1 introduction edwin l. hemwall, phd vice president worldwide regulatory & scientific affairs...
TRANSCRIPT
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Introduction
Edwin L. Hemwall, PhDVice President
Worldwide Regulatory & Scientific AffairsJohnson & Johnson – Merck Consumer Pharmaceuticals
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NDA: 21-213
Nonprescription lovastatin 20 mg
MEVACOR™ DAILY
Indication: To help lower LDL “bad” cholesterol, which may prevent a first heart attack
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Background
July 2000: Joint Advisory Committee Review– Benefit of 10 mg dose not established– Statin OTC safety generally accepted– Consumer behavior needs further investigation
August 2000: FDA withdraws official guidance that discouraged development of OTC cholesterol-lowering drugs
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Background
2000 to Present: New OTC paradigm established and tested with input from FDA and academic experts
– OTC dose increased to 20 mg per day; treatment to LDL-C goal
– Primary prevention target population consistent with NCEP Guidelines (ATP III, May 2001)
– CUSTOM Actual Use Study
• 3000+ consumers evaluated OTC option
• 1000+ used for up to 6 months
• Comprehensive consumer support program
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Key Topics for Discussion Today
Can an OTC option enable consumers to have a greater role in the prevention of cardiovascular disease?
– OTC target population and label eligibility criteria
– Consumer behavior with regard to label benefit and safety directions
– Role of MEVACOR™ Self-Management System and healthcare professional
– Overall benefit / risk for lovastatin 20 mg OTC
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Agenda
Introduction Edwin L. Hemwall, PhD
Rationale for MEVACOR™ OTC Richard Pasternak, MD
OTC Label and Self-Management System Jerry Hansen, R.Ph.
Consumer Behavior Robert Tipping, MS
Potential of MEVACOR™ OTC Jerome Cohen, MD
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Expert Consultants Jeffrey L. Anderson, MD
Professor of Internal MedicineUniversity of Utah
Associate Chief of CardiologyLDS Hospital
Salt Lake City, UT
Herman Gibb, Ph.D.Senior Epidemiologist
Sciences International IncAlexandria, VA
Antonio M. Gotto, Jr., MD, DPhilDean of the Weill Medical College of Cornell University
Cornell University Medical CollegeNew York, NY
Thomas A. Pearson, MD, PhD. MPHAlbert D. Kaiser Professor & Chair
Department of Community & Preventative MedicineUniversity of Rochester Medical Center
Rochester, NY
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Expert Consultants (Cont’d) David Gray, Ph.D.
Program Director for ToxicologySciences International Inc
Alexandria, VA
Sandra J. Lewis, MDClinical Associate Professor of Medicine
Oregon Health Sciences University Director of Research and Prevention
Portland Cardiovascular InstitutePortland, OR
Thomas A. Pearson, MD, PhD. MPHAlbert D. Kaiser Professor & Chair
Department of Community & Preventative MedicineUniversity of Rochester Medical Center
Rochester, NY
J. Sanford Schwartz, MDProfessor of Medicine, Health Management and Economics
University of Pennsylvania School of MedicinePhiladelphia, PA
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Expert Consultants (Cont’d) Keith Tolman, MD
Professor of MedicineDirector of Clinical PharmacologyGastroenterology/Liver Division
University of Utah School of MedicineSalt Lake City, UT
Paul Watkins, MDVerne S. Caviness Distinguished Professor of Medicine
Professor of Pharmacotherapy Director, Clinical Research Center
University of North Carolina Chapel Hill, NC
Robert L. Wortmann, MDProfessor & Chair, Department of Internal Medicine
University of Oklahoma Health Sciences Center, Tulsa CampusTulsa, OK
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Rationale for MEVACOR™ OTC
Richard Pasternak, MDVice President
Clinical Research Cardiovascular & AtherosclerosisMerck Research Laboratories
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Rationale for MEVACOR™ OTC
Growing cardiovascular public health problem
Appropriate OTC target and product profile
Opportunity to improve public health
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Growing Cardiovascular Public Health Problem CVD: The #1 cause of death in the United States*
– Annual events• 1.2 million CHD events
– Economic burden: $133 billion for CHD alone
*AHA Heart Disease and Stroke Update 2004; Foot et al. JACC 2000; 35:5: 66B-80B.
0
10
20
30
40
2001 2010 2020 2030 2040 2050
Estimated CHD Prevalence Growth
Mill
ions
of
Am
eric
ans
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Importance of Cholesterol in Heart Disease Prevention
LDL-Cholesterol (mg/dL)
Rel
ativ
e R
isk
of C
HD
(Lo
g S
cale
)
40 70 100 130 160 190
3.7
2.9
2.2
1.7
1.3
1.0
ATP III Update Grundy et al. Circulation: 2004.
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Trends in Cholesterol Management
0
50
100
150
200
250
1988-1994 1999-2002
Tot
al C
hole
ster
ol m
g/dL
NHANES III NHANES
205 203
Healthy People 2000 Goal: <200Healthy People 2010 Goal: <197
Mean Total Cholesterol Among US Adults*
*CDC/NCHS, Health, 2004, Table 68, pgs 239-240.
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Current Status of Cholesterol Management
Ford et al. Circulation 2003; 107: 2185-89.
TC > 240 mg/dL
TC > 200 mg/dLor receiving Rx
72%
70%
Tested
24%
12%
Treated
NHANES 1999-2000 (N = 4880)
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Need for Improved Treatment
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003.
0
5
10
15
20
25
Moderate RiskPrimary Prevention
11-18 million
24-26 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
Recommended for drug therapy
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Need for Improved Treatment
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003.
0
5
10
15
20
25
Moderate RiskPrimary Prevention
11-18 million
24-26 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
Rx treated
3-5 million
9-11 million
Gap
Gap
Recommended for drug therapy
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Need for Improved Treatment
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003.
0
5
10
15
20
25
Moderate RiskPrimary Prevention
11-18 million
24-26 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx focus
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
Rx treated
3-5 million
9-11 million
Gap
Gap
Recommended for drug therapy
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Need for Improved Treatment
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003.
0
5
10
15
20
25
Moderate RiskPrimary Prevention
11-18 million
24-26 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx focus
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
Rx treated
3-5 million
9-11 million
Gap
Gap
Recommended for drug therapy
OTCOption
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Growing cardiovascular public health problem
Appropriate OTC target and product profile – Target population consistent with NCEP Guidelines
Rationale for MEVACOR™ OTC
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NCEP-ATP III Treatment Guidelines & 2004 Update Report
Grundy et al. Circulation. 2004;110:227.
Risk CategoryLDL-C Goal
(mg/dL)Initiate TLC
(mg/dL)Consider Drug
Therapy
HighCHD, CHD risk equivalent
(10-y risk >20%)
<100(<70 Optional) ≥100 ≥100
(<100 Optional)
Moderately high≥2 Risk factors
(10-y risk 10%-20%)
<130(<100 Optional) ≥130 ≥130
(100-129 Optional)
Moderate≥2 Risk factors
(10-y risk <10%)<130 ≥130 ≥160
Low0-1 Risk factors <160 ≥160 ≥190
(160-189 Optional)
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Proposed OTC Target Population
“Moderate risk” per NCEP Guidelines
Label approach– LDL 130-170 mg/dL– Plus 2 risk factors– Treatment to goal: LDL<130 mg/dL
Comprehensive cholesterol management approach– Lifestyle changes - diet and exercise– Self-management system reinforces label– Collaboration with healthcare professional
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Growing cardiovascular public health problem
Appropriate OTC target and product profile – Target population consistent with NCEP Guidelines– Proven efficacy and safety of lovastatin 20 mg
Rationale for MEVACOR™ OTC
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Statins
2002 ACC/AHA/NHLBI Clinical Advisory
– “Statins have demonstrated a decrease in CHD and total mortality, reductions in myocardial infarctions, revascularization procedures, stroke, and peripheral vascular disease…”
– “Statins have been proved to be extremely safe in the vast majority of patients receiving them…post-marketing reports of adverse events have been very limited when considered in comparison to the very large number of persons safely receiving these drugs.”
