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GLOBAL REPORT 2012




PAINS                      Of all their Latin American neighbors, Brazilians and Mexicans have enjoyed
                           the most impressive economic growth and with it, are more prone to chronic
                           disease. But can they afford medications? Ana Schaeffer and Simeon Pickers
                           on why market access factors can make or break a product in these countries


                                   Mexico C
                                           ity, 2012




                                                                                     currently see in developed nations. Combine this with high
                                                                                    urbanization and lifestyle changes and we can perceive the
                                                                                    trend—populations more prone to chronic disease.

                                                                                  The importance of accessibility
                                                                                    When discussing factors for success in emerging markets—
                                                                                   or any other market for that matter—the usual top-of-mind
                                                                                   considerations are focused on market access: Which clinical
                                                                                  trials, safety and efficacy data ought to be presented? What
                                                                                 are the steps toward regulatory approval? How can support


A
       s attention turns to                                                      by opinion leaders be ensured? What has to be done in order
       emerging markets due to the limited                                      to obtain public and private reimbursement?
       potential of developed ones, Latin America has become one                All are relevant and technical points, although sometimes, little
of the most promising regions for growth. The stars are Brazil and          thought is spent on how or if the average patient will be able to afford
Mexico, together encompassing a population bigger than the United           the medication. As both Brazil and Mexico are mainly out-of-pocket
States and a domestic product similar to that of Germany.                   markets, where highest growth is seen in the lower classes, overlook-
   In relation to the recent financial crisis, Brazil was one of the last   ing these aspects can prove to be an error in such countries.
countries to be affected and the first one out of the crisis. Whereas,         Middle and upper classes in Brazil and Mexico represent a minor-
Mexico, due to its proximity and close commercial ties to the US,           ity among the population as a whole. The most significant growth
was hit in 2009 but from there onwards recovered at a good pace.            comes from the high portion of lower classes that are dynamically
   Both countries are profiting from a “demographic bonus” (a rela-         emerging, the so-called base of the pyramid. According to the
tively high proportion of young people at a productive age) but will        United Nations Economic Commission for Latin America and the
shift toward aging societies over the next decades, similar to what we      Caribbean, “in Brazil and Mexico…28 million and 14 million people


38 MM&M x AUGUST 2012 x mmm-online.com
12
                        ity, 20
                Mexico C


                                                                          as their relationships, last year Psyma conducted a series of short
                                                                          quantitative phone surveys with pharmacists (50 in each country).
                                                                          In addition, a qualitative portion included 12 ethnographic/in-home
                                                                          interviews with patients (diabetes, hypertension, dyslipidemia) from
                                                                          different socioeconomic grades, as well as in-office interviews with
                                                                          physicians (endocrinologists, cardiologists) and pharmacists.
                                                                             Not surprisingly, we found that typical bills and responsibilities
                                                                          drain the household budget but that modern life has also turned
                                                                          some former luxuries into commodities—i.e., the mobile phone,
                                                                          cable/satellite TV and broadband, to name a few. Lower income
                                                                           patients and the elderly who depend on retirement funds or are
                                                                           commonly poly-medicated appear to be affected most.
                                                                              Regardless of social class, most patients tend to seek out cheaper
                                                                          options and generics, and when needed, even go without certain
                                                    respectively moved medications, possibly only buying the priority drug.
                                           up to the middle class during     We see additional cost pressure in Mexico, where patients prefer
