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Our Understanding of the
             Global Blueprint for Patient Adherence




              Establishing a global positive health outcomes framework through
                scalable, measurable, cost effective patient-centric programs

Gaurav Kapoor                                                   Shakun Gidwani
Head, Strategic Marketing Solutions                             Director, Strategic Marketing Solutions
Page 2 of 16   Our Understanding of the Global Blueprint for Patient Adherence
Background
                                                                                                                            The global pharmaceutical industry is presently undergoing a
                                                                                                                            phase of significant transformation which in turn is impacting their
                                                                                                                            strategies and challenging them to think differently and thereby
                                                                                                                            align better to their consumers and prescribers. It’s imperative for
                                                                                                                            us to realize that the health economic equation across the globe is
                                                                                                                            rapidly changing and we view some of the following changes will
                                                                                                                            redefine the role of different stakeholders.


                         Number of drugs approved by US FDA A systemic decline                                              Continuity Evidence
 40                                                                                                                         FDA approval process on drugs is becoming more stringent.
 35
 30                                                                                                                         The number of drugs getting approved over the years has seen a
 25                                                                                                                         significant decline.
 20
 15                                                                                                                         More drugs are hitting the recall list these days. As CNN Money
 10                                                                                                                         reports, the number of recalls hit 1,742 last year--that’s an
   5                                                                                                                        increase of 309 percent over 2008.1
   0
                         2000 2001       2002    2003    2004     2005        2006     2007     2008                        Issues and warnings around the ban of Avandia and Actos, Vioxx,
                                Number of drugs approved by US FDA: A systemic decline.                                     MyLotarg etc. seem to indicate need for data on drugs.
                                         Adapted from the Wall Street Journal.




                           The Pharma innovation gap-increased R& D spending                                                Revenue Leakage
                                     yielding lesser drug approvals
                                                                                                                            Large number of drugs nearing the patent expiry period. Weak
                          $60                                                                   50
                                                                                                                            pipelines with fewer molecules available that can be positioned as
 Pharma R&D ($Billion)




                                                                                                       New Drug Approvals




                          $50
                                                                                                 40                         block busters.
                          $40
                                                                                                 30
                          $30                                                            Pharma
                                                                                       Innovation                           Data indicates that major pharmaceutical companies will lose
                                                                                          Gap     20
                          $20                                                                                               between 15 – 40 % of their revenues as they approach patent
                          $10                                                                    10
                                                                                                                            expiry.2
                           $0                                                                    0
                                1992 1996 2000 2001 2002 2003   2004   2005     2006   2007                                 Since, pharmaceutical companies will have very few launches in
                                   Pharma R&D Investment         BioPharm R&D Investment                                    their key therapeutic focus groups, strategic focus to maximize
                                              New Drug Approvals by US FDA                                                  returns through better ROI per patient and also strengthening
  Source: Pharmaceutical Research and Manufactures (PhRMA) Annual Report
                                                                                                                            health outcomes data Pharma companies need to minimize
 2007; Burill & Company Report 2003; PhRMA Annual Member Survey, 2007: US
                    Food & Drug Administration Databases.                                                                   revenue leakage by locking in consumers on brand.




                                                                                                                            Market Access
                                                                                                                            Emerging markets are growing in size. The policy makers and
                                                                                                                            payors in these markets need substantial data around cost versus
                                                                                                                            benefits to allow access and re-imbursements. They look for cost
                                                                                                                            benefit ratios to allow for drug launch and re-imbursement and
                                                                                                                            co-pay coverage.




Page 3 of 16                                                                                                                                     Our Understanding of the Global Blueprint for Patient Adherence
Top 14 Pharma markets, 2005                                              Top 14 Pharma markets, 2015                            Critical for pharma companies who want to lock in customers across
                US (248)                                                         US (444)                                            regions before any competitor gains access to the same market.
                Japan (68)                                                       Japan (82)                                          Health outcome data captured through 12-24 months. Data can be
                                    France (32)                                                      France (46)                     an extremely important differentiator from a region can provide a
                                    Germany (31)                                                  Germany (38)
                             Italy (20)                                                           China (38)                         better case for gaining access into other larger markets.
                            UK (19)                                                             UK (32)
                         Spain (14)                                                          Spain (25)
                         Canada (13)                                                         Italy (25)
                         China (13)                                                          Canada (25)                             Non adherence to prescription medication regimens, especially for
                        Mexico (10)                                                         India (20)                               chronic therapy areas is seen to have severe implications in terms
                       Brazil (9)                                                          Brazil (20)
                                                                                                                                     of patient health outcomes and increased costs to the The patient
                      South Korea (8)                                                      Mexico (19)
                      Turkey (7)                                                         South Korea (15)                            as well as the healthcare system. It is now being viewed as a very
                     India (6)                                                           Turkey (15)                                 serious issue globally, to the extent that in the United States, it is
                                                                                                                                     referred to as ‘America’s other drug problem3’.
   Figures in $billion
   Source: IMS World Review, analyst projections,                                                                                    National Council on Patient Information and Education (NCPIE),
   McKinsey India Pharma demand model.
                                                                                                                                     which is a non-profit coalition of more than 100 organizations, has
                                                                                                                                     even released a 10-step action plan4 to reduce the adverse health
                                                                                                                                     and economic consequences associated with this growing public
                                                                                                                                     health threat.

                                                                                                                                     To effectively address all the above discussed market pressures,
                                                                                                                                     our industry has started to take steps to strengthen disease
                                                                                                                                     management ecosystems by measuring and analyzing long term
                                                                                                                                     health outcome data, integrating various stakeholders to manage
                                                                                                                                     outcomes and seamlessly transmitting data across various
                                                                                                                                     synaptic points.

                                                                                                                                     As we move into a new landscape where patients, payors and
                                                                                                                                     policy makers take an extremely critical role in decision making
                                                                                                                                     process, pharma industry’s role is extending beyond marketing to
                                                                                                                                     physicians. Providing each player with strong credible case for
                                                                                                                                     drug support becomes an important function for pharma today.


                     100%                                                                                                            Current Landscape and Insights
                     90%
                     80%                                                                                                             According to the World Health Organization, of the 1.8 billion
Percent persistent




                     70%
                                                                                                                                     prescriptions dispensed every year, only 50% are taken correctly
                     60%
                     50%                                                                                                             by the patient. Along with poor individual health outcomes
                     40%                                                                                                             and increasing mortality rates, medication non adherence has
                     30%
                     20%
                                                                                                                                     significant economic ramifications. Non adherence in chronic
                     10%                                                                                                             disease areas with prescribed medication regimens continue to
                      0%
                            0   30 60     90 120 150 180 210 240 270 300 330 360 390 420 450 480 510 540 570 600 630 660 690 720
                                                                                                                                     result in pharmaceutical companies losing revenues for brands to
                                Oral antidiabetics     ARBs       Statins     Bisphosphonates    Prostaglandins    OAB medications   the tune of billions of dollars. It can be directly linked to as much as
                                                                                                                                     $290 billion annually in increased medical costs and is responsible
                                                                Days
                                        Time to Discontinuation of Six Chronic Drug Classes3                                         for 33% to 69% of all medication-related hospital admissions, at a
                                                                                                                                     cost of about $100 billion per year.5




Page 4 of 16                                                                                                                                               Our Understanding of the Global Blueprint for Patient Adherence
While there are many patient support and assistance programs
               available, they may not be able to address the requirements. The
               key challenges that plague these programs pertain to unification
               of stakeholders, execution, definition of relevant success
               metrics, and replication across geographies. Some of these
               challenges precipitate from the fact that programs are executed
               at individual brand levels and may not be necessarily aligned to
               the overall regional or global strategic imperatives defined by the
               organization.

