ims health rwe accesspoint 7 - november 2013

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News, views and insights from leading experts in RWE and HEOR.

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  • AccessPointNews, views and insights from leading experts in RWE and HEOR

    Page 1 IMS HEALTH ECONOMICS AND OUTCOMES RESEARCHOUTCOMES - Issue 1 Page 1

    Carl de Moorconsiderschallenges ofimmortal time biasPage 34

    Mike Nelsonvalidates trial-basedhealth economicanalysis using RWEPage 16

    Nathalie Grandfilsexplores guidelineadherence with IMSDiabetes CohortPage 38

    Key issues formarket accessin India

    European pricecomparison

    VOLUME 4, ISSUE 7NOVEMBER 2013

    IMS REAL-WORLD EVIDENCE SOLUTIONS ANDHEALTH ECONOMICS & OUTCOMES RESEARCH

    The promise of predictiveanalyticsA new crystal ball for healthcare?

    Bias challengesin epidemiology

    Designing outuncertainty

    Adaptive techniquesimprove eciency

    The South-West testTechniques to interpret

    cost-eectiveness ratios

  • AccessPointNews, views and insights from leading experts in RWE and HEOR

    Interpreting cost-eectiveness resultsWhy ICERs in the South-West quadrant should not be ignoredpage 43

    Accounting for bias in epidemiologyApproaches for strengthening the validity of studiespages 28 & 34

    Innovative designs in observational studiesAdjusting for uncertainty with adaptive techniquespage 22

    Fulfilling the promise of predictive analyticsWhy a major methodological shift is keypage 10

    VOLUME 4, ISSUE 7NOVEMBER 2013

    A roadmap for healthcare access in IndiaHow action across four key dimensions can reduce out-of-pocket spendingpage 48

    IMS REAL-WORLD EVIDENCE SOLUTIONS & HEOR

  • Contents

    NEWS2 INTEgRATED EVIDENCE HUBS3 LINKED DATA COMPLETES PATIENT PATH6 DEEPER INSIgHTS FOR SAFETY7 IMS INSTITUTE 2017 OUTLOOK8 EVALUATINg PHARMACY INTERVENTIONS9 FORMALIZINg HTA IN LATIN AMERICA

    INSIGHTS10 PREDICTIVE ANALYTICS

    Fulfilling the potential16 IMS HEALTH SYMPOSIUM

    Is RWE making a difference?22 OBSERVATIONAL METHODOLOgY

    Innovative approaches to uncertainty28 CHALLENgES IN EPIDEMIOLOgY

    Adjusting for bias and confoundingCorrecting immortal time bias

    38 FRENCH DIABETES COHORTSupporting best practice

    43 INTERPRETINg ICERs Issues in the SW quadrant48 HEALTHCARE ACCESS IN INDIA

    A roadmap for action54 PHARMA PRICE COMPARISONS France impacts EU price gaps

    PROJECT FOCUS60 VENOUS THROMBOEMBOLISM

    RWE validates economic analysis63 ALZHEIMER'S DISEASE

    Evaluating alternative Medicare data

    IMS RWES & HEOR OVERVIEW66 ENABLINg YOUR REAL-WORLD SUCCESS

    Solutions, locations and expertise

    WelcomeThank you for reading the latest issue of AccessPoint IMS Healths periodic journal that explores issues shaping theHEOR, safety and RWE landscape. In this edition, we are focusedon innovation across several themes:

    New realities in generating data. The life science historicalmodel of reactive data and dataset fragmentation needs tobe revisited. Through strategic planning and new databasetechniques, companies can now plan ahead for their evidenceneeds, creating proactive hubs that can increase the depth andbreadth of analytics, accelerate timelines and fully tap into thepower of RWE.

    Accelerating demand for evidence in many forms. A newEMA framework will shape drug safety monitoring in EU whileLatin American countries look to increase the importance ofHTAs. Market-level initiatives such as the UKs CommunityPharmacy Future (CPF) indicate a vision for using RWE-generated insights to establish more strict guidance onhealthcare practice. And interest in using analytics to solvesome of the toughest global challenges from France to Indiareflects its boundless potential.

    Methodologies and technology are changing the deliveryof evidence and, potentially, the role of HEOR. We spotlightpredictive analytics, a newly developed dynamic data andanalysis platform, and adaptive designs as examples of driversincreasing the reliability and value of RWE. We also dedicatetime to reflecting on insights to ensure the best quality fromepidemiology and other studies.

    IMS Health continues to invest in enabling further RWEadvances. With over 230 multi-disciplinary experts focused onRWE solutions and HEOR globally, we continue to enhance ourRWE platform of scientifically-validated datasets throughstrategic data sourcing, sophisticated linkage and powerfulevidence technologies. Our new disease-focused datasets andpatented approaches to develop unprecedented tracking ofUS patients across their treatment journey, and standardizedDUS are a few profiled examples.

