Value Demonstration: Local, National or Multinational Retrospective Chart Review Studies

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Value Demonstration: Local, National or Multinational Retrospective Chart Review Studies Retrospective chart review designed to fulfill real-world evidentiary requirements Retrospective chart review

1 Value Demonstration: Local, National or Multinational Retrospective Chart Review Studies Retrospective chart review designed to fulfill real-world evidentiary requirements Retrospective chart review studies are often warranted in the absence of suitable healthcare databases and other secondary sources of information. Chart review methodology can resolve database gaps and facilitate the rapid collection of clinical, safety, and healthcare utilisation data. This method results in tailored, international patient-level datasets that are ideally suited as inputs to a wide range of burden of illness, drug utilisation, safety, and health economic analyses. These studies enable you to: Delineate longitudinal patterns of care and resource utilisation profiles by sub-groups of interest that can be monetised in local currencies Evaluate relationships between patterns of care and clinical outcomes of interest Meet EMA or FDA drug utilisation and/or safety outcomes requirements such as Post Authorisation Safety Studies (PASS) Quantify and describe off-label medication use Evaluate the impact of EMA- or FDA-mandated RMPs and REMS Describe the real-world safety profile of marketed products Identify unmet clinical need Inform clinical trial and other prospective study designs through cohort characterisation and analyses of variability UBC is a partner centre of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) scientific network which is coordinated by the EMA. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We register studies in the ENCePP E-Register of Studies, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

2 Chart data may include the following alongside patient-level clinical outcomes data: Demographics Disease symptoms and co-morbidities Treatment and diagnostic history Medications prescribed Physician and emergency room visits Real-World Evidence and Research Needs Characterise patients and patterns of care Inform trial or registry design Hospitalisations by length of stay and location Diagnostic test results Procedures Safety outcomes Chart Review Opportunity Describe patient cohort and sub-groups of interest Characterise usual care treatment patterns Ensure results are void of the Hawthorne effect since data are retrospective Identify treatment pathways Quantify variability in patient characteristics and outcomes Support sample size calculations Identify unmet clinical need Describe burden of illness Identify gaps in care pathways Quantify resource utilisation (RU) and estimate costs of care Capture RU from medical charts so that local unit costs can be applied to estimate costs of care Quantify planned versus actual RU (i.e., drug doses prescribed versus received) Meet FDA/EMA Risk Evaluation and Management Strategy (REMS) evaluation requirements Evaluate effectiveness of RMP or REMS Document (in)appropriate medication use Collect clinical outcomes Collect patient-level data describing clinical outcomes (i.e., death, significant medical events) over time and by sub-group of interest Capture and characterise safety outcomes Collect data on adverse and serious adverse events (AEs/SAEs) and their severity and associated management

3 UBC Approach UBC provides a proven approach to the full-service design and conduct of global, multinational retrospective chart review studies. Specifically, UBC offers significant scientific, epidemiologic, and health economics and outcomes research expertise resulting in tailored chart review designs. Project teams are lead by project managers who utilise innovative and flexible project management techniques and approaches to successfully implement these studies. Our global team of clinical research associates (CRAs) and clinical site specialists (CSSs) have local language capabilities and experience liaising with centres. UBC regulatory and contract managers demonstrate in-depth knowledge of country-specific regulatory practices and legislation. UBC has a proprietary electronic data capture (EDC) system that is 21 CRF Part 11/EU Annex 11-compliant and has been developed and refined over time specifically for chart review studies. The UBC team has expertise in the design, implementation, monitoring, safety reporting, cleaning, statistical analysis, and dissemination of retrospective chart review data. The teams build from the following functional areas: Scientists in Value Demonstration, Safety, Epidemiology, Registries, and Risk Management Operations Data management Analytics and biostatistics Pharmacovigilance Custom software design Sample Design Overview Study Period Chart Review Initiation Eligibility Period Case 1 Case 2 Start Date Start Date End Date (Date of death) End Date (Date of chart study, initiation or x time post index event/dx/visit [e.g. 6 months]) Case 3 Start Date End Date (Lost to follow-up)

The UBC approach to designing and managing chart review studies ensures that each study is: Quality Controlled Practical and Convenient Efficient Consistent Designed to withstand rigor of scientific

4 The UBC approach to designing and managing chart review studies ensures that each study is: Quality Controlled Practical and Convenient Efficient Consistent Designed to withstand rigor of scientific peer review Employs data validations at the point of data entry Enables scientifically valid chart sampling and disposition tracking Employs a remote monitoring model, thereby avoiding the need for on-site monitoring and oversight Facilitates site and data monitoring in real-time Permits a clean dataset within days of database closure Enables simultaneous data collection across multiple countries Employs a standard protocol and paper or electronic case report form (CRF) resulting in standardised local or multinational data Experience UBC has conducted chart review studies in more than 15 countries around the world. The studies have varied in scale from fewer than 10 sites to more than 300, with patient cohorts ranging from a few hundred to thousands. UBC s experience across therapeutic areas includes, but is not limited to, oncology, cardiovascular, renal and infectious diseases/disorders, intensive care populations, and orphan diseases. Studies have included evaluations of burden of illness, patterns and costs of care, mandated Drug Utilisation Studies (DUS), Post-Authorisation Safety Studies (PASS), and REMS evaluations. For more information on UBC s comprehensive services, us at: info@ubc.com Express Scripts Holding Company. All Rights Reserved. EU Headquarters Hammersmith Grove London, W6 7HA United Kingdom +44 (0) US Headquarters 920 Harvest Drive Suite 200 Blue Bell, PA

