Confidential - Quintiles and IMS Health
Alliance Filed by Quintiles Transnational Holdings Inc. pursuant to Rule 425 of the Securities Act of 1933, as amended, and deemed filed pursuant to Rule 14a-12 of the Securities Exchange Act of 1934, as amended Subject Company: IMS Health Holdings,
Inc. Commission File No.: 333-211794 The following presentation will be used by representatives of Quintiles Transnational Holdings, Inc. in meeting with customers regarding the real-world evidence alliance between Quintiles and IMS Health Holdings,
Inc. and joint offering for enriched studies:
Enriched Studies Quintiles-IMS Health
Real-World Evidence Alliance
Confidential - Quintiles and IMS Health
Alliance
Confidential - Quintiles and IMS Health
Alliance
Confidential - Quintiles and IMS Health
Alliance
Confidential - Quintiles and IMS Health
Alliance
Note on IMS Health-Quintiles Pending
Transaction IMS Health and Quintiles announced a transaction on May 3, 2016 This transaction is very exciting. But it is subject to certain regulatory approvals, shareholder approvals and customary closing conditions. It is expected to close in the
second half of 2016. Until closing, IMS Health and Quintiles will remain separate and independent. It remains “business as usual” at both companies. IMS Health and Quintiles will continue to operate separately and independently, just as
in the past. Please continue to contact IMS Health about its offerings and Quintiles about its offerings. Please do not contact either company about the other’s offerings. IMS Health and Quintiles announced an “Alliance” in Oct.
2015 to collaborate on engagements that involve certain late stage offerings. This Alliance is separate from and pre-dates the proposed transaction. Nothing will change about the Alliance until closing. The Alliance will keep operating in a manner
consistent with past practice. IMS Health and Quintiles will continue to serve existing customers and consider opportunities to address additional customer needs through the Alliance. IMS Health and Quintiles of course will also continue to serve
customers outside of the Alliance, including both individually and in other partnerships as appropriate.
Traditional trade-offs of observational
studies Retrospective analysis Prospective data collection Pros Large data sets Real-life patterns Analysis can uncover new insights Control around collected data, confounders, sample size Focus on hypothesis Cons Data verification/ quality issues
Incomplete data Time lags Coding issues Costly, time-consuming Smaller sample sizes Delays in initiation due to recruitment
The real-world landscape is changing
Challenges facing real-world evidence generation Sponsors need to generate better data, reduce inefficiencies and maximize value Regulatory needs: Regulatory requirements and conditional reimbursement Electronic health data: Increased availability
and opportunities Patient-centricity: Heightened focus on insights collected from patients directly Growing multi-stakeholder demands: Stakeholders are demanding stronger evidence to answer more questions
The solution: Enriched Studies Use
retrospective analysis to characterize patient populations, assess feasibility for the study Generate insights from rich RWD about treatments and patients Use learnings to design practical, optimal prospective study Target appropriate sites for
prospective study Collect data prospectively to complete insights Recruit physicians, sites for participation Collect new data through EMR, patient reported outcomes (PRO) and directly from physician (e-CRF) Gather targeted data not typcially
collected Combine the best of retrospective and prospective research
How Enriched Studies work in practice
Retrospective Analyze RWD to form the foundation of the analysis “Bridge” Use retro learnings to make a better prospective study Prospective Collect and analyze new data Identify data sources Extract needed data Create database for
analysis Analyze to establish current situation Quality insights could be published First data capture from patient (ePRO) and physician (eCRF) Follow-up data capture from EMR, ePRO, eCRF Combined EMR, e-CRF and PRO datasets are analyzed Assess
quality, variability issues of EMR data Verify feasibility of prospective data collection Provide input into protocol and study design Select sites Recruit patients
Integrated multi-source data for a
comprehensive patient view EMR data Other datasets (e.g. claims) Study database EMR “backbone” Aids patient recruitment Provides core patient information Retrospective Prospective study EMR data Other datasets (e.g. claims) Data
