Rx-To-OTC Switching Strategies: Lifecycle management and building brand equity in the US, EU and ROW

Table of Contents

Rx-to-OTC Switching Strategies

Executive Summary

• An introduction to OTC markets
• Rx-to-OTC switching in major markets
• The Rx-to-OTC market in the US
• The Rx-to-OTC market in Europe
• The Rx-to-OTC market in the rest of the world
• Rx-to-OTC switching strategies
• Rx-to-OTC switching best practices

Contributors to this report

Chapter 1

An introduction to OTC markets

• Summary
• Introduction
• Defining Rx-to-OTC switching
• Key OTC therapeutic categories
• Key OTC product companies

Chapter 2

Rx-to-OTC switching in major markets

• Summary
• Introduction
• Advantages and disadvantages of Rx-to-OTC switching
• Consumers
• Governments
• Pharmaceutical and OTC companies
• Healthcare professionals
• Major therapeutic categories with future Rx-to-OTC switch candidates
• Key drivers of Rx-to-OTC switching
• Government and regulatory drivers
• Manufacturer drivers
• Retailer drivers
• Consumer drivers
• Switching strategy focus -- Europe v US

Chapter 3

The Rx-to-OTC market in the US

• Summary
• Introduction
• Rx medicine sales
• Generic competition
• Regulation of Rx and OTC medicines
• Regulatory approval of Rx-to-OTC switches
• The impact of regulation
• Potential improvements
• Possible pharmacy-only OTC classification
• Pseudoephedrine laws
• Changes in pharmacy stores
• Pricing considerations
• Reimbursement by privately-funded health insurance
• Reimbursement by taxation-funded health insurance
• Rx-to-OTC trends
• Future drug switches
• Future drivers
• Regulatory environments
• Sales and marketing
• Saturated therapeutic categories
• Pricing and profitability
• Support of healthcare professionals

Chapter 4

The Rx-to-OTC market in Europe

• Summary
• Introduction
• Rx-to-OTC switching
• The impact of regulation
• UK
• Growth in the UK OTC market
• Rx-to-OTC switching in the UK
• Rx-to-OTC trends
• Pending drug switches
• Future drug switches
• Future drivers of switches
• France
• Regulation of Rx medicines and OTC products
• Advertising of OTC products
• Retail outlets for OTC products
• Pricing and profitability
• Size of the OTC product market
• Rx-to-OTC switches
• Germany
• Regulation of Rx medicines and OTC products
• Advertising of OTC products
• Retail outlets for OTC products
• Pricing
• Size of the OTC product market
• Rx-to-OTC switches
• Italy
• Regulation of Rx medicines and OTC products
• Advertising of OTC products
• Retail outlets for OTC products
• Pricing and reimbursement
• Government promotion of self-medication
• Size of the OTC product market
• Rx-to-OTC switches

Chapter 5

The Rx-to-OTC market in the rest of the world

• Summary
• Australia and New Zealand
• Regulation of Rx and OTC medicines in Australia
• Reclassification to OTC status in Australia
• Regulation of Rx and OTC medicines in New Zealand
• Rx-to-OTC reclassification approvals in New Zealand
• Regulatory environments
• Pricing considerations
• Rx-to-OTC trends
• Future drivers of switches
• Japan
• Regulation of Rx medicines and OTC products
• Advertising of OTC products
• Retail outlets for OTC products
• Pricing
• Rx-to-OTC switching

Chapter 6

Rx-to-OTC switching strategies

• Summary
• Introduction
• Product lifecycle management and building brand equity
• Product differentiation