Proven Efficacy, Proven Safety
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2° Prevention / Very High CHD Risk
1° Prevention / Low-Moderate
CHD Risk
Proven Benefit Across Risk GroupsE
stim
ated
Rat
e o
f C
HD
Dea
th a
nd
N
on
-Fat
al M
I in
Pla
ceb
o S
ub
ject
s/10
Yrs
6%
52%
36%
24%
20%
16%
12%
10%
26%
(Lovastatin)AFCAPS/TexCAPS
(Atorvastatin)ASCOT
(Atorvastatin)CARDS
(Pravastatin)WOSCOPS
(Simvastatin)HPS
(Pravastatin)LIPID
(Simvastatin)4S
CARE(Pravastatin)
PROSPER(Pravastatin)
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2° Prevention / Very High CHD Risk
1° Prevention / Low-Moderate
CHD Risk
Proven Benefit Across Risk GroupsE
stim
ated
Rat
e o
f C
HD
Dea
th a
nd
N
on
-Fat
al M
I in
Pla
ceb
o S
ub
ject
s/10
Yrs
6%
52%
36%
24%
20%
16%
12%
10%
26%
(Lovastatin)AFCAPS/TexCAPS
(Atorvastatin)ASCOT
(Atorvastatin)CARDS
(Pravastatin)WOSCOPS
(Simvastatin)HPS
(Pravastatin)LIPID
(Simvastatin)4S
CARE(Pravastatin)
PROSPER(Pravastatin)
25-50%Relative Risk ReductionRegardless of Baseline
Risk
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Significant Risk Reduction Across LDL Levels
Grundy et al. Circulation: 2004.
LDL-Cholesterol (mg/dL)
Rel
ativ
e R
isk
of C
HD
(Lo
g S
cale
)
40 70 100 130 160 190
3.7
2.9
2.2
1.7
1.3
1.0
50%
39%Relative Risk Reduction
33%
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Efficacy of Lovastatin
Megatrials in ~15,000 patients – EXCEL: 20-80 mg/day, 48 weeks– AFCAPS/TexCAPS: 20-40 mg/day, 5 yrs
Lovastatin 20 mg:– Improves Lipid Profile:
• LDL-C -24%, HDL-C +6%, Total-C -17%
Reduces the risk of a first coronary event by 37% in moderate risk individuals (AFCAPS/TexCAPS)
Proven Benefit
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Potential Benefit in OTC Eligible Population
0.0 0.5 1.0 1.5 2.0
Favors Lovastatin Favors Placebo
All AFCAPS/TexCAPS, 20/40 mgN = 6,605
Relative Risk (95% Confidence Interval)Cox Proportional Hazards Model
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Potential Benefit in OTC Eligible Population
0.0 0.5 1.0 1.5 2.0
OTC Eligible,Achieved LDL-C < 130, 20/40 mgN = 2,518
Favors Lovastatin Favors Placebo
All AFCAPS/TexCAPS, 20/40 mgN = 6,605
Relative Risk (95% Confidence Interval)Cox Proportional Hazards Model
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Potential Benefit in OTC Eligible Population
0.0 0.5 1.0 1.5 2.0
OTC Eligible, 20 mg onlyN = 1,550 (Non-Titrators)
OTC Eligible,Achieved LDL-C < 130, 20/40 mgN = 2,518
Favors Lovastatin Favors Placebo
All AFCAPS/TexCAPS, 20/40 mgN = 6,605
Relative Risk (95% Confidence Interval)Cox Proportional Hazards Model
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Safety of Lovastatin
Extensive experience– 17+ years in market– 27+ million patient-treatment years
Strong clinical data – AFCAPS/TexCAPS & EXCEL
• ~15,000 patients• Doses from 20-80mg
– 20-40mg comparable to placebo for potential safety concerns
• Liver, muscle, drug interactions
Proven Safety
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Lovastatin Safety: Liver
Asymptomatic minor elevations of LFTs are:– Seen with all statins, fibrates, niacin– Dose and potency dependent– Often transient and resolving on therapy – Not associated with clinical liver disease
Liver function testing not proposed for OTC dose
Tolman. Am J Cardiol. 2002;89:1374-80.
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Lovastatin Safety: Liver
Liver EnzymesALT Consecutive Elevations 3X Upper Limit of Normal
PlaceboN (%)
20 mgN (%)
40 mgN (%)
EXCEL(1 year) 2/1639 (0.1%) 2/1625 (0.1%) 12/1629 (0.9%)
AFCAPS/TexCAPS(5+ years) 11/3248 (0.3%)
20/40 mg 18/3243 (0.6%)
20 mg 11/1586 (0.7%)
40 mg 7/1657 (0.4%)
Clinical Data
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Worldwide Adverse Experience System (WAES)
Spontaneous reports of adverse events in postmarketing experience
Voluntary reporting system
Includes all reports independent of perceived causality
Does not provide incidence rate
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Lovastatin Safety: Liver
Acute liver failure
– Background rate
• 1-10 cases/million annually
– Reports with lovastatin
• 25 cases
• ~1 report/million patient-treatment-years
WAES reports from health care professionals up to 01-Nov-2003.
Worldwide Adverse Experience System (WAES)
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Lovastatin Safety: Muscle
Muscle toxicity is rare for low-dose statins:
– Occurs with all statins and fibrates
– Dose related
– Self-recognizable muscle symptoms
• Prompt recovery on discontinuation
• Rarely severe (rhabdomyolysis)
Thompson et al. JAMA. 2003;289:1681-90.; Gotto. Arch Intern Med 2003;163:657-9; Bradford et al. Arch Int Med. 1991;151:43-9; Downs et al. Am J Cardiol. 2001;87:1074-79.
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Lovastatin Safety: Muscle
Muscle EnzymesCPK>10X Upper Limit of Normal
PlaceboN (%)
20 mgN (%)
40 mgN (%)
EXCEL(1 year) 7 (0.4%) 3 (0.2%) 3 (0.2%)
AFCAPS/TexCAPS(5+ years) 21 (0.6%)
20/40 mg: 21 (0.6%)
20 mg: 11 (0.7%) 40 mg: 10 (0.6%)
No significant difference between lovastatin 20-40 mg and placeboNo significant difference between lovastatin 20-40 mg and placebo
Clinical Data
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Lovastatin Safety: Muscle
Myopathy: Myalgia with CPK>10x ULN
Rhabdomyolysis: Myopathy with end-organ damage
Myopathy
Rhabdomyolysis
AFCAPS/TexCAPS
Lovastatin20-40 mg(N=3304)
0
1
Placebo
(N=3301)
0
2
EXCEL
Lovastatin20 mg
(N=1642)
0
0
Placebo
(N=1663)
0
0
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Lovastatin Safety: Muscle
Rhabdomyolysis rare
– 336 spontaneous reports
• 1.2 / 100,000 patient-treatment-years
• 158 without potentially interacting drugs†
– 41 reports with lovastatin 20 mg
Worldwide Adverse Experience System (WAES)
† Fibrates, niacin, cyclosporine, and/or strong CYP3A4 inhibitors.WAES reports from Health Care Professionals up to 01-Nov-2003.