                           the years from 1990 to 2007.” This trend is phone consultations, which usually do not trigger a consultation fee
           likely to get stronger rather than weaker in the current as would a formal doctor visit (i.e., to renew a prescription).
decade, despite the economic slowdown of recent years.                       In both countries, samples are welcomed by patients and physicians.
   Both Brazil and Mexico, in theory, are welfare states approach- Coverage of consultation fees is different. In Mexico some patients
ing universal coverage in health services and supplies. Although would rather wait for a doctor visit in a public institution than pay
the majority of people in Brazil and Mexico have access to public for it out of pocket. In Brazil consultation fees are covered free of
insurance coverage, a large portion of that group seeks private charge by medical insurances and the public setting, although in more
healthcare because of facility saturation and poor availability of severe situations patients might access out-of-network doctors.
drugs and services within the public system.                                 Out-of-pocket spending might still be necessary, in which case
   For instance, public pharmacies not only suffer from lack of stock for cheap generic options become more attractive. An exception to
certain drugs, but also frequently                                          this rule involved family child care, where branded products
face shortages. The latter has                                                                                    demonstrated more significance.
become a political hot potato in                               Sao Paulo, B                                          This view held among the Bra-
                                                                            razil 2 012
Mexico. Brazilians enjoy universal                                                                                  zilian respondents, including
access to hospital and emergency                                                                                    those from higher socioeco-
treatment via the public system,                                                                                   nomic brackets, while the pat-
however, not to all the newest                                                                                     tern was strongly observed in
drug options (insulin and met-                                                                                     Mexico, independent of socio-
formin are free; DPP-IVs must                                                                                      economic status.
be bought out of pocket).                                                                                             Notwithstanding differ-
   Healthcare finance and                                                                                         ences in each country, cost is a
resources are often misman-                                                                                      daily issue for patients, and this
aged; analysts have shown that                                                                                   hasn’t been lost on physicians.
the overall cost of a Cesarean                                                                                  As patients shop for clinicians
surgery in Mexico’s social                                                                                      that offer lower-cost medica-
security institute is higher                                                                                   tions, doctors match medications
than the same procedure at a                                                                                  to the patient’s pocket so as not to
“Los Angeles” hospital, one                                                                                   jeopardize compliance and physi-
of the premium private hos-                                                                                  cian loyalty. They often prescribe
pital groups in Mexico.                                                                                      cheaper alternatives (possibly older
   Patients, pharmacists and medical professionals                                                           generations) or a more conserva-
are well aware of these deficiencies and know that                                                            tive prescription of branded drugs
in order to enable satisfactory patient care, other                                                           (shorter treatment cycles). Some
pathways to treatment and medication have to be                                                                medical professionals also recom-
employed. Market access factors, although necessary,                                                            mend patented drugs for the main
are still not yet sufficient for market success. Alongside                                                       disease and generics for less seri-
physician support, market accessibility is what can make                                                         ous ailments.
or break a product in these countries, establish it in the                                                           Pharmacists said about 50%
market, and allow for blockbuster market share.                                                                   of clients request information
   In order to gain a better understanding of how the                                                              regarding cheaper options.
high rate of out-of-pocket spending in Brazil and Mexico                                                           Through in-shop observations,
influences the different stakeholders’ behavior as well                                                            it was perceived that patients


