Pricing and Reimbursement 2005 / 2006, Evaluating Key Strategic Issues

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One of the two major issues for a drug company, besides gaining market authorisation, is persuading the country in question to reimburse them, that is pay for the drug that the company is attempting to market. But price is the key here, if a drug is priced too low revenues will be compromised, and if priced too high the drug company reduces the chances of reimbursement, severely denting profits.

All countries have different pricing and reimbursement systems; all with a differing emphasis. Some countries have a drug reference pricing system where the price of the drug has to correspond to a basket of prices from other leading countries; some allow a price only based on permitted future profits, and the US alone has a supposedly free market where the drug company is free to set any price. Although, the reality of this 'free market' is perhaps not as free as the US system of pricing implies. Also the new Medicare Act 2003 has even more implications for the fate of drug prices in the US healthcare economy and possibly favourable consequences for the future profitability of drug companies in the US market.

Visiongain's Pricing and Reimbursement 2005 / 2006, Evaluating Key Strategic Issues discusses this particular issue at depth and the intricacies of Pricing & Reimbursements system throughout the rest of the developed world.

This report will give you insight and clarity into what can be a confusing and contradictory labyrinth and therefore becomes an essential guide of the best method of approaching reimbursement problems. Visiongain's Pricing and Reimbursement 2005 / 2006, Evaluating Key Strategic Issues in-depth and fully researched report details the Pricing & Reimbursement systems of the following key countries:

US
Japan
UK
Germany
France
Italy
Spain

Each chapter not only describes the individual country-specific P&R systems, but also describes new regulatory developments and how these changes will affect future drug pricing and therefore the drug revenues of your company.

A very important aspect of Pricing & Reimbursement concerns the US market, which currently takes 50% of the worlds' drug revenues. The dominating issue in drug pricing is whether the US will adopt price controls. Such controls now exist in one form or another throughout the rest of the developed world. When will it happen in the US, if at all? This issue is explored at length in this report and what control Medicare/Medicaid will have over future drug pricing in the US is outlined and discussed in detail.

Buying visiongains' report Pricing and Reimbursement 2005 / 2006, Evaluating Key Strategic Issues will enable a clearer understanding of the large bureaucratic and legislative hurdles that this final stage of drug marketing holds.

Other major issues that have an effect on drug pricing are also discussed which include:

Parallel trade
The re-importation of drugs into the US from Canada
The countries with the quickest time for drug approvals
The possibility of a single European price for pharmaceuticals
The effect of EU expansion on the drug prices
The increasing control governments are exerting over drug pricing
The future of drug pricing

Also, the healthcare economy of each of the country sections is highlighted showing how much each country spends on its health systems and what proportion of this is taken by drug spending. Other vital statistics concerning healthcare spending are also shown.

With 13 Chapters, over 200 pages, including over 20 tables; visiongain's Pricing and Reimbursement, 2005 will give you clear descriptions of how best to understand and solve important reimbursement issues. Visiongain's Pricing and Reimbursement 2005 / 2006, Evaluating Key Strategic Issues is a vital tool for any drug pricing strategy.