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Lovastatin Safety: Drug Interactions
Strong CYP3A4 inhibitors – May increase risk of myopathy with
concomitant administration
OTC label instructs: Ask doctor or pharmacist if taking any prescription medicine
– Package insert and education materials list potentially interacting drugs
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Lovastatin Safety: Drug Interactions
† Serious, drug-related, or caused discontinuation.‡ Erythromycin, clarithromycin, ketoconazole, itraconazole, nefazodone.
Clinical Experience with Strong CYP3A4 Inhibitors‡AFCAPS/TexCAPS (N=6605)
Musculoskeletaladverse experience
Myalgia
Muscle weakness
Myopathy/rhabdomyolysis
Adverse Experience†
42 (8.0)
3 (1.0)
1 (0.2)
0 (0.0)
Lovastatin20 to 40 mg
(N=535)n (%)
39 (8.0)
4 (1.0)
2 (0.4)
0 (0.0)
Placebo(N=512) n (%)
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Lovastatin Safety: Drug Interactions
Rhabdomyolysis with Interacting Drugs
– 178 of 336 reports include potentially interacting drugs
• Fibrates (97)
• Cyclosporine (34)
• Niacin (34)
• Strong CYP3A4 Inhibitors (41)
– With strong CYP3A4 inhibitor only (28/41)
• Erythromycin/clarithromycin (16)
• Itraconazole/ketoconazole (5)
• Nefazodone (3)
• Mibefradil (3)
• Protease inhibitor (1)
Worldwide Adverse Experience System (WAES)
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Lovastatin Safety: Pregnancy
Prescription label: pregnancy Category X– Non-specific animal findings at 10-80 times maximum
human dose (80 mg) based on plasma AUC values– No benefit of short-term treatment during pregnancy
Proposed OTC label– “Do NOT use if you are pregnant or breast-feeding”
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Strong Product Profile for OTC Use
Data demonstrates
– Significant benefit of 20 mg in OTC target population
• Cholesterol lowering efficacy
• Reduction in cardiovascular outcomes
– Safety profile comparable to placebo up to 40 mg
• No apparent risk of liver adverse events
• Low risk of muscle adverse events
• Labeling will further minimize risks
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Growing cardiovascular public health problem
Appropriate OTC target and product profile
Opportunity to improve public health– Consumer interest in an OTC option
Rationale for MEVACOR™ OTC
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Consumer Interest in OTC Options National Lipid Association 2004 survey*
– Majority of consumers are making more health decisions on their own
– 72% of cholesterol concerned consumers are interested in learning more about an OTC statin option
National Consumer’s League 2004 survey**– 3 of 4 consumers at moderate risk and not taking
prescription therapy say they prefer OTC for heart health prevention
Consumers spend more than $1 billion per year on heart health OTC and food products***
UK approved non-prescription ZOCOR
*Pearson et al. AJC. 2004;94:16F-21F; **National Consumer League/Harris Interactive 2004 Survey Q#611;***Information Resources Inc.
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Growing cardiovascular public health problem
Appropriate OTC target and product profile
Opportunity to improve public health– Consumer interest in OTC option – Public health prevention approach
Rationale for MEVACOR™ OTC
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Need for Comprehensive Approach to Cholesterol Management
US Population (>45 Yrs.) by Total Cholesterol (NHANES ‘99-’02)
0
5
10
15
20
25
30
75 100 125 150 175 200 225 250 275 300 >325
Total Cholesterol (mg/dL)
Mill
ions
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Need for Comprehensive Approach to Cholesterol Management
0
5
10
15
20
25
30
75 100 125 150 175 200 225 250 275 300 >325
Total Cholesterol (mg/dL)
Mill
ions
US Population (>45 Yrs.) by Total Cholesterol (NHANES ‘99-’02)
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Growing cardiovascular public health problem
Appropriate OTC target and product profile
Opportunity to improve public health
Summary Rationale for MEVACOR™ OTC
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Growing cardiovascular public health problem
Appropriate OTC target and product profile
Opportunity to improve public health
Demonstrated appropriate consumer behavior
Rationale for MEVACOR™ OTC
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MEVACOR™ OTCLabel & Self-Management System
Jerry Hansen, RPhVice President
New Product Development and Consumer ResearchJohnson & Johnson – Merck Consumer Pharmaceuticals
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Extensive Consumer Research
Consumer understanding (attitude & behavior)
Label development & comprehension
Self-Management System development
Actual use studies (lovastatin 10 & 20 mg)
Total
Research
10,600
8,900
2,700
12,400
34,600
Approximate Numberof Participants
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People Likely to Take Actionwith OTC Option
Demographics representative of US population
– Older (45+)
– Other factors similar to US averages
• Gender
• Income
• Race
• Education
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People Likely to Take Actionwith OTC Option
Attitudes and behaviors not representative
– Very active in own healthcare - more likely to:
• Knowledgeable about health issues
• Diet & exercise
• Take aspirin for heart health
• Take vitamins & supplements
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People Likely to Take Actionwith OTC Option
Attitudes and behaviors not representative
– Very active in own healthcare
• Strong relationship with physician
– 80%+ see doctor at least once a year
– 70%+ had a cholesterol test in past year
– 80% have discussed cholesterol with doctor
• “Motivated health-conscious”
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Higher Interest in OTC vs. RxUntreated Potential or Known Moderate Risk
N=730
National Consumer League/Harris Interactive 2004 Survey Q#611.
Consider taking
Recommend to family member or friend
Seek more information about
76
76
75
OTC%
24
24
25
Rx%
Please tell us which product you would be more likely to…
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Why Moderate Risk Untreated Prefer OTC to Rx
Q#606: Please tell us which product you believe would be….Untreated Potential or Known Moderate Risk.National Consumer League/Harris Interactive 2004 Survey.
RxOTC
9%91%Easier to buy at a store where
you shop
27%73%Easier to keep taking every day
84%16%More suitable for someone who is
in poor health
22%78%More suitable for someone who
takes charge of his health
30%70%More suitable for someone with
your health care needs
N=730
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Label & Self-Management System
Development process
– Consistent with NCEP Guidelines but understandable by consumers
– Incorporated iterative consumer feedback
– Developed language & tools to ensure effective communication
– Comprehensive approach to cholesterol management
• Diet, exercise
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Label & Self-Management System
Healthcare professional collaboration
– Before using any OTC for the first time, healthcare professionals are frequently consulted*
• Doctor (79%)
• Pharmacist (64%)
– Data is consistent for those likely to use MEVACOR™ OTC**
• 80% claim they will talk to a doctor prior to, or shortly after beginning use
*Prevention Magazine National Survey. **BASES, NLA , NCL.
