The Reality of Market Access in Europe: the role of Health Technology Assessment
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.
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:
Pharmaceutical manufacturers are increasingly faced with changing rules and practices on reimbursement. In this report, you will discover:
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.
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
- 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
- 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?
- 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.
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
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
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