               To quote some figures that measures the existing programs:

                  •	 Evidence         states       that   it     costs     less
                       dollars     to       retain      a    patient    versus
                       acquire new patients. As an industry, we spend only 3%6
                       on a patient which is rather shocking considering that
                       they are more informed decision makers today and an
                       important stakeholder to drive criticality of managing
                       revenue leakage due to non-adherence.

                  •	      7 out of 10 programs are dropped after 8-12 months
                       because of lack of patient data on adherence and low
                       interest by doctors.7

                  •	 Findings from expert interviews propose many key design
                       principles for successful adherence programs, including
                       suggestions to tailor overall intervention strategies based
                       on patient segmentation as attitudinal and behavioral
                       barriers vary widely among the patient population.8

                  •	 Integration of multiple stakeholders (physician, nurses,
                       pharmacists and practice care assistants) is essential for
                       adherence to medication, especially for adherence in the
                       prescription medication regimen while also increasing
                       patient-centricity. With physicians and pharmacists part
                       of patient recruitment cycle one can expect a jump in
                       the numbers of enrolments on a program in the range of
                       17–36 %7 based on regions and disease type.

                  •	 Most patient support programs go unnoticed due to poor
                       visibility among patients and influencers7. Capitalize on
                       stakeholder relationships to improve communication and
                       ensure continuous contact with the patient and maintain
                       and develop this established relationship to address
                       patients’ concerns and provide support.

                  •	 Most patients may initially engage in support programs for
                       the incentives but tend to lose connect if the program does
                       not add value to management of their health outcomes,
                       although a majority of patients can be motivated to stay on
                       therapy through education and peer support.7

                  •	 There are few or almost no programs that leverage profiling
                       and segmentation approaches for patients or capture
                       metrics across the program lifecycle to assess progress.



Page 5 of 16                        Our Understanding of the Global Blueprint for Patient Adherence
•	 In certain drug categories pharmacists9 play the role of
                                                   an advisor and hence it is key to loop them in the patient
                                                   recruitment and education cycle.

                                               •	 Reasons for non-adherence although varied are relatively
                                                   simple and can be tackled through pointedly addressing
                                                   individual patient concerns.7

                                               •	 Consumer studies indicate increasing numbers of patients
                                                   leverage the internet to understand more about their
                                                   disease condition and actively research their prescription
                                                   medications.10

                                            Most of these programs don’t have aggressive drives to recruit
                                            patients and other stakeholders in the ecosystem. The template
                                            should be designed keeping the strictest requirements in mind and
                                            then giving the flexibility to the local affiliates to adapt within those
                                            boundaries.

                                            Patient support programs, while being integral to patient engagement
                                            strategies, continue to pose a dilemma to pharmaceutical
                                            companies on decisions pertaining to investments. With “more for
                                            less” being the order of the day, optimized communication mix that
                                            yield maximum returns is desired by pharmaceutical companies.


                                            Critical Factors for a Developing a Successful
                                            Blueprint
                                            Over the years Indegene has worked on hundreds of patient
                                            support programs for brands across the globe in varied therapy
                                            areas. In our opinion there are some very critical factors that need
                                            to be reviewed and managed when defining a global blue print for
                                            a program.

                                            Patient Profiling and Segmentation: Patient 360

                                            Each patient is unique and has specific challenges from a disease
                        Patient profiling
                                            outcome management perspective. It is important to look at these
                        & Segmentation      varied perspectives and engage with them as “individuals” and
                                            not as “ideals.”

                                            Patient behavior is influenced by multiple factors. These can be
       Cost effective
                                            broadly categorized on a two-dimensional axis under “Degree of
      balance between                       Difficulty”11 versus “Level of Enablement.”11
       global & local
        frameworks
                                            Degree of Difficulty is defined as the demand of managing a disease
                                            and treatment placed on a patient. A patient’s degree of difficulty
                                            may be influenced by several factors such as nature of the disease,
                        Mechanisms to       co-morbid conditions, treatment complexity—duration, time, and
                         capture data
                          & analytics       response, and economic access which is financial and logistical
                          to measure        access to treatment.




Page 6 of 16                                                      Our Understanding of the Global Blueprint for Patient Adherence
Level of Enablement is the capacity of the patient to address the
               demands of disease and treatment. Patients’ level of enablement
               is influenced by demographic factors (e.g., age, level of education,
               and economic status). It could also be influenced by cognitive and
               psychosocial aspects of the patient.

               Considering all the above factors, the patient personalization
               metrics becomes quite varied in terms of the number of attributes
               one need to track and leverage for engagement on their disease
               management continuum. Indegene’s proprietary framework
               Optimax allows for the calculation of the individual risk levels for
               each of these profiles over a period of time and track how individual
               patients are faring over these profiles. Based on this, personalized
               engagement plans are drawn that are not only relevant to the
               patient but also impact their health outcomes.

               Data is collated on an ongoing basis while patients are engaged on
               a therapy program through patient surveys, electronic health record
               systems, and interactions with different program components, for
               example, the number of times a card was swiped or discount
               coupons downloaded to buy refills. It is important to ensure that
               there is flexibility to capture information through different systems
               that feed into profiling the patient into different segments and
               further managing them as individuals within the segment.
                  •	 Self-Sufficiency11: Bringing patients to a stage where
                      they can manage the low demands of their disorder/
                      treatment. Let us look at patients who have been recently
                      diagnosed with diabetes and are at the initial stage of their
                      therapy. In addition to this, they may not have a high level
                      of enablement. The primary goal for this category would
                      be to ensure that one is able to motivate this group to take
                      their diabetes medications and also provide them with
                      educational resources and promote diabetes awareness.
                      Providing them with reminders and empowering them with
                      a basic level of education and ensuring timely refills along
                      with some self-help tools like BMI calculators, diet engines
                      etc. could assist in their adherence journey.

                  •	 Proactive     Efficiency11: Manage preventive and
                      screening processes as well as contemporary treatment.
                      For instance a section that may still be in the early
                      stages of diabetes, and they are empowered with
                      means to connect and draw relevant inputs from their
                      ecosystem with ease. This group would require early
                      diabetes awareness and risks of non-adherence at a more
                      microscopic level. Lab values like HbA1c levels, TCH,
                      LDL values and other significant ones would need to be
                      captured and updated on a regular basis.

                  •	 Treatment      Congruency11: Achieve the patient’s
                      cooperation with the treatment team and acceptance
                      of the above average amount of assistance required.
                      As an illustration, this consumer base would consist



Page 7 of 16                        Our Understanding of the Global Blueprint for Patient Adherence
of a relatively older group who has lived with diabetes
                      for a longer duration. Sharing information on the
                      importance of controlling their diabetes by making certain
                      lifestyle changes like incorporating exercise into their
                      daily routine, following a recommended diet plan
                      etc. would be of assistance. Motivational counseling
                      through qualified health coaches, capturing and
                      monitoring relevant lab values on a regular basis along
                      with tools for tracking their condition and facilitating
                      interactions with their physicians would be of great
                      benefit to this group.

