User Centric Product Design for Greater End-User Adherence Primary Data on a 360 o Analysis
Panel Discussion Gary Hall, Jr. 10 time Olympic Medalist & Diabetes Patient Russell Rothman, MD, MPP Assistant Professor, Internal Medicine & Pediatrics Vanderbilt University Medical Center Sandra Leal, Pharm.D., CDE President, Association of Clinicians for the Underserved, Clinical Pharmacy Supervisor El Rio Health Center Daniel Ruppar Moderator Industry Manager (North America) Pharmaceuticals & Biotechnology - Frost & Sullivan 2
Patient Compliance & Product Design in Diabetes Compliance Issue in chronic disease treatment Among newly treated Type 2 patients 53% adhered to treatment regimen (1) Multifaceted Impact in Diabetic Patients Product/Drug Design Innovation Factor Patient Needs, Physician Needs Differentiation, Clear Benefits 1 Hertz RP, Unger AN, Lustik MB. Adherence with pharmacotherapy for type 2 diabetes: a retrospective cohort study of adults with employersponsored health insurance. Clin Ther. 2005;27:1064-1073 3
U.S. Drug Delivery Usage Patterns, Preferences and Opportunities in the U.S. Customer Research January 2008
Objectives Identify physician prescribing trends relative to drug delivery considerations Identify physician perception of different drug delivery approaches as well as the key drivers of adoption or non-adoption Identify drug delivery trends within specific disease areas Determine product attributes relative to delivery that are considered important by physicians and patients Identify prospective patient preferences and willingness to try new technologies as well as determine key drivers of adoption/non-adoption 5
Objectives Disease categories include: Diabetes, Chronic Pain, Inflammation (Ex: Rheumatoid Arthritis, Crohn s Disease, Psoriasis), Neurological Disorders (Ex: Alzheimer s disease, Schizophrenia, ADHD, Depression). Patient and Physician respondents will be in the Diabetes, Chronic Pain, and Inflammation areas. Neurological Disorders will only have Physician responses. 6
Scope: Drug Delivery Categories Injection Transdermal Intranasal Oral Pulmonary The figure shows the 7 major drug delivery categories that were evaluated. Detailed analyses may selectively include minor categories (e.g. buccal, rectal, vaginal) and sub-categories (e.g. ocular cream, ocular drops). Implant Ocular 7
Methodology Sample Doctors (206) and patients (450) in the US were invited to participate in the survey. The structure of the sample is shown in the table. Data Collection Methods Sample Structure Doctors 206 Primary Care Physicians 50 Endocrinologists 50 Psychiatrists 27 Rheumatologists 26 Neurologists 28 Physical Medicine/ Rehab 10 Anesthesiologist / Pain Management 15 Patients 450 Diabetes 150 Chronic Pain 150 Inflammation 150 The study utilized Frost & Sullivan s web-based survey capability. A structured questionnaire with the appropriate metrics was set-up in web format (GMI-MR software). Appropriate screening questions and quota controls were provided to ensure that only qualified respondents participate in the survey. 8
Compliance 9
Factors Affecting Patient Compliance MD Efficacy, adverse side effects, ease-of-use, and patient education are perceived by doctors as the most important drivers of patient compliance. 100% 90% 80% 38% 28% 28% 27% 24% 24% 22% 15% 15% 70% 31% 60% 30% 47% 59% 52% 56% 46% 54% 46% 55% 45% 0% 14% 12% 18% 15% 1% 1% 2% 2% Efficacy Adverse side effects Ease of Use Patient Education 26% 5% 25% 22% 30% 28% 1% 1% 4% 2% Cost Comfort Convenience Personal Responsibility Dosing Frequency 9% 2% Length of time on medication Not Important At All Slightly Important Moderately Important Very Important Most Important How would you categorize the importance of the following factors on patient compliance? 10
Patient s Adherence to Therapy by Drug Delivery Method MD Adherence is best for oral medication, transdermal patches, topical gel/cream and implants. Adherence is perceived as poorest for rectal and vaginal drug delivery methods. 100% 90% 80% 70% 60% 30% 0% 6% 27% 42% 30% 21% 3% 12% 11% 28% Injection Intravenous Infusion 47% 37% 27% 53% 39% 25% 14% 13% 3% 2% 2% 2% 4% Transdermal Patch 3% Active Transdermal 7% 1% 2% Topical Pulmonary Gel/Cream /Inhaled 15% 42% 33% 21% 25% 33% 2% 26% 22% 51% 35% 45% 1% 2% 5% 4% 5% 33% 34% 41% 37% 35% 47% 14% 18% 24% 11% 23% 9% 9% 7% 4% 2% 1% 4% 4% Ocular Implant Intranasal Oral Buccal Rectal Vaginal Sublingual 6% Very Poor Poor Average Good Very Good Q6. How would you rate patient adherence to therapy for drugs delivered by each of the following drug delivery types? 11
