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Transferability of a EUnetHTA relative effectiveness assessment to low- and middle-income countries setting

Published online by Cambridge University Press:  28 April 2022

T. I. Armina Padmasawitri Open the ORCID record for T. I. Armina Padmasawitri [Opens in a new window]  and
Ahmad Fuady
T. I. Armina Padmasawitri*
Affiliation:
Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung, Bandung, Indonesia
Ahmad Fuady
Affiliation:
Department of Community Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
*
*Author for correspondence: T. I. Armina Padmasawitri, E-mail: armina@itb.ac.id
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Abstract

In 2020, European Network for Health Technology Assessment (EUnetHTA) published a relative effectiveness analysis (REA) of Pretomanid in combination with Bedaquiline and Linezolid for the treatment of extensively drug-resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) (REA PTJA14). This REA may have a significant value for low- and middle-income countries (LMICs) outside Europe, particularly those with a high burden of drug-resistant TB. This commentary focuses on whether the REA PTJA14 can be transferred and to what extent a REA can be translated to LMICs context outside Europe. We found that the assessments on the clinical effectiveness and risks of bias reported in REA PTJA14 are useful for LMICs outside Europe. The highly standardized management of TB will support the applicability of the REA to LMICs outside of Europe. Transferring this REA can reduce workload and efficiently use limited resources to conduct health technology assessment (HTA). However, the transfer should consider several critical issues, including variations in health system delivery and clinical practice and setting-specific constraints. In the TB context, the differences in the current standard treatment for XDR or nonresponsive MDR TB, resources availability for drug-resistant TB management, and how healthcare is delivered in the countries can complicate the applicability of the REA PTJA14. Given that LMICs have limitations in doing HTA, it is now critical to develop standard guidelines for transferring REA or other HTA results from high-income countries or other LMICs to maximize the benefits of the REA for LMICs outside Europe.

Keywords

Rapid Effectiveness AnalysisHTATransferabilityLow-income countriesMiddle-income countriesLMICTuberculosisDrug-resistantMDR TBXDR TB
Type
Article Commentary
Information
International Journal of Technology Assessment in Health Care , Volume 38 , Issue 1 , 2022 , e42
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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References