                  •	 Sustained Effectiveness11: Maintain high levels of
                      adherence to successfully improve outcomes and sustain
                      their progress. Drawing for diabetes as a therapy area,
                      this set of people would have been on therapy for a
                      relatively longer period of time with comorbid conditions.
                      In this case, ensuring relevant lab values like HbA1c
                      levels, triglyceride, LDL and HDL levels along with more
                      intensive tests for advanced stages of diabetes like
                      routine eye checks, feet checks, monitoring for co-
                      morbid conditions like nephropathy, cardiovascular
                      disease etc. While they may have the means to
                      manage their condition rightly, the key here would be
                      to provide them with evidence and reports on positive
                      health outcomes.


               Multiple Channel and Stakeholders
               Success at different stages likes recruitment, collation of data,
               engagement to drive adherence and hence a positive health
               outcome is important for a patient support program. Considering
               the varied nature of the disease, market considerations and profile
               of patients it’s important to ensure that one is able to offer as much
               flexibility as possible to support interactions with patients. Voice,
               email, web, text messaging, eFax, direct mailing, scan and capture
               techniques are some of the approaches that one can look at to
               offer patients the option to engage based on their convenience.
               Intelligent configuration of these for a patient support program
               allows for end goals to be met irrespective of whether a patient
               chooses to use one or more of these channels or not.

               For instance, leveraging multiple channels like voice
               support, email, web text messaging, direct mailers
               etc. to provide refill reminders, educational awareness
               material and health assessment surveys for patients in the
               ‘Self-Sufficiency’ group is critical since they may
               have access to fewer numbers of channels; while the
               ‘Treatment Congruency’ group would best leverage
               push-based interventions like calls from health coaches along
               with refill and follow-up reminders; support resources and direct
               mailers like educational posters, health system navigation packets
               etc.


Page 8 of 16                        Our Understanding of the Global Blueprint for Patient Adherence
In fact new innovative ways to track and collate patient data and
                                                                                                             provide them education on their mobile devices, through virtual
                                                                                                             health and lifestyle coaches seem to be gaining momentum. Bar
                                                                                                             code data, chips, product packaging etc. are being looked upon by
                                                                                                             early innovators as mediums to capture adherence related data.

                                                                                                             While varied channels may be used the framework also needs to
                                                                                                             offer the flexibility to turn them on and off based on market related
                                                                                                             data and nuances and still not jeopardize or break the framework
                                                                                                             due to the limitations.

                                                                                                             In addition to the primary sources of data secondary, such as
                                                                                                             electronic health record systems, CRMs, also need to be leveraged
                                                                                                             for patients with the hospital environment.

                                                                                                             While channels of engagement is one part of the overall
                                                                                                             engagement aspect one also view a variety of stakeholders are
                                                                                                             beneficiaries of patient’s positive health outcomes. These are the
                                                                                                             payers, pharmacists, physicians, nurses, compliance associates,
                                                                                                             care givers, patient groups and communities. The framework
                                                                                                             needs to offer the flexibility to execute their role in the disease
                                                                                                             support continuum with ease.

                                                                                                             Patients requiring extensive physician time stand to benefit
                                                                                                             immensely from a healthcare ecosystem that includes other
                                                                                                             stakeholders. Qualified HCPs such as pharmacists, accredited
                                                                                                             experts, counselors, and associations, have started playing an
                                                                                                             integral role in patient care.

                                                                                                             A physician can view this information from the perspective of
                                                                                                             monitoring patient progress and accessing their reports, while the
                                                                                                             other partners in the ecosystem like pharmacists can help manage
                                                                                                             refills and educators can assist in providing the right advice to the
                                                                                                             patients. The other interesting emergence as the new stakeholder
                                                                                                             is that of insurance companies. Insurance companies strive to
                  Patient                                                                                    reduce payouts to patients by maximizing patient adherence by
                 Immediate         Patient support system component;
                                                                                                             becoming an equal partner in managing patient health outcomes
                  Network           closest in proximity to the patient in terms
               (Caregiver and        of emotional connect and focusing on the real                           and even incentivize them on managing their health.
                 Physicians)          issues for the patient


                                           Second in line in the support ecosystem in                        All this can be achieved when you have a central framework
                Significant Ties            terms of administrating prescriptions,
               (Pharmacist, AHP)             dispensing medications, and essentially being
                                               responsible for patient health outcomes
                                                                                                             or a platform that allows you to integrate channels, people and
                                                                                                             processes.
                                                     Provide information outside of what is offered
               Empathizers                            by the Significant Ties group based on personal
           (Patient Groups and                         experience; often this category is considered prior
              Communities)                                to or alongside the Significant Ties groupes




Page 9 of 16                                                                                                                      Our Understanding of the Global Blueprint for Patient Adherence
Mechanisms to Capture Data and Analytics to
                Measure
                While the process of engaging patients leverages varied channels,
                to gain maximum benefit from a program the tools to collate data
                points should be equally varied. Patient support programs need
                to leverage the strategic advantages offered by the web, mobile
                solutions, and the human interaction component to allow patients a
                convenient choice of medium. Data should be collated during each
                patient interaction starting from the registration process through
                the entire engagement along with tracking of usage and usage
                duration of the selected intervention medium and evaluating its
                effectiveness against the patient wellness index recorded.

                Once specific program goals have been identified the next step
                would be to look at how these goals are to be measured. Let’s look
                at a patient support program catering to diabetes. For recruitment
                related goals analytics need to demonstrate patient and physician
                volumes segmented by regions. When we talk about tracking
                patient health and diagnostic results, improvement in lab results
                like HbA1c levels, total cholesterol, LDL, HDL, blood pressure,
                hemoglobin etc. and increase in adherence compared to the
                previous intervention would provide suitable measures. Providing
                interventions according to medium of choice would involve tracking
                of usage and usage duration of the selected intervention medium
                and evaluating its effectiveness against patient wellness index
                recorded previously and finally medication adherence outcomes
                can be measured based on test results over a period of time.

                It is common business sense that programs ought to be measured.
                While defining a patient support program, it is critical for a company
                to define what it would consider as ROI and how they would actually
                calculate it. It is recommended that a pilot program be rolled out
                to assess what really works. One could look at starting a program
                with a smaller patient group; understand the impact of different
                elements, and then scale-up to add volumes and regions.

                Define measures—that is the first step. These could either come
                through collation of information directly from a patient or through
                indirect interpretation based on how a patient engages in a
                program.

                Some of the indices to consider could be as follows:

                   •	 Patient Risk Profile Index11: Measured by calculating
                       patients risk profile on a 7 point scale based on their
                       disease condition, Rx pattern, access to medication,
                       cognitive and psychosocial elements, etc. Based
                       on therapy areas, one could define the frequency
                       at which one would want this data to be captured
                       in the system.




Page 10 of 16                        Our Understanding of the Global Blueprint for Patient Adherence
•	 Adherence Index11: The adherence index is often captured
                      and detailed in the form of a patient’s persistence on to
                      medications, refill ratios, medication possession ratios, and
                      proportion of days covered. There are standard and defined
                      formulas that are available and based on the different
                      components of the program; one can decide which of
                      these metrics are actually collated.

                   •	 Brand Belief Index11: The impact and perception of
                      brand among key stakeholders such as pharmacists,
                      physicians, and patients. How your patient support
                      program influence the various stakeholders and how
                      it is perceived by them is critical to understand the
                      success factor and also make calculated investment
                      decisions in the future. Patient support programs are
                      not a burst of one-time activities but continuous
                      engagement with your consumers, prescribers, and
                      influencers; hence the perception and its impact on
                      adherence is critical. Patients with a positive perception
                      in brand are proven to show higher percentage of
                      adherence which in turn has a cascading effect
                      on more physicians not recommending switch. Scores
                      based on persistence, new Rx, health outcomes reports,
                      physician and patient reputation index, and ROI help
                      calculate and assess a brand belief index (BBI).