Product Design 12
Drug Delivery Method Should be Made Available - Diabetes MD Which drug delivery method 100% 90% 80% 70% 60% 30% 0% (if any) that is currently unavailable, do you think should be made available for the for the treatment of Diabetes 3% 41% 6% 4% 9% 7% 10 % 6% 4% 9% Diabetes A significant proportion of doctors look forward to the availability of transdermal patches for diabetes. Inhaled and Intranasal are also of interest. Others Sublingual Vaginal Buccal Pulmonary/Inhaled Ocular Implant Intranasal Topical Gel/Cream Active Transdermal Transdermal Patch Oral Intravenous Infusion Rectal Injection 13
Reasons for Drug Delivery Method to be Made Available - Diabetes MD What are the top 3 attributes of <method chosen> that make it appealing for the treatment of Diabetes? Patient convenience, ease-of-use, and satisfaction are the most appealing attributes of transdermal patches. Pulmonary and intranasal methods are both associated with rapid onset of action, though intranasal is more identified with ease of use. 70% 60% 52% 58% 58% 55% 64% 46% 42% 46% 30% 25% 25% 25% 19% 8% 8% 8% 8% 8% 6% 4% 2% 25% 25% 25% 8% 8% 27% 9% 27% 27% 9% 0% Transdermal Patch Pulmonary/Inhaled Intranasal Easy for patient to use Patient satisfaction Low cost Minimal adverse side effects Easy for doctor to administer Requested by patients Patient convenience Rapid onset of action Patient comfort Bioavailability Low frequency of dosing Well designed device Higher drug absorption Dose accuracy Ease of cost reimbursement Formulary tiering of product with the delivery form Speedy recovery Close proximity of drug to target area Others 14
Drug Delivery Method Willingness to Use Diabetes Type I Patient For each of the following types of drug delivery, please indicate your degree of willingness to use it in the future for Diabetes Type I, assuming all these are available, affordable, and can be prescribed by your doctor There appears to be a significant opportunity for transdermal patches in terms of patients willingness to use. Unwilling compliance is highest for intravenous infusion. About 21% of the respondents are very willing to use transdermal patch for Diabetes Type I. Resistance is highest for rectal and vaginal modes of delivery. 100% 90% 80% 70% 60% 30% 0% 24% 31% 17% 17% 7% 7% 31% 21% 35% 21% 7% 21% 21% 31% 14% 14% 24% 7% 28% 28% 35% 35% Injection IntravenousTransdermal Topical Inf usion Patch Gel/Cream Indifferent/Don't Know 7% 3% 3% Pulmonary /Inhaled 21% 31% 41% Unwilling but will comply if prescribed by doctor Very Willing to Use It 21% 24% 31% 35% 3% 24% 31% 35% 28% 24% 14% 3% 3% 3% 3% 21% 7% 17% 31% 48% 45% 48% 14% 17% 28% 31% 28% 31% Ocular Implant Intranasal Oral Buccal Rectal Vaginal Sublingual Will Definitely Not Use It Willing To Use It 15
Drug Delivery Method Willingness to Use Diabetes Type II Patient For each of the following types of drug delivery, please indicate your degree of willingness to use it in the future for Diabetes Type II, assuming all these are available, affordable, and can be prescribed by your doctor About 35% of Diabetes Type 2 patients are willing to use a transdermal patch or a topical gel/cream in future 100% 90% 80% 70% 21% 19% 1% 8% 27% 11% 9% 7% 24% 27% 30% 2% 4% 3% 8% 11% 12% 15% 15% 22% 57% 3% 3% 1% 2% 2% 3% 15% 9% 15% 11% 8% 60% 38% 11% 19% 22% 14% 26% 37% 37% 32% 37% 55% 63% 35% 30% 25% 0% 14% 9% Injection 26% Intravenous Infusion 30% 33% Transdermal Patch Topical Gel/Cream 29% Pulmonary /Inhaled 39% 26% 38% 4% 6% 8% 27% 24% Ocular Implant Intranasal Oral Buccal Rectal Vaginal Sublingual 39% Indifferent/Don't Know Unwilling but will comply if prescribed by doctor Very Willing to Use It Will Definitely Not Use It Willing To Use It 16
Patient Reasons for Willingness to Use Drug Delivery Methods Diabetes Type I More Diabetes Type I patients consider injection as easy to self-administer. Topical gel/cream, together with buccal, oral and sublingual are also considered easy to self-administer by a significant proportion of diabetes patients. 100% 90% 80% 70% 60% 13% 13% 11% 11% 6% 11% 6% 44% 75% 33% 63% 13% 22% 22% 11% 25% 25% 11% 33% 11% 75% 11% 11% 30% 25% 25% 33% 11% 22% 13% 25% 44% 44% 0% Injection Intravenous Infusion Transdermal Patch Topical Gel/Cream Pulmonary /Inhaled Implant Intranasal Oral Buccal Sublingual Easy to self administer Rapid Onset of Drug Action Low frequency of dosing Minimal Side effects No (or Minimal) Discomfort / Pain Low Cost / Insurance Co-Pay Likelihood of Reimbursement Very Convenient Well designed device My doctor prefers it Other * Low incidence (low proportion of willing users) delivery types are excluded. Q2h What is your Top reason for your willingness to use these types of drug delivery in the future for Diabetes Type I? 17