                                                                                                            mmm-online.com x AUGUST 2012 x MM&M 39
OUT-OF-POCKET PAINS


usually initiated the discussion for cheaper options, generics and
discounts, regardless of class or disease, whereas price-matching                 Pocket change
                                                                                  Out-of-pocket spending as a percentage of citizens’ private
and shopping around for the best option is a behavior that is more
                                                                                  expenditure on healthcare
strongly observed in Brazil than in Mexico.
   Generics utilization is registered in both countries, with Brazilian            100
pharmacists reporting that generics account for about half of total Rx                             Mexico
                                                                                    80
sales. Additional campaigning by the Brazilian government has helped                                92%
to foster a generally positive perception toward these alternatives.                60
                                                                                                                                Brazil
   Although the “similar” drugs category has recently been eliminated               40                                          58%
in Mexico, both the Brazilian and Mexican governments require
                                                                                    20                                                   USA
bioequivalence testing for generics. But Mexicans still have a high                                                                      24%
degree of distrust for generics. It has become difficult for patients to             0

determine whom to trust when, for example, standard generics are
bundled and marketed under umbrella brands with strong media                      Source: WHO Global Health Observatory, 2010
support. This has produced a predominant inclination toward branded
or patented options, even if it means higher overall spend.
   Physicians in both countries demonstrate a preference toward               n Branded generics. Huge potential exists for pharmaceutical compa-
brands, but accept that the decision is up to the patient. Physicians         nies to seize the trust banked in their brands to provide economically
promote branded drugs whenever possible. However, pharmacists                 competitive generic options, with the added confidence that these
can legally offer generic options of any branded medication, although         options maintain a high degree of quality, safety and efficacy. Several
they insist that they do not influence the patient’s decision.                important companies have moved ahead already—Novartis with
                                                                              Sandoz, Sanofi with Medley, and now Pfizer with Pfizer Vitales.
Enhancing accessibility                                                       n Intelligent promotions and discount cards. These are advancing,
Major manufacturers are already working on enhancing the acces-               not with the flat scheme of “2 for 1” or “20% discount on everything,”
sibility of their products. Certain trends can already be observed,           but designed to encourage and reward treatment compliance and
some at more advanced stages than others:                                     brand loyalty. In Brazil, pharmaceutical companies offer monthly
                                                                              discounts for certain products to patients who register through their
                                                                              customer services hotline. This improves treatment compliance
                                                                              and helps retain brand loyalty. In Mexico some patients voiced the
 Argentina beckons as clinical trials host                                    desire for support in covering consultation/professional fees or other
                                 Brazil and Mexico may boast the most         healthcare services in exchange for compliance with treatment.
                                 upwardly mobile middle classes in            n Investment in customer lifetime value. Many patients, especially
                                 Latin America. But Argentina is carving      those with lower incomes, lack disease education. This can lead to dire
                                 out a niche as a “clinical research          consequences. The closer the brand physically gets to the patient—i.e.,
                                 powerhouse,” says one analyst firm.          through mobile clinics, informative leaflets, or support for patient
                                     In 2010, the clinical trial market in    organizations, support programs or financing options—the greater
                                   Argentina was valued at $49.4 million in
                                                                              impact the programs will have. One should also recognize the strong
 terms of revenue and is forecast to grow at a compound annual rate of
                                                                              informal bonds of mutual support that exist among members of a
 9% between 2010 and 2015, says GBI Research.
    What makes the region so attractive for clinical research organiza-       specific group, be it the family, neighborhood or community. If a
 tions (CROs), and by extension biopharma? Cost reduction, for one.           group’s support for a member can act as a guarantee, then access to
    “Services and Investigator fees are generally speaking around 25%         credit based on this can help enhance treatment and compliance.
 less,” says Anne Blanchard, CEO and clinical operations manager of           n Distribution channels. Although a challenging measure to imple-
 Blanchard & Asociados, a CRO with offices in Buenos Aires. “But taxes        ment, reducing intermediaries or shortening the distribution channels
 for importation, patient insurance and regulatory fees should not be         will have a positive impact on the end prices for consumers. Patients
 underestimated.”                                                             even suggested the establishment of branded outlets for drugs.
    Patients can more easily be recruited for trials, too, claims GBI,           Considering the large shares of out-of-pocket spending, and the
 thanks to a large, willing patient pool coupled with what it calls “more
                                                                              extent to which the population depends on the public healthcare
 limited medical facilities.” Government investigator sites in metro areas,
                                                                              systems, the fortune at the base of the pyramid is still undervalued.
 where relatively few have health insurance, help in enrolling subjects.
    Blanchard says that Argentinians enjoy “relatively good access to         Future public plans will further invest in healthcare, especially as
 health and strong patient-doctor relationships, leading to good compli-      emerging countries adopt preventive measures. With the increasing
 ance and retention rates (minimal dropout rates).”                           middle class and shrinking poor working classes, companies who are
    Overall, she tells MM&M, the country provides “a good balance of          already established with respectable company images and products
 timelines, recruitment potential and costs, while guaranteeing the           and who can identify with patients at the base of that pyramid will
 E6 GCP standard and permanently monitors clinical research activity          certainly be one step ahead. n
 through site inspections.”
    As such, GBI predicts pharma and biotech firms will have good reason      Ana Schaeffer is managing director, Psyma Pesquisas de Mercado
 to outsource clinical trials there.
                                                                              (Sao Paolo), and Simeon Pickers is managing director, Psyma Latina
                                                                              (Mexico City).


40 MM&M x AUGUST 2012 x mmm-online.com

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Healthcare Research and Access in Latin America- article Sep 2012