                   •	 Campaign and Content Popularity Index11: One critical
                      point to measure is how the investment is done by you
                      on engaging a patient being perceived and utilized.
                      Companies may use this decision to further fine-tune
                      strategy and invest right.


                Cost Effective Balance Between Global and Local
                Frameworks
                Having discussed the critical success factors for a program
                one of the key questions to ask is what is all this going to cost.
                Considering the program leverages a range of resources and
                services it is always critical to understand how one can get the
                most out of their buck. This can be ensured by anchoring program
                infrastructure centrally and providing regional controls to enable
                and disable roles and channels and also have the flexibility to
                configure the program framework to market and disease need.
                A simple example could be leveraging web to recruit patients in
                the Asian countries to ensuring a physician desktop channel is
                available to do the same across France and Italy.

                Companies have access to the same CRM tool which can be
                configured with different content assets for an Alzheimer’s patients
                or a diabetes patient. However one may still need to factor for the
                difference in the associates interacting with the patients; in the
                case of Alzheimer’s one could be talking about seniors talking to
                seniors versus diet educators talking to patient for diabetes.



Page 11 of 16                       Our Understanding of the Global Blueprint for Patient Adherence
Selection of channel for ongoing engagements may vary by regions.
                For instance using internet to engage patients in the European
                countries region would work well versus text messaging in some
                other parts of the world.

                The program needs to offer the flexibility of working seamlessly
                irrespective of whether a channel or a role is leveraged across a
                certain region or a therapy area or not.

                It is important to strike the right balance between global and local
                and have the most appropriate Localization map drawn keeping
                market-specific parameters such as channels preferences overall,
                stakeholders to be leveraged and integrated into the patient
                ecosystem and trust loop, and format of education in perspective.

                Having understood the need for a global blueprint, one cannot be
                privy to the fact that there are certain things that would actually
                need to be anchored at a local level. While a central platform helps
                automate and leverage a lot of resources and processes, internal and
                external stakeholders’ involvement is equally critical and so is the
                regional-specific considerations. While one would look at economies
                through a central blueprint, it is equally important to factor these local
                considerations, hence the need to strike the right balance between
                global and local becomes critical. Therefore it is critical to select a
                partner who has a global reach and will provide you local market
                insigts to ensure seamless entry and access to a local market.

                So the obvious question one might ask is where to invest and how
                does one know if it is working. Investing in a patient support program
                requires you to listen to your consumers. What do they really want
                and what of this can you give them? Research indicates that patients
                expect a range of things from a support program as highlighted
                alongside. Having understood this, how does one ensure that
                these services are indeed leveraged by them and help you analyze
                the impact they have on your business and brand. Then comes a
                range of services that remind them, ensure enough data points
                are being collated to demonstrate evidence not just for you but for
                the patients and partners in their ecosystem to prevent switch. So
                how much does one really invest in patients? On average, pharma
                companies should be willing to invest anything between 1% and
                3%12 of their cost per patient on a program to observe results. The
                impact of these measured against different indices such as Patient
                Risk Profile Index, Adherence Index, Physician Engagement Index,
                Brand Belief Index, and Content Popularity Index.


                Rollout Framework
                Now that we know what should be the different measurement
                criteria’s one may consider for a patient support program it is also
                important to see the transition happen at regular intervals to review



Page 12 of 16                         Our Understanding of the Global Blueprint for Patient Adherence
how well aligned the program is towards your business goals.
                Measurement data from the indices and the regular check points
                build will facilitate business decisions to fine tune the company’s
                strategy. In other words your patient support program journeys will
                be validated for progression to the next stage.


                Conclusion
                  •	 The pharmaceutical industry has more reasons and ways to
                       connect with consumers and prescribers.

                   •	 It is not just a product but the services coupled with the
                       product that impact a patient’s health outcome, and this is
                       key to preventing switch by consumers and prescribers to
                       other variants and competitors.

                   •	 Pharma companies should look at investing 3% to 5% of
                       annual ROI per patient on a pilot and subsequent rollout of
                       programs.

                   •	 Any patient support program should lead to 50% adherence
                       over a 3-year time frame.

                   •	 Segmentation and profiling allows for more targeted
                       engagement and helps build program credibility in the
                       minds of the stakeholders.

                   •	 Multiple stakeholders in the ecosystem have to be leveraged to
                       enroll patients on a program.

                   •	 Using the right blend of channels and services is critical to
                       ensure alignment to the consumers, prescribers, and the
                       influencer’s ecosystem.

                   •	 Multiple data sources such as pharmacies, surveys, and
                       virtual health coaches and connects have to be leveraged
                       to get data into the system for meaningful analysis and
                       reporting.

                   •	 Start with smaller patient groups, understand the baseline
                       measures, and scale-up to add larger groups and regions.

                   •	 Impact of patient support programs need to translate into
                       measureable goals outlined in the form of different indexes.

                   •	 It is critical to maximize ROI by leveraging cost-effective
                       platforms that allow for drawing up a global blueprint that
                       can be localized keeping market considerations,regulatory,
                       and other nuances in mind.


                References
                 1 Drug recalls hit all-time high in 2009 - FiercePharma http://www.fiercepharma.
                   com/story/drug-recalls-hit-all-time-high-2009/2010-08-17#ixzz0yGKjo0oP
                 2 AXA Farmington
                 3 http://www.marketwire.com/press-release/Americas-Other-Drug-Problem-Poor-
                   Medication-Adherence-756583.htm



Page 13 of 16                           Our Understanding of the Global Blueprint for Patient Adherence
4 http://www.marketwire.com/press-release/Americas-Other-Drug-Problem-Poor-
                                                                          Medication-Adherence-756583.htm
                                                                        5 2010 Benchmarks in Medication Adherence Results of HIN Monthly E-survey on
                                                                          Trends Shaping the Healthcare Industry.
                                                                        6 Frost and Sullivan. Patient non-adherence: Tools for combating persistence and
                                                                          compliance issues 2005.
                                                                        7 Optimax Business Insights
                                                                        8 http://www.frost.com/prod/servlet/cpo/115071626.pdf
                                                                        9 http://www.freedomdataservices.com/downloads/2009med-adherence-report.
                                                                          pdf
                                                                        10 Susannah Fox and Lee Rainie. The Online Health Care Revolution: How the web helps
                                                                           Americans take better care of themselves. Pew Internet & American Life
                                                                           Project,          Washington DC, November 26, 2000. http://www.pewinternet.
                                                                           org/PPF/r/26/report_display.asp. Accessed August 6, 2004.
                                                                        11 Optimax Segmentation and Individualized Framework.
                                                                        12 Frost and Sullivan. Patient non-adherence: Tools for combating persistence and
                                                                                  compliance issues 2005.




About Optimax
optimax@indegene.com


                        Optimax is an integrated multichannel patient adherence and management platform with different compo-
                        nents to maximize medication adherence. It is designed to cater to different patient profiles and behaviors
                        with the option to reach patients through varied medium such as e-mails, calls, direct mailers, and texts
                        according to convenience and choice. The program is configurable across states and countries and can be
                        offered in multiple languages.

