Increasing Access to Nonprescription Medicines: A Global Public Health Challenge and Opportunity Edwin Hemwall, PhD

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1 Edwin Hemwall, PhD

2 Session Overview The case for public health benefit from Rx-to-OTC Switch and the role in modern healthcare settings The global switch environment today Opportunities and Challenges for a new paradigm Future Switch innovation enabled through technology A stakeholder call to action

3 The Public Health Opportunity Self-care is the logical first step in the healthcare continuum and should be integrated with professional medical care Already well-established in the management of common acute conditions Closely linked to public health strategy Influencing consumer & patient behavior can reduce costs and better utilize scarce healthcare resources Creates avenues to address the challenges of chronic disease prevention, diagnosis and treatment Accompanying education and support systems can enable a better informed consumer to engage healthcare services more effectively

4 The Self-Care to Doctor-Care Continuum Traditional Switch Collaborative Care Rx Condition Acute Symptomatic Condition Chronic Asymptomatic Dr. driven diagnosis with treatment focus Treatment Self-diagnosable Limited HCP involvement Prevention Tech-aided diagnosis HCP interaction as needed

5 Factors Driving Rx-to-OTC Switch Makes sense for business enterprise: Effective Lifecycle Management tool for Rx brands Creates enduring global consumer brands Over prior 10 years Switch has propelled growth of OTC category worldwide: 31% of growth in US 8% of growth ex- US Government and private Healthcare systems cost pressures Aging population seeking new healthcare options Increasing worldwide trend towards self care and wellness Technology can enable new categories to be considered for OTC 5

6 Switch Success Stories Regulatory and Commercial Analgesics for pain Antihistamines and intranasal steroids for allergy H2RAs & PPIs for heartburn Smoking cessation (drug + program) Antifungals Regulatory Success but Commercial Disappointment Ali for weight loss (drug + program) Statin in UK for cholesterol/heart disease Oxytrol for Overactive Bladder in US & Flomax for BPH in UK

7 Public Health Success Can be Quantified In the US after vaginal antifungal products became available OTC in 1991, and over the next four years, doctor visits for this condition declined by 15% In US increased access to NRT has resulted in a 10-25% increase in the number of smokers who have quit smoking In Australia an estimated 68,750 premature deaths were avoided through OTC NRT We need more studies like these to quantify the benefits of Switch

8 Global Variations in How Switch Products are Sold Retail status options Pharmacy only: BTC Pharmacy only: open shelf with self service General sales: all retail outlets Advertising restrictions removed Retail status directly affects sales OTCs in a cabinet reduces sales by approx 25% BTC status reduces sales by approx 50-60% Pharmacist often uncomfortable diagnosing and prefer dispensing Complex pharmacy protocols and questionnaires disliked by consumers However, the BTC option allows for more innovative switches

9 Switch Environment in the United States Largest opportunity with 75% of sales volume for a global Switch Binary two class system is unique in global market All OTCs sold on open retail shelf in all outlets with minimal restriction or professional guidance Few exceptions (e.g., pseudoephedrine) Requires rigorous label development and testing to prove consumers can manage their condition and use the product safely Regulatory risk, expense and complex consumer behavior studies can deter investment in risky or breakthrough switch initiatives. Possibility for exclusivity can mitigate risk with 3-year market lead for innovative brands before generic entry

10 Switch Environment in Most of World BTC 3 rd class exists in most countries which can make Switch simpler Less rigorous label comprehension required: Smaller sample sizes (25-30) Hurdles much more reasonable (75%-80% correct) Self-Selection or Actual Use studies not usually required Need to test or validate any pharmacy protocols KOLs important Regulators want support from the medical community Notice of switch often posted for public comment No public advisory committee hearings BUT, financial opportunity is generally not as large as in the US

11 A Closer Look at EU/AUS/NZ Pharmacy-only Third Class allows more control over self-selection but also acts as a barrier to access. Pharmacists play key role in assisting consumers to understand their condition and often help in diagnosis Several first-in-class switches have occurred in EU countries and NZ Statin (2004) for heart disease and tamsulosin (2009) for BPH in UK Triptans for migraine in Germany Sildenafil for erectile dysfunction in New Zealand Most EU switches occur on a country-by-country basis due to variations in market conditions and regulatory attitudes. Balance required between uniformity and local nuance UK and northern EU more open to switch Few examples of pan-european switches using Centralized Procedure