  • 1. GLOBAL REPORT 2012 PAINS Of all their Latin American neighbors, Brazilians and Mexicans have enjoyed the most impressive economic growth and with it, are more prone to chronic disease. But can they afford medications? Ana Schaeffer and Simeon Pickers on why market access factors can make or break a product in these countries Mexico C ity, 2012 currently see in developed nations. Combine this with high urbanization and lifestyle changes and we can perceive the trend—populations more prone to chronic disease. The importance of accessibility When discussing factors for success in emerging markets— or any other market for that matter—the usual top-of-mind considerations are focused on market access: Which clinical trials, safety and efficacy data ought to be presented? What are the steps toward regulatory approval? How can support A s attention turns to by opinion leaders be ensured? What has to be done in order emerging markets due to the limited to obtain public and private reimbursement? potential of developed ones, Latin America has become one All are relevant and technical points, although sometimes, little of the most promising regions for growth. The stars are Brazil and thought is spent on how or if the average patient will be able to afford Mexico, together encompassing a population bigger than the United the medication. As both Brazil and Mexico are mainly out-of-pocket States and a domestic product similar to that of Germany. markets, where highest growth is seen in the lower classes, overlook- In relation to the recent financial crisis, Brazil was one of the last ing these aspects can prove to be an error in such countries. countries to be affected and the first one out of the crisis. Whereas, Middle and upper classes in Brazil and Mexico represent a minor- Mexico, due to its proximity and close commercial ties to the US, ity among the population as a whole. The most significant growth was hit in 2009 but from there onwards recovered at a good pace. comes from the high portion of lower classes that are dynamically Both countries are profiting from a “demographic bonus” (a rela- emerging, the so-called base of the pyramid. According to the tively high proportion of young people at a productive age) but will United Nations Economic Commission for Latin America and the shift toward aging societies over the next decades, similar to what we Caribbean, “in Brazil and Mexico…28 million and 14 million people 38 MM&M x AUGUST 2012 x mmm-online.com
  • 2. 12 ity, 20 Mexico C as their relationships, last year Psyma conducted a series of short quantitative phone surveys with pharmacists (50 in each country). In addition, a qualitative portion included 12 ethnographic/in-home interviews with patients (diabetes, hypertension, dyslipidemia) from different socioeconomic grades, as well as in-office interviews with physicians (endocrinologists, cardiologists) and pharmacists. Not surprisingly, we found that typical bills and responsibilities drain the household budget but that modern life has also turned some former luxuries into commodities—i.e., the mobile phone, cable/satellite TV and broadband, to name a few. Lower income patients and the elderly who depend on retirement funds or are commonly poly-medicated appear to be affected most. Regardless of social class, most patients tend to seek out cheaper options and generics, and when needed, even go without certain respectively moved medications, possibly only buying the priority drug. up to the middle class during We see additional cost pressure in Mexico, where patients prefer the years from 1990 to 2007.” This trend is phone consultations, which usually do not trigger a consultation fee likely to get stronger rather than weaker in the current as would a formal doctor visit (i.e., to renew a prescription). decade, despite the economic slowdown of recent years. In both countries, samples are welcomed by patients and physicians. Both Brazil and Mexico, in theory, are welfare states approach- Coverage of consultation fees is different. In Mexico some patients ing universal coverage in health services and supplies. Although would rather wait for a doctor visit in a public institution than pay the majority of people in Brazil and Mexico have access to public for it out of pocket. In Brazil consultation fees are covered free of insurance coverage, a large portion of that group seeks private charge by medical insurances and the public setting, although in more healthcare because of facility saturation and poor availability of severe situations patients might access out-of-network doctors. drugs and services within the public system. Out-of-pocket spending might still be necessary, in which case For instance, public pharmacies not only suffer from lack of stock for cheap generic options become more attractive. An exception to certain drugs, but also frequently this rule involved family child care, where branded products face shortages. The latter has demonstrated more significance. become a political hot potato in Sao Paulo, B This view held among the Bra- razil 2 012 Mexico. Brazilians enjoy universal zilian respondents, including access to hospital and emergency those from higher socioeco- treatment via the public system, nomic brackets, while the pat- however, not to all the newest tern was strongly observed in drug options (insulin and met- Mexico, independent of socio- formin are free; DPP-IVs must economic status. be bought out of pocket). Notwithstanding differ- Healthcare finance and ences in each country, cost is a resources are often misman- daily issue for patients, and this aged; analysts have shown that hasn’t been lost on physicians. the overall cost of a Cesarean As patients shop for clinicians surgery in Mexico’s social that offer lower-cost medica- security institute is higher tions, doctors match medications than the same procedure at a to the patient’s pocket so as not to “Los Angeles” hospital, one jeopardize compliance and physi- of the premium private hos- cian loyalty. They often prescribe pital groups in Mexico. cheaper alternatives (possibly older Patients, pharmacists and medical professionals generations) or a more conserva- are well aware of these deficiencies and know that tive prescription of branded drugs in order to enable satisfactory patient care, other (shorter treatment cycles). Some pathways to treatment and medication have to be medical professionals also recom- employed. Market access factors, although necessary, mend patented drugs for the main are still not yet sufficient for market success. Alongside disease and generics for less seri- physician support, market accessibility is what can make ous ailments. or break a product in these countries, establish it in the Pharmacists said about 50% market, and allow for blockbuster market share. of clients request information In order to gain a better understanding of how the regarding cheaper options. high rate of out-of-pocket spending in Brazil and Mexico Through in-shop observations, influences the different stakeholders’ behavior as well it was perceived that patients mmm-online.com x AUGUST 2012 x MM&M 39
