Disclosures. Real World Data Sources

Transcription

1 Disclosures Real World Data Sources Christopher M. Blanchette, PhD, MBA Director, HEOR, Otsuka America Pharmaceutical Inc. Research Associate Professor, Public Health Sciences, University of North Carolina, Charlotte Editor in Chief, Drugs in Context I am an employee of Otsuka America Pharmaceutical Inc. I am a faculty member of the University of North Carolina, Charlotte I am the editor in chief of Drugs in Context The statements presented here are my own and do not represent that of Otsuka America Pharmaceutical Inc., UNC Charlotte or Drugs in Context.

2 Data are disparate globally IMS Capabilities Real World Data Types Feeding Models Electronic Medical Records Administrative claims / billing Hospital / event Surveys Longitudinal cohorts Payer EMR Hospital Rx Oncology Lab

3 Electronic Medical Records An electronic chart used to document the care and treatment of a patient within a patient care setting Clinical detail including laboratory values and clinical measures Longitudinal follow up for natural history data Electronic Medical Record Examples Database name Centricity IMS Health Cegedim Strategic Data Patient Databases MedMining Company GE Healthcare IMS Health Cegedim MedMining Source Doctors using GE Healthcare medical record system Multiple sources (outpatient) Pulse Complete EHR product Number of lives 15 million 20 million Unknown 1 million Geisinger Health plan Northeast PA Historical data 1996 to present 2006 to present Unknown 1998 to present Update frequency Daily Daily Daily Daily Number of doctors 15,000? 20,000 workstations Unknown Typically lacking complete view of healthcare use Missing data, no incentives to complete records Limited populations, typically not inclusive of modeled population US National dispersion US National dispersion Linkable to subset of patient s claims 35 specialties Deep penetration in Europe for European EMR analyses Link to Geisinger claims for more details Closed system

4 Administrative claims / billing An electronic record of claims submitted for the purpose of payment for services Provides a longitudinal view into a patient s use of healthcare services Economic theory provides assurances of services inclusion Typically includes reimbursed, patient paid amounts Typically lacking clinical depth Patients are not representative of the population but rather only those with health insurance Database name Claims Data Sources Clinformatics Data Mart Clinformatics Data Mart Multiplan MarketScan Company Optum Insight Optum Insight Thomson HealthCore Source UnitedHealth Group UnitedHealth Group plus 46 regional plans Large employers and mid market HMOs Number of lives 13 million 22 million 47 m total; 29 m per year HealthCore Integrated Research Database Wellpoint health plan Blue Cross Blue Shield and Anthem plans 34 million Historical data 36+ months 36+ months 1992 to present 2000 to present Update frequency Semi annual/ quarterly Semi annual/ quarterly Semi annual/ quarterly Quarterly Data Lag 90 days 180 days 90 days 90 days Enrollment Full Partial, some inferred Full Full Lab results Ability to link to other data sources Chart abstractions Diversity of payers Considerable use so researchers have experience Often least costly Lab results Chart abstractions

5 Hospital Hospital based chargemaster / administrative data Provides a detailed view into a patient s use of services in the hospital Economic theory provides assurances of services inclusion Database name Hospital Data Sources MarketScan Hospital (US) Belgian Inpatient HES/HPA (UK) Premier Perspective Database (US) Company Thomson IMS Health IMS Health Premier Source Hospital charge master data (from HCI and Solucient acquisitions) Hospital inpatient stay information Hospital Episode Statistics integrated with hospital drug usage and GP EMR data Number of lives Unknown Unknown Unknown Unknown Hospital billing records and details from hospital/ outpatient clinic systems Historical data 2006 to present 1999 to present Update frequency Unknown monthly Typically lacking clinical depth Patients are not representative of the population but rather only in the hospital Unit of analysis is the event, not the patient Limited follow up outside of the hospital Number of sites (facilities) % bed coverage nationally Not readily linkable to other data Includes inpatient and hospital based outpatient Age & gender, Admit & discharge dates, Diagnosis Procedures, Clinical History, Risk, Post-discharge care, Readmissions, Date and time of transaction, Product, form and strength dispensed to patient 600 (47m inpatient records; 248m outpatient records) Linked to Optum data through probablistic match

6 National Surveys Population based surveys collecting patient reported information Provides a detailed view into a patient s experience with health and disease May be longitudinal Typical population based May not be clinically valid results Typically lacking link to clinical detail or healthcare services data Response bias National Surveys Database name NHANES (US) National Health & Wellness Survey Company CDC Kantar Health Source US Population Global (US, EU-5, Russia, Japan, China, Brazil) Number of lives Variable US: 75,000 EU 5: 20 Russia: 10,000 Japan: 25,000 China: 20,000 Brazil: 12,000 Historical data 1999 to present US: 1998 EU 5: 2000 Russia: 2011 Japan: 2008 China: 2009 Brazil: 12,000 Update frequency Annually? Number of sites (facilities) NA NA Nationally representative, some clinical data depending on the focus for that year. History of healthcare and diagnosis. Health behaviors. Patient attitudes, behaviors, demographics, characteristics Population epidemiology, trends and treatment behaviors

7 Longitudinal Cohorts Observational cohort followed over time to observe disease progression Provides a detailed view into a patient s progression of disease over many years Data are typically very rich including treatment, clinical data, patient reported symptoms and burden Longitudinal Cohorts Database name Lovelace Smokers Cohort Framingham Heart Study Company Lovelace Respiratory Research Institute NHLBI / Boston University Source Albuquerque, New Mexico Framingham, Massachusetts Number of lives 2000 (enrolling) Variable Historical data Approx 10 years 1948 Update frequency Annually Continuously Number of sites (facilities) 1 1 city Longitudinal follow up on the effects of smoking and to identify biomarkers for progression Long term follow up on a cohort of individuals and their children to assess heart disease. Expensive Typically not linked to utilization data outside of the disease Limited sample size and geographical representation