collected directly from MD (e-CRF) Patient reported outcomes (PRO) E-CRF and PRO provide supplementary data on variables not in EMR, including QoL Linkage and de-ID patient information Final study database linking all data sources
Quintiles-IMS Health collaboration Key
study steps Objective Finalize protocol and study planning by using secondary data integrated with site expertise Reduce timelines with patient targeting and optimize eCRF design to reduce the site burden Provide fit-for-research integrated data
sources with on demand analysis tools Recruit physicians with target patients, meeting study criteria (e.g. representativeness) Integrated approach Optimize protocol via RWD analysis to minimize amendments 530m patient records 13+ countries
Recruitment modelling for study planning Design sample to meet study requirements (e.g. representative-ness) Prioritize target physicians (prescribing / Tx of target population; historical performance) Enroll physicians manually or via portal Build
EDC tools per data spec; pop-up or web-based EMR infra. for patient enrolment, data collection, at point of care Data extraction (EMR, EDC, PRO) and validation Data integration and linkage using tokenization Merging into an integrated study dataset
1 2 3 4 A joint approach to study execution Study design & planning Site & physician identification Study execution Data integration and analysis
Applying enriched RWD studies Initial
perspectives on applications – for discussion: Strong foundational data, where most of the data is complete but key variables are not collected electronically; can enrich for the last 10-20% of data, rather than gathering all the data through
eCRF TAs where the patient perspective through capture of PROs is critical; enable linkage of PROs to clinical data Chronic diseases where long-term follow-up is required to evaluate outcomes; electronic follow up reduces drop-out and is less costly
Data from disparate sources required, such as deep clinical information combined with full healthcare resource utilization costs What other RWE applications or challenges with existing RWE methods that the enriched approach could address? Key
Benefits Stronger evidence Enhanced study value Improved probability of success Efficiency
Achieve better patient outcomes with an
innovative approach
Appendix
Alliance capabilities: Synergies
provide the best solutions Project Management Unified global coordination and project management; single contact point for project management and contracting Early collaboration on the research design & data collection approach Full scale of
analytic methods and data sources to meet study needs (i.e. full retrospective, enriched prospective RWD, and full prospective) Real-world & Late Phase operational expertise: site start-up, site management and monitoring, regulatory submissions,
and quality management systems (96K+ sites, 810+ enrolled patients, 100+ countries since 2011) Scientific and therapeutic expertise (1,100 MDs, 1,050 PhDs), commercial acumen Seamless integration of primary and secondary data via linkable
information architecture Global data management consistency and coordination Data Integration Software for Study and Analysis applications including direct-to-patient solutions (Evidence 360™, Quintiles Infosario® platform) Access to
500m+ de-identified patient records from sources including EMR, pharmacy systems, hospitals, payers and governments across 18+ countries Global relationships with research sites for primary data collection Integration of the voice of the patient
with other sources of data Analytics / Expertise Technology Information / Data
Study Applications for Quintiles-IMS
Health Alliance A tailored approach to evidence planning and generation, combining best in class evidence generation approaches allowing clients to use and re-use information efficiently and consistently across multiple departments (Medical Affairs,
Clinical Development, HEOR, Market Access, & Commercial Teams and geographies around the world) Drug Utilization Studies Enriched RWD Studies Evidence Hubs Combine existing healthcare data (e.g., EMR, claims) with primary data collection (e.g.,
eCRF, PRO) into a single study, to address one or more research questions, creating robust and meaningful multi-purpose evidence. Innovative benefit risk programs including PASS/PAES study design with full spectrum primary and secondary data
collection for monitoring and measuring safety and effectiveness to meet regulatory requirements and stakeholder objectives Multi-asset and geo-scalable evidence platforms leveraging secondary data with additional primary data collection (e.g.,
PROs, deep clinical information). Typically specific to a therapeutic area.
