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Access in Emerging Markets: HTA is Making Inroads

  • April 2015
  • -
  • Datamonitor Healthcare

This report includes an analysis of the growing use of HTA in emerging market countries and its impact on pricing, reimbursement, and market access Drivers and resistors to use of HTA in emerging markets are discussed, as well as the different ways in which HTA has been implemented in key emerging markets so far

Features and benefits

Understand key trends in HTA development and use in emerging markets

Gain insight into how HTA is impacting access in emerging markets

Visualize where HTA fits in the pricing and reimbursement process in key emerging markets and its impact on decision-making

Highlights

A discussion of the drivers and resistors of HTA use, as well as an overview of the different ways in which HTA has been implemented thus far in key emerging markets

Detailed analysis of HTA processes and their impact on pricing and reimbursement in Brazil, China, Mexico, Poland, South Korea, and Taiwan

An analysis of how pharma companies’ strategies are changing in order to engage a new group of stakeholders

Your key questions answered

What are the differences between HTA use in different emerging market countries?

How have pharma’s strategies adapted in reaction to the changes brought about by HTA?

What channels exist for pharma-HTA engagement?

What are the key lessons for success in overcoming hurdles presented by HTA in emerging markets?

Table Of Contents

Access in Emerging Markets: HTA is Making Inroads
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

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

List of Figures

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

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

List of Tables

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

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