About the authors
Gaurav Kapoor, Head, Strategic Marketing Solutions and Emerging Markets

                        Gaurav is one of the founding members of Indegene. He has more than a decade of experience in the
                        pharmaceutical industry in various positions including product management, international marketing,
                        marketing management, and general management. He has a graduation degree in pharmacy from
                        St. John's College of Pharmacy, Bangalore, and an MBA from ENPC, Paris.


Shakun Gidwani, Director, Strategic Marketing Solutions

                        Shakun is part of the strategic marketing solutions group at Indegene. At Indegene, her role involves
                        product development and rollouts on the Patient and Physician Engagement side. She has been closely
                        involved with rollouts of several patient support and adherence programs across the globe for leading
                        pharma majors. She completed her BSc from Fergusson College, Pune, and earned her Postgraduate
                        Diploma in Marketing and Finance from Symbiosis Institute of Management Studies.




Page 14 of 16                                                                                   Our Understanding of the Global Blueprint for Patient Adherence
Page 15 of 16   Our Understanding of the Global Blueprint for Patient Adherence
About Indegene
   Indegene is a scientific partner to global pharmaceutical and life sciences companies. We deliver a spectrum of medical, marketing, and
   analytics services and a range of proprietary platforms for marketing and analytics.
   Through the depth of our scientific expertise, scale of our operations, offshore delivery model, and global footprint, we deliver value across
   multiple dimensions:
   •	 Costs – Through our scalable hybrid delivery model, we provide significant cost benefits in Medical Education, Sales Training,
      Medical Writing, Medical Information Management, Business Intelligence, and Analytics.
   •	 Value Addition – Indegene has a formidable track record in working with KOLs and managing marketing programs worldwide. By
      success fully collaborating with teams in global headquarters and in local affiliates of pharmaceutical companies, we have delivered
      significant cost savings as well as consistency in messaging.
   •	 Innovation – Indegene has developed proprietary platforms that lie at the heart of the transformation in the global pharmaceutical
      industry. Our platforms include sophisticated solutions for e-marketing, patient compliance management, and clinical trial analytics.


       Services                                                                         Proprietary Platforms

       •	 Medical Education, Marketing and e-marketing                                  •	 Phynyx – a multi-channel solution for e-marketing and
          programs                                                                         physician engagement
       •	 Publication writing                                                           •	 Optimax – a versatile patient support and compliance
                                                                                           platform
       •	 Training and eLearning
                                                                                        •	 Medengage – a proprietary virtual platform for
       •	 Medical Information Management
                                                                                           management of advisory boards and KOL engagement
       •	 Medical fact checking and review of all marketing and
                                                                                        •	 TrialPediaTM – a sophisticated clinical trial analytics
          training materials
                                                                                           and benchmarking platform
       •	 Patient Compliance and Adherence program
          management
       •	 Management and updates of all knowledge databases
       •	 Research, analytics and insights

       Highlights
       •	 Proven track record of delivery with 15 of the Top 20 global pharmaceutical companies
       •	 Offshore partner for strategic commercialization and marketing to 4 of the Top 10 pharmaceutical companies
       •	 Global footprint—offices in the United States, Europe, S.E. Asia, Australia, and India as well as presence in China, Middle East, and Africa
       •	 More than 300 employees, 50% with a medical background—rich clinical and scientific expertise and a decade of experience servicing the
           pharmaceutical industry
       •	 Awards—regular winner of prestigious awards for medical marketing and training initiative




www.indegene.com                                                                                                                © Indegene. All rights reserved. 2010

   Page 16 of 16                                                                                          Our Understanding of the Global Blueprint for Patient Adherence

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Global Blueprint For Patient Adherence