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Key Label Messages
OTC target consistent with NCEP Guidelines
– LDL (130-170 mg/dL)
– Male ≥ 45; female ≥ 55
– Plus one additional risk factor
• Family history
• Smoking
• Low HDL
• High blood pressure
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Key Label Messages (Cont’d) Do not use if:
– Liver disease– Pregnant or breast-feeding– Allergy to lovastatin
Do not use – see doctor about Rx therapy:– CHD– Diabetes– Taking cholesterol medicine– Triglycerides ≥ 200 mg/dL
Clear Safety Warnings– Drug interactions– Muscle pain
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Key Label Messages (Cont’d)
Encourage lifestyle changes & testing
– Before using you must have:
• Tried diet & exercise to reduce cholesterol
• Had a fasting cholesterol test within the past year
– Test at 6 weeks to see if you got to goal
• If yes, keep taking daily and test yearly
– Continue diet & exercise while taking MEVACOR™ OTC
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Key Label Messages (Cont’d)
Drives ongoing healthcare professional interaction
– Consult doctor or pharmacist if questions
• If do not reach LDL goal, talk to doctor: “OTC may not be enough for you”
• Talk to doctor if there is a change in your health
• Talk to your doctor or pharmacist if you are taking a new prescription
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Package Label Comprehension Study
Methodology
– Representative sample tested
• Projectable representative sample: n=696
• Low literacy subgroup: n=203 (REALM)
• Ethnic subgroup: n=207
– Respondents reviewed label & answered questions
• Identical label used in CUSTOM
– “Correct” and “correct/acceptable” scoring
• “Acceptable” often referred to checking with doctor
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Package Label Comprehension Study
Results 80% correct/acceptable for most measures 90% correct/acceptable for key safety messages
Conclusions– Very effective at communicating key messages in all
groups (low literacy/ethnic) – Consumers understood to ask healthcare
professionals if questions
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Self-Management System
Goal: To provide additional information & tools to reinforce key label messages
– Incorporated input from external experts
– Multiple methods of delivering information to appeal to different learning styles
– All elements part of proposed NDA labeling
• Required in-market
– Self-Management System tested in CUSTOM
Overview
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In-StorePre-Purchase Post-Purchase
Healthcare Professional Interaction
MEVACOR™ OTCSelf-Management System
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Healthcare Professional Interaction
MEVACOR™ OTCSelf-Management System
In-StorePre-Purchase Post-Purchase
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Communication & Education– Know your numbers– OTC is not right for everyone,
ask if you're not sure
Eligibility Assistance– Physician & pharmacist– Trained product specialist
• Toll-free & on-line• Questions and related services
Pre-Purchase Assistance
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Post-Purchase
Pre-Purchase
Healthcare Professional Interaction
MEVACOR™ OTCSelf-Management System
In-Store
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In-Store Assistance
Pharmacy Support– “Pharmacy Care OTC”– Pharmacist & staff training
Enhanced Retail Communication– Interactive tools to support label
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“Pharmacy Care OTC”
New approach developed by American Pharmacists Association (APhA) and other leading pharmacy groups
Features– Distributed voluntarily only in stores with a pharmacy– On open shelf with current OTC products– Does not require pharmacist intervention but strongly
supports it– Expands supportive services
• Cholesterol testing, counseling
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Store Shelf Communication
Highlights two decision processes Interactive tools Encourages dialogue with pharmacist
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In-Store
Healthcare Professional Interaction
Pre-Purchase
MEVACOR™ OTCSelf-Management System
Post-Purchase
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Post-Purchase Assistance
In-package materials
– Educational brochure
– Package insert & Q&A
– “Quick Start Guide”
– Cholesterol testing
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Cholesterol Testing
Cholesterol testing referral system
Coupon for six-week cholesterol test
Options– Doctor’s office/laboratory/hospital– Retail setting– Walk-in clinics– At-home kit
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Post-Purchase Assistance
Adherence Program
– Toll-free hotline & website
– Video & AHA cookbook
– Newsletters, postcards, e-mail reminders
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Adherence Program
Customized to start date
First three months focus on– Eligibility– Treatment to goal
Subsequent focus– Diet & exercise– Adherence– Healthcare professional
interaction
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Post-PurchaseIn-StorePre-Purchase
Healthcare Professional Interaction
MEVACOR™ OTCSelf-Management System
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Healthcare Professionals
Encourages ongoing dialogue concerning– OTC questions– Testing & monitoring– Higher CHD risk referral
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Pre-Purchase In-Store
Healthcare Professional Interaction
Post-Purchase
MEVACOR™ OTCSelf-Management System
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Conclusions
Those likely to take action: “Motivated Health Conscious”
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Conclusions
Those likely to take action: “Motivated Health Conscious”
Self-Management System offers multi-faceted support to reinforce key label messages
– Included as part of proposed NDA labeling and required in-market
– Demonstrated feasibility with key partners• Retail, pharmacy, testing companies
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Conclusions
Those likely to take action: “Motivated Health Conscious”
Self-Management System offers multi-faceted support to reinforce key label messages
– Included as part of proposed NDA labeling and required in-market
– Demonstrated feasibility with key partners• Retail, pharmacy, testing companies
Committed to extensive post-marketing surveillance
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Conclusions
Those likely to take action: “Motivated Health Conscious”
Self-Management System offers multi-faceted support to reinforce key label messages
– Included as part of proposed NDA labeling and required in-market
– Demonstrated feasibility with key partners• Retail, pharmacy, testing companies
Committed to extensive post-marketing surveillance
Self-Management System fully evaluated in CUSTOM
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CONSUMER BEHAVIOR
Robert W. Tipping, MSDirector, Clinical BiostatisticsMerck Research Laboratories
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Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit?
