Oncology Market Access in Latin America
Oncology Market Access in Latin America
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Latin America’s multi-billion dollar pharmaceutical markets have attracted controversy related to intellectual property in recent times, but oncology remains a key growth area in the region.
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Latin America’s multi-billion dollar pharmaceutical markets have attracted controversy related to intellectual property in recent times, but oncology remains a key growth area in the region. At a time when Latin American populations are aging and becoming wealthier, reforms in markets such as Colombia and Argentina bode well for future expansion. Despite economic and political problems in Brazil, healthcare entitlements continue to enable patients to access the latest innovations. In Mexico, certain privileged segments of the population are driving demand in oncology, despite the lackluster shape of the overall pharmaceutical market.
Due to the complex and bureaucratic nature of Latin American oncology markets, and the region’s unique challenges around geography, climate, and affordability, successful market access is difficult to achieve. This report fully explores the policy, pricing, and reimbursement environment for oncology drugs in four key markets, as well as the exceptional access mechanisms that manufacturers must navigate. A full review of evidentiary requirements and the latest trends in payer preferences further captures the opportunity in oncology in this dynamic region.
Table of contents
6 EXECUTIVE SUMMARY
7 REGIONAL COMPARISON AND OUTLOOK
7 Economic prospects are mixed in Latin America
8 Cancer prevalence data illustrate Latin America’s untapped potential
10 Mortality rates highlight the treatment gap in Latin America
12 Pricing and access differentiate the Latin American markets
13 Physicians and patients remain key partners
14 Success drivers and resistors for oncology market access in Latin America
17 Bibliography
20 ARGENTINA
20 Argentina is an attractive but fragmented market
21 Coverage gaps remain
22 Non-PMO access to novel cancer drugs is achievable under exceptional mechanisms
24 Concerns over sustainability of central coverage distort market access
24 Exceptional access drives an emerging payer class
24 Pricing is nominally free in Argentina, but negotiation drives value
27 Case study analysis: Suprefact Depot and Keytruda
28 Bibliography
31 BRAZIL
31 Brazil is a valuable but complex oncology market
32 Brazil is home to a varied mix of public and private stakeholders
38 Brazil imposes a heavy evidence load on originators
40 Industrial strategy impacts market access
41 Short-term outlook is negative, and immediate reforms are unlikely
41 Case study analysis: Afinitor and Rituxan
43 Bibliography
47 COLOMBIA
47 Government is attempting to improve cancer care, as costs rise inexorably
51 New reforms will cement Colombia’s guidelines culture
53 Civil society stakeholders can be effective partners in driving access in oncology
54 Colombia’s oncology market is set for transformative change
54 Case studies: Gleevec and Herceptin
56 Bibliography
60 MEXICO
60 Mexico is a fragmented oncology market, but offers a sizable opportunity
61 An increasingly harsh pricing environment
67 Outlook is for very little change in the near term
68 Case studies: Velcade and Nexavar
LIST OF FIGURES
6 Figure 1: SWOT analysis: oncology market access in Latin America
8 Figure 2: Five-year prevalence of major tumor types in Latin America (total number of cases),
by country
9 Figure 3: Five-year prevalence of selected less common tumor types in Latin America (total
number of cases), by country
11 Figure 4: Mortality by percentage of all cancer deaths (major tumor types) in Latin America
and the US, by country
14 Figure 5: Strategies for achieving market access success in oncology in Latin America
15 Figure 6: Critical success factors for oncology market access in Latin America, by business
function
20 Figure 7: SWOT analysis: Argentina oncology market access
21 Figure 8: Oncology market access stakeholders in Argentina
25 Figure 9: Documentation required for Exceptional Pathway (PAMI), SUR, and Social
Development Ministry reimbursement
27 Figure 10: Case study 1: Suprefact Depot in prostate cancer
27 Figure 11: Case study 2: Keytruda in melanoma and NSCLC
31 Figure 12: SWOT analysis: Brazil oncology market access
32 Figure 13: Oncology market access stakeholders in the Brazilian public sector
34 Figure 14: CMED pricing decision pathway
38 Figure 15: Oncology market access stakeholders in the Brazilian private sector
39 Figure 16: Key data requirements in Brazil, by agency
41 Figure 17: Case study 1: Afinitor in breast cancer
42 Figure 18: Case study 2: Rituxan in non-Hodgkin’s lymphoma
47 Figure 19: SWOT analysis: Colombia oncology market access
49 Figure 20: Oncology market access stakeholders in Colombia
52 Figure 21: Colombia: reformed market access model for new therapies, 2016–17
54 Figure 22: Case study 1: Gleevec in CML, ALL, and GIST
55 Figure 23: Case study 2: Herceptin in breast cancer
60 Figure 24: SWOT analysis: Mexico oncology market access
61 Figure 25: Pharmaceutical price formation in Mexico
63 Figure 26: Oncology market access stakeholders in Mexico
65 Figure 27: Comparison of stakeholder evidence requirements in Mexico
68 Figure 28: Case study 1: Velcade in multiple myeloma
68 Figure 29: Case study 2: Nexavar in kidney and liver cancers
List of tables
7 Table 1: Latin America: basic economic and healthcare indicators, by country
12 Table 2: Key oncology market access attributes of Argentina, Brazil, Colombia, and Mexico
22 Table 3: “Emerging” technologies covered by the SUR fund
36 Table 4: Brazil’s private sector insurance archetypes
Table 1: Latin America: basic economic and healthcare indicators, by country
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