  • 1. Our Understanding of the Global Blueprint for Patient Adherence Establishing a global positive health outcomes framework through scalable, measurable, cost effective patient-centric programs Gaurav Kapoor Shakun Gidwani Head, Strategic Marketing Solutions Director, Strategic Marketing Solutions
  • 2. Page 2 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 3. Background The global pharmaceutical industry is presently undergoing a phase of significant transformation which in turn is impacting their strategies and challenging them to think differently and thereby align better to their consumers and prescribers. It’s imperative for us to realize that the health economic equation across the globe is rapidly changing and we view some of the following changes will redefine the role of different stakeholders. Number of drugs approved by US FDA A systemic decline Continuity Evidence 40 FDA approval process on drugs is becoming more stringent. 35 30 The number of drugs getting approved over the years has seen a 25 significant decline. 20 15 More drugs are hitting the recall list these days. As CNN Money 10 reports, the number of recalls hit 1,742 last year--that’s an 5 increase of 309 percent over 2008.1 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 Issues and warnings around the ban of Avandia and Actos, Vioxx, Number of drugs approved by US FDA: A systemic decline. MyLotarg etc. seem to indicate need for data on drugs. Adapted from the Wall Street Journal. The Pharma innovation gap-increased R& D spending Revenue Leakage yielding lesser drug approvals Large number of drugs nearing the patent expiry period. Weak $60 50 pipelines with fewer molecules available that can be positioned as Pharma R&D ($Billion) New Drug Approvals $50 40 block busters. $40 30 $30 Pharma Innovation Data indicates that major pharmaceutical companies will lose Gap 20 $20 between 15 – 40 % of their revenues as they approach patent $10 10 expiry.2 $0 0 1992 1996 2000 2001 2002 2003 2004 2005 2006 2007 Since, pharmaceutical companies will have very few launches in Pharma R&D Investment BioPharm R&D Investment their key therapeutic focus groups, strategic focus to maximize New Drug Approvals by US FDA returns through better ROI per patient and also strengthening Source: Pharmaceutical Research and Manufactures (PhRMA) Annual Report health outcomes data Pharma companies need to minimize 2007; Burill & Company Report 2003; PhRMA Annual Member Survey, 2007: US Food & Drug Administration Databases. revenue leakage by locking in consumers on brand. Market Access Emerging markets are growing in size. The policy makers and payors in these markets need substantial data around cost versus benefits to allow access and re-imbursements. They look for cost benefit ratios to allow for drug launch and re-imbursement and co-pay coverage. Page 3 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 4. Top 14 Pharma markets, 2005 Top 14 Pharma markets, 2015 Critical for pharma companies who want to lock in customers across US (248) US (444) regions before any competitor gains access to the same market. Japan (68) Japan (82) Health outcome data captured through 12-24 months. Data can be France (32) France (46) an extremely important differentiator from a region can provide a Germany (31) Germany (38) Italy (20) China (38) better case for gaining access into other larger markets. UK (19) UK (32) Spain (14) Spain (25) Canada (13) Italy (25) China (13) Canada (25) Non adherence to prescription medication regimens, especially for Mexico (10) India (20) chronic therapy areas is seen to have severe implications in terms Brazil (9) Brazil (20) of patient health outcomes and increased costs to the The patient South Korea (8) Mexico (19) Turkey (7) South Korea (15) as well as the healthcare system. It is now being viewed as a very India (6) Turkey (15) serious issue globally, to the extent that in the United States, it is referred to as ‘America’s other drug problem3’. Figures in $billion Source: IMS World Review, analyst projections, National Council on Patient Information and Education (NCPIE), McKinsey India Pharma demand model. which is a non-profit coalition of more than 100 organizations, has even released a 10-step action plan4 to reduce the adverse health and economic consequences associated with this growing public health threat. To effectively address all the above discussed market pressures, our industry has started to take steps to strengthen disease management ecosystems by measuring and analyzing long term health outcome data, integrating various stakeholders to manage outcomes and seamlessly transmitting data across various synaptic points. As we move into a new landscape where patients, payors and policy makers take an extremely critical role in decision making process, pharma industry’s role is extending beyond marketing to physicians. Providing each player with strong credible case for drug support becomes an important function for pharma today. 100% Current Landscape and Insights 90% 80% According to the World Health Organization, of the 1.8 billion Percent persistent 70% prescriptions dispensed every year, only 50% are taken correctly 60% 50% by the patient. Along with poor individual health outcomes 40% and increasing mortality rates, medication non adherence has 30% 20% significant economic ramifications. Non adherence in chronic 10% disease areas with prescribed medication regimens continue to 0% 0 30 60 90 120 150 180 210 240 270 300 330 360 390 420 450 480 510 540 570 600 630 660 690 720 result in pharmaceutical companies losing revenues for brands to Oral antidiabetics ARBs Statins Bisphosphonates Prostaglandins OAB medications the tune of billions of dollars. It can be directly linked to as much as $290 billion annually in increased medical costs and is responsible Days Time to Discontinuation of Six Chronic Drug Classes3 for 33% to 69% of all medication-related hospital admissions, at a cost of about $100 billion per year.5 Page 4 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 5. While there are many patient support and assistance programs available, they may not be able to address the requirements. The key challenges that plague these programs pertain to unification of stakeholders, execution, definition of relevant success metrics, and replication across geographies. Some of these challenges precipitate from the fact that programs are executed at individual brand levels and may not be necessarily aligned to the overall regional or global strategic imperatives defined by the organization. To quote some figures that measures the existing programs: • Evidence states that it costs less dollars to retain a patient versus acquire new patients. As an industry, we spend only 3%6 on a patient which is rather shocking considering that they are more informed decision makers today and an important stakeholder to drive criticality of managing revenue leakage due to non-adherence. • 7 out of 10 programs are dropped after 8-12 months because of lack of patient data on adherence and low interest by doctors.7 • Findings from expert interviews propose many key design principles for successful adherence programs, including suggestions to tailor overall intervention strategies based on patient segmentation as attitudinal and behavioral barriers vary widely among the patient population.8 • Integration of multiple stakeholders (physician, nurses, pharmacists and practice care assistants) is essential for adherence to medication, especially for adherence in the prescription medication regimen while also increasing patient-centricity. With physicians and pharmacists part of patient recruitment cycle one can expect a jump in the numbers of enrolments on a program in the range of 17–36 %7 based on regions and disease type. • Most patient support programs go unnoticed due to poor visibility among patients and influencers7. Capitalize on stakeholder relationships to improve communication and ensure continuous contact with the patient and maintain and develop this established relationship to address patients’ concerns and provide support. • Most patients may initially engage in support programs for the incentives but tend to lose connect if the program does not add value to management of their health outcomes, although a majority of patients can be motivated to stay on therapy through education and peer support.7 • There are few or almost no programs that leverage profiling and segmentation approaches for patients or capture metrics across the program lifecycle to assess progress. Page 5 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 6. • In certain drug categories pharmacists9 play the role of an advisor and hence it is key to loop them in the patient recruitment and education cycle. • Reasons for non-adherence although varied are relatively simple and can be tackled through pointedly addressing individual patient concerns.7 • Consumer studies indicate increasing numbers of patients leverage the internet to understand more about their disease condition and actively research their prescription medications.10 Most of these programs don’t have aggressive drives to recruit patients and other stakeholders in the ecosystem. The template should be designed keeping the strictest requirements in mind and then giving the flexibility to the local affiliates to adapt within those boundaries. Patient support programs, while being integral to patient engagement strategies, continue to pose a dilemma to pharmaceutical companies on decisions pertaining to investments. With “more for less” being the order of the day, optimized communication mix that yield maximum returns is desired by pharmaceutical companies. Critical Factors for a Developing a Successful Blueprint Over the years Indegene has worked on hundreds of patient support programs for brands across the globe in varied therapy areas. In our opinion there are some very critical factors that need to be reviewed and managed when defining a global blue print for a program. Patient Profiling and Segmentation: Patient 360 Each patient is unique and has specific challenges from a disease Patient profiling outcome management perspective. It is important to look at these & Segmentation varied perspectives and engage with them as “individuals” and not as “ideals.” Patient behavior is influenced by multiple factors. These can be Cost effective broadly categorized on a two-dimensional axis under “Degree of balance between Difficulty”11 versus “Level of Enablement.”11 global & local frameworks Degree of Difficulty is defined as the demand of managing a disease and treatment placed on a patient. A patient’s degree of difficulty may be influenced by several factors such as nature of the disease, Mechanisms to co-morbid conditions, treatment complexity—duration, time, and capture data & analytics response, and economic access which is financial and logistical to measure access to treatment. Page 6 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 7. Level of Enablement is the capacity of the patient to address the demands of disease and treatment. Patients’ level of enablement is influenced by demographic factors (e.g., age, level of education, and economic status). It could also be influenced by cognitive and psychosocial aspects of the patient. Considering all the above factors, the patient personalization metrics becomes quite varied in terms of the number of attributes one need to track and leverage for engagement on their disease management continuum. Indegene’s proprietary framework Optimax allows for the calculation of the individual risk levels for each of these profiles