1. Executive Summary: Pricing and Reimbursement 2005

1.1 Aims and Scope of Pricing and Reimbursement 2005

2 Introduction to Pricing and Reimbursement: The Increasing Control of Drug Prices by Governments

2.1 Price is the Key (I)
2.2 Reimbursement: Who Pays
2.3 Price is the Key (II)
2.4 The Reimbursement System
2.5 Different Reimbursement Systems Different Drug Prices
2.6 The Different Systems of Reimbursement
- 2.6.1 International Reference Pricing
- 2.6.2 Therapeutic Class Reference Pricing
- 2.6.3 Profit Controls
- 2.6.4 Doctors Budgets
- 2.6.5 Direct Price Controls
- 2.6.6 Volume Limitations
- 2.6.7 Rebate Requirements
- 2.6.8 Reimbursement Restrictions
- 2.6.9 Fourth Hurdle Requirements/Cost-Effectiveness Reviews
- 2.6.10 Positive/Negative Lists
2.7 The Influence of Parallel Trade on Drug Pricing
2.8 Marketing Approval is Necessary Prior to Reimbursement
2.9 Pricing Approval Comes After Marketing Approval
2.10 The High Costs of Bringing a Drug to Market
2.11 Drug Purchase Decisions by Doctors Are All Important in Drug Sales
2.12 The Price Inelasticity of Doctor's Decisions Over Drug Prescription
2.13 Government Influence on Doctor in Drug Prescription Does Lower Drug Costs
2.14 Healthcare Costs Throughout the Developed World are Increasing
2.15 Drivers of Drug Expenditure
2.16 Restraints on Drug Expenditure
2.17 The US Spent the Highest Proportion of its GDP on Healthcare and Hungary Spent the Highest Proportion of its Healthcare on Pharmaceuticals
2.18 The UK had the Highest Health Expenditure Growth Rates
2.19 All Governments Want to Cut their Drug Bill and Drug Prices are an Obvious Method of Control
2.20 The Market and Company Factors that Influence Drug Pricing
2.21 OTC Drugs are Not Price Controlled
2.22 Generic Drugs Lower Healthcare Costs
2.23 Increase Use of Generic Drugs Will Create High Savings for Healthcare Systems
2.24 Price Controls May Affect Drug Launch
2.25 Cost Containment Methods have Limited Effects
2.26 US and Europe Drug Pricing Models Compared
2.27 The Future of Global Pricing and Reimbursement

3. Pricing and Reimbursement in the US: The Advent of Price Controls?

3.1 US and Europe Drug Pricing Models Compared
3.2 The US Healthcare System
3.3 Private Insurance through MCOs and the State Organise US Healthcare
3.4 The Development of Present-Day Managed Care in the US
3.5 Private Health Insurance Premiums are Beginning to Rise
3.6 Private Insurance through MCOs and the State Organise US Healthcare
3.7 The Managed Care System in the US
3.8 What are HMOs?
3.9 PPOs Plans
3.10 POS Plans
3.11 Different MCOs Compared
3.12 The Role of the Employer in the US Healthcare System: The Rise of PPO Health Plans
3.13 Health Insurance Options for the Unemployed: COBRA
3.14 The Uninsured Patient in the US
3.15 Medicaid: An Overview
3.16 Medicare: An Overview
3.17 Drug Reimbursement and MCOs and Medicare/Medicaid
- 3.17.1 Medicare/Medicaid
3.18 The US Spends Nearly 15% of its GDP on Healthcare
3.19 Private Insurance Pays for Less than Half of US Healthcare Needs
3.20 In 2003 US Drug Prescription Costs were 10.7% of Total Healthcare Spend But Hospital Care was Highest
3.21 US Healthcare Spending is Estimated to Increase by nearly 8% in 2005

Used on the Increases in Drug Price, 1997-2002

3.22 US Pricing and Federal Discounts
3.23 US Drug Prices are the Highest in the World
3.24 Prices for the Same Drug in the US also Vary Greatly
3.25 Medicare Prescription Drug Improvement and Modernization Act, 2003
3.26 Under the New Act Prescription Drug Savings for Seniors Seem Real
3.27 The Medicare Act 2003 Will Vastly Benefit Drug Companies

4. Pricing and Reimbursement in Europe: An Overview

4.1 Reference Pricing is a Common P&R Mechanism Throughout Europe

4.2 Reference Pricing will Always Cause Drugs to be Priced Below the Market Level
4.3 Price Differentials in the EU
4.4 Generic Prescribing and Substitution Varies in Europe
4.5 Generic Use Varies in Europe
4.6 EU Accession Will Encourage Price Differentials and Generic Usage
4.7 A Single European Price for Pharmaceuticals is Unlikely
4.8 European Hospital Drug Prices
4.9 Parallel Trade Is Used as Cost Containment Method
4.10 EU Accession Will Increase Parallel Trade
4.11 The Impact of the Euro on Drug Prices4.12 Different Forms of EU Health Care Financing
4.13 Single Payer
4.14 Social Insurance - Sickness Funds
4.15 Private Insurance
4.16 EU Accession Countries May Be Included in Reference Pricing Systems
4.17 The Payment of European Pharmacists
4.18 The Future of Drug Pricing and the Market for Drugs in Europe