Our Solutions: Drug Utilization Studies
(DUS) Innovative benefit risk programs including full spectrum primary and secondary data, PASS study design and execution for monitoring and measuring safety and effectiveness to meet regulatory requirements and your stakeholder objectives
Efficiencies leveraged in: Sampling frame Risk minimization surveys Cost (unified approach vs. multiple standalone projects) Broad access to expertise for the optimal design of your Risk Management Plan for increased regulatory success The most
comprehensive primary and secondary capabilities available to meet your post-authorisation study needs Benefit - Risk Management (BRM) • Benefit Risk Management and Regulatory Consulting • Database feasibility for PASS conduct PASS
• Database analyses to inform site sampling approach. • Effectiveness of risk minimization measures surveys • Primary data capture study full service design and execution • Effectiveness of risk minimization measures surveys
Synergistic Offerings PAES, National DUS, Site sampling, Hybrid studies, Prospective BOI, treatment pattern and CER studies DUS Chart Review DUS Database Study • Database analyses to inform site sampling approach • Secondary data capture
study full service design and execution • Secondary data capture study full service design and execution • Design consulting on a case by case basis
Our Solutions: Enriched RWD Studies
Enhanced value of study insights Optimize collection of data needed to address critical questions by leveraging existing secondary data from health IT systems, supplemented by prospective collection Faster access to insights from secondary data
enabling early publications Streamlined execution Informed study design, feasibility, prospective collection needs, site selection & recruitment Enhanced patient follow up Integration of patient-reported outcomes & clinical assessments
Enriched RWD Studies expand the value of large, long-term studies: Healthcare Data Primary Data Primary Data (Examples) Physician Reported (eCRF) Patient Reported (PRO) Linkage & de-ID Study Dataset Healthcare Data (Examples) EMR Hospital Payer
Claims Pharmacy Claims Study Extracts Study Start Examine Risk Factors & Demographics Enriched Prospective RWD Studies Enriched Prospective RWD Studies may also include a “mosaic” approach with data source varying by country Enriched
Prospective RWD Studies combine existing healthcare data (e.g., EMR) with primary data collection (e.g., eCRF, PRO) in a single study to address one or more research questions, creating stronger evidence and faster insights while reducing site
burden
Our Solutions: Real World Evidence Hubs
Multi-asset and geo-scalable evidence platform leveraging secondary electronic data with supporting analytic tools, providing integrated view of outcomes and treatments Addresses gaps in analytic information, speed of evidence generation &
response Efficiency in evolving to more tailored information sets, including prospective data
Timelines Streamline study execution
& patient recruitment through improved physician and patient targeting, protocol feasibility and optimization Patient-centricity Enrich existing data with patient-reported data and database driven and site based feasibility Participation Improve
site and patient participation by reducing data collection burden and errors and assess site study participation interest and recruitment through EMR linking. Provide patient reminders and data clarification needs for ongoing PRO collection
Innovation Create integrated data platform for ongoing analyses and access central data management, including site data ETLs, quality controls, integration through encryption The benefits Bringing together the best of both worlds: combining
retrospective and prospective data collection methods generates greater insights and stronger evidence with increased efficiency Value Increase ROI by answering multiple questions for multiple stakeholders through a single study Earlier insights
Generate greater insights and extract value sooner by leveraging existing healthcare data Evidence Generate stronger evidence and improve validation of exposures and endpoints with greater understanding of disease with combined retrospective and
prospective data
Case study: Enriched RWD Epidemiology
Study Delivered through IMS and Quintiles Collaboration Primary objective: describe disease management patterns and clinical evolution over 3 years in type 2 diabetes patients initiating a 2nd line anti-diabetic treatment Scope: 30+ countries
Required expertise: RWD and retrospective; prospective observational research; scientific expertise Approach Tailored approach based on country-specific capabilities. IMS and Quintiles lead the approach for specific countries playing to each
company’s respective strengths In a subset of countries, the methodology leverages foundational EMR to collect baseline data and collects supplemental information needed for the study as an eCRF pop-up; data from the EMR systems does not need
to be re-collected in a CRF, creating efficiencies. This approach also facilitates patient recruitment and long-term follow up by establishing an automated system for data extraction in the out years while minimizing site burden Two coordinated
teams. Project teams bring distinct areas of expertise and come together under the same objectives, protocol and sharing research results and analysis to complete a single, cohesive study
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