over a period of time and track how individual patients are faring over these profiles. Based on this, personalized engagement plans are drawn that are not only relevant to the patient but also impact their health outcomes. Data is collated on an ongoing basis while patients are engaged on a therapy program through patient surveys, electronic health record systems, and interactions with different program components, for example, the number of times a card was swiped or discount coupons downloaded to buy refills. It is important to ensure that there is flexibility to capture information through different systems that feed into profiling the patient into different segments and further managing them as individuals within the segment. • Self-Sufficiency11: Bringing patients to a stage where they can manage the low demands of their disorder/ treatment. Let us look at patients who have been recently diagnosed with diabetes and are at the initial stage of their therapy. In addition to this, they may not have a high level of enablement. The primary goal for this category would be to ensure that one is able to motivate this group to take their diabetes medications and also provide them with educational resources and promote diabetes awareness. Providing them with reminders and empowering them with a basic level of education and ensuring timely refills along with some self-help tools like BMI calculators, diet engines etc. could assist in their adherence journey. • Proactive Efficiency11: Manage preventive and screening processes as well as contemporary treatment. For instance a section that may still be in the early stages of diabetes, and they are empowered with means to connect and draw relevant inputs from their ecosystem with ease. This group would require early diabetes awareness and risks of non-adherence at a more microscopic level. Lab values like HbA1c levels, TCH, LDL values and other significant ones would need to be captured and updated on a regular basis. • Treatment Congruency11: Achieve the patient’s cooperation with the treatment team and acceptance of the above average amount of assistance required. As an illustration, this consumer base would consist Page 7 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 8. of a relatively older group who has lived with diabetes for a longer duration. Sharing information on the importance of controlling their diabetes by making certain lifestyle changes like incorporating exercise into their daily routine, following a recommended diet plan etc. would be of assistance. Motivational counseling through qualified health coaches, capturing and monitoring relevant lab values on a regular basis along with tools for tracking their condition and facilitating interactions with their physicians would be of great benefit to this group. • Sustained Effectiveness11: Maintain high levels of adherence to successfully improve outcomes and sustain their progress. Drawing for diabetes as a therapy area, this set of people would have been on therapy for a relatively longer period of time with comorbid conditions. In this case, ensuring relevant lab values like HbA1c levels, triglyceride, LDL and HDL levels along with more intensive tests for advanced stages of diabetes like routine eye checks, feet checks, monitoring for co- morbid conditions like nephropathy, cardiovascular disease etc. While they may have the means to manage their condition rightly, the key here would be to provide them with evidence and reports on positive health outcomes. Multiple Channel and Stakeholders Success at different stages likes recruitment, collation of data, engagement to drive adherence and hence a positive health outcome is important for a patient support program. Considering the varied nature of the disease, market considerations and profile of patients it’s important to ensure that one is able to offer as much flexibility as possible to support interactions with patients. Voice, email, web, text messaging, eFax, direct mailing, scan and capture techniques are some of the approaches that one can look at to offer patients the option to engage based on their convenience. Intelligent configuration of these for a patient support program allows for end goals to be met irrespective of whether a patient chooses to use one or more of these channels or not. For instance, leveraging multiple channels like voice support, email, web text messaging, direct mailers etc. to provide refill reminders, educational awareness material and health assessment surveys for patients in the ‘Self-Sufficiency’ group is critical since they may have access to fewer numbers of channels; while the ‘Treatment Congruency’ group would best leverage push-based interventions like calls from health coaches along with refill and follow-up reminders; support resources and direct mailers like educational posters, health system navigation packets etc. Page 8 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 9. In fact new innovative ways to track and collate patient data and provide them education on their mobile devices, through virtual health and lifestyle coaches seem to be gaining momentum. Bar code data, chips, product packaging etc. are being looked upon by early innovators as mediums to capture adherence related data. While varied channels may be used the framework also needs to offer the flexibility to turn them on and off based on market related data and nuances and still not jeopardize or break the framework due to the limitations. In addition to the primary sources of data secondary, such as electronic health record systems, CRMs, also need to be leveraged for patients with the hospital environment. While channels of engagement is one part of the overall engagement aspect one also view a variety of stakeholders are beneficiaries of patient’s positive health outcomes. These are the payers, pharmacists, physicians, nurses, compliance associates, care givers, patient groups and communities. The framework needs to offer the flexibility to execute their role in the disease support continuum with ease. Patients requiring extensive physician time stand to benefit immensely from a healthcare ecosystem that includes other stakeholders. Qualified HCPs such as pharmacists, accredited experts, counselors, and associations, have started playing an integral role in patient care. A physician can view this information from the perspective of monitoring patient progress and accessing their reports, while the other partners in the ecosystem like pharmacists can help manage refills and educators can assist in providing the right advice to the patients. The other interesting emergence as the new stakeholder is that of insurance companies. Insurance companies strive to Patient reduce payouts to patients by maximizing patient adherence by Immediate Patient support system component; becoming an equal partner in managing patient health outcomes Network closest in proximity to the patient in terms (Caregiver and of emotional connect and focusing on the real and even incentivize them on managing their health. Physicians) issues for the patient Second in line in the support ecosystem in All this can be achieved when you have a central framework Significant Ties terms of administrating prescriptions, (Pharmacist, AHP) dispensing medications, and essentially being responsible for patient health outcomes or a platform that allows you to integrate channels, people and processes. Provide information outside of what is offered Empathizers by the Significant Ties group based on personal (Patient Groups and experience; often this category is considered prior Communities) to or alongside the Significant Ties groupes Page 9 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 10. Mechanisms to Capture Data and Analytics to Measure While the process of engaging patients leverages varied channels, to gain maximum benefit from a program the tools to collate data points should be equally varied. Patient support programs need to leverage the strategic advantages offered by the web, mobile solutions, and the human interaction component to allow patients a convenient choice of medium. Data should be collated during each patient interaction starting from the registration process through the entire engagement along with tracking of usage and usage duration of the selected intervention medium and evaluating its effectiveness against the patient wellness index recorded. Once specific program goals have been identified the next step would be to look at how these goals are to be measured. Let’s look at a patient support program catering to diabetes. For recruitment related goals analytics need to demonstrate patient and physician volumes segmented by regions. When we talk about tracking patient health and diagnostic results, improvement in lab results like HbA1c levels, total cholesterol, LDL, HDL, blood pressure, hemoglobin etc. and increase in adherence compared to the previous intervention would provide suitable measures. Providing interventions according to medium of choice would involve tracking of usage and usage duration of the selected intervention medium and evaluating its effectiveness against patient wellness index recorded previously and finally medication adherence outcomes can be measured based on test results over a period of time. It is common business sense that programs ought to be measured. While defining a patient support program, it is critical for a company to define what it would consider as ROI and how they would actually calculate it. It is recommended that a pilot program be rolled out to assess what really works. One could look at starting a program with a smaller patient group; understand the impact of different elements, and then scale-up to add volumes and regions. Define measures—that is the first step. These could either come through collation of information directly from a patient or through indirect interpretation based on how a patient engages in a program. Some of the indices to consider could be as follows: • Patient Risk Profile Index11: Measured by calculating patients risk profile on a 7 point scale based on their disease condition, Rx pattern, access to medication, cognitive and psychosocial elements, etc. Based on therapy areas, one could define the frequency at which one would want this data to be captured in the system. Page 10 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 11. • Adherence Index11: The adherence index is often captured and detailed in the form of a patient’s persistence on to medications, refill ratios, medication possession ratios, and proportion of days covered. There are standard and defined formulas that are available and based on the different components of the program; one can decide which of these metrics are actually collated. • Brand Belief Index11: The impact and perception of brand among key stakeholders such as pharmacists, physicians, and patients. How your patient support program influence the various stakeholders and how it is perceived by them is critical to understand the success factor and also make calculated investment decisions in the future. Patient support programs are not a burst of one-time activities but continuous engagement with your consumers, prescribers, and influencers; hence the perception and its impact on adherence is critical. Patients with a positive perception in brand are proven to show higher percentage of adherence which in turn has a cascading effect on more physicians not recommending switch. Scores based on persistence, new Rx, health outcomes reports, physician and patient reputation index, and ROI help calculate and assess