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The Reality of Market Access in Europe: the role of Health Technology Assessment
[Published by FirstWord Pharma]

Published by FirstWord Pharma: 10 Mar 2014 | 105 | In Stock

Introduction

Introduction


Faced with slipping or negligible GDP growth and an economic crisis, Eurozone countries are drilling down into healthcare budgets as a means of controlling expenditure.


From price cuts, tighter reimbursement criteria and greater patient co-payments to the wider use of generics and manufacturer risk-sharing agreements, the largest markets are examining ways to balance the public good with fiscal goals.


Set against that background is Health Technology Assessment (HTA). Widely used as part of the pricing and reimbursement process in Europe, HTA is nevertheless still in the early stages of being coordinated into a system across Europe.


In The Reality of Market Access in Europe: the role of Health Technology Assessment, FirstWord skilfully addresses the issues surrounding HTA, both for its potential to rationalise treatment on economic grounds and as a means to assess the cost effectiveness of new products. Focused on the agencies, procedures and approaches of HTA in the six largest EU markets, the report provides a coherent and current overview of pricing and reimbursement, controversies over issues like rule-making and individual product cases, and what the future of HTA will look like.


Puchase Reasons


Key Benefits


Attitudes to drug reimbursement have been shaped by economics. In The Reality of Market Access in Europe: the role of Health Technology Assessment, you will:


  • Understand how economic uncertainties are affecting pharmaceutical reimbursement spending

  • Gain insight into how HTA has become more formalised and transparent in recent years

  • Know which countries have the most advanced HTA systems and why

  • Understand how HTA can provide a more certain route to market, and raise the bar for new drugs entering the market

  • Filled with compelling and important insights into an evolving market, the report offers:


  • Up-to-date charts and figures, translated European sources and insights into the HTA process

  • A look at different approaches—and outcomes—in the top six EU markets

  • Insight on how HTA affects market access for new drugs, and the additional information HTA agencies demand

  • Insight into moves to co-ordinate HTA approaches across the EU

  • Discussion of how health budgets are affected by the EU’s current economic reality

  • Key Questions Answered


  • How have national attitudes towards drug reimbursement been shaped by economic realities?

  • Which countries have the most advanced HTA systems and which countries are following the lead?

  • How have HTA reforms created market hurdles?

  • What changes in information provision now affect manufacturers?

  • How can HTA increase access to new drugs?

  • How have coordinating moves at EU level affected the conduct of the HTA process?

  • Highlights


    Key facts


  • Despite worsening economic circumstances, health spending accounts for a greater proportion of the GDP in France, Germany, Italy, Poland, Spain and the United Kingdom than in 2009.

  • Expensive medicines are more widely distributed in European countries, along with specific high-cost therapy areas such as cancer.

  • Although established in 2006, the EUnetHTA is still in the early stages of harmonising HTA approaches across the Eurozone.

  • Content Highlights


    Pharmaceutical manufacturers are increasingly faced with changing rules and practices on reimbursement. In this report, you will discover:


  • The role of the key governing agencies and how they operate in six key European markets

  • How the downward pressure of cost containment is being met with the upward push from patient groups for the latest products

  • The most up-to-date and expertly translated charts and data
  • Table of Contents
    for The Reality of Market Access in Europe: the role of Health Technology Assessment [Published by FirstWord Pharma]

    • 1.Executive summary

      2.Drivers for cost-containment: economic background

      2.1.Economic drivers

      2.1.1.Effects on public spending

      2.1.2.Health expenditure

      3.Pharmaceutical environment

      3.1.Rising hospital spending in France, Spain and the UK

      3.2.Germany, rising prominence of cancer medicines

      4.Activity at European level

      4.1.An overview of the European drug approval process

      4.2.Pricing and reimbursement at European level

      4.2.1.European pricing and reimbursement directive

      4.2.2.Directive 2011/24/EU on patients’ rights in cross border healthcare

      4.2.3.NM CAPR

      4.3.HTA collaboration: EUnetHTA

      4.3.1.Activities and development

      5.Country focus: France

      5.1.Pricing and Reimbursement in France

      5.1.2.HAS

      5.1.3.CEPS

      5.2.The Transparency Committee

      5.2.1.ASMR ratings

      5.3.New indications

      5.4.ASMR level I to III: CEESP review

      5.5.Reform plans: ITR to replace SMR/ASMR?

      6.Country focus: Germany

      6.1.Pricing and reimbursement in Germany

      7.HTA in Germany: The role of IQWIG

      7.1.How is a benefit assessment conducted according to EBM criteria?

      7.2.DIMDI

      7.3.Orphan drugs

      7.4.Access to data: the case of reboxetine

      7.5.Effects of AMNOG on the market

      8.Country focus: Italy

      8.1.AIFA

      8.1.1.Reimbursement process and criteria

      8.1.2.Pricing

      8.2.Regional variations

      8.3.Conduct of HTA

      8.3.1.OsMed

      8.3.2.Agenas

      9.Country focus: Poland

      9.1.Pricing and reimbursement in Poland

      9.1.1.2012 Reimbursement Act

      9.2.Agency for Health Technology Assessment in Poland (AHTAPol)

      9.2.1.Clinical Analysis

      9.2.2.Economic analysis

      10.Country focus: Spain

      10.1.Pricing and Reimbursement in Spain

      10.2.HTA in Spain

      10.2.1.National level: ISCIII

      10.2.1.1.AETS

      10.2.1.2.AUNETS

      10.2.2.Regional institutions

      10.2.2.1.An example: Catalonia

      10.2.3.Reforms, a single appraisal system?

      10.2.4.IPT reports

      11.Country focus: United Kingdom

      11.1.Pricing and reimbursement in the UK

      11.2.Health Technology Assessment in England & Wales

      11.2.1.What does NICE do?

      11.2.2.NICE Assessment process and criteria

      11.2.2.1.QALY assessment

      11.2.3.Review of recent activity

      11.2.3.1.Current workload

      11.2.3.2.Planned appraisals

      11.2.4.Assessing the impact of NICE on prescribing

      11.2.5.Parliamentary review of NICE, 2007

      11.2.6.Data availability: the case of Tamiflu

      11.2.7.National Institute for Health Research

      11.3.Health Technology Assessment in Scotland

      12.Conclusions

    Additional Details

    Publisher

    FirstWord Pharma

    Publisher Information

    Reference

    105 |

    Number of Pages

    82

    Report Format

    PDF

    FirstWord Pharma Reports

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