TABLE OF CONTENTS

6 EXECUTIVE SUMMARY

8 DRIVERS AND RESISTORS OF HTA USE

8 Healthcare growth containment drives need for HTA

9 A number of obstacles remain to effective HTA use

13 More challenging market access conditions are resulting from HTA use

15 Bibliography

17 HTA IS IMPLEMENTED IN A VARIETY OF WAYS

17 HTA is adopted and implemented in a variety of ways depending on a country’s needs and

preferences

25 International collaboration is shaping HTA development and capacity building in emerging

markets, but variations will remain

29 Bibliography

34 PHARMA’S INVESTMENT IN HEOR IS GROWING

34 Growing pharma sales in the public segment necessitate shift in strategy

34 Pharma’s investment in HEOR in emerging markets is growing, but a pragmatic approach is

critical to maximize ROI

37 Bibliography

39 HTA AND STAKEHOLDER ENGAGEMENT

39 Formal HTA advice channels focus on technical aspects

44 Informal engagement of stakeholders and policy makers is commonplace

45 Public-private partnerships present an opportunity for wider engagement with governments

and providers

46 Bibliography

48 BRAZIL

48 Brazil has established itself as a leader in HTA in Latin America

50 Universal healthcare coverage necessitated introduction of a formal HTA process

50 Establishment of CONITEC represents a major step in strengthening HTA process in Brazil

62 Communication with CONITEC focuses on the technical checking of the dossiers, but the

agency is open to further engagement

62 Threat of spill-over effect into private insurance coverage enhances importance of CONITEC

approval

63 Bibliography

66 CHINA

66 China lags behind in its capacity to use HTA, but slow change is set to occur

67 Universal health insurance coverage as a result of healthcare reforms

71 Bibliography

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4

LIST OF FIGURES

73 MEXICO

73 HTA in Mexico lags behind Brazil

75 The Mexican health insurance system is fragmented

76 The CSG is the key HTA body in Mexico and decides on national reimbursement

83 Bibliography

85 POLAND

85 Poland is a leader in HTA in Central and Eastern Europe

87 Public health insurance provides coverage to 98% of the Polish people

94 Bibliography

96 SOUTH KOREA

96 South Korea’s HIRA has emerged as the leader in HTA in the Asia Pacific region

98 South Korea’s health insurance system is based on a single major payer

99 HIRA and NECA are the key HTA bodies in South Korea

105 Bibliography

108 TAIWAN

108 Taiwan has introduced HTA, but has limited capacity to carry out full assessment

110 The Taiwanese healthcare system has a single payer

110 The pricing and reimbursement process was reformed in 2013

118 Bibliography

8 Figure 1: Drivers and resistors of increasing use of HTA in reimbursement decision-making in

emerging markets

22 Figure 2: More complex pharmacoeconomic evaluations are conducted in countries with more

mature HTA systems

43 Figure 3: More mature HTA systems offer greater opportunities for formal HTA engagement

49 Figure 4: Brazil’s HTA system is at an established stage of development

51 Figure 5: Structure of CONITEC

51 Figure 6: Summary of CONITEC’s role in the market access process in Brazil

56 Figure 7: CONITEC’s assessments split by therapeutic area

58 Figure 8: CONITEC’s positive and negative recommendations, by therapeutic area, December

2011 to May 2014

59 Figure 9: Reasons for CONITEC’s positive recommendations

61 Figure 10: Reasons for CONITEC’s negative recommendations

66 Figure 11: China’s HTA system is immature

67 Figure 12: The selection of medicines for the NRDL in China is largely influenced by experts at

the national and provincial levels

75 Figure 13: Mexico’s HTA system is at an intermediate level of maturity

75 Figure 14: Public health insurance bodies in Mexico

76 Figure 15: The pricing and reimbursement process in Mexico

Market Access Market Access / Pricing & Reimbursement DMKC0138547 | Published on 16/04/2015

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5

LIST OF TABLES

87 Figure 16: Poland’s HTA system is leaning toward a higher degree of maturity compared to

other emerging markets

88 Figure 17: Pricing and reimbursement process for drugs in Poland

98 Figure 18: South Korea’s HTA system is leaning toward a higher degree of maturity compared

to other emerging markets

99 Figure 19: Pricing and reimbursement process in South Korea

101 Figure 20: Pricing of reimbursed medicines in South Korea depends on whether they offer

added benefit over comparators

109 Figure 21: Taiwan’s HTA system is at an intermediate level of maturity compared to other

emerging markets

111 Figure 22: Pricing and reimbursement process in Taiwan

112 Figure 23: Pricing rules and dossier requirements for Category 1 and Category 2 products in

Taiwan

18 Table 1: Stage of development of HTA in selected emerging markets

27 Table 2: Selected collaborations between NICE/NICE International and healthcare

organizations in emerging markets

41 Table 3: Summary of routes for HTA advice and stakeholder engagement in key emerging

markets

48 Table 4: Summary of key facts on use of HTA in Brazil

53 Table 5: Key features of pharmacoeconomic guidelines in Brazil

69 Table 6: Key features of pharmacoeconomic guidelines in China

73 Table 7: Summary of key facts on use of HTA in Mexico

79 Table 8: Key features of pharmacoeconomic guidelines in Mexico

85 Table 9: Summary of key facts on use of HTA in Poland

90 Table 10: Key features of pharmacoeconomic guidelines in Poland

96 Table 11: Summary of key facts on use of HTA in South Korea

102 Table 12: Key features of pharmacoeconomic guidelines in South Korea

108 Table 13: Summary of key facts on use of HTA in Taiwan