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The CUSTOM StudyConsumer Use Study of OTC MEVACOR™
Demonstrating Consumer Behavior in an OTC Setting
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• No specificlabel eligibilitycriteria
• 14 sites in7 geographicareas
• Minority ads
• TV• Print• Radio
OTC-likeRecruitment
CUSTOM Study Design
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• No specificlabel eligibilitycriteria
• 14 sites in7 geographicareas
• Minority ads
• TV• Print• Radio
OTC-likeRecruitment
• Naturalistic retail setting• In-store components of System• All comers accepted
Site Visit Initial Use Decision
CUSTOM Study Design
Self Assessment
• Review of label• Option to leave to obtain information• Purchase cholesterol test (optional)• Pharmacist available to answer
questions if asked• Purchase of drug required
Naturalistic Observation
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• No specificlabel eligibilitycriteria
• 14 sites in7 geographicareas
• Minority ads
• TV• Print• Radio
OTC-likeRecruitment
• Naturalistic retail setting• In-store components of System• All comers accepted
Site Visit Initial Use Decision
CUSTOM Study Design
Self Assessment
• Review of label• Option to leave to obtain information• Purchase cholesterol test (optional)• Pharmacist available to answer
questions if asked• Purchase of drug required
On-going Use
Naturalistic Observation
Self-guided Behavior
& Product Use
• Follow-up test• Treatment to goal• New conditions
6 months
Visits not scheduled
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• No specificlabel eligibilitycriteria
• 14 sites in7 geographicareas
• Minority ads
• TV• Print• Radio
OTC-likeRecruitment
• Naturalistic retail setting• In-store components of System• All comers accepted
Site Visit Initial Use Decision
CUSTOM Study Design
Self Assessment
• Review of label• Option to leave to obtain information• Purchase cholesterol test (optional)• Pharmacist available to answer
questions if asked• Purchase of drug required
On-going Use
Naturalistic Observation
Self-guided Behavior
& Product Use
• Follow-up test• Treatment to goal• New conditions
6 months
Visits not scheduled
Pre & post lipid values obtained
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• No specificlabel eligibilitycriteria
• 14 sites in7 geographicareas
• Minority ads
• TV• Print• Radio
OTC-likeRecruitment
• Naturalistic retail setting• In-store components of System• All comers accepted
Site Visit Initial Use Decision
CUSTOM Study Design
En
d O
f S
tud
y Q
ues
tio
ns
Self Assessment
• Review of label• Option to leave to obtain information• Purchase cholesterol test (optional)• Pharmacist available to answer
questions if asked• Purchase of drug required
On-going Use
Naturalistic Observation
Self-guided Behavior
& Product Use
• Follow-up test• Treatment to goal• New conditions
6 months
Visits not scheduled
Pre & post lipid values obtained
![Page 96: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/96.jpg)
96
• No specificlabel eligibilitycriteria
• 14 sites in7 geographicareas
• Minority ads
• TV• Print• Radio
OTC-likeRecruitment
Po
st C
US
TO
M S
urv
ey
• Naturalistic retail setting• In-store components of System• All comers accepted
Site Visit Initial Use Decision
CUSTOM Study Design
En
d O
f S
tud
y Q
ues
tio
ns
Self Assessment
• Review of label• Option to leave to obtain information• Purchase cholesterol test (optional)• Pharmacist available to answer
questions if asked• Purchase of drug required
Self-guided Behavior
& Product Use
• Follow-up test• Treatment to goal• New conditions
6 months
On-going Use
Naturalistic Observation
Visits not scheduled
Pre & post lipid values obtained
![Page 97: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/97.jpg)
97
Pre-Purchase In-Store
Healthcare Professional Interaction
Post-Purchase
MEVACOR™ OTCSelf-Management System
![Page 98: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/98.jpg)
98
CUSTOM Study Design
Decisions about product purchase and use– Initial decision to use– Ongoing decisions regarding continued use
Interactions with healthcare professionals– Important factor in determining appropriateness
of product use– Creating and maintaining partnerships
Diet and exercise
Analysis of Behavior
![Page 99: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/99.jpg)
99
CUSTOMActual Use Results
![Page 100: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/100.jpg)
100
CUSTOM ResultsParticipant Flow Through Study
11252 Callers
(Responded to advertising)
3316 Evaluators
(Evaluated MEVACOR™ OTC System at the Site)
2111 Non- purchasers
1205 Purchasers
52Behavior Not Analyzed
50 Missing data2 Protocol violators
1059 Users
398 Post- CUSTOM
Survey
94
Purchaser, Non-Users
11252 Callers
(Responded to advertising)
3316 Evaluators
(Evaluated MEVACOR™ OTC System at the Site)
2111 Non- purchasers
1205 Purchasers
52Behavior Not Analyzed
50 Missing data2 Protocol violators
1059 Users
398 Post- CUSTOM
Survey
94
Purchaser, Non-Users
![Page 101: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/101.jpg)
101
CUSTOM Results
59% men
Median age – 53 yrs
28% Non-Caucasian
12% Low-literacy
Population ProfileEvaluators(n=3316)
![Page 102: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/102.jpg)
102
CUSTOM Results
1 serious, drug-related AE– 63 year-old female with acute allergic
reaction
1 death, probably not related to drug– 50 year-old male with CVA
No serious, drug-related muscle or liver AEs
No new safety issues identified
MEVACOR™ was generally safe and well tolerated in this OTC population
Safety SummaryUsers
(n=1061)
![Page 103: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/103.jpg)
103
CUSTOM
Benefit Criteria
Initial Use
Benefit Criteria
Ongoing Use
Safety Warnings
Initial Use
Safety Warnings
Ongoing Use
Label
![Page 104: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/104.jpg)
104
CUSTOM
Benefit Criteria
Initial Use
Benefit Criteria
Ongoing Use
Safety Warnings – Initial Use
Pregnant/breast feeding Liver disease Previous muscle pain Interacting meds Rx Lipid-lowering therapy
Safety Warnings - Ongoing Use
New Rx New medical condition Unexplained muscle pain
Label
![Page 105: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/105.jpg)
105
CUSTOM
Benefit Criteria – Initial Use
Age Lipids Risk Factors
Benefit Criteria – Ongoing Use
Follow up Lipid Test LDL-C Goal
Safety Warnings
Initial Use
Safety Warnings
Ongoing Use
Label
![Page 106: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/106.jpg)
106
CUSTOM
Benefit Criteria – Initial Use
Age Lipids Risk Factors
Benefit Criteria – Ongoing Use
Follow up Lipid Test LDL-C Goal
Safety Warnings – Initial Use
Pregnant/breast feeding Liver disease Previous muscle pain Interacting meds Rx Lipid-lowering therapy
Safety Warnings - Ongoing Use
New Rx New medical condition Unexplained muscle pain
Label
![Page 107: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/107.jpg)
107
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit?
![Page 108: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/108.jpg)
108
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions? 3316 Evaluators
– 2111 Chose not to purchase– 64 Purchased but chose not to use– 659 Chose to use appropriately (safety and
benefit criteria)
![Page 109: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/109.jpg)
109
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions? 3316 Evaluators
– 2111– 64 – 659
Key Questions
= 2834 (86%)
![Page 110: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/110.jpg)
110
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions? 3316 Evaluators
– 2111– 64 – 659
– 109 (3%) use inconsistent with label safety warnings
Key Questions
= 2834 (86%)
![Page 111: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/111.jpg)
111
CUSTOM ResultsParticipant Flow Through Study
11252 Callers
(Responded to advertising)
3316 Evaluators
(Evaluated MEVACOR™ OTC System at the Site)
2111 Non-purchasers
1205 Purchasers
52Behavior Not Analyzed
50 Missing data2 Protocol violators
1059 Users
398 Post-CUSTOM
Survey
94
Purchaser, Non-Users
11252 Callers
(Responded to advertising)
3316 Evaluators
(Evaluated MEVACOR™ OTC System at the Site)
2111 Non-purchasers
1205 Purchasers
52Behavior Not Analyzed
50 Missing data2 Protocol violators
1059 Users
398 Post-CUSTOM
Survey
94
Purchaser, Non-Users
![Page 112: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/112.jpg)
112
CUSTOM: Non-Purchaser Behavior
2111 Non-purchasers
21%“Needed More Info”
79%“Not Interested in Buying”
19%Talked to their doctor
63%“Believed Not Right for Them”
18%Other
(Cost, convenience, etc.)
