Integrate Risk Evaluation & Mitigation Strategies (REMS) with Health Management Craig Kephart, President & CEO Centric Health Resources, Inc. July 15, 2009

Patient Centered Health Management® Risk-Benefit Can We Leverage REMS To Grow The Benefit Number? RISKBENEFIT Lower 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 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

Patient Centered Health Management® Health outcomes Education, compliance, adherence Therapeutic benefit Looking for Value Health Management More, better decisions By 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 BENEFITS Market differentiation Patient/Physician loyalty and retention Enhanced 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

Patient Centered Health Management® HM and REMS ElementsHMREMS 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 Comparison DISTRIBUTION

Patient Centered Health Management® Sell a program not a drug Investor confidence Compliance & Loyalty Comparative Effectiveness P4P VBBD 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.