Health Technology Assessment of Medical Devices Through the Ad Hoc Methodology: Experience of the Social Health Insurance in Peru

Authors

  • Lida Esther Hildebrandt Pinedo Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Lima, Perú Author
  • Rover Gomez-Morillo Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Daysi Zulema Diaz Obregón Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Rodrigo Vargas-Fernández Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Moises Apolaya-Segura Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Consuelo María Josefina Li Sing Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Marco Miguel Soto Barba Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Christy Grace Holguin Cordova Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author
  • Cristian Diaz-Vélez Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Seguro Social de Salud (EsSalud), Lima, Perú Author

Keywords:

Peru, Public Health, Health Management, Evidence-Based Medicine, Medical Devices, Health Technology Assessment

Abstract

Introduction: Health technology assessment (HTA) plays a key role in supporting decisions regarding the adoption and use of healthcare technologies. Medical devices pose unique challenges because of their technological heterogeneity, rapid innovation, and dependence on implementation settings, requiring adapted assessment methodologies.

Objective: To describe the experience of implementing an ad hoc methodology for health technology assessment of medical devices within the Peruvian Social Health Insurance system (EsSalud).

Materials and Methods: A retrospective descriptive observational study was conducted using HTA reports of medical devices published by the Institute for Health Technology Assessment and Research (IETSI) between 2020 and 2025. The methodology included PICO question development and validation, evidence search and selection, critical appraisal, evidence synthesis, methodological review, and preparation of the final recommendation. Institutional, clinical, and technological variables were analyzed using descriptive statistics.

Results: A total of 76 HTA reports were included; 37 (48.7%) received favorable recommendations and 39 (51.3%) unfavorable recommendations. The highest number of assessments occurred in 2023 and 2025. Most requests originated from the Rebagliati, Almenara, and Sabogal healthcare networks and the National Cardiovascular Institute (INCOR). Surgical specialties and adult populations predominated. Favorable recommendations were mainly related to cardiology/cardiovascular surgery, traumatology, interventional oncology, and therapeutic gastroenterology technologies.

Conclusions: The ad hoc methodology enabled timely and structured assessments of medical devices through an evidence-based institutional process supported by methodological review and evaluation of institutional applicability, strengthening transparent and context-specific decision-making within EsSalud.

Downloads

Download data is not yet available.

References

1. O’Rourke B, Oortwijn W, Schuller T; International Joint Task Group. The new definition of health technology assessment: a milestone in international collaboration. Int J Technol Assess Health Care. 2020;36(3):187-190. doi:10.1017/S0266462320000215.

2. World Health Organization. Health technology assessment of medical devices. 2nd ed [Internet]. Geneva: World Health Organization; 2025 [citado 2026 Jun 01]. Disponible en: https://www.who.int/publications/i/item/9789240110878

3. Banta D. The development of health technology assessment. Health Policy. 2003;63(2):121-132. doi:10.1016/S0168-8510(02)00059-3.

4. Tarricone R, Torbica A, Drummond M. Challenges in the assessment of medical devices: the MedtecHTA project. Health Econ. 2017;26 Suppl 1:5-12. doi:10.1002/hec.3469.

5. Fuchs S, Olberg B, Panteli D, Perleth M, Busse R. HTA of medical devices: challenges and ideas for the future from a European perspective. Health Policy. 2017;121(3):215-229. doi:10.1016/j.healthpol.2016.08.010.

6. Ming J, He Y, Yang Y, Hu M, Zhao X, Liu J, et al. Health technology assessment of medical devices: current landscape, challenges, and a way forward. Cost Eff Resour Alloc. 2022;20(1