O’Rourke, B, Oortwijn, W, Schuller, T (2020) Announcing the new definition of health technology assessment. Value Health. 23, 824–825. https://doi.org/10.1016/j.jval.2020.05.001.CrossRefGoogle ScholarPubMed
Tantivess, S, Chalkidou, K, Tritasavit, N, Teerawattananon, Y (2017) Health technology assessment capacity development in low- and middle-income countries: Experiences from the international units of HITAP and NICE. F1000Res. 6, 2119. https://doi.org/10.12688/f1000research.13180.1.CrossRefGoogle ScholarPubMed
Babigumira, JB, Jenny, AM, Bartlein, R, Stergachis, A, Garrison, LP (2016) Health technology assessment in low- and middle-income countries: A landscape assessment. J Pharm Health Serv Res. 7, 37–42. https://doi.org/10.1111/jphs.12120.CrossRefGoogle Scholar
Oortwijn, W, Mathijssen, J, Banta, D (2010) The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries. Health Policy. 95, 174–184. https://doi.org/10.1016/j.healthpol.2009.12.008.CrossRefGoogle ScholarPubMed
Oortwijn, W, Broos, P, Vondeling, H, Banta, D (2013) Mapping of health technology assessment: Developing and testing an evaluation matrix in selected countries. Int J Technol Assess Health Care. 29, 424–434. https://doi.org/10.1017/S0266462313000469.CrossRefGoogle Scholar
Bijlmakers, L, Mueller, D, Kahveci, R, Chen, Y, van der Wilt, GJ (2017) INTEGRATE-HTA: A low- and middle-income country perspective. Int J Technol Assess Health Care. 33, 599–604. https://doi.org/10.1017/S0266462317000927.CrossRefGoogle ScholarPubMed
Barnsley, P, Marsden, G, Towse, A, Henshall, C (2014) Background paper: Transferability of Hta, Htai Asia policy forum meeting; [cited 9 April 2021]. Available at: https://htai.org/wp-content/uploads/2018/02/17023_HTAi_AsiaForumBackground2014.pdf (Accessed 2021).Google Scholar
Goeree, R, He, J, O’Reilly, D, et al (2011 ) Transferability of health technology assessments and economic evaluations: A systematic review of approaches for assessment and application. Clinicoecon Outcomes Res. 3, 89–104. https://doi.org/10.2147/CEOR.S14404.CrossRefGoogle ScholarPubMed
Németh, B, Goettsch, W, Kristensen, FB, et al (2020 ) The transferability of health technology assessment: The European perspective with focus on central and Eastern European countries. Expert Rev Pharmacoecon Outcomes Res. 20, 321–330. https://doi.org/10.1080/14737167.2020.1779061.CrossRefGoogle ScholarPubMed
Kristensen, FB, Lampe, K, Wild, C, et al (2017 ) The HTA core model®-10 years of developing an international framework to share multidimensional value assessment. Value Health. 20, 244–250. https://doi.org/10.1016/j.jval.2016.12.010.CrossRefGoogle ScholarPubMed
Kleijnen, S, Toenders, W, de Groot, F, et al (2015) European collaboration on relative effectiveness assessments: What is needed to be successful? Health Policy. 119, 569–576. https://doi.org/10.1016/j.healthpol.2015.01.018.CrossRefGoogle ScholarPubMed
Drummond, M, Augustovski, F, Kaló, Z, et al (2015) Challenges faced in transferring economic evaluations to middle income countries. Int J Technol Assess Health Care. 31, 442–448. https://doi.org/10.1017/S0266462315000604.CrossRefGoogle ScholarPubMed
Kisser, A, Knieriemen, J, Fasan, A, et al (2021 ) Towards compatibility of EUnetHTA JCA methodology and German HTA: A systematic comparison and recommendations from an industry perspective. Eur J Health Econ. https://doi.org/10.1007/s10198-021-01400-2.CrossRefGoogle ScholarPubMed
EUnetHTA European Network for Health Technology Assessment (2011) EUnetHTA European network for health technology assessment. Adapting existing HTAs from one country into other settings. Working Package 5; [cited 14 March 2022]. Available at: https://www.eunethta.eu/wp-content/uploads/2011/01/EUnetHTA_adptation_toolkit_2011_version_5.pdf (Accessed 2022).Google Scholar
EUnetHTA European Network for Health Technology Assessment (2020) Relative effectiveness assessment of pharmaceutical technologies, Pretomanid in combination with Bedaquiline and Linezolid in adults for the treatment of pulmonary extensively drug-resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis; [cited 25 May 2021]. Available at: https://eunethta.eu/wp-content/uploads/2020/08/PTJA14-Final-Assessment-Reportv1.0.pdf (Accessed 2021).Google Scholar
Falzon, D, Mirzayev, F, Wares, F, et al (2015) Multidrug-resistant tuberculosis around the world: What progress has been made? Eur Respir. 45, 150–160. https://doi.org/10.1183/09031936.00101814.CrossRefGoogle Scholar
Fuady, A, Houweling, TAJ, Mansyur, M, Burhan, E, Richardus, JH (2020) Cost of seeking care for tuberculosis since the implementation of universal health coverage in Indonesia. BMC Health Serv Res. 20, 502. https://doi.org/10.1186/s12913-020-05350-y.CrossRefGoogle ScholarPubMed