  • 3. OUT-OF-POCKET PAINS usually initiated the discussion for cheaper options, generics and discounts, regardless of class or disease, whereas price-matching Pocket change Out-of-pocket spending as a percentage of citizens’ private and shopping around for the best option is a behavior that is more expenditure on healthcare strongly observed in Brazil than in Mexico. Generics utilization is registered in both countries, with Brazilian 100 pharmacists reporting that generics account for about half of total Rx Mexico 80 sales. Additional campaigning by the Brazilian government has helped 92% to foster a generally positive perception toward these alternatives. 60 Brazil Although the “similar” drugs category has recently been eliminated 40 58% in Mexico, both the Brazilian and Mexican governments require 20 USA bioequivalence testing for generics. But Mexicans still have a high 24% degree of distrust for generics. It has become difficult for patients to 0 determine whom to trust when, for example, standard generics are bundled and marketed under umbrella brands with strong media Source: WHO Global Health Observatory, 2010 support. This has produced a predominant inclination toward branded or patented options, even if it means higher overall spend. Physicians in both countries demonstrate a preference toward n Branded generics. Huge potential exists for pharmaceutical compa- brands, but accept that the decision is up to the patient. Physicians nies to seize the trust banked in their brands to provide economically promote branded drugs whenever possible. However, pharmacists competitive generic options, with the added confidence that these can legally offer generic options of any branded medication, although options maintain a high degree of quality, safety and efficacy. Several they insist that they do not influence the patient’s decision. important companies have moved ahead already—Novartis with Sandoz, Sanofi with Medley, and now Pfizer with Pfizer Vitales. Enhancing accessibility n Intelligent promotions and discount cards. These are advancing, Major manufacturers are already working on enhancing the acces- not with the flat scheme of “2 for 1” or “20% discount on everything,” sibility of their products. Certain trends can already be observed, but designed to encourage and reward treatment compliance and some at more advanced stages than others: brand loyalty. In Brazil, pharmaceutical companies offer monthly discounts for certain products to patients who register through their customer services hotline. This improves treatment compliance and helps retain brand loyalty. In Mexico some patients voiced the Argentina beckons as clinical trials host desire for support in covering consultation/professional fees or other Brazil and Mexico may boast the most healthcare services in exchange for compliance with treatment. upwardly mobile middle classes in n Investment in customer lifetime value. Many patients, especially Latin America. But Argentina is carving those with lower incomes, lack disease education. This can lead to dire out a niche as a “clinical research consequences. The closer the brand physically gets to the patient—i.e., powerhouse,” says one analyst firm. through mobile clinics, informative leaflets, or support for patient In 2010, the clinical trial market in organizations, support programs or financing options—the greater Argentina was valued at $49.4 million in impact the programs will have. One should also recognize the strong terms of revenue and is forecast to grow at a compound annual rate of informal bonds of mutual support that exist among members of a 9% between 2010 and 2015, says GBI Research. What makes the region so attractive for clinical research organiza- specific group, be it the family, neighborhood or community. If a tions (CROs), and by extension biopharma? Cost reduction, for one. group’s support for a member can act as a guarantee, then access to “Services and Investigator fees are generally speaking around 25% credit based on this can help enhance treatment and compliance. less,” says Anne Blanchard, CEO and clinical operations manager of n Distribution channels. Although a challenging measure to imple- Blanchard & Asociados, a CRO with offices in Buenos Aires. “But taxes ment, reducing intermediaries or shortening the distribution channels for importation, patient insurance and regulatory fees should not be will have a positive impact on the end prices for consumers. Patients underestimated.” even suggested the establishment of branded outlets for drugs. Patients can more easily be recruited for trials, too, claims GBI, Considering the large shares of out-of-pocket spending, and the thanks to a large, willing patient pool coupled with what it calls “more extent to which the population depends on the public healthcare limited medical facilities.” Government investigator sites in metro areas, systems, the fortune at the base of the pyramid is still undervalued. where relatively few have health insurance, help in enrolling subjects. Blanchard says that Argentinians enjoy “relatively good access to Future public plans will further invest in healthcare, especially as health and strong patient-doctor relationships, leading to good compli- emerging countries adopt preventive measures. With the increasing ance and retention rates (minimal dropout rates).” middle class and shrinking poor working classes, companies who are Overall, she tells MM&M, the country provides “a good balance of already established with respectable company images and products timelines, recruitment potential and costs, while guaranteeing the and who can identify with patients at the base of that pyramid will E6 GCP standard and permanently monitors clinical research activity certainly be one step ahead. n through site inspections.” As such, GBI predicts pharma and biotech firms will have good reason Ana Schaeffer is managing director, Psyma Pesquisas de Mercado to outsource clinical trials there. (Sao Paolo), and Simeon Pickers is managing director, Psyma Latina (Mexico City). 40 MM&M x AUGUST 2012 x mmm-online.com