Report: Rx-to-OTC Strategies: Maximizing the Commercial Potential of an Rx-to-OTC Switch TOC

CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Key findings
CHAPTER 2 OVERVIEW OF RX-TO-OTC SWITCHING
- Why implement lifecycle management strategies?
- Classification of medicine types
- What is Rx-to-OTC switching?
- Why switch? - Drivers and resistors of Rx-to-OTC switching
  - Pharmaceutical companies - Drivers
    - A lifecycle management tool to generate revenues towards the end of an Rx drug' s life
    - Boosting brand awareness
    - Gaining additional periods of exclusivity
    - Opportunity to differentiate between brands
  - Pharmaceutical companies - Resistors
    - Loss of reimbursement
    - Limited applicability
    - The cost of OTC launch and prospect of facing limited uptake if not first-to-market
    - OTC products often have a lower price point
  - Consumers - Drivers
    - Increasing public demand for healthcare knowledge and access to a variety of healthcare options
  - Consumers - Resistors
    - Out-of-pocket cost
    - Misdiagnosis, product misuse/non-compliance, and lack of trust in OTC products
  - Payers and Governments - Drivers
    - Switching allows limited healthcare budgets to cover the cost of drugs not available OTC
  - Healthcare professionals - Drivers
    - Transferring patients from the physician to the pharmacist leads to long-term healthcare cost savings
  - Healthcare professionals - Resistors
    - Increased pressure on pharmacists to act as healthcare providers rather than simply as dispensers
- What to switch? - Which products are targeted for Rx-to-OTC switching?
- Who is switching? - Which companies are the leading Rx-to-OTC switchers?
- What are the likely future Rx-to-OTC switches?
  - Zyrtec-D enters a crowded market
  - Trial run of Viagra OTC
  - Schering-Plough files for OTC Zegerid in the US
- When to switch? - When is the optimal time to implement an Rx-to-OTC switch?
- How to switch? - What are the US and EU regulatory processes?
  - Rx-to-OTC regulatory processes in the US
  - Rx-to-OTC regulatory processes in the EU
  - Marketing and promotion of switched products
    - DTC recommendations for Rx-to-OTC switched products
  - The cost of switching
  - Selecting a price
    - Zocor Heart Pro in the UK
    - Strategic pricing in GlaxoSmithKline' s EU triptan franchise
- Summary of key Rx-to-OTC switch success factors
CHAPTER 3 RX-TO-OTC SWITCHING ACROSS THE SEVEN MAJOR MARKETS
- Declining OTC usage across the seven major markets
- Overview of the US OTC market
  - US medicines classification
  - Market assessment of Rx and OTC classifications in the US
  - Drivers and resistors in the US market
    - Gaining 3 years additional exclusivity
    - Potential loss of reimbursement
  - BTC - A future switching option in the US?
    - Unofficial BTC drugs - limiting misuse
    - Pros and cons of implementing a new class of medicines in the US
    - Suitability of drugs for a BTC classification
    - Recommendations on proceeding with the potential introduction of BTC medicines
    - BTC implementation by the FDA - will they, won' t they?