5. Pricing and Reimbursement in the UK

5.1 Drug Approval Process

5.2 Health Care Coverage
5.3 Patient Co-payment
5.4 Pricing and the Pharmaceutical Price Regulation Scheme
5.5 New PPRS Regulations 2005
5.6 Pharmaceutical Companies and the Monitoring of Drug Profit
5.7 National Institute of Clinical Effectiveness (NICE) has Become an Instrument for Cost Enhancement and Not Containment
5.8 Pharmacy Payments
5.9 The Criteria for Reimbursement
5.10 The Size of Reimbursement
5.11 Doctor's Budgets are Unpopular with Some But Reduced Drug Expenditure
5.12 Generic Use is Increasing
5.13 Drug Prices are Reduced in the UK Market
5.14 Doctor's Budgets the Most Successful Aspect of UK's Pricing and Reimbursement System

6. Pricing and Reimbursement in France

6.1 The Price of Drugs in France Matches the European Average

6.2 The French Healthcare System
6.3 Health Care Coverage
6.4 The French Healthcare System
6.5 Voluntary Health Insurance
6.6 Out-Of-Pocket Payments
6.7 French Drug Pricing is Tightly Regulated
6.8 An Informal Reference Pricing System Exists in France
6.9 Wholesale and Pharmacy Prices
6.10 The Criteria for Reimbursement
6.11 The Size of Reimbursement
6.12 The Nature of the Drug Price Agreements Between the Pharmaceutical Industry and the CEPS
6.13 Generic Substitution as an Attempt to Curb Drug Costs
6.14 French Health System Reform has Largely Failed

7. Drug Pricing and Reimbursement in Germany

7.1 The German Pharmaceutical Market
7.2 German Health Care System is Characterised by Financial Shortfall
7.3 The German Response to its Healthcare System Shortfall
7.4 The Effect of Reunification on the German National Health System
7.5 The German Drug Approval's Process is the Fastest in Europe
7.6 German Drug Prices are Higher than the European Average
7.7 The German Reference Price System Now Includes Patented Drugs7.8 Reference Pricing
7.9 Criteria for Reimbursement and Negative Lists
7.10 The Limits on Co-Pay
7.11 Generic Substitution is Allowed in Germany
7.12 Doctors Budgets Imposed in An Attempt to Cut Drug Costs
7.13 German Government Imposes 16% Drug Discounts on Mnaufacturers
7.14 Conclusion: Drug Regulations are Lenient in Germany

8. Pricing and Reimbursement in Spain

8.1 The Spanish National healthcare System
8.2 Reimbursement Levels
8.3 The Criteria for Reimbursement and Negative Lists
8.4 Drug Authorisations and Other Bodies
8.5 The Pricing of Drugs in Spain
8.6 Reference Pricing Comparisons are Only Used with Generic Drugs
8.7 The Penetration of Generics is Low in Spain
8.8 Spanish Parallel Trade and Dual Pricing
8.9 The Price of Drugs in Spain
8.10 Spain Practices Generic Substitution
8.11 The Distribution of Drugs
8.12 Cost Containment and Doctor Budgets
8.13 Conclusion: Spain Uses Price Freeze as Main Cost Containment Method But Will Use Saparingly in the Future

