Rx-To-OTC Switches Building Competitive Advantage

Transcription

1 April 20, 2016 Rx-To-OTC Switches Building Competitive Advantage Dr. Alexander Kandybin Strategy& Consumer Healthcare Practice

2 Switch Environment 1

3 Prescription to OTC switch accounted for 19% of OTC sales and 27% of growth between 2010 and ) 2) Global Consumer Healthcare Market , TECHNAVIO.COM 2

4 Paradigm Shifts in Switch Regulation 3

5 The future is now global regulatory & economic pressure to switch 15+ Years Ago Rx drug lifecycle generally seen as up to loss of patent Health care costs growing very rapidly Pressures building to substitute generics at LOE e.g., by higher US co-pays US and UK most aggressive at switch Past 5 years Health care costs skyrocketing government and patient pricesensitivity to new drugs and prescribing limits Growing pressures from governments/insurers toward mandated switch Generic substitution driving Rx value loss Aggressive global competitors with considerable switch experience Current Trends Government-directed switches across geographies Pharmacist prescribing and Rx availability without a script may drive complex switches New indications including chronic conditions switched Consumer advocate stance among insurers, regulators (e.g., WellPoint/FDA) Economic Considerations driving switch decisions Low economic importance of Rx-to-OTC switches Rx-to-OTC seen as way to recapture value and expand markets Era of sophisticated molecule lifecycle strategies 4

6 Symptomatology Expanding boundaries of Switchability have been increasing the opportunities for Rx-to-OTC switches globally Expansion of Switchability Boundary Emergency contraceptives Muscle relaxants [ ?] Rx Cholesterol (statins) Osteoporosis Shifting Paradigms: Acute to chronic Symptomatic to asymptomatic Treatment to prevention Health Consideration to Pharmacoeconomics Asymptomatic Symptomatic OTC Monistat (1990) Lotrimin (1989) Imodium (1988) Advil/Nuprin (1984) Nicorette (1996) Benign Prostatic Hyperplasia Overactive Bladder Claritin (2002) PPI s ( ) Pepcid AC (1995) Rogaine (1997) Acute Treatment Duration Chronic 5

7 Will the FDA allow non-self-diagnosable ailments to be treated by OTC products? E.g. statins, which treat high cholesterol, have failed to gain FDA Rx-to-OTC switch approval List of statins 1 Advicor Lescol Pravachol Tulip Altocor Lipex Selektine Vytorin Altoprev Lipitor Simcard Zocor Atorlip Lipobay Simcor Baycol Lipostat Simlup Caduet Lipvas Sortis Canef Livalo Torvacard Crestor 2 Mevacor Torvast Inegy Pitava Totalip 1) Statin Drugs List: spacedoc..com 2) Coming off-patent in

8 Leveraging mobile health to enable self-care for certain conditions (currently being evaluated by NSURE 1 ) More conditions may be candidates for OTC treatment as mobile health technologies (in the form of smartphone apps) allow consumers to perform diagnostic monitoring on their own and digitally share information with HCPs Potential future switch candidates via mobile health 2 Indication Erectile dysfunction Migraine High cholesterol Overactive bladder Benign prostatic hypertrophy Potential Candidates Viagra, Cialis, Levitra Axert, Relpax, Amerge Lipitor, Mevacor, Pravachol VESIcare, Detrol, Trospium Flomax 1) Nonprescription Drug Safe Use Regulatory Expansion: FDA task force to address the undertreatment of common diseases or conditions by allowing prescription drug products to be available as non prescription through the use of new technologies or other conditions of safe use 2) pharmacytimes.com: Rx-to-OTC Switches: Trends to Watch; Feb

9 Will drugs that are OTC in Europe go OTC in the US? As the FDA observes the successful performance of certain OTC medications outside the US, those treatments may have a better chance of going OTC in the US Examples of medications that are available OTC outside the US 1 Medication Carafate (Sucralfate) Bentyl (Dicyclomine) Reglan (Metoclopramide) Nitrostat (Nitroglycerin) Fluconazole (oral) Ilotycin (Erythromycin) Zithromax (Azithromycin) Imitrex (Sumatriptan) Zomig (Zolmitriptan) Countries with OTC Availability Austria, Denmark, Finland, France, Hungary, and Italy United Kingdom Belgium, Hungary, and Italy Denmark, Hungary, United Kingdom Finland, United Kingdom Belgium, Poland United Kingdom Germany, Sweden, United Kingdom Sweden 1) pharmacytimes.com: Rx-to-OTC Switches: Trends to Watch; Feb

10 Will the FDA consider economic impact when evaluating switch candidates in the future? FDA switch considerations 1 Swedish SMPA switch considerations 2 Safe and Effective Not prone to abuse Can be properly labeled Treats an ailment that can be selfdiagnosed Safe and Effective Not prone to abuse Can be properly labeled Has a positive economic impact and reduces total healthcare costs 1) Statins and The RX to OTC Switch Pipeline, 2) Switching omeprazole in Sweden and the United States, 9

11 Drugs Coming Off-Patent in the Next 5 Years 10

12 As much as $171B in prescription drug sales will go off-patent during Number of drug patents ending Key patent-loss facts 3 Includes Crestor, Benicar and Zetia; an estimated $11.2B in annual sales Up to 90% of sales are lost to generics when drugs go offpatent Generic drugs are 80-85% cheaper than patented drugs on average ) drugpatentwatch.com 2) dixondata.com 3) dixondata.com; Drug Patent Expirations: $190 Billion Is Up for Grabs, marketrealist.com; The top 10 patent losses of 2015, 11

13 Switch Commercial Best Practices 12

14 Switch commercial best practices Best practice success factors Well-managed pricing dynamics postswitch Meaningful product differentiation against in-market OTC products Clear positioning and engaging advertising that draws former Rx and new consumers to the OTC product Comprehensive trade support in early years Smooth retail execution Year 1 sales vs. media spend for new switches ($MM) 1 Est. Year Year 1 1 Sales Year 1 Media Spend Allergy 1 $610 $116 Allergy 2 $552 $96 Heartburn 1 $433 $68 Allergy 3 $305 $134 Other 1 $245 $118 Heartburn 2 $220 $87 1): Best Practices for Successful Rx-to-OTC Product Launches: iriworldwide.com 13

15 Switches from 2000 to Monistat 3 combo pk Monistat 1 (supp) Lotrimin Ultra Nicotrol TD Mucinex ER Tablet Claritin Tablets, Reditabs and Syrup Claritin-D Claritin-D 24- hour Prilosec OTC Claritin Hives Relief Tablets, Reditabs and Syrup Mucinex DM ER Tablet Mucinex D ER Tablet Lamisil Derm Gel Plan B MiraLax Zaditor Alaway Alli Zyrtec-D Children s Zyrtec Allergy and Children s Zyrtec Hives Relief (syrup, chewables) Zyrtec Allergy and Zyrtec Hives Relief (tablets) Prevacid 24 HR Zegerid OTC Oxytrol for Women Nasacort Allergy 24HR (nasal spray) Nexium 24 HR (esomeprazole magnesium) Flonase Allergy Relief (fluticasone proprionate) Allegra D 12 hr Allegra 24 hr Allegra Rhinocort Allergy Spray (budesonide) 1) 14