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市場調查報告書
EU主要5國的價格設定、補助、規範的最新資訊
5EU: Pricing, Reimbursment and Regulatory Update
| 出版商 |
Datamonitor |
| 出版日期 |
2011年10月 |
商品編碼 |
229428 |
| 內容資訊 |
英文 Pages: 35 |
| 價格 |
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EU主要5國的價格設定、補助、規範的最新資訊 是由出版商Datamonitor在2011年10月所出版的。
這份英文市場調查報告書包含Pages: 35 價格從美金1900起跳。
EU主要5市場的政府、追求2011年的規範、價格設定、補助的改革實行。降價影響品牌、非專利支援政策、新市場的連結、補助的必要條件對製藥企業帶來負面的影響、但是對特定新藥的患者連結有提升的趨勢。
本報告書內容包括:法國、德國、義大利、西班牙、英國的規範/價格設定/補助問題、以及規範改革問題的分析、內容綱要摘記如下:
第1章 實施摘要
- 策略性調查範圍與焦點
- Datamonitor的主要結果
- 再緊縮政策之下所引進的降低價值
- 非專利支持政策威脅製藥企業的利益幅度
- 對新藥的市場連結與補助交涉
- 新藥的連結提升對製藥企業帶來正面的影響
第2章 法國：價格設定、補助、規範的最新資訊
- AFSSAPS的失敗成為2011年的焦點
- 新藥的臨床試驗與活躍的比較藥劑競爭
- 醫藥品安全性監視的改良預計
- 製藥企業所要求的新課稅
- 銷售員的醫院探訪取代團隊訪問
- 改革法案帶入其他政策
第3章 德國：價格設定、補助、規範的最新資訊
- 更加明確的德國最近會有價格交涉同意
- 企業不須請求就須提出文件
- 企業與比較藥劑的問需與G-BA交涉
第4章 義大利：價格設定、補貼、規範的最新資訊
- 義大利的新緊縮政策預計會再引進患者負擔費用
- 義大利的新基準價格降低的設定
- AIFA提出中央集中清冊到藥劑的地方
- 義大利的不當醫藥品增加
第5章 西班牙：價格設定、補助、規範的最新資訊
- 新的委員會對費用與效果的審查負責
- 15%價格降低的報告對醫藥品銷售所帶來的影響
- 目前西班牙、醫師須對國際一般性名稱開立處方
- 新基準價格設定集團的設置
第6章 英國：價格設定、補助、規範的最新資訊
- MHRA的藥品連結改良計畫的斷念
- NHS改革計畫的持續批判
- 2011年的NHS改革計畫的持續性進化
- 更加明確的價值對應之價格設定、但另有其他方法
- 英國製藥業界的批判之認定外處方提案
- 保健省的PPRS價格調整交易的終止
- 一般醫所接受與製藥企業的直接風險共有契約權
第7章 參考文獻
第8章 附錄
Description
Introduction
Governments across the five major EU markets (France, Germany, Italy, Spain, and the UK) have been busy implementing regulatory, pricing, and reimbursement reforms in 2011. Price cuts have impacted brands, while pro-generic measures and new market access and reimbursement requirements could negatively impact pharma. However, there are moves to improve patient access to certain novel drugs.
Features and benefits
- Insight into regulatory and pricing and reimbursement issues in France, Germany, Italy, Spain, and the UK.
- Overview of regulatory reform issues in France, Germany, Italy, Spain and the UK.
Highlights
- Driven by their high budget deficits post-recession, both Italy and Spain pushed through their austerity packages in 2011, which has led to substantial drug price cuts in both countries. Furthermore, pro-generic measures are being introduced to help reduce overall drug expenditures.
- Pharmaceutical companies will also need to be mindful of new market access and reimbursement requirements which could make it harder to secure reimbursement, with new drugs needing to prove their cost effectiveness against active comparators in both France and Germany.
- Several countries are working on improving access for patients to certain innovative and expensive drugs. As well as benefiting patients by giving them access to drugs they would not otherwise have been able to obtain, these measures will have a positive impact on pharma by securing higher revenue streams for companies that manufacture them.
Your key questions answered
- Evaluate the key pricing, reimbursement, and regulatory issues in the 5EU markets and their impact on branded pharmaceutical market access and uptake
- Gain insight into the strategies employed by pharmaceutical companies in response to changes in the regulatory environment.
TOC
Executive Summary
- Strategic scoping and focus
- Datamonitor key findings
- Price cuts have been brought in under austerity measures
- Pro-generic measures are threatening pharmaceutical companies' profit margins
- Market access and reimbursement negotiation for novel drugs
- Improved novel drug access will have a positive effect on pharma
FRANCE - PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
- The failings of AFSSAPS are brought into the spotlight in 2011
- Clinical trials for new drugs must be conducted against active comparators
- Pharmacovigilance is to be improved
- Pharmaceutical companies will be required to pay a new industry tax
- Sales representative visits to hospitals could be replaced by team visits
- Other measures addressed by the reform bill
GERMANY - PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
- Further clarity on Germany's upcoming price negotiation agreement revealed
- Companies may be required to submit a dossier without being requested to do so
- Companies will need to negotiate with the G-BA on issues concerning the comparator
ITALY - PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
- Italy's new austerity measures will see re-introduction of patient co-pay
- Italy sets new reference price reductions
- AIFA makes it mandatory for regions to supply drugs from a centralized list
- The number of counterfeit drugs is rising in Italy
SPAIN - PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
- A new committee will take responsibility for examining cost-effectiveness
- 15% price cuts announced set to further impact pharmaceutical sales
- Doctors must now prescribe by international non-proprietary name in Spain
- New reference pricing groups are to be created
UK - PRICING, REIMBURSEMENT, AND REGULATORY UPDATE
- MHRA scheme to improve access to drugs is dropped
- Disparities are appearing in cancer drug access
- NHS reform plan continues to attract criticism
- NHS reform plans continue to evolve in 2011
- Greater clarity on value-based pricing, but there is still some way to go
- Off-label prescribing proposal is criticized by UK pharma
- Department of Health ends price adjustment deal under PPRS
- GPs given powers to make risk-sharing agreements directly with pharma
BIBLIOGRAPHY
- Publications and online articles
APPENDIX
- Exchange rates used in this report
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