Chapter 7

Rx-to-OTC switching best practices

• Summary
• Zocor Heart-Pro (simvastatin) in the UK
• The UK POM statin market
• Indication and guidelines for GPs and pharmacists
• Stakeholder consultation before the switch
• Marketing and pharmacist training campaigns for OTC Zocor Heart-Pro
• Patients adherence to statin therapy
• Reimbursement of Rx Zocor compared to the cost of OTC Zocor Heart-Pro
• Healthcare professionals opinion of OTC Zocor Heart-Pro
• Sales of OTC Zocor Heart-Pro
• Implications for the future
• Switching statins in the rest of Europe
• Switching statins in the US
• Switching statins in New Zealand and Australia
• Lovenelle (levonorgestrel) emergency post-coital contraceptive pill in the UK
• Plan B (levonorgestrel) in Canada
• Plan B (levonorgestrel) in the US
• Second generation proton pump inhibitors (PPIs)
• Claritin (loratadine) in the US
• Xenical (orlistat) in Australia and New Zealand
• Private-label OTC product
• Galpharm Healthcare in the UK
• Leiner Health Products in the US

Chapter 8

Appendix

• Primary research methodology
• Pharmaceutical executive survey
• Expert interview details
• Secondary research methodology
• References
• Index

List of Figures

• Figure 1.1: Key differences between Rx and OTC medicines
• Figure 1.2: Predictions of annual growth in OTC sales
• Figure 1.3: Expected sales growth across OTC therapeutic categories
• Figure 2.4: Leading OTC therapeutic categories ranked by anticipated switching activity
• Figure 2.5: Relative importance of Rx-to-OTC switching drivers
• Figure 2.6: Markets where switching strategies will be focused
• Figure 3.7: OTC medicine approvals in the US, 1996-2003
• Figure 4.8: Rx-to-OTC switches in the EU and US, 1983-2002
• Figure 4.9: Rx-to-OTC switches by therapeutic category in the EU, 1983-2002
• Figure 4.10: Rx-to-OTC switches by therapeutic category in the US, 1983-2002
• Figure 6.11: Pharmaceutical companies anticipating switching Rx medicines to OTC status in the next five years
• Figure 6.12: Number of Rx medicines that pharmaceutical companies anticipate switching in the next 5 years
• Figure 6.13: Strategies companies use when switching a medicine from Rx to OTC status
• Figure 8.14: Location of pharmaceutical executives surveyed

List of Tables

• Table 1.1: Differences in medicine classifications and outlets across the major markets
• Table 1.2: Key OTC therapeutic categories and US sales, 2004
• Table 1.3: Major companies in the global OTC market
• Table 1.4: Major companies operating in the US OTC market only
• Table 1.5: Major companies operating in the European OTC market only
• Table 1.6: Major companies operating in the Japanese OTC market only
• Table 2.7: Advantages and disadvantages of Rx-to-OTC switching
• Table 3.8: The effect of switching Prilosec and Claritin on Rx medicine formularies and patient co-pays
• Table 3.9: OTC retail sales in the US, 2001-2004
• Table 3.10: High and low growth OTC categories in the US, 2001-2004
• Table 4.11: OTC medicine sales in the UK, 2003-2004
• Table 4.12: POM-to-P switch candidates in the UK, 2002
• Table 4.13: POM-to-P switch candidates in the UK, 2002 (contd)
• Table 4.14: POM-to-P switches in the UK, 2001-2005
• Table 4.15: Non-prescription sales in France (€m), 2002-2004
• Table 4.16: Rx-to-OTC switches in France, 1996-2004
• Table 4.17: Non-prescription sales in Germany (€m), 2002-2004
• Table 4.18: Rx-to-OTC switches in Germany, 2001-2004
• Table 4.19: Non-prescription sales in Italy (€m), 2002-2004
• Table 4.20: Rx-to-OTC switches in Italy, 2003
• Table 5.21: OTC sales in pharmacies in Australia (AU$bn), 2001-2003
• Table 5.22: Rx-to-OTC switches in Australia, 2003-2004
• Table 5.23: Definition and classification of pharmaceutical and medicinal products in Japan
• Table 5.24: Rx-to-OTC switches in Japan, 2000-2004