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NOAC (新規経口抗凝固薬) の薬価・償還・アクセス

NOACs Pricing, Reimbursement, and Access

発行 Datamonitor Healthcare 商品コード 527416
出版日 ページ情報 英文 153 Pages
納期: 即日から翌営業日
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NOAC (新規経口抗凝固薬) の薬価・償還・アクセス NOACs Pricing, Reimbursement, and Access
出版日: 2017年06月12日 ページ情報: 英文 153 Pages
概要

当レポートでは、NOAC (新規経口抗凝固薬)の薬価・償還・市場アクセスの動向を調査し、主要国における承認ラベル、世界の保険者およびキーオピニオンリーダーによる各種考察、主要国別の動向分析、戦略的提言などをまとめています。

エグゼクティブサマリー

法規制上のラベル表示

  • 上市済みNOACの承認ラベル:米国・日本・EU5カ国

世界の保険者およびキーオピニオンリーダーの考察

  • 考察・戦略的提言
  • NOACの高コスト性:米国に比べ欧州での懸念が大きい
  • 実際の臨床データを用いた大出血の発症率の低減の実現:NOACの導入推進因子に
  • 医療費支払い者:臨床的側面からNOACは非常に類似していると認識
  • パイプラインに関する考察

米国の薬価

米国の償還

  • 考察・戦略的提言

日本

  • メリットの多さやイノベーションによる薬価加算
  • 上市済みのSPAF・VTE治療薬の薬価

EU5カ国における薬価

フランス

  • 考察・戦略的提言

ドイツ

  • 考察・戦略的提言

イタリア

  • 考察・戦略的提言

スペイン

  • 考察・戦略的提言
  • 国の償還決定:アクセスの障壁ではない
  • 地域のフォーミュラリーまたはアセスメント

英国

  • 考察・戦略的提言
  • NICE承認:市場アクセスの主な障壁
  • 地域のフォーミュラリーの決定
  • SMC:SPAF・VTEでのNOAC利用を推奨

調査手法

図表

目次
Product Code: DMKC0172764

A combination of the high cost of novel oral anticoagulants (NOACs) (relative to highly genericized vitamin K antagonists) and the large patient populations these drugs address, has resulted in this class of compounds being a top priority for European payers. The impact of NOACs on European budgets is so great that a UK payer stated that this represented their single largest budgetary concern over the past year. However, in the US, payers were not as concerned with the budgetary impact of the NOACs, citing that this falls outside of their top 20 budgetary concerns. Additionally, most interviewed US payer view NOACs as the new standard of care due to their reduction of serious bleeding events and hence cost saving as compared to vitamin K antagonists.

Payers interviewed by Datamonitor Healthcare generally view the marketed NOAC compounds as highly similar, acknowledging that while there are some minor differences in the clinical data of these compounds, the rate of events in their trials is so low that it is hard to attribute these differences to the medications. Moving forward, payers view patients with poor renal function as an area of high unmet need. Payers interviewed discussed how they would welcome a simple dosing regimen that would not need to be modified for patients with poor renal function; this "one size fits all" dosing regimen would simplify the prescribing of physicians and ensure that all of the patients received the correct dose regardless of their renal function. However, payers cautioned that it is unlikely that improvements in treatment with respect to efficacy and safety can be achieved given the opposing coagulation and anticoagulation processes in the body. They also stress the importance of delivering game-changing improvements and emphasize that a new agent with the same mechanism of action would be unlikely to capture market share or even be reimbursed unless it targeted specific subpopulations that are currently underserved. Opinions around the clinical attractiveness of betrixaban (pipeline medication in development for prophylaxis of venous thromboembolism) were split, with some viewing the results from the APEX trial as clinically relevant while others did not feel the medication provided benefit.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

REGULATORY LABELS

  • Approved labels for marketed NOACs in the US, Japan, and five major EU markets
  • Bibliography

GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS

  • Insights and strategic recommendations
  • The high cost of NOACs is a much greater concern in Europe than in the US
  • An ability to show a reduction in the rate of major bleeds using real-world clinical data should help uptake of NOACs
  • Payers generally view NOACs as highly similar from a clinical perspective
  • Pipeline insights
  • Bibliography

US PRICING

US REIMBURSEMENT

  • Insights and strategic recommendations
  • Bibliography

JAPAN

  • Price premiums are awarded for added benefit or innovation
  • Pricing of launched SPAF and VTE treatments
  • Bibliography

PRICING IN THE FIVE MAJOR EU MARKETS

FRANCE

  • Insights and strategic recommendations
  • Bibliography

GERMANY

  • Insights and strategic recommendations
  • Bibliography

ITALY

  • Insights and strategic recommendations
  • Bibliography

SPAIN

  • Insights and strategic recommendations
  • National reimbursement decisions are not a barrier to access
  • Regional formularies or assessments
  • Bibliography

UK

  • Insights and strategic recommendations
  • NICE approval is a key market access barrier
  • Regional formulary decisions
  • The SMC recommends the use of NOACs in SPAF and VTE
  • Bibliography

METHODOLOGY

  • Primary research
  • Price assumptions
  • Bibliography

LIST OF TABLES

  • Table 1: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
  • Table 2: Levers impacting access to anticoagulants in the five major EU markets
  • Table 3: Levers impacting access to NOACs in the US and five major EU markets
  • Table 4: French and German HTA decisions
  • Table 5: US pricing of key marketed drugs
  • Table 6: Prior authorization criteria for NOACs in six major health plans
  • Table 7: Formulary placement of NOACs in selected 2016 commercial formularies
  • Table 8: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
  • Table 9: Formulary placement of NOACs in selected large Medicaid states' preferred drug lists
  • Table 10: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
  • Table 11: Pricing of NOACs in Japan
  • Table 12: Price calculation methodologies for NOACs in Japan
  • Table 13: Pricing of key NOACs in the five major EU markets
  • Table 14: Transparency Commission's ASMR ratings and pricing implications
  • Table 15: Transparency Committee's SMR ratings and pricing implications
  • Table 16: Transparency Commission's assessment of SPAF treatments in France
  • Table 17: Transparency Commission's assessment of VTE treatments in France
  • Table 18: Transparency Commission's assessment of Praxbind (reversal agent for Pradaxa) in France
  • Table 19: G-BA assessment of key SPAF therapies in Germany
  • Table 20: G-BA assessment of key VTE therapies in Germany
  • Table 21: AIFA's reimbursement decisions for NOACs in Italy
  • Table 22: Reimbursement conditions for antidotes in Italy
  • Table 23: Local formulary decisions for NOACs in Italy
  • Table 24: Spain regional assessments of anticoagulants
  • Table 25: NICE assessments of key SPAF therapies in the UK
  • Table 26: NICE assessments of key VTE therapies in the UK
  • Table 27: Regional formulary decisions for SPAF therapies in the UK
  • Table 28: Regional formulary decisions for VTE therapies in the UK
  • Table 29: SMC decisions on key SPAF therapies
  • Table 30: SMC decisions on key VTE therapies
  • Table 31: SMC decisions on key antidotes
  • Table 32: Price sources and calculations, by country
  • Table 33: Exchange rates used for calculating prices
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