best outcome of the health technology assessment?

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET CONTEXT

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

US

• 7. Pricing
• 8. Reimbursement
• 9. Bibliography

JAPAN

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

FIVE MAJOR EU MARKETS

• 14. Pricing
• 15. Reimbursement and health technology assessment
• 16. Bibliography