9. Pricing and Reimbursement in Italy

9.1 The Italian HealthCare System

9.2 Drug Reimbursement
9.3 Authorities in Reimbursement Decision Making
9.4 The CIPE: Setting the Drug Price
9.5 Italian Pharmacies
9.6 Italian Pharmaceutical Law
9.7 Changes in Distribution Margins
9.8 The Introduction of Generics
9.9 Influencing the Prescriber
9.10 The Effect of Drug Pricing Strategies on Italian Drug Spend
9.11 Italy's Generic Use May Increase

10 Pricing and Reimbursement in Japan

10.1The Japanese Healthcare System

10.2 Revisions to the Health Insurance Law Saw an Increase in Co-Pay
10.3 Japanese Drug Pricing
10.4 The Japanese Reference System
10.5 The Reexamination and Reevaluation Drug Systems are Used to Predict Drug Safety
10.6 Japan Has Reduced Healthcare Spending Including Drugs
10.7 Generic Drug Prices are Set at 70% of the Original Drug Price
10.8 There is No Generic Substitution in Japan
10.9 The Japanese Wholesale Market in Consolidation
10.10 Bungyo: the Separation of Dispensing and Prescribing is Rapidly Increasing
10.11 Bungyo Separation Has Dramatic Effect on Retail Pharmacies
10.12 New Developments: Contract Manufacturing Will Increase
10.13 New Drug Approval and License System Will Cut Drug Approval Time
10.14 Changes in Approval Times Will Aid Foreign Company Entry into the Japanese Pharmaceutical Market
10.15 Conclusion: The Japanese Government Directly Controls Drug Prices through Price Cuts

11. Canada and US Drug Reimporatation: A Revolution by the Consumer

11.1 Drug Reimportation from Canada Will Not Affect US Drug Prices
11.2 Drugs are Not Always Cheaper in Canada Compared to the US
11.3 Generic Drugs Cheaper in the US than Canada
11.4 It is Legal for the US to Import Drugs from Canada but only if the Drugs are Proven Safe
11.5 The US States Currently Active in US/Canada Drug Reimportation
11.6 Why are Pharmaceutical Prices Lower in Canada?
11.7 Reimportation is a Form of Price Control which may have Poor Financial Consequences for the Pharmaceutical Industry
11.8 The Response of the Major Drug Companies on Drug Reimportation from Canada
11.9 The Response of the Canadian Pharmacies to Drug Reimportation
11.10 The Overall Savings from Drug Reimportation for the Consumer and the US Government is Small
11.11 Drug Reimportation Will Never Work on a Large Scale
11.12 The New Medicare Act 2003 Will Slow Down Drug Reimportation

12. Parallel Trade and Its Effect on Drug Prices

12.1 Parallel Trade is Predominantly a European Activity

12.2 The UK is the Largest Importer of Parallel Traded Drugs
12.3 The Method of Parallel Trade Importing into the UK
12.4 The Regulation of UK Parallel Trade
12.5 Price is Not the Only Factor in Determining the Parallel Trade Potential of a Drug
12.6 The Repackaging of Pharmaceuticals is an Important Aspect of Parallel Trade
12.7 The Exhaustion of IPR Allows for the Importation of Drugs
12.8 Current EU Case Law on Parallel Imports of Pharmaceutical Products
12.9 EU Free Pricing is a Myth
12.10 The Arguments For and Against Parallel Trade
12.11 The Savings from Parallel Trade are Small
- 12.11.1 Denmark
- 12.11.2 Germany
- 12.11.3 Sweden
- 12.11.4 The Netherlands
- 12.11.5 United Kingdom
12.12 York Study Did Show that PT Did Reduce Healthcare Costs Albeit by Small Amounts
12.13 Swedish Study Confirms Price Competitive Effect of Parallel Traded Drugs
12.14 LSE Publication Contradicts EFPIA Financed Study
12.15 EU Drug Price Harmonisation Is Unlikely
12.16 The Drug Company's Arguments Against Parallel Trade are Weak
12.17 Different Organisational Positions on Parallel Trade
12.18 Visiongain Questionnaire on Parallel Trade: A Surprising Consensus Between Both Big Pharma and the W&D Industry

