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乾癬治療薬の薬価・医療費償還・アクセス

Psoriasis Pricing, Reimbursement, and Access

発行 Datamonitor Healthcare 商品コード 911287
出版日 ページ情報 英文 96 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=110.80円で換算しております。
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乾癬治療薬の薬価・医療費償還・アクセス Psoriasis Pricing, Reimbursement, and Access
出版日: 2019年03月28日 ページ情報: 英文 96 Pages
概要

当レポートでは、世界の乾癬治療薬市場について調査し、市場の概要、規制環境、アクセス促進要因、エビデンス・評価付け、国別の市場考察・提言などをまとめています。

概要

規制ラベル

  • 米国、日本、およびEU主要5ヶ国市場における市販の乾癬治療薬
  • 参考資料

世界のアクセス促進要因

  • 乾癬生物製剤への支出は保険者にとって特に懸念事項
  • 生物製剤の高額な薬価は、アクセスへの障害とその他のディスカウントを提供する圧力を招く
  • 保険者は、入札、医師へのインセンティブ、および保険適用除外サービスを使用してバイオシミラーの普及を後押し、ほか

エビデンス・評価付け

  • 保険者および医師はPASIとDLQIを最も重要なエンドポイントと見なす
  • PASIまたはDLQIに基づいた新たな物質の差別化には範囲が制限される
  • 治療の休止またはドラッグフリー寛解の提供は将来のパイプライン治療を差別化できる、ほか

近年認可された医薬品・パイプライン薬へのアクセス

  • IL-17 および IL-23 阻害薬はより効果的な医薬品と見なされるが、TNFアルファ阻害薬は第一の生物製剤にとどまる
  • IL-23物質は素晴らしい高価を示すが、Il-17より優先されるアクセスは達成できずにいる
  • 保険者は、地方または地域におけるディスカウントまたは契約を通じて、インターロイキンの領域における競争の激化を利用する計画、ほか

薬価

米国

カナダ

日本

フランス

ドイツ

イタリア

スペイン

英国

調査手法

目次

Launch of multiple IL inhibitors with impressive efficacy has significantly reduced unmet need in the disease, and also provided payers with leverage in price negotiations as they seek to control growing treatment cost.

TABLE OF CONTENTS

OVERVIEW

REGULATORY LABELS

  • Marketed psoriasis products in the US, Japan, and five major EU markets
  • Bibliography

GLOBAL ACCESS LEVERS

  • Spend on psoriasis biologics is a particular concern for payers
  • High prices of biologics are leading to access barriers and pressure to offer discounts
  • Payers use tenders, physician incentives, and formulary exclusions to drive biosimilar uptake
  • Payers prefer straight discounts to outcomes-based risk agreements

EVIDENCE AND VALUE

  • Payers and physicians regard PASI and DLQI as the most important endpoints
  • Limited scope for differentiation of new agents based on PASI or DLQI
  • Providing treatment holidays or drug-free remissions could differentiate future pipeline treatments
  • Head-to-head trials with active comparators are critical in establishing differentiation
  • Minimum efficacy data of six months needed for good formulary access
  • Six-monthly or annual maintenance dosing regimens may be advantageous for pipeline agents
  • Cardioprotective effect of interleukins remains speculative, but data are welcome
  • Real-world evidence could be used to bolster local or regional positioning in the treatment algorithm

ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS

  • IL-17 and IL-23 inhibitors are viewed as more efficacious drugs, but TNF-alpha inhibitors will remain first-line biologics
  • IL-23 agents exhibit impressive efficacy but struggle to achieve preferred access versus IL-17s
  • Payers plan to leverage growing competition in the interleukin space through local or regional discounts or contracts
  • Tremfya's superiority results against Cosentyx will drive prescribing but not pricing or formulary access
  • Siliq's prospects remain poor, despite no correlation to suicide
  • Dosing frequency is not an important point of differentiation
  • Weaker PASI scores dampen Ilumya's access prospects
  • Risankizumab's strong efficacy data boost access prospects, but there is limited scope for a price premium
  • Moderate appetite for an oral inhibitor competitor to Otezla in psoriasis

PRICING

US

  • Insights and strategic recommendations

CANADA

  • Insights and strategic recommendations

JAPAN

  • Insights and strategic recommendations
  • Japan's pricing strategy is reliant on pricing 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 psoriasis medicines varies in Spain
  • Bibliography

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 for the US and EU, by country

LIST OF TABLES

  • Table 1: Marketed products and approved indications for psoriasis in the US, Japan, and five major EU markets
  • Table 2: Biosimilar access levers in the US and five major EU markets
  • Table 3: Levers impacting access to psoriasis drugs in the US and five major EU markets
  • Table 4: Summary of important key endpoints in psoriasis clinical trial design
  • Table 5: National reimbursement decisions for marketed and assessed Ils
  • Table 6: Contracting and financial agreements for interleukins
  • Table 7: Likely reimbursement for Ilumya in psoriasis
  • Table 8: Likely reimbursement for risankizumab in psoriasis
  • Table 9: Pricing of key psoriasis drugs in the US, Japan, and five major EU markets, by country, 2019
  • Table 10: Pricing premiums given to medicines in Japan that can demonstrate benefit over comparators
  • Table 11: Transparency Committee's ASMR ratings and pricing implications
  • Table 12: Transparency Committee's SMR ratings and pricing implications
  • Table 13: Spanish Society of Hospital Pharmacy ratings
  • Table 14: Exchange rates used for calculating drug prices
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