5 Clinical Development & Late Stage Research» Risk Management & Pharmacovigilance VALUE DEMONSTRATION: LOCAL, NATIONAL OR MULTINATIONAL RETROSPECTIVE CHART REVIEW STUDIES Retrospective Chart Review Studies Help Fulfill Real-world Evidentiary Requirements. *Blue indicates UBC Scientist.» Selected Recent Publications Payne KA, Stein D. Retrospective chart review studies: An old dog with some new tricks? PharmaPhorum. Dec 30, Payne KA, Stein D, Marshall L, Sohal J, Jersino J-M. Chart Toppers. Multinational chart reviews offer effective and efficient real-world data capture to support various evidence needs, representing both good science and pragmatic methodology. Int Clin Trials 2012: Shreay S, Desrosiers M-P, Corey-Lisle P, Payne KA. A retrospective study to evaluate the time burden associated with outpatient red blood cell transfusions indicated for anemia due to concomitantly administered chemotherapy in cancer patients. Supportive Care in Cancer Payne KA, Rofail D, Baladi JF, Viala M, Abetz L, Desrosiers MP, Lordan N, Ishak K, Proskorovsky I. Iron Chelation Therapy: Clinical Effectiveness, Economic Burden and Quality of Life of Patients with Iron Overload. Adv Ther August; 25(8): Payne KA, Desrosiers MP, Caro JJ, Baladi JF, Lordan N, Proskorovsky I, Ishak K, Rofail D. Clinical and Economic Burden of Infused Iron Chelation Therapy in the United States. Transfusion October; 47(10): info@ubc.com

6 Clinical Development & Late Stage Research» Risk Management & Pharmacovigilance VALUE DEMONSTRATION: LOCAL, NATIONAL OR MULTINATIONAL RETROSPECTIVE CHART REVIEWS Selected Sample Chart Review Study Abstracts and Presentations *Blue indicates UBC Scientist. Payne KA, Stein D. Retrospective chart review studies and safety reporting requirements: issues and considerations. DIA; March 25-27, 2014; Vienna. Stein D, Bassel M, Payne KA. Drug utilization and safety evaluations: lessons learned from multi-national retrospective chart review case studies. Canadian Association for Population Therapeutics (CAPT) Annual Conference; November 17-19, 2013; Toronto, Ontario. Desrosiers M-P, Lordan N, Reynolds MR, Robinson Jr DW, Payne KA. Using Retrospective Chart Review Methodology to Characterize Patients, Treatment Patterns and Resource Utilization in a Cohort of Patients with Multicentric Castleman s Disease. Canadian Association for Population Therapeutics (CAPT) Annual Conference; November 17-19, 2013, Toronto. Stein D, Joulain F, Usman Iqbal, Naoshy S, Muszbek N, Payne KA, Ferry D. Quality of life in patients with metastatic colorectal cancer (mcrc): A utilities study in the United Kingdom (UK) and the Netherlands. ISPOR 16th Annual European Congress; Nov 4-6, 2013; Dublin. Stein D, Sise C, Sherwood M, Mortimer Ö. Endotoxin-associated Sterile Peritonitis Observational Study (e-steps): Safety Findings. 29th International Conference on Pharmacopidemiology and Therapeutic Risk Management (ICPE); August 25-28, 2013, Montréal Convention Center, Montréal. Sise, C, Rutherford P, Kovács L, Konings S, Zimmerman J, Cramp H, Stein D. Endotoxin-associated sterile peritonitis observational study (e-steps) results. 50th ERA-EDTA 2013 Annual Congress; May 18-21, Istanbul. Payne KA, Stein D, Stemhagen A. Multi-national retrospective chart review studies: Lessons learned from application of methodology to international evaluations of burden of illness and drug utilization and safety. ISPOR 18th Annual International Meeting; May , New Orleans. Desrosiers M-P, Lordan N, Reynolds MR, Robinson Jr DW, Payne KA. Using chart review methods to characterize patients, treatment patterns and clinical outcomes in a cohort of patients with multi-centric Castleman s disease. ISPOR 18th Annual International Meeting; May , New Orleans. Rahaghi F.F, Ferrer G, Zhang, J, Massaro S, Boulanger L, Alas V, Benjamin N, Payne K, Desrosiers M-P. COPD treatment pattern difference between pulmonologists and primary care physicians. ATS, Corey-Lisle P, McGarvey N, Desrosiers M-P, Donahue E, Badre S, Hubbard S. Development of a multi-national cross-sectional study to determine disease burden of cancer patients suffering from anemia in usual care and their caregivers. ONS Conference, Payne KA, Neasham D. Drug Utilization Studies: Opportunities and Challenges. Late Phase Drug Development World December 6, London. Payne KA, Stein D, De Cock E. Retrospective multinational chart review studies of adverse and serious adverse events in Europe: opportunities and challenges. 28th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE); August 23-26, CCIB Barcelona. Corey-Lisle P, Shreay S, Collins H, Payne KA, Desrosiers M-P. Retrospective study to evaluate the patient time burden associated with outpatient red blood cell transfusions in cancer patients receiving chemotherapy. MASCC 2012 International Symposium (Multinational Association of Supportive Care in Cancer); New York City; June 28-30, Payne KA, Wasiak R, Stein D, Chancellor J. Multi-national chart review studies in Europe: Opportunities and challenges. ISPOR 13th Annual European Congress; November 6-9, 2010; Prague. info@ubc.com

Retrospective Chart Review Studies

Retrospective Chart Review Studies Designed to fulfill requirements for real-world evidence Retrospective chart review studies are often needed in the absence of suitable healthcare databases and/or other