Importance of Overall Device in Final Selection to Prescribe MD The device itself is an important consideration when selecting device-driven drugs. Only 11 percent of doctors consider it as only slightly important or not important at all. Most Important 4% Not Important At All 3% Slightly Important 9% Very Important Moderately Important 44% Q7. For Device Driven Drug Delivery (Examples: Inhaler, Autoinjector) How important is the overall device in your final selection to prescribe that drug product? 18
Device Driven Drug Delivery Method Factors Patient Top factors for considering device driven drug delivery method are ease of self administration (37%) followed by Physician s recommendation (24%) 100% 90% 4% 80% 70% 60% 30% 0% 14% 26% 37% Easy to self administer 13% 12% 11% 9% 7% 6% 3% 6% Size of Device 12% 16% 24% 13% 13% 12% 14% Specific Recommended Out of adverse side effects by Physician Pocket Cost 11% 12% 9% 12% 8% 9% 8% 7% 9% 6% 7% 13% 8% 4% 7% 5% 2% 3% 1% 3% 4% 3% 5% 3% 2% 3% Appealing appearance Published Clinical data Does not Complexity of require device batteries / pow er source Need to refrigerate drug portion Reusable / Environmentally Friendly Rank 1 Rank 2 Rank 3 Rank 4 Rank 5 Q7. For Device Driven Drug Delivery what are the top 5 factors that you consider? (1=most important, 2=2 nd most important, 3=3 rd most important, etc.) 19
Attitude Towards New Delivery Forms MD Majority of respondent doctors are willing to prescribe new drug delivery forms. Forty-one percent adopt new delivery forms earlier than their peers. Thirty-four percent disagree that they are very cautious about prescribing new delivery forms, while an equal proportion would agree to the same statement. 100% 90% 6% 9% 4% 80% 70% 60% 61% 33% 30% 32% 41% 30% 28% 29% 0% 16% 4% 2% 2% I am generally willing to prescribe products that require patients to try a new drug delivery form. I usually adopt new drug delivery forms earlier than most of my peers. 5% I am generally very cautious and would rather not prescribe drug delivery forms that are just new in the market. Strongly Disagree Disagree Neutral Agree Strongly Agree Q9. To what extent would you agree or disagree with the following statements, as they apply to your own beliefs and practices? 20
Exubera - Awareness Patient Forty-five percent of patients with diabetes are familiar with Exubera. TV ads is the major source of awareness. Awareness of Exubera Source of Awareness Familiar 7% Slightly Familiar 32% Saw TV advertisement Magazine/New spaper 26% Very Familiar 6% Internet Physician Friend/Family member Other Non Physician healthcare 7% 6% 8% 0% 30% 60% Unfamiliar 55% Q9a How would you categorize your familiarity with Pfizer s Pulmonary/Inhaled insulin product: Exubera (insulin human [rdna origin] inhalation powder)? Q9b How did you hear about Exubera? 21
Exubera - Usage, Satisfaction, Desired Improvements Patient Only 5% have ever used Exubera, including 2% who are currently using it. Only are satisfied with the product. Improvements in the delivery device and a decrease in side effects are most desired. Usage Change in Exubera desired Yes, currently using 2% Never used 95% Delivery device 60% Have used previously - no longer using 3% Satisfaction with Exubera Neutral Decrease or eliminate side effects Decrease or eliminate dosing pain/discomfort Reduce frequency of dosing 0% 60% 80% Dissatisfied Very Dissatisfied Satisfied Q10c) Have you used Exubera? Q10d How satisfied are you with your overall experience using Exubera? Q10e What would you like to change about your usage experience with Exubera? 22
Panel Discussion Points Factors Impacting Compliance, Patient Challenges Areas of Improvement Opportunity in Diabetes Therapy Burden of Both Rx Medication and Monitoring on Patients Steps Taken By Patients to Lessen Copay/Cost Role of Device in MD Decision to Prescribe Devices- Reusability a Concern? Willingness to Try New 1 st in Class non-oral delivery Desirable/Draw Factors for New Products 23
Question and Answer 24
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