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July 15, 2009

Integrate Risk Evaluation & Mitigation Strategies (REMS) with Health Management Craig Kephart, President & CEO Centric Health Resources, Inc. July 15, 2009. RISK. BENEFIT. Can We Leverage REMS To Grow The Benefit Number?. Risk-Benefit.

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July 15, 2009

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  1. Integrate Risk Evaluation & Mitigation Strategies (REMS) with Health ManagementCraig Kephart, President & CEOCentric Health Resources, Inc. July 15, 2009

  2. RISK BENEFIT Can We Leverage REMS To Grow The Benefit Number? Risk-Benefit Lower risk, higher benefit = greater value + greater sales

  3. REVENUE MARGIN COST Risk-Cost REMS = Cost • Preparation • FDA delays • Implementation • Compliance • Evolving FDA guidelines REVENUE MARGIN 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. COST 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

  4. Safe Access Assure Safe Use Mandatory 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 REMS Elements and Fit with SPs

  5. Health Management • More, better decisions • By patient and physician, resulting in: • Protocol adherence • Better health • Lower cost • Improved Quality of Life Looking for Value • Health outcomes • Education, compliance, adherence • Therapeutic benefit

  6. REVENUE REVENUE Health Mgmt. MARGIN MARGIN Platform COST COST 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

  7. educational and communications interventions: Core Educational Program (LMS) Supplemental specific educational materials Assessments Monitoring Feedback PHC Support More, better decisions By patient and physician, resulting in: Protocol adherence Better health Lower cost Improved Quality of Life behavior change Driven by this holistic, comprehensive support CHR Health Management Approach CHR’s goal is to improve theeffectiveness of the patient/physician interaction • BENEFITS • Market differentiation • Patient/Physician loyalty and retention • Enhanced value proposition to the payer market

  8. Health Outcomes • Opportunities to drive value beyond therapy • Mitigation of co-morbidities • Avoid unscheduled HC visits • Avoid hospitalizations • Avoid ER • Higher QOL • Productivity “Effects of a Disease Management Program in Patients with Alpha-1 Antitrypsin Deficiency,” Journal of COPD, Feb. 2009 • 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

  9. HM and REMS • HM and REMS Comparison

  10. Sell a program not a drug Investor confidence Compliance & Loyalty Comparative Effectiveness P4P VBBD Barriers to competition

  11. 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.

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