a brand belief index (BBI). • Campaign and Content Popularity Index11: One critical point to measure is how the investment is done by you on engaging a patient being perceived and utilized. Companies may use this decision to further fine-tune strategy and invest right. Cost Effective Balance Between Global and Local Frameworks Having discussed the critical success factors for a program one of the key questions to ask is what is all this going to cost. Considering the program leverages a range of resources and services it is always critical to understand how one can get the most out of their buck. This can be ensured by anchoring program infrastructure centrally and providing regional controls to enable and disable roles and channels and also have the flexibility to configure the program framework to market and disease need. A simple example could be leveraging web to recruit patients in the Asian countries to ensuring a physician desktop channel is available to do the same across France and Italy. Companies have access to the same CRM tool which can be configured with different content assets for an Alzheimer’s patients or a diabetes patient. However one may still need to factor for the difference in the associates interacting with the patients; in the case of Alzheimer’s one could be talking about seniors talking to seniors versus diet educators talking to patient for diabetes. Page 11 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 12. Selection of channel for ongoing engagements may vary by regions. For instance using internet to engage patients in the European countries region would work well versus text messaging in some other parts of the world. The program needs to offer the flexibility of working seamlessly irrespective of whether a channel or a role is leveraged across a certain region or a therapy area or not. It is important to strike the right balance between global and local and have the most appropriate Localization map drawn keeping market-specific parameters such as channels preferences overall, stakeholders to be leveraged and integrated into the patient ecosystem and trust loop, and format of education in perspective. Having understood the need for a global blueprint, one cannot be privy to the fact that there are certain things that would actually need to be anchored at a local level. While a central platform helps automate and leverage a lot of resources and processes, internal and external stakeholders’ involvement is equally critical and so is the regional-specific considerations. While one would look at economies through a central blueprint, it is equally important to factor these local considerations, hence the need to strike the right balance between global and local becomes critical. Therefore it is critical to select a partner who has a global reach and will provide you local market insigts to ensure seamless entry and access to a local market. So the obvious question one might ask is where to invest and how does one know if it is working. Investing in a patient support program requires you to listen to your consumers. What do they really want and what of this can you give them? Research indicates that patients expect a range of things from a support program as highlighted alongside. Having understood this, how does one ensure that these services are indeed leveraged by them and help you analyze the impact they have on your business and brand. Then comes a range of services that remind them, ensure enough data points are being collated to demonstrate evidence not just for you but for the patients and partners in their ecosystem to prevent switch. So how much does one really invest in patients? On average, pharma companies should be willing to invest anything between 1% and 3%12 of their cost per patient on a program to observe results. The impact of these measured against different indices such as Patient Risk Profile Index, Adherence Index, Physician Engagement Index, Brand Belief Index, and Content Popularity Index. Rollout Framework Now that we know what should be the different measurement criteria’s one may consider for a patient support program it is also important to see the transition happen at regular intervals to review Page 12 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 13. how well aligned the program is towards your business goals. Measurement data from the indices and the regular check points build will facilitate business decisions to fine tune the company’s strategy. In other words your patient support program journeys will be validated for progression to the next stage. Conclusion • The pharmaceutical industry has more reasons and ways to connect with consumers and prescribers. • It is not just a product but the services coupled with the product that impact a patient’s health outcome, and this is key to preventing switch by consumers and prescribers to other variants and competitors. • Pharma companies should look at investing 3% to 5% of annual ROI per patient on a pilot and subsequent rollout of programs. • Any patient support program should lead to 50% adherence over a 3-year time frame. • Segmentation and profiling allows for more targeted engagement and helps build program credibility in the minds of the stakeholders. • Multiple stakeholders in the ecosystem have to be leveraged to enroll patients on a program. • Using the right blend of channels and services is critical to ensure alignment to the consumers, prescribers, and the influencer’s ecosystem. • Multiple data sources such as pharmacies, surveys, and virtual health coaches and connects have to be leveraged to get data into the system for meaningful analysis and reporting. • Start with smaller patient groups, understand the baseline measures, and scale-up to add larger groups and regions. • Impact of patient support programs need to translate into measureable goals outlined in the form of different indexes. • It is critical to maximize ROI by leveraging cost-effective platforms that allow for drawing up a global blueprint that can be localized keeping market considerations,regulatory, and other nuances in mind. References 1 Drug recalls hit all-time high in 2009 - FiercePharma http://www.fiercepharma. com/story/drug-recalls-hit-all-time-high-2009/2010-08-17#ixzz0yGKjo0oP 2 AXA Farmington 3 http://www.marketwire.com/press-release/Americas-Other-Drug-Problem-Poor- Medication-Adherence-756583.htm Page 13 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 14. 4 http://www.marketwire.com/press-release/Americas-Other-Drug-Problem-Poor- Medication-Adherence-756583.htm 5 2010 Benchmarks in Medication Adherence Results of HIN Monthly E-survey on Trends Shaping the Healthcare Industry. 6 Frost and Sullivan. Patient non-adherence: Tools for combating persistence and compliance issues 2005. 7 Optimax Business Insights 8 http://www.frost.com/prod/servlet/cpo/115071626.pdf 9 http://www.freedomdataservices.com/downloads/2009med-adherence-report. pdf 10 Susannah Fox and Lee Rainie. The Online Health Care Revolution: How the web helps Americans take better care of themselves. Pew Internet & American Life Project, Washington DC, November 26, 2000. http://www.pewinternet. org/PPF/r/26/report_display.asp. Accessed August 6, 2004. 11 Optimax Segmentation and Individualized Framework. 12 Frost and Sullivan. Patient non-adherence: Tools for combating persistence and compliance issues 2005. About Optimax optimax@indegene.com Optimax is an integrated multichannel patient adherence and management platform with different compo- nents to maximize medication adherence. It is designed to cater to different patient profiles and behaviors with the option to reach patients through varied medium such as e-mails, calls, direct mailers, and texts according to convenience and choice. The program is configurable across states and countries and can be offered in multiple languages. About the authors Gaurav Kapoor, Head, Strategic Marketing Solutions and Emerging Markets Gaurav is one of the founding members of Indegene. He has more than a decade of experience in the pharmaceutical industry in various positions including product management, international marketing, marketing management, and general management. He has a graduation degree in pharmacy from St. John's College of Pharmacy, Bangalore, and an MBA from ENPC, Paris. Shakun Gidwani, Director, Strategic Marketing Solutions Shakun is part of the strategic marketing solutions group at Indegene. At Indegene, her role involves product development and rollouts on the Patient and Physician Engagement side. She has been closely involved with rollouts of several patient support and adherence programs across the globe for leading pharma majors. She completed her BSc from Fergusson College, Pune, and earned her Postgraduate Diploma in Marketing and Finance from Symbiosis Institute of Management Studies. Page 14 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 15. Page 15 of 16 Our Understanding of the Global Blueprint for Patient Adherence
  • 16. About Indegene Indegene is a scientific partner to global pharmaceutical and life sciences companies. We deliver a spectrum of medical, marketing, and analytics services and a range of proprietary platforms for marketing and analytics. Through the depth of our scientific expertise, scale of our operations, offshore delivery model, and global footprint, we deliver value across multiple dimensions: • Costs – Through our scalable hybrid delivery model, we provide significant cost benefits in Medical Education, Sales Training, Medical Writing, Medical Information Management, Business Intelligence, and Analytics. • Value Addition – Indegene has a formidable track record in working with KOLs and managing marketing programs worldwide. By success fully collaborating with teams in global headquarters and in local affiliates of pharmaceutical companies, we have delivered significant cost savings as well as consistency in messaging. • Innovation – Indegene has developed proprietary platforms that lie at the heart of the transformation in the global pharmaceutical industry. Our platforms include sophisticated solutions for e-marketing, patient compliance management, and clinical trial analytics. Services Proprietary Platforms • Medical Education, Marketing and e-marketing • Phynyx – a multi-channel solution for e-marketing and programs physician engagement • Publication writing • Optimax – a versatile patient support and compliance platform • Training and eLearning • Medengage – a proprietary virtual platform for • Medical Information Management management of advisory boards and KOL engagement • Medical fact checking and review of all marketing and • TrialPediaTM – a sophisticated clinical trial analytics training materials and benchmarking platform • Patient Compliance and Adherence program management • Management and updates of all knowledge databases • Research, analytics and insights Highlights • Proven track record of delivery with 15 of the Top 20 global pharmaceutical companies • Offshore partner for strategic commercialization and marketing to 4 of the Top 10 pharmaceutical companies • Global footprint—offices in the United States, Europe, S.E. Asia, Australia, and India as well as presence in China, Middle East, and Africa • More than 300 employees, 50% with a medical background—rich clinical and scientific expertise and a decade of experience servicing the pharmaceutical industry • Awards—regular winner of prestigious awards for medical marketing and training initiative www.indegene.com © Indegene. All rights reserved. 2010 Page 16 of 16 Our Understanding of the Global Blueprint for Patient Adherence