In-Store OTC System DiscouragedInappropriate People from Purchasing
![Page 113: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/113.jpg)
113
CUSTOM: Purchaser, Non-User Behavior
94Purchaser, Non-Users
30 Did not Leave site with MEVACOR™ OTC
64 Left site with MEVACOR™ OTC But Never Used
Majority said either: “Dr. advised against” or
“Learned not right for me”
Post-Purchase OTC System Discouraged Additional Inappropriate People from Using
![Page 114: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/114.jpg)
114
CUSTOM ResultsParticipant Flow Through Study
11252 Callers
(Responded to advertising)
3316 Evaluators
(Evaluated MEVACOR™ OTC System at the Site)
2111 Non-purchasers
1205 Purchasers
52Behavior Not Analyzed
50 Missing data2 Protocol violators
1059 Users
398 Post-CUSTOM
Survey
94
Purchaser, Non-Users
11252 Callers
(Responded to advertising)
3316 Evaluators
(Evaluated MEVACOR™ OTC System at the Site)
2111 Non-purchasers
1205 Purchasers
52Behavior Not Analyzed
50 Missing data2 Protocol violators
1059 Users
398 Post-CUSTOM
Survey
94
Purchaser, Non-Users
![Page 115: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/115.jpg)
115
CUSTOM Results
80%
Initial Decision to Use(N=1059)
Benefit and Safety Behavioral Assessment
![Page 116: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/116.jpg)
116
CUSTOM Results
Initial Decision to Use(N=1059)
Benefit and Safety Behavioral Assessment
Label SafetyWarnings
SupplementalAnalyses
90%
n=1044
80%
![Page 117: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/117.jpg)
117
CUSTOM Results
Initial Decision to Use(N=1059)
Benefit and Safety Behavioral Assessment
Label BenefitCriteria
Label SafetyWarnings
SupplementalAnalyses
66%
90%
n=1044
80%
![Page 118: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/118.jpg)
118
CUSTOM Results
Initial Decision to Use(N=1059)
Benefit and Safety Behavioral Assessment
All LabelCriteria
Label BenefitCriteria
Label SafetyWarnings
Pre-SpecifiedAnalysis
SupplementalAnalyses
55%66%
90%
n=1037n=1044
80%
![Page 119: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/119.jpg)
119
CUSTOM Results
Met Did NotMeet
90%
10%
% o
f U
sers
(n=
1044
)
0
10
20
30
40
50
60
70
80
90
100
Label Safety Criteria
Users who did not talk with doctor (n=109)
Safety Warnings - Initial Use
![Page 120: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/120.jpg)
120
CUSTOM Results
Met Did NotMeet
Pregnant LiverDisease
PreviousMuscle
Pain
On RxLLT
90%
10%
12
80
300
152
609
PotentiallyInteracting
Med
Evaluators
Users who did not talk with doctor (n=109)
% o
f U
sers
(n=
1044
)
0
10
20
30
40
50
60
70
80
90
100
# of
Ind
ivid
uals
0
100
200
300
400
500
600
Label Safety Criteria
Safety Warnings - Initial Use
![Page 121: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/121.jpg)
121
CUSTOM Results
Met Did NotMeet
Pregnant LiverDisease
PreviousMuscle
Pain
On RxLLT
90%
10%
12
80
3
300
53
152
1052
609
PotentiallyInteracting
Med
Evaluators
Users who did not talk with doctor (n=109)
0
% o
f U
sers
(n=
1044
)
0
10
20
30
40
50
60
70
80
90
100
# of
Ind
ivid
uals
0
100
200
300
400
500
600
Label Safety Criteria
Safety Warnings - Initial Use
![Page 122: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/122.jpg)
122
CUSTOM Results
Met Did NotMeet
Pregnant LiverDisease
PreviousMuscle
Pain
On RxLLT
90%
10%
12
80
3
300
53
152
1052
609
PotentiallyInteracting
Med
Evaluators
Users who did not talk with doctor (n=109)
OTC System Discourages Inappropriate Purchase
0
% o
f U
sers
(n=
1044
)
0
10
20
30
40
50
60
70
80
90
100
# of
Ind
ivid
uals
0
100
200
300
400
500
600
Label Safety Criteria
Safety Warnings - Initial Use
![Page 123: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/123.jpg)
123
0
10
20
30
40
50
60
70
80
90
100
CUSTOM Results%
of
Use
rs (
n=
1044
)
Met or Closely Met Label
Criteria
Did not Meet Label Benefit
Criteria
66%
34%
Benefit Criteria - Initial Use
![Page 124: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/124.jpg)
124
0
10
20
30
40
50
60
70
80
90
100
CUSTOM Results%
of
Use
rs (
n=
1044
)
Met or Closely Met Label
Criteria
Did not Meet Label Benefit
Criteria
66%
34%
72% eligible for statin therapy according to NCEP Guidelines
Benefit Criteria - Initial Use
![Page 125: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/125.jpg)
125
0
10
20
30
40
50
60
70
80
90
100
CUSTOM Results%
of
Use
rs (
n=
1044
)
Met or Closely Met Label
Criteria
Did not Meet Label Benefit
Criteria
Did not Know Lipid Profile
(n=188)
66%
34%
18%
93% had elevated lipids
51% knew TC
Median LDL-C = 165 mg/dL
Benefit Criteria - Initial Use
![Page 126: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/126.jpg)
126
0
10
20
30
40
50
60
70
80
90
100
CUSTOM Results%
of
Use
rs (
n=
1044
)
Met or Closely Met Label
Criteria
Did not Meet Label Benefit
Criteria
Did not Know Lipid Profile
(n=188)
Triglycerides >200 mg/dL
(n=170)
66%
34%
18% 16%
92% had elevated lipids
Median total-C = 253 mg/dL
Median LDL-C = 146 mg/dL
74% had triglycerides <400 mg/dL
Benefit Criteria - Initial Use
![Page 127: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/127.jpg)
127
0
10
20
30
40
50
60
70
80
90
100
CUSTOM Results%
of
Use
rs (
n=
1044
)
Met or Closely Met Label
Criteria
Did not Meet Label Benefit
Criteria
Did not Know Lipid Profile
(n=188)
Triglycerides >200 mg/dL
(n=170)
Substituted for Rx
Therapy (n=11)
66%
34%
18% 16%
1%
Out of 609 Evaluators on Rx LLT
Benefit Criteria - Initial Use
![Page 128: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/128.jpg)
128
0
10
20
30
40
50
60
70
80
90
100
CUSTOM Results%
of
Use
rs (
n=
1044
)
Met or Closely Met Label
Criteria
Did not Meet Label Benefit
Criteria
Did not Know Lipid Profile
(n=188)
Triglycerides >200 mg/dL
(n=170)
CHD, Stroke, Diabetes
(n=70)
Substituted for Rx
Therapy (n=11)
66%
34%
18% 16%
7%1%
Benefit Criteria - Initial Use
![Page 129: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/129.jpg)
129
0
100
200
300
400
500
600
CUSTOM Results #
of I
ndiv
idua
ls
Evaluators(n=3316)
at Higher Risk
570Initial Decision to Use
Consumers at Higher Risk (CHD, Stroke, Diabetes)
![Page 130: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/130.jpg)
130
0
100
200
300
400
500
600
CUSTOM Results#
of I
ndiv
idua
ls
Evaluators(n=3316)
at Higher Risk
Users(n=1059)
at Higher Risk
570
167
Initial Decision to Use
Consumers at Higher Risk (CHD, Stroke, Diabetes)
![Page 131: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/131.jpg)
131
0
100
200
300
400
500
600
CUSTOM Results#
of I
ndiv
idua
ls
Evaluators(n=3316)
at Higher Risk
Users(n=1059)
at Higher Risk
570
167
97
Initial Decision to Use
Did speak with doctor before use
Consumers at Higher Risk (CHD, Stroke, Diabetes)
![Page 132: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/132.jpg)
132
0
100
200
300
400
500
600
CUSTOM Results#
of I
ndiv
idua
ls
Evaluators(n=3316)
at Higher Risk
Users(n=1059)
at Higher Risk
Users Who Did Not Speak to
Doctor Before Use
570
167
70
97
Initial Decision to Use
Consumers at Higher Risk (CHD, Stroke, Diabetes)
Did speak with doctor before use
![Page 133: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/133.jpg)
133
0
100
200
300
400
500
600
CUSTOM Results#
of I
ndiv
idua
ls
Evaluators(n=3316)
at Higher Risk
Users(n=1059)
at Higher Risk
570
167
70
97
Initial Decision to Use
26
Had doctor interaction during study
Consumers at Higher Risk (CHD, Stroke, Diabetes)
Did speak with doctor before use
Users Who Did Not Speak to
Doctor Before Use
![Page 134: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/134.jpg)
134
0
100
200
300
400
500
600
CUSTOM Results#
of I
ndiv
idua
ls
Evaluators(n=3316)
at Higher Risk
Users(n=1059)
at Higher Risk
570
167
70
97
Initial Decision to Use
26
86% had elevated lipids
66% not on lipid lowering therapy at time of study
Consumers at Higher Risk (CHD, Stroke, Diabetes)
Did speak with doctor before use
Had doctor interaction during study
Users Who Did Not Speak to
Doctor Before Use
![Page 135: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/135.jpg)
135
CUSTOM Results
3%
3%
8%
86%
Summary of Initial Use DecisionsN=3316
Consumers Can Select Appropriately
Non-Purchasersn=2111
Purchaser, Non-Usersn=64
Users making appropriate decisionsn=659
Unknown
Safety Warnings
Benefit Criteria
![Page 136: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/136.jpg)
136
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit?