- Overview of the Japanese OTC market
  - Japan' s medicines classification
  - Market assessment of Rx and OTC classifications in Japan
  - Drivers and resistors in the Japanese market
    - Free pricing system
    - Low utilization of OTC products at present, but demand for low-cost medicines is set to rise
    - Recent update of Rx-to-OTC switch procedures to ease transition
    - Increased access to OTC products drives uptake
    - Less than one-third of the population are aware of self-medication
- EU approach to Rx-to-OTC switching
- Overview of the UK Rx-to-OTC market
  - UK medicines classification
  - Market assessment of Rx and OTC classifications in the UK
  - Drivers and resistors in the UK market
    - The UK OTC market is underperforming, but has significant growth potential
    - No OTC patent protection, but 1 year' s data exclusivity
    - Change in marketing and promotion laws limits capitalization on Rx branding
    - Consumer willingness to self-medicate is influenced by co-payment for prescription drugs
    - Other OTC drivers and resistors in the UK market
- Overview of the German OTC market
  - Germany' s medicines classification
  - Market assessment of Rx and OTC classifications in Germany
  - Drivers and resistors in the German market
    - Minimum 9-month regulatory switch procedure
    - No dual status limits scope of Rx-to-OTC switch strategy
    - Limited OTC availability limits uptake
    - OTC de-reimbursement led to decline in OTC usage
    - Deregulation has not led to price competition
    - Increased leniency set for OTC product advertising
- Overview of the French OTC market
  - France' s medicines classification
  - Market assessment of Rx and OTC classifications in France
  - Drivers and resistors in the French market
    - Underdeveloped OTC market
    - France' s shrinking OTC market
    - Free pricing in the French OTC market
    - OTC products in France are non-reimbursable
    - Marketing and promotion of pharmaceuticals is strictly regulated in France
    - Internet pharmacies are not permitted in France
    - The absence of chain pharmacies limits national branding potential
    - The government has taken small steps to improve price competition
- Overview of the Italian OTC market
  - Italy' s medicines classification
  - Market assessment of Rx and OTC classifications in Italy
  - Drivers and resistors in the Italian market
    - Introduction of OTC classification which can be promoted to the general public
    - Introduction of pricing flexibility and discounting promotes competition
    - Greater distribution flexibility increases public access to OTC medicines
    - Drive to increase awareness and confidence in OTCs
    - Training future pharmacists on the benefits of OTC medicines
- Overview of the Spanish OTC market
  - Spain' s medicines classification
  - Market assessment of Rx and OTC classifications in Spain
  - Drivers and resistors in the Spanish market
    - No dual status permitted in Spain limits attractiveness of Rx-to-OTC switching
    - Overhaul of product advertising
    - Increased access to OTC medicines
CHAPTER 4 RX-TO-OTC CASE STUDY ANALYSIS
- The varying success of GlaxoSmithKline' s EU triptan Rx-to-OTC/pharmacy-only strategies
  - An unsuccessful Rx switch strategy for sumatriptan in the UK
    - Potential advantages of Imigran Recovery
    - A failed generic defense strategy
    - Factors limiting the impact of Imigran' s switch
    - Key take-home message
  - GlaxoSmithKline successfully switches naratriptan in Germany
    - Key strengths of the GlaxoSmithKline' s naratriptan
    - Key take home message
  - The varying success of GlaxoSmithKline' s non-Rx triptan franchises - Formigran versus Imigran Recovery
- The rise and fall of Alli
  - Key strengths of Alli
  - Why Alli sales plummeted post launch
  - Key take-home message
- Antiulcerants - a prime target for Rx-to-OTC switching
  - Zantac' s multiple formulations maintain OTC franchise momentum
  - Evaluating the success of Zantac 150 Max Strength
  - Key strengths of the Zantac Rx-to-OTC switch
  - Key take-home message
- MiraLAX - fulfilling an unmet need in a highly genericized market
  - Key strengths of Schering-Plough' s MiraLAX Rx-to-OTC switch
  - Key take-home message
CHAPTER 5 BIBLIOGRAPHY
- Publications and online articles
- Publications, online articles and meetings
- Datamonitor resources
- Databases
- Abbreviations
List of Tables
- Table 1: OTC product differentiation, therapeutic and commercial drivers, and additional data required for regulatory approval
- Table 2: Rx-to-OTC switches in the US since 2001
- Table 3: Therapeutic categories likely to be targeted for Rx-to-OTC/BTC switches in the next 5 years in the US
- Table 4: OTC/BTC products could capture $1 billion in sales from drugs facing patent expiry in the US during 2008-2012
- Table 5: Summary of Rx and OTC antiulcerant, GERD and heartburn products, 2003-08
