Benefits and Challenges of Patient Record Methodologies in Emerging Markets

Aarti Shah, Team Executive Jeff Glor, Team Executive

BioVid Corporation

The Focus on Emerging Markets

Pfizer signaled the importance of emerging markets to its future earlier this year when it became the first big drug maker in the US to break out its drug sales [for those] countries. In recent months, its been making deals with companies like a $238 million agreement in October with a Brazilian generic-drug maker in order to build its line-up of products that patients abroad can afford. The margins in emerging markets (are) at least as good, and in some cases better than in Europe 50% of what we make is sold in emerging markets.

Abbott also announced the formal creation of a stand-alone Established Products Division (EPD) concentrated on expanding the market for Abbott's established pharmaceutical portfolio outside of the U.S., particularly focused in emerging markets. GSK's efforts in Brazil build on the company's strategy to increase its presence in emerging markets, particularly in the vaccines space. The key reason for this strategy lies in the sizable (and largely untapped) market opportunities for vaccines in emerging economies.

The Focus on Emerging Markets

Emerging markets constitute 20% of the world economy, but 80% of its population.

In 2010, 17% of Pfizer sales were in EMs; for Merck it was 18%; for Abbott, almost a quarter. About 50% of growth in the pharma industry is predicted to come from emerging markets by 2013 (from IMS Health).

Who are we talking about?

Outline for this Discussion

Challenges/Potential Pitfalls of Patient Record Research in EMs

Benefits of Patient Record Research in EMs

Case Study Examples

Outline for this Discussion

Challenges/Potential Pitfalls of Patient Record Research in EMs

Benefits of Patient Record Research in EMs

Case Study Examples

Challenges of Market Research in EMs

In truth, many of these are inter-related, and cultural & infrastructure issues can exacerbate patient record-specific challenges.

Cultural Challenges of Research in EMs

Language
Cultural interpretations of words like severe

Perception of the importance of MR & norms/attitudes regarding time

Show rates Timeliness

Differential response biases

Social desirability Acquiescence Use of scale extremes

Differential acceptance of developed countrybased guidelines and scoring systems

MR Infrastructure Challenges of Research in EMs

Variable quality of translation & translation checking services Less clarity in overall market dynamics Lack of secondary data Less developed recruiting databases Respondents less savvy/familiar regarding market research Need for different or mixed methodological platforms

Patient Record-related Challenges of Research in EMs

Different patient record information Confidence in random record pull Challenges due to low incidence Greater concern about privacy of patients, and physicians as well Accessibility of patient records Skewing of patient pool due to SES

Outline for this Discussion

Challenges/Potential Pitfalls of Patient Record Research in EMs

Benefits of Patient Record Research in EMs

Case Study Examples

Benefits of Patient-record Research in EMs

We may know less about the mindset of EM physicians and how they make treatment decisions
In these situations, a bottom-up process can be advantageous

We may also have less clarity around the structure & workings of physician practices in these countries
A patient-level approach may provide a more consistent, grounded context in which physicians can respond

Benefits of Patient-record Research in EMs

Patient-level data can be used to produce surrogates to developedcountry treatment guidelines/scoring systems & to tailor communications to a different worldview With multiple patient records per respondent, we multiply the number of observations on which inferences & conclusions are based Where secondary data are sparse or unreliable, unique analytics of patient-record data can fill gaps

Outline for this Discussion

Challenges/Potential Pitfalls of Patient Record Research in EMs

Benefits of Patient Record Research in EMs

Case Study Examples

Case Study 1: Virology

Core given several likely product profiles and several possible future market Objective

To determine the likely global demand for a future anti-infective product conditions (e.g., availability of additional new products).

Patient Chart Selection

Random patient pull for patients diagnosed with the specific condition and currently still suffering from the condition (i.e., not successfully treated for the condition in the past)

Challenges
Several related to varying medical practice:
Treated patient varies due to use of traditional (non-pharmaceutical) medicine Differing proportions/profiles for nave vs. treated patients Limited clarity as to which specialties are making the appropriate treatment decision

Case Study 1: Virology

Patient Ownership
Mitigation of cultural differences in defining patient management and authority over treatment decisions Able to overcome country/ cultural differences in definitions of eligibility/ ineligibility for treatment Reasons for classification elucidated

Patient Categorization

Outcomes Derived from Patient Record Methodology

Sizing of Patient Categories

A more granular assessment allows subsequent size to be less culturally variable

Case Study 2: Neurology

To estimate the commercial viability (sizes) of patient segments within the current market and future market environment that may include multiple Core Objective new products. To profile each segment to assess physician prescribing by segment and identify patient characteristics by segment.

Patient Chart Selection

Purposeful selection by disease subcategory, but randomization of treatment status within sub-category

Challenges
Cultural, infrastructure-related, and chart-specific challenges:
Limited physician experience due to very low incidence of disease and by higher levels of untreated patients Varying treatment algorithms/product availability/use from country-to-country Brand availability restrictions biases HCP ability to predict future prescribing behavior Unique confidentiality/privacy concerns about patient information and related physician information

Case Study 2: Neurology

Patient Profiling & Sizing of Patient Categories
Profiling of patients on the factors that represent clear drivers of therapy selection that physicians were not able to articulate More accurate segment assignment and sizing across all patient records collected A clearer context on which to evaluate country-tocountry differences in paradigms and patient types, over and above differences based on brand availability

Outcomes Derived from Patient Record Methodology

Cross-country Comparison

Case Study 3: Oncology

Core patient & treatment flow, detailed usage information and treatment Objective

To provide an in-depth exploration of the market landscape, encompassing outcomes.

Patient Chart Selection

Patients who have completed at least 1 line of therapy for metastatic disease within the past year, but who may still be receiving subsequent treatment

Challenges
Substantial hurdles exist with this tumor type in EMs Very low incidence tumor type (physicians may only have 1 or 2 patients) Access to patient data (and physicians in some cases) requires administrative clearance at the Director-of-Hospital level Poor Internet access potentially limits the level of complexity in the survey

Case Study 3: Oncology

Patient Categorization
Allowed collection of both the subjective assessment of risk and the specific lab values used to calculate a Developed-market risk score and to understand the disconnect between the two scores Provided insight into tailoring physician education materials to reframe product positioning as appropriate Allowed for clear understanding of the sequencing of treatment across lines of therapy, as well as:
Describing variations in treatment selections by patient types Determining the match of actual sequencing vs. ideal sequencing (if cost/access was not an issue)

Outcomes Derived from Patient Record Methodology

Sequencing of Therapies

Top Tips for Research in Emerging Markets

Ensure that the purpose of the survey and how the data will be handled, as well as respondent confidentiality, is explained clearly to potential respondents Consider multi-modal interviewing to achieve sample sizes almost plan for the eventuality in survey design Need to have some flexibility with regards to schedule - in some markets, multiple appointments may need to be made with each potential respondent Exclusion based on past participation in market research may not be possible/compromise sample size achieved if there is a limited pool of potential respondents If conducting tracking work, exclusion of previous-wave participants may not be possible if there is a limited pool of potential respondents Be sure to consider major holidays that can completely close down market research efforts on the research schedule (e.g. Ramadan, Chinese New Year) Check whether access to hospital-based respondents may require approval from the hospital Generally quantitative surveys lasting more that 45 minutes are less acceptable in Emerging markets (perhaps even shorter for online surveys) In general, be prepared to challenge your assumptions about any standard operating procedures to which you have become accustomed!

BioVid Corporation
Princeton, NJ 609.750.1400 www.biovid.com