CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 5
CHAPTER 2 OVERVIEW OF RX-TO-OTC SWITCHING 12
Why implement lifecycle management strategies? 13
Classification of medicine types 14
What is Rx-to-OTC switching? 16
Why switch? - Drivers and resistors of Rx-to-OTC switching 18
Pharmaceutical companies - Drivers 20
A lifecycle management tool to generate revenues towards the end of an Rx drug's life 20
Boosting brand awareness 22
Gaining additional periods of exclusivity 23
Opportunity to differentiate between brands 26
Pharmaceutical companies - Resistors 28
Loss of reimbursement 28
Limited applicability 30
The cost of OTC launch and prospect of facing limited uptake if not first-to-market 32
OTC products often have a lower price point 33
Consumers - Drivers 34
Increasing public demand for healthcare knowledge and access to a variety of healthcare options 34
Consumers - Resistors 35
Out-of-pocket cost 35
Misdiagnosis, product misuse/non-compliance, and lack of trust in OTC products 36
Payers and Governments - Drivers 40
Switching allows limited healthcare budgets to cover the cost of drugs not available OTC 40
Healthcare professionals - Drivers 41
Transferring patients from the physician to the pharmacist leads to long-term healthcare cost savings 41
Healthcare professionals - Resistors 43
Increased pressure on pharmacists to act as healthcare providers rather than simply as dispensers 43
What to switch? - Which products are targeted for Rx-to-OTC switching? 45
Who is switching? - Which companies are the leading Rx-to-OTC switchers? 47
What are the likely future Rx-to-OTC switches? 50
Zyrtec-D enters a crowded market 54
Trial run of Viagra OTC 54
Schering-Plough files for OTC Zegerid in the US 56
When to switch? - When is the optimal time to implement an Rx-to-OTC switch? 58
How to switch? - What are the US and EU regulatory processes? 60
Rx-to-OTC regulatory processes in the US 60
Rx-to-OTC regulatory processes in the EU 62
Marketing and promotion of switched products 65
DTC recommendations for Rx-to-OTC switched products 66
The cost of switching 67
Selecting a price 68
Zocor Heart Pro in the UK 69
Strategic pricing in GlaxoSmithKline's EU triptan franchise 69
Summary of key Rx-to-OTC switch success factors 71
CHAPTER 3 RX-TO-OTC SWITCHING ACROSS THE SEVEN MAJOR MARKETS 75
Declining OTC usage across the seven major markets 76
Overview of the US OTC market 80
US medicines classification 80
Market assessment of Rx and OTC classifications in the US 80
Drivers and resistors in the US market 81
Gaining 3 years additional exclusivity 81
Potential loss of reimbursement 82
BTC - A future switching option in the US? 82
Unofficial BTC drugs - limiting misuse 82
Pros and cons of implementing a new class of medicines in the US 84
Suitability of drugs for a BTC classification 88
Recommendations on proceeding with the potential introduction of BTC medicines 89
BTC implementation by the FDA - will they, won't they? 91
Overview of the Japanese OTC market 92
Japan's medicines classification 92
Market assessment of Rx and OTC classifications in Japan 92
Drivers and resistors in the Japanese market 93
Free pricing system 93
Low utilization of OTC products at present, but demand for low-cost medicines is set to rise 93
Recent update of Rx-to-OTC switch procedures to ease transition 94
Increased access to OTC products drives uptake 95
Less than one-third of the population are aware of self-medication 96
EU approach to Rx-to-OTC switching 97
Overview of the UK Rx-to-OTC market 99
UK medicines classification 99
Market assessment of Rx and OTC classifications in the UK 99
Drivers and resistors in the UK market 101
The UK OTC market is underperforming, but has significant growth potential 101
No OTC patent protection, but 1 year's data exclusivity 102
Change in marketing and promotion laws limits capitalization on Rx branding 103
Consumer willingness to self-medicate is influenced by co-payment for prescription drugs 103
Other OTC drivers and resistors in the UK market 105
Overview of the German OTC market 106
Germany's medicines classification 106
Market assessment of Rx and OTC classifications in Germany 106
Drivers and resistors in the German market 108
Minimum 9-month regulatory switch procedure 108
No dual status limits scope of Rx-to-OTC switch strategy 108
Limited OTC availability limits uptake 108
OTC de-reimbursement led to decline in OTC usage 108
Deregulation has not led to price competition 109
Increased leniency set for OTC product advertising 109
Overview of the French OTC market 110
France's medicines classification 110
Market assessment of Rx and OTC classifications in France 110
Drivers and resistors in the French market 112
Underdeveloped OTC market 112
France's shrinking OTC market 112
Free pricing in the French OTC market 112
OTC products in France are non-reimbursable 113
Marketing and promotion of pharmaceuticals is strictly regulated in France 113
Internet pharmacies are not permitted in France 113
The absence of chain pharmacies limits national branding potential 114
The government has taken small steps to improve price competition 114
Overview of the Italian OTC market 115
Italy's medicines classification 115
Market assessment of Rx and OTC classifications in Italy 116
Drivers and resistors in the Italian market 118
Introduction of OTC classification which can be promoted to the general public 118
Introduction of pricing flexibility and discounting promotes competition 118
Greater distribution flexibility increases public access to OTC medicines 119
Drive to increase awareness and confidence in OTCs 119
Training future pharmacists on the benefits of OTC medicines 119
Overview of the Spanish OTC market 120
Spain's medicines classification 120
Market assessment of Rx and OTC classifications in Spain 120
Drivers and resistors in the Spanish market 122
No dual status permitted in Spain limits attractiveness of Rx-to-OTC switching 122
Overhaul of product advertising 122
Increased access to OTC medicines 123
CHAPTER 4 RX-TO-OTC CASE STUDY ANALYSIS 124
The varying success of GlaxoSmithKline's EU triptan Rx-to-OTC/pharmacy-only strategies 125
An unsuccessful Rx switch strategy for sumatriptan in the UK 126
Potential advantages of Imigran Recovery 126
A failed generic defense strategy 126
Factors limiting the impact of Imigran's switch 128
Key take-home message 129
GlaxoSmithKline successfully switches naratriptan in Germany 130
Key strengths of the GlaxoSmithKline's naratriptan 132
Key take home message 134
The varying success of GlaxoSmithKline's non-Rx triptan franchises - Formigran versus Imigran Recovery 135
The rise and fall of Alli 136
Key strengths of Alli 138
Why Alli sales plummeted post launch 140
Key take-home message 142
Antiulcerants - a prime target for Rx-to-OTC switching 143
Zantac's multiple formulations maintain OTC franchise momentum 144
Evaluating the success of Zantac 150 Max Strength 145
Key strengths of the Zantac Rx-to-OTC switch 147
Key take-home message 147
MiraLAX - fulfilling an unmet need in a highly genericized market 148
Key strengths of Schering-Plough's MiraLAX Rx-to-OTC switch 150
Key take-home message 151
CHAPTER 5 BIBLIOGRAPHY 153
Publications and online articles 153
Publications, online articles and meetings 161
Datamonitor resources 162
Databases 163
Abbreviations 163
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