13. Conclusion: Drug Pricing Control Will Become Ever More Stringent

List of Tables

Table 2.1 Comparative Drug Prices in Selected Developed Countries, 2005

Table 2.2 Percentage Excess in Drug Prices in the US Compared to Selected Countries, 2003

Table 2.3 Drug Purchase Decision Making

Table 2.4 Healthcare Spending by Country, 2002

Table 2.5 Total Health Spending ($) and Drug Expenditure per Patient ($), 2002

Table 2.6 The Top Five Countries by Public Expenditure on Health (% GDP), 2002

Table 2.7 The Top Five Countries by Total Expenditure on Health (% GDP), 2002

Table 2.8 The Top Five Countries by Total Expenditure on Drugs as % Total Expenditure on Health, 2002

Table 2.9 Top Five Countries by Total Health Spending Per Capita ($ PPP), 2002

Table 2.10 Annual Average Growth Rates (%) in GDP, Total and Public Health Expenditure of Principle Countries, 1997-2002

Table 2.11 All Factors that Influence Drug Prices

Table 2.12 Generic Market Share in Selected Countries, 2004

Table 2.13 Current Practices in the Development of Increased Generic Use, 2004

Table 3.1 Annual Growth in Private Health Insurance Premiums (%)

Table 3.2 A Comparison in Plan Cost Between Several Different Californian HMOs, 2004

Table 3.3 Monthly Insurance Premiums (Single and Family Enrollee in Group Health Plans), 2004

Table 3.4 The US Spend on Healthcare 2002

Table 3.5 Sources of US Health Payments (%), 2003

Table 3.6 Distribution of Spending (%): Public Vs. Private, 2003

Table 3.7 US Healthcare Spending by Category ($bn) (%), 2003

Table 3.8 Annual Growth Rates by Health Spending Categories, 2003

Table 3.9 US Healthcare Spending ($) 2000-2005

Table 3.10 The Relative Contributions of Price, Utilisation and Types of Prescription Drugs

Table 3.11 A Comparison of Prescription Drug Prices For a 30-day supply: US and Europe

Table 4.1 Price Control or Drug Supply Control Mechanisms as Part of P&R Systems

Table 4.2 The Different Pricing and Reimbursement Systems of Selected European Countries, 2005

Table 4.3 The Two Broad P&R Systems within Europe, 2005

Table 4.4 EU Countries and Reference Pricing, 2005

Table 4.5 Price Differences per unit ($) in some EU Countries DDD-adjusted, 2002

Table 4.6 Generic Use in Europe, 2004

Table 4.7 Generic Market Share in Selected Countries, 2004

Table 4.8 The Advantages and Disadvantages of a Single European Price for All Drugs

Table 5.1 Different Aspects of UK Healthcare Spending, 1997-2002

Table 6.1 Different Aspects of French Healthcare Spending, 1997-2002

Table 7.1 Different Aspects of German Healthcare Spending, 1997-2002

Table 8.1 Different Aspects of Spanish Healthcare Spending, 1997-2002

Table 9.1 Different Aspects of Italian Healthcare Spending, 1997-2002

Table 9.2 Different Reimbursement Classes of Drugs in the Italian Market, 2005

Table 10.1 Different Aspects of Japanese Healthcare Spending, 1997-2002

Table 10.2 Classification and Rate of Japanese Drug Pricing Premiums

Table 11.1 Comparison of Drug Prices Between the USA and Canada (as of June 15, 2004)

Table 11.2 Comparison of Generic Drug Prices Between the USA and Canada (October 2004)

Table 12.1 World Differential Prices for Branded Amoxil 250mg, 2004

Table 12.2 Major Parallel Exporters of Drugs in the EU, 2003

Table 12.3 Retail Pharmaceutical Penetration by Parallel Imports, 2002

Table 12.4 Direct Savings ($m) from Use of Parallel Sourced Drugs, 2002

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