- Table 6: Pros and cons of early Rx-to-OTC strategy implementation
- Table 7: The varying success of GlaxoSmithKline' s OTC/pharmacy-only triptan franchise - Formigran versus Imigran Recovery
- Table 8: Development and regulatory timeline for Rx-to-OTC product switching
- Table 9: The pros and cons of pricing a drug too high or too low
- Table 10: The varying success of GlaxoSmithKline' s OTC/pharmacy-only triptan franchise - Formigran versus Imigran Recovery
- Table 11: OTC market volume, value and price trend data across the seven major markets, 2003-07
- Table 12: Summary of GlaxoSmithKline/UCB' s Rx and OTC/pharmacy-only triptan products
- Table 13: Imigran Non-Rx and Rx franchise in the UK, 2003-07
- Table 14: Germany naratriptan OTC and Rx franchise 2003-07
- Table 15: The varying success of GlaxoSmithKline' s non-Rx triptan franchise in Germany and the UK - Formigran versus Imigran Recovery
- Table 16: Summary of Rx and OTC orlistat products in the US, 2008
- Table 17: Orlistat OTC and Rx franchise in the US, 2006-07
- Table 18: Summary of Rx and OTC antiulcerant, GERD and heartburn products in the US, 2003-08
- Table 19: Ranitidine OTC and Rx franchise in the US, 2003-07
- Table 20: Ranitidine OTC and Rx franchise in the US, 2003-07
- Table 21: Polyethylene glycol OTC and Rx market in the US, 2006-07
List of Figures
- Figure 1: A wide range of brand defense strategies are available, however timing of implementation is critical
- Figure 2: Differences between Rx and OTC drugs
- Figure 3: Rx-to-OTC/pharmacy-only switches in the US and UK, 2001-07
- Figure 4: Pros and cons of Rx-to-OTC switching
- Figure 5: Benefits and risks of responsible self-medication
- Figure 6: OTC Zantac becomes market leading ranitidine antiulcerant franchise, Q1 2003-Q4 2007
- Figure 7: Response by payers once a prescription drug becomes available OTC
- Figure 8: Factors to be considered when evaluating an Rx-to-OTC strategy
- Figure 9: OTC products yield significantly greater sales per promotional spend than Rx drugs during the first 9 months post launch
- Figure 10: Online patient decision support tool for Zocor Heart Pro
- Figure 11: Rx-to-OTC switch and decision support tools may actually increase the number of patient-doctor consultations
- Figure 12: Effect of Rx-to-OTC switching on the level of patient-physician interaction and healthcare costs
- Figure 13: Leading Rx-to-OTC drug classes in the US and UK, 2001-07
- Figure 14: Rx-to-OTC switch initiator companies in the US and UK since 2001
- Figure 15: Branded sales at risk following US patent expiries during 2008-2012
- Figure 16: Sales of Viagra in UK retail pharmacies, 2006-07
- Figure 17: The evolution of prescription-only medicines (POM) to pharmacy-only and to general sales list (GSL) status in the UK
- Figure 18: Regulatory approval process for product reclassification by the UK' s MHRA and the Committee on Safety of Medicines (CSM)
- Figure 19: High price of Zocor Heart Pro limited its uptake in the UK
- Figure 20: Disparity between OTC volume and value growth trends across the seven major markets, 2003-07
- Figure 21: Drivers and resistors of Rx-to-OTC switching across the seven major markets.
- Figure 22: Value ($) and volume (SU) of the US' s Rx and OTC markets, 2003-07
- Figure 23: Pros and cons of implementing a new class of medicines in the US
- Figure 24: Key comments made by the APhA supporting the FDA introduction of BTC status, March 2008
- Figure 25: Value ($) of Japan' s Rx and OTC markets, 1997-2005
- Figure 26: Enhanced Rx-to-OTC switch scheme proposed by the PAFSC, March 2007
- Figure 27: Value ($) and volume (SU) of the UK' s Rx and OTC markets, 2003-07
- Figure 28: Summary of drivers and resistors of implementing non-Rx strategies in the UK market outlined by the PAGB
- Figure 29: Value ($) and volume (SU) of Germany' s Rx and OTC markets, 2003-07
- Figure 30: Value ($) and volume (SU) of France' s Rx and OTC markets, 2003-07
- Figure 31: Italian OTC product trademark
- Figure 32: Value ($) and volume (SU) of Italy' s Rx and OTC markets, 2003-07
- Figure 33: Value ($) and volume (SU) of Spain' s Rx and OTC markets, 2003-07
- Figure 34: Sumatriptan OTC and Rx franchise in the UK, 2003-07
- Figure 35: Naratriptan OTC and Rx franchise in Germany, 2003-07
- Figure 36: Price of naratriptan OTC and Rx products in Germany, 2003-07
- Figure 37: Orlistat OTC and Rx franchise in the US, 2006-07
- Figure 38: Promotional spend of orlistat products in the US, 2006-07
- Figure 39: Ranitidine OTC and Rx franchise in the US, 2003-07
- Figure 40: Polyethylene glycol OTC and Rx market in the US, 2006-07
- Figure 41: Promotional spend on PEG products in the US market, Q2 2006- Q4 2007
- Figure 42: Pricing of PEG products in the US, 2006-07

Rx-to-OTC Strategies: Maximizing the Commercial Potential of an Rx-to-OTC Switch

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