![Page 137: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/137.jpg)
137
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
2. Self-manage the potential safety risks over time? 1059 Users
– 693 No emergent medical condition/situation– 366 With emergent medical condition/situation
• 345 (94%) continued use consistent with label• 21 (6%) continued use inconsistent with label
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138
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
3. Self-manage their cholesterol over time and obtain benefit? 1059 Users
– 74% of users obtained follow-up test or discontinued before 6 weeks
– 75% of users with follow-up test followed label directives regarding LDL-C goal
– 21% reduction in LDL-C
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139
CUSTOM Results
75%
Ongoing Decisions about Use(N=1059)
Benefit and Safety Behavioral Assessment
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140
CUSTOM Results
75%
Label SafetyWarnings
SupplementalAnalyses
94%
n=366
Ongoing Decisions about Use(N=1059)
Benefit and Safety Behavioral Assessment
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141
CUSTOM Results
Ongoing Decisions about Use(N=1059)
Benefit and Safety Behavioral Assessment
Label BenefitCriteria
Label SafetyWarnings
SupplementalAnalyses
53%
94%
n=936n=366
75%
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142
CUSTOM Results
Ongoing Decisions about Use(N=1059)
Benefit and Safety Behavioral Assessment
Label BenefitCriteria
Label SafetyWarnings
Pre-SpecifiedAnalysis
SupplementalAnalyses
53%
94%
n=936n=366
All LabelCriteria
50%
n=986
75%
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143
CUSTOM Results%
of
Use
rs w
ith
New
Con
ditio
n(n
=36
6)
94%
0
20
30
40
50
60
70
80
90
100
10
Met Did NotMeet
Label Safety Criteria
6%
Safety Warnings - Ongoing Use
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144
CUSTOM Results%
of
Use
rs w
ith
New
Con
ditio
n(n
=36
6)
94%
0
50
100
150
200
250
300
350
400
270
New Rx
161
New Medical
Condition
63
UnexplainedMuscle Pain
0
20
30
40
50
60
70
80
90
100
10
Met Did NotMeet
Label Safety Criteria
6%
# of
Ind
ivid
uals
Safety Warnings - Ongoing Use
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145
CUSTOM Results%
of
Use
rs w
ith
New
Con
ditio
n(n
=36
6)
94%
0
50
100
150
200
250
300
350
400
270
New Rx
161
3
New Medical
Condition
63
16
UnexplainedMuscle Pain
0
20
30
40
50
60
70
80
90
100
10
Met Did NotMeet
Label Safety Criteria
6%2
# of
Ind
ivid
uals
Safety Warnings - Ongoing Use
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146
98% 2%
Consumers Can Manage Potential Safety Risks Over Time
CUSTOM Results
No new conditionn=693
Users making appropriate decisionsn=345
Safety Warningsn=21
Summary of Ongoing Use Decisions – Safety WarningsN=1059
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147
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit? • Follow-up lipid test
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148
0
20
40
60
80
100
CUSTOM Results
% ofUsers
(n=1059)
26%
11%
63%74% of users
made appropriate decision to get follow-up test
Got a Test
D/C Before Needing Test
Did Not Get Test
Follow-Up Cholesterol Test
Benefit Criteria - Ongoing Use
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149
0
20
40
60
80
100
% ofUsers
(n=1059)
26%
11%
63%
Got a Test
D/C Before Needing Test
Did Not Get Test
75% followed label directivesregarding LDL-C goal
CUSTOM Results
Follow-Up Cholesterol Test
Benefit Criteria - Ongoing Use
![Page 150: 1 Introduction Edwin L. Hemwall, PhD Vice President Worldwide Regulatory & Scientific Affairs Johnson & Johnson – Merck Consumer Pharmaceuticals](https://reader036.vdocument.in/reader036/viewer/2022070400/56649ec65503460f94bd0f11/html5/thumbnails/150.jpg)
150
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit? • Follow-up lipid test• Lipid results
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151
CUSTOM ResultsUsers Achieved Beneficial Lipid Lowering
with Lovastatin 20 mg/day
24% 24%
Controlled Clinical Studies
21%25%
CUSTOM Study
AFCAPS/TexCAPS
EXCELFastedFasted
&Non-Fasted
50%
40%
30%
20%
10%
0%n=243 n=811 n=2276 n=1642
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152
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit? • Follow-up lipid test• Lipid results• Persistence/compliance
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153
CUSTOM Results
0
20
40
60
80
100
% ofUsers
(n=1059)
21%
17%
62%79% of users
made appropriatepersistence decision
Persistent for 6 months
Appropriately discontinued
Other discontinued
“Did not reach goal” “Doctor advised me to discontinue” “Learned OTC was not right for me”
Persistence
Benefit Criteria - Ongoing Use
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154
Key Questions
Will the MEVACOR™ OTC Self-Management System allow consumers to:
1. Make appropriate initial use decisions?
2. Self-manage the potential safety risks over time?
3. Self-manage their cholesterol over time and obtain benefit? • Follow-up lipid test• Lipid results• Persistence/compliance• Diet and exercise
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Dietary Habits*
0%
20%
40%
60%
80%
100%
Baseline Week 26
CUSTOM Results
* Diet assessed with MEDFICTS.
Step II dietStep I dietNeither
47%59%
36%30%
17% 11%
Heart-Healthy Lifestyle Behaviors Improve
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156
CUSTOM Results
74% of users obtained follow-up test or discontinued before 6 weeks
75% of users with follow-up test followed label directives regarding LDL-C goal
21% reduction in LDL-C
CUSTOM ResultsSummary of Ongoing Use Decisions – Benefit Criteria
N=1059
Consumers Can Manage Their Cholesterol Over Time and Obtain Benefit
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157
CUSTOM Results
Will the MEVACOR™ OTC Self-Management System promote consumer interactions with
healthcare professionals?