    We at IMS Health are passionate about improving patientoutcomes and advancing healthcare at every level. I hope youenjoy AccessPoint and invite you to share your views with us.

    Leading companies are leveraging advances in evidence to turn the unknown into actionable insights.

    Jon ResnickVice President and general Manager Real-World Evidence SolutionsIMS HealthJresnick@imshealth.com

    AccessPoint is published twice yearly by the IMS Real-World Evidence (RWE) Solutions and Health Economics & Outcomes Research (HEOR) team. VOLUME 4, ISSUE 7. PUBLISHED NOVEMBER 2013.

    IMS HEALTH 210 Pentonville Road, London N1 9JY, UK Tel: +44 (0) 20 3075 4800 www.imshealth.com/rweRWEinfo@imshealth.com

    2013 IMS Health Incorporated and its affiliates. All rights reserved.Trademarks are registered in the United States and in various other countries.

    ACCESSPOINT VOLUME 4 ISSUE 7 PAgE 1

  • NEWS | INTEgRATED EVIDENCE HUBS

    continued on next page

    PAgE 2 IMS REAL-WORLD EVIDENCE SOLUTIONS & HEOR

    Integrated evidence hubs drive timely, cost-ecient insights

    Dynamic data and analysis platform enables value and evidence from the real world to meet growing post-launch requirements.

    Achieving and maintaining market access anddriving competitive differentiation for newtherapeutic agents requires a comprehensiveapproach to meet post-launch evidencerequirements. A newly developed dynamic dataand analysis platform is providing a solution tothese continuous evidence demands. These platforms integrate data from a variety of existingand new real-world sources to enable assessment andmonitoring of treatment patterns, clinical outcomes andsafety, centered on disease areas of interest (see Figure 1 forthe range of platforms IMS Health is collaborating withclients to build and run). By integrating and linking, where relevant, patient-leveldata from multiple sources, the evidence hub overcomesthe limitations of assessing outcomes using a single datasource. This distinguishing feature allows specific businessand research questions to be addressed that can only beadequately answered by identifying and integrating datasources that fully reflect the real-world patient journey.

    VALUE ALREADY BEING REALIZEDThe integrated platforms have delivered early andcontinuous value to franchise teams across a number ofdimensions, such as:

    Novel studies & external credibility: Execution ofobservational studies, for conference abstracts andpublications, centered on disease knowledge, patternsof care, clinical and safety outcomes, and comparativeeffectiveness (CE) research, with a recent chronic diseaseplatform leading to five publications within the firsteight months of platform creation.

    Internal validity & alignment: Monthly delivery of over20 analytical metrics (in an excel dashboard) on data tiedto key brand and market performance indicators, suchas evolving dynamics in treatment switching, line oftherapy, and discontinuation; relapse benchmarkingand population profiles.

    Timeliness: Ability to respond to payer requests foradditional CE evidence in less than two weeks, therebyavoiding costly market access delays.

    Cost efficiencies: Efficient hypothesis generation and testing.

    WHERE TO NEXT?After the foundational data integration and platformcreation phase, the next question becomes how to scale thedata and analysis capabilities:

    Scaling data access through strategic sourcing:A core capability of these platforms is IMS Healths abilityto strategically source deeper and richer clinical dataacross geographies to address evolving client needs andfill existing data gaps. Depending on the specific therapy area, this can include gaining access tostructured clinical data on disease severity, progression,or outcomes from specialty clinics to link to existingclaims based in the evidence hub. It can also includesourcing clinical endpoints and attributes fromspecialists or specialty clinics across a number ofgeographies to link to existing administrative datasets.

    FIGURE 1: EXAMPLES OF LINkED DATA MARTS DEVELOPED BY IMS HEALTH

    Hematology/Oncology

    Nephrology

    Neurology 1

    Ophthalmology

    Neurology 2

    Oncology

    Diabetes

    Pharmacy claims

    Medical claims

    PharMetrics Plus

    Electronic Medical Records

    Laboratory data

    Hospital charge data master

    Mortality data, patient surveys

  • ACCESSPOINT VOLUME 4 ISSUE 7 PAgE 3

    COMPREHENSIVE DISEASE RECORDS | NEWS

    New linkage of patient data heralds significant disease-focused research potential withpreviously unavailable clinical detail on the patient continuum of care in the US.

    IMS Comprehensive Disease Records complete US patient journey

    As a committed partner in the life sciences, IMS Health has invested in creating disease-specificofferings that combine patient-level data across US settings of care for researchers focused onspecific therapy areas. Leveraging IMS patented, HIPAA-compliant matching technique, newComprehensive Disease Records make it possibleto track patients across their treatme

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