Balaji, V, Daley, P, Anand, AA, et al (2010) Risk factors for MDR and XDR-TB in a tertiary referral hospital in India. PloS One. 5, e9527. https://doi.org/10.1371/journal.pone.0009527.CrossRefGoogle Scholar
Ismail, N, Ismail, F, Omar, SV et al (2018 ) Drug resistant tuberculosis in Africa: Current status, gaps and opportunities. Afr J Lab Med. 7, 781. https://doi.org/10.4102/ajlm.v7i2.781.CrossRefGoogle ScholarPubMed
He, S, Tao, N, Liu, Y, Zhang, X, Li, H (2017) Epidemiological trends and outcomes of extensively drug-resistant tuberculosis in Shandong, China. BMC Infect Dis. 17, 555. https://doi.org/10.1186/s12879-017-2652-x.CrossRefGoogle ScholarPubMed
Gandhi, NR, Nunn, P, Dheda, K, et al (2010 ) Multidrug-resistant and extensively drug-resistant tuberculosis: A threat to global control of tuberculosis. Lancet. 375, 1830–1843. https://doi.org/10.1016/S0140-6736(10)60410-2.CrossRefGoogle ScholarPubMed
Koch, A, Cox, H, Mizrahi, V (2018) Drug-resistant tuberculosis: Challenges and opportunities for diagnosis and treatment. Curr Opin Pharmacol. 42, 7–15. https://doi.org/10.1016/j.coph.2018.05.013.CrossRefGoogle ScholarPubMed
Khan, FA, Salim, MAH, du Cros, P, et al (2017 ) Effectiveness and safety of standardised shorter regimens for multidrug-resistant tuberculosis: Individual patient data and aggregate data meta-analyses. Eur Respir. 50, 1700061. https://doi.org/10.1183/13993003.00061-2017.CrossRefGoogle Scholar
Sotgiu, G, Migliori, GB (2017) Effect of the short-course regimen on the global epidemic of multidrug-resistant tuberculosis. Lancet Respir Med. 5, 159–161. https://doi.org/10.1016/S2213-2600(16)30432-5.CrossRefGoogle ScholarPubMed
Bhering, M, Duarte, R, Kritski, A (2019) Predictive factors for unfavourable treatment in MDR-TB and XDR-TB patients in Rio de Janeiro State, Brazil, 2000–2016. PloS One. 14, e0218299. https://doi.org/10.1371/journal.pone.0218299.CrossRefGoogle Scholar
Seung, KJ, Keshavjee, S, Rich, ML (2015) Multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Cold Spring Harb Perspect Med. 5, a017863. https://doi.org/10.1101/cshperspect.a017863.CrossRefGoogle ScholarPubMed
Gotham, D, McKenna, L, Frick, M, Lessem, E (2020) Public investments in the clinical development of Bedaquiline. PloS One. 15, e0239118. https://doi.org/10.1371/journal.pone.0239118.CrossRefGoogle ScholarPubMed
Bassili, A, Qadeer, E, Floyd, K, et al (2013) A systematic review of the effectiveness of hospital- and ambulatory-based management of multidrug-resistant tuberculosis. Am J Trop Med. 89, 271–280. https://doi.org/10.4269/ajtmh.13-0004.CrossRefGoogle ScholarPubMed
Institute of Medicine (U.S.) (2009) Forum on drug discovery and translation. In: Addressing the threat of drug-resistant tuberculosis: A realistic assessment of the challenge: Workshop summary. Washington, DC: National Academies Press.Google Scholar
de Vries, G, Tsolova, S, Anderson, LF, et al (2017 ) Health system factors influencing management of multidrug-resistant tuberculosis in four European Union countries - Learning from country experiences. BMC Public Health. 17, 334. https://doi.org/10.1186/s12889-017-4216-9.CrossRefGoogle ScholarPubMed
Ministry of Health Republic of Indonesia Decree on The National Guideline for HIV Care, No. HK.01.07/MENKES/90/2019, enacted 19 February 2019. Google Scholar
Oluwasanu, MM, Hassan, A, Adebayo, AM, et al (2020) General and tuberculosis-specific service readiness in two states in Nigeria. BMC Health Serv Res. 20, 792. https://doi.org/10.1186/s12913-020-05626-3.CrossRefGoogle ScholarPubMed
Agency for Care Effectiveness (2018) Ministry of Health Republic of Singapore, Medical technologies evaluation methods and process guide; [cited 14 March 2022]. Available at: https://www.ace-hta.gov.sg/docs/default-source/process-methods/ace-methods-and-process-guide-for-medical-technologies-evaluation-(1-oct-2018).pdf (Accessed 2022).Google Scholar
Swedish Agency for Health Technology Assessment and Assessment of Social Services (2018) Assessment of methods in health care and social services; [cited 14 March 2022]. Available at: https://www.sbu.se/contentassets/76adf07e270c48efaf67e3b560b7c59c/eng_metodboken.pdf (Accessed 2022).Google Scholar
World Health Organization (2020) Good reliance practices in regulatory decision-making for medical products: High-level principles and considerations; [cited 9 April 2021]. Available at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_851_Rev_1_Good_Reliance_Practices.pdf?ua=1 (Accessed 2021).Google Scholar