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158
CUSTOM Results
0
10
20
30
40
50
60
70
80
90
100
% o
f In
divi
dual
sC
onsu
lting
Doc
tor
22%
57%
74%
Non Users N = 2111
Users N = 1059
High CHD Risk Users
N = 167
MEVACOR™ OTC Self-Management SystemEncourages Consumer Involvement with HCP
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159
CUSTOM Conclusions
The Self-Management System discourages inappropriate use
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160
CUSTOM Conclusions
The Self-Management System discourages inappropriate use
The majority of consumers who choose to use MEVACOR™ OTC will
– Be appropriate for self-management– Gain clinical benefit– Be at minimal safety risk
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161
CUSTOM Conclusions
The Self-Management System discourages inappropriate use
The majority of consumers who choose to use MEVACOR™ OTC will
– Be appropriate for self-management– Gain clinical benefit– Be at minimal safety risk
There will be important public health benefits from the Self-Management System including
– Increased healthcare professional interactions– Improved heart health awareness and behavior
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162
The Potential of MEVACOR™ OTC
Jerome D. Cohen, MD, FACC, FACP, FAHAProfessor Internal Medicine
Director of Preventive Cardiology ProgramSt. Louis University
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163
Key Questions
Is there a need for an OTC option?
Is MEVACOR™ 20 mg safe for OTC use?
Can consumers manage cholesterol effectively with OTC?
Will OTC divert consumers from physician care and from heart-healthy lifestyle practices?
What’s the overall benefit/risk of MEVACOR™ OTC?
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164
Key Questions
Is there a need for an OTC option?
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Large Treatment Gaps Remain
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003.
0
5
10
15
20
25
Moderate RiskPrimary Prevention
11-18 million
24-26 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
Rx treated
3-5 million
9-11 million
Gap
Gap
Recommended for drug therapy
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166
Key Questions
Is there a need for an OTC option?
Is MEVACOR™ 20 mg safe for OTC use?
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167
Proven Safety Profile
17+ years in-market experience
27+ million patient-years of treatment
Safety profile comparable to placebo
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168
Key Questions
Is there a need for an OTC option?
Is MEVACOR™ 20 mg safe for OTC use?
Can consumers manage cholesterol effectively with OTC?
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169
Consumers Are Already Using OTC Productsfor Chronic Asymptomatic Conditions
~35 million use calcium*
~26 million use aspirin for heart health**– 27% self-initiated
~14 million use heart health supplements*** – e.g., Garlic, vitamin E, antioxidants, niacin,
red rice yeast
*Osteoporosis Omnibus Study, 2001.**McNeil Pharmaceutical internal data.***Cholesterol Omnibus Study, 2004.
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170
Consistent Data Show Consumers Exhibit Appropriate Behavior
* Made decision to purchase.
OTC Users:
Total Cholesterol >200 mg/dL(Pre-treatment)
Taking Rx lipid therapy
OTC User Behaviors:
Appropriately self-selectSafety
Benefit
n/a
5
97
68
Lovastatin 10 mgActual UseStudy 081N=1229*
%
93
3
95
66
Lovastatin 10 mgActual UseStudy O76N=2662*
%
87
5
90
66
CUSTOMN=1059
%
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a Pearson et al. Arch Intern Med 2000; 160:459-67. b Frolkis et al. Am J Cardiol 2004; 94:1310-1312.c Benner et al. JAMA 2002;288:455-461. d Grant et al. Arch Intern Med 2004; 164:2343-2348.e AFCAPS data. f EXCEL data.
Key Results of OTC Therapy Consistent with Prescription Experience
Obtained goal
Appropriate persistence (6 months)
Average LDL-C reduction
Current Stateof Rx Care(Statins)
(%)
37a-57b
56c-80d
24e-25f
CUSTOMResults
(%)
62
62-79
21
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172
Key Questions
Is there a need for an OTC option?
Is MEVACOR™ 20 mg safe for OTC use?
Can consumers manage cholesterol effectively with OTC?
Will OTC divert consumers from physician care and from heart-healthy lifestyle practices?
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173
MEVACOR™ OTC System Encourages Interaction with Healthcare Professionals
0
10
20
30
40
50
60
70
80
90
100
% o
f In
divi
dual
sC
onsu
lting
Doc
tor
22%
57%
74%
Non UsersN = 2111
UsersN = 1059
Higher Risk Users
N = 167
CUSTOM Results
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174
CUSTOM Results
0
20
40
60
80
100
% o
f U
sers
(n=
105
9)
Improved
Maintained
Previously Tried to Lower
Cholesterol with Diet or Exercise
Change in Dietary Patterns
During Study
Change in Exercise
Patterns During Study
40%
58%
24%
70%
80%
Promotes Lifestyle Changes
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175
Key Questions
Is there a need for an OTC option?
Is MEVACOR™ 20 mg safe for OTC use?
Can consumers manage cholesterol effectively with OTC?
Will OTC divert consumers from physician care and from heart-healthy lifestyle practices?
What’s the overall benefit/risk of MEVACOR™ OTC?
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176
OTC Can Narrow Treatment Gap
0
5
10
15
20
25
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003. BASES 2002.
Gap
Moderate RiskPrimary Prevention
11-18 million
+ 4-5 million
3-5 million
Currently on Rx therapy
OTC users
Recommended for drug therapy
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177
OTC Can Narrow Treatment Gap
0
5
10
15
20
25
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003. BASES 2002.
Gap
Moderate RiskPrimary Prevention
11-18 million
+ 4-5 million
3-5 million
Currently on Rx therapy
OTC users
Recommended for drug therapy
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178
OTC Can Narrow Treatment Gap
0
5
10
15
20
2524-26 million
9-11 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003. BASES 2002.
Gap
Gap
+ 1-2 million
Moderate RiskPrimary Prevention
11-18 million
+ 4-5 million
3-5 million
Currently on Rx therapy
OTC users
Rx therapy due to OTC
Recommended for drug therapy
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179
OTC Can Narrow Treatment Gap
0
5
10
15
20
2524-26 million
9-11 million
High RiskSecondary Prevention/CHD Risk Equivalents
Rx
Elig
ible
Am
eric
ans
(Mill
ions
)
NHANES 1994, IMS 2003, Ingenix Treatment Gap Data 2003. BASES 2002.
Gap
Gap
+ 1-2 million
Moderate RiskPrimary Prevention
11-18 million
+ 4-5 million
3-5 million
Currently on Rx therapy
OTC users
Rx therapy due to OTC
Recommended for drug therapy
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CUSTOM DataUsers Achieved Beneficial Lipid Lowering
OTC Can Help Shift the Curve
0
2
4
6
8
10
12
14
16
% o
f U
sers
LDL-C levels (mg/dL)
Baseline (N=931)
130 170 200100 24070
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181
OTC Can Help Shift the Curve
% o
f U
sers
LDL-C levels (mg/dL)
Baseline (N=931)
End of Study (N=878)
130 170 200100 24070
CUSTOM DataUsers Achieved Beneficial Lipid Lowering
0
2
4
6
8
10
12
14
16
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182Carleton R.A. et al., Circulation 1991, vol 83. 2154-2232.
100 200 300 4000
2
4
6
8
10Cholesterol distribution in USpopulation NHANES II
Expected shift in populationdistribution of cholesterol valueswith application of ATP guidelines
Pe
rce
nt o
f Po
pul
atio
n
Serum Cholesterol Level (mg/dL)
Expected shift in populationdistribution of cholesterol valuesif recommendations of PopulationPanel results in 10% decrease ofcholesterol
The Additive Effect of a Primary Prevention Strategy
200
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Overall Benefit of MEVACOR™ OTC
For example:
– 1 million OTC users for 10 years
• Applying CHD risk distribution in CUSTOM population
• Assumed risk reduction ~25%
– Benefit
• 25,000 – 35,000 events prevented