12 A Look at other Regions/Countries: Global Differences Affect Strategy & Decisions to Switch OTC expenditures Popular categories HCP attitudes Reimbursement rules Local company success Rx erosion rates Local brand loyalty Distribution channels Regulations

13 Global Approach To Switch Strategy & Priorities Programs start in countries with supportive track record Leaders UK, New Zealand, Australia, North EU, US Followers Canada, East/South EU, Mexico, China, Japan Trailers Brazil, S. Korea, S. Africa, Russia, others Possible if business supports India, S. America, Africa, others Greatest opportunities

14 Fundamental Difference: Who Decides What You Can Buy? United States: Consumer is responsible for correct selection and use and companies must prove they can safely select and use the product on their own. ROW: BTC/Pharmacy class holds the pharmacist as gatekeeper to inform the consumer of risks and confirm the product is right for their condition Can technology provide a bridge from consumer choice to pharmacist decision in helping consumers understand their condition and correctly choose and use the right product?

15 Opportunities for a New Paradigm Consumer knowledge and enthusiasm for self-care Leveraging Pharmacy Point-of-Care model Emphasis on primary care and disease prevention Moving beyond traditional approaches Importance of an educated consumer Programs, not just products Technology aided consumer interface Drive doctor visits when needed and reduce when not

16 Challenges to a New Paradigm Developing a business case for ROI Chronic asymptomatic conditions Cost to consumers vs convenience Conventional regulatory mindsets Incorporation of medical device regulations? Exclusivity needed to incentivize innovation investments Continued cost pressure on health care systems

17 How can technology help? Increasing access to OTCs through technology-aided labeling Improve understanding of label concepts text alone Consumer Self-Selection or qualification Recognition of medical condition and potential to benefit Eligibility to use Need for diagnostic test Driving correct ongoing use Emergent worsening of symptoms or a new condition Monitoring response/effect Recognition of adverse reactions Re-establishing eligibility for continued use

18 Tech-Enabled Switch: Qualification Options Internet: PC or Device Livechat or videochat Toll free call

19 Tech-Enabled Switch: Delivery Options

20 Tech-Enabled Switch: Identity Verification Text code or MMS barcode to cellphone Text code or MMS barcode to iphone Scan at Speedbuy - or - give this code to pharmacist: GF7TD Print at home

21 Tech-Enabled Switch: Purchase Options Speedbuy: scan at entrance collect at checkout Auto-payment with SmartPhone checkout Take token to pharmacist or checkout Scan token at vending machine

22 Tech-Enabled Switch: Additional services Health advice Medical records Compliance reminders auto-payment navigation

23 Registration Qualification Labeling Order Med Pick Up Med Follow Up Other Info What Do Consumers Prefer? Website Telephone Web Chat Smart Phone Kiosk- Vending

24 Tech-Enabled Switch: Points to Consider Technology continues to evolve but we have the basic tools now Potential to send more engaged patients to physicians and other HCPs Pharmacists need not be gatekeeper Reduces concerns about time, cost, training, liability Continue to perform valuable advisory role Pharmacy Point-of-Care can be leveraged Sponsors need incentive to invest: a period of exclusivity Proving the system works as intended?

25 Take Home Messages OTCs are not just consumer goods - They are an intrinsic part of the healthcare continuum and should be seen as such by all stakeholders Consumers prefer Self-Care as a first step and have embraced the enabling technologies of the digital and internet age Governments struggling with inflating healthcare costs should embrace Switch as an increasingly appealing option The public health case for increasing access to medicines through Switch can be made in both medical and economic frameworks

26 A Call to Action Self-care can and should be the first step in healthcare The benefit story must move beyond convenience of access to a public health opportunity Industry needs to be creative and data driven Regulators need to recognize the opportunity and be open to the concept of incremental risk compared to Rx-only availability Consumers must adhere to labeling and seek professional help when recommended Population wellness will be enhanced with more efficient use of scarce healthcare resources