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Integrate Risk Evaluation & Mitigation Strategies (REMS) with Health Management
Craig Kephart, President & CEOCentric Health Resources, Inc.
July 15, 2009
Patient Centered Health Management®
Risk-Benefit
Can We Leverage REMS To Grow The Benefit Number?
RISKBENEFI
T
Lower risk, higher benefit = greater value + greater salesLower risk, higher benefit = greater value + greater sales
Patient Centered Health Management®
Risk-Cost
REMS = Cost Preparation FDA delays Implementation Compliance Evolving FDA guidelines
COST
MARGIN
REVENUE
COST
MARGIN
REVENUE
Add to that: price pressure from the growing
government payer sector the infrastructure needed to collect
data in order to provide measurable outcomes for patients and payers.
How do you manage the cost of the REMS?
Consider that SPs are great platforms Integrate with an SP Probably most efficient way to handle
the REMS
Patient Centered Health Management®
REMS Elements and Fit with SPs
Safe Acces
sAssure Safe
UseMandatory registry
Documentation of patient monitoring Nurse training Technology to collect data lab
results, patient health measures
Assessments and Monitoring
Health management Voluntary patient registry Assessments Therapy compliance and adherence
Integrated systems with pharmacy dispensing data
Enhance Communications
Pharmacist education/counseling 24/7 Clinical support Training Nurse training, education, and clinical services
Patient Centered Health Management®
Health outcomes
Education, compliance, adherence
Therapeutic benefit
Looking for Value
Health ManagementHealth Management
More, better decisionsBy patient and physician, resulting in:
• Protocol adherence
• Better health
• Lower cost
• Improved Quality of Life
More, better decisionsBy patient and physician, resulting in:
• Protocol adherence
• Better health
• Lower cost
• Improved Quality of Life
Patient Centered Health Management®
Benefit
Future – focus on benefit – Why?
Mitigate the cost of REMS One platform for REMS, Distribution,
& HM = efficiency Use REMS platform to gain
additional benefits, such as Higher sales Longer product life cycle Market share Payer acceptance Competitive advantage
Ultimately allows you to be prepared for changing reimbursement environment that may include
P4P VBBD CE
COST
MARGIN
REVENUE
COST
MARGIN
REVENUE
Health Mgmt.
Platform
Patient Centered Health Management®
CHR Health Management Approach
educational and
communications
interventions:
Core Educational Program (LMS)
Supplemental specific educational materials
Assessments
Monitoring
Feedback
PHC Support
behavior change
Driven by this holistic, comprehensive support
BENEFITSMarket differentiation
Patient/Physician loyalty and retentionEnhanced value proposition to the payer market
CHR’s goal is to improve the effectiveness of the patient/physician interaction
More, better decisions
By patient and physician, resulting in:
Protocol adherence
Better health
Lower cost
Improved Quality of Life
Patient Centered Health Management®
Health Outcomes
Opportunities to drive value beyond therapy Mitigation of co-morbidities Avoid unscheduled HC
visits Avoid hospitalizations Avoid ER Higher QOL Productivity
Each has an economic value Measure, capture, influence = grows benefit side
How do we do that? REMS and HM from one platform = efficiency + additional
value
“Effects of a Disease Management Program in Patients with Alpha-1 Antitrypsin Deficiency,” Journal of COPD, Feb. 2009“Effects of a Disease Management Program in Patients with Alpha-1 Antitrypsin Deficiency,” Journal of COPD, Feb. 2009
Patient Centered Health Management®
HM and REMS
Elements HM REMS
Education/MedGuide
Communications
Assessments (patient and physician)
ETASU
Pharmacy & HC provider certification
Monitoring
Registry
Dispensing in certain HC settings
Interventions
Compliance
Adherence to Therapy
Patient Relationships
Improved Quality of Life
HM and REMS ComparisonDISTRIBUTION
Patient Centered Health Management®
Sell a program not a drug
Investor confiden
ce
Compliance & Loyalty
Comparative Effectiveness
P4PVBBD
Barriers to competition
Patient Centered Health Management®
Summary
Companies that are willing to put the right structure in place to monitor patients, collect data, and measure outcomes should find that REMS can work to their advantage.
Also an opportunity to capture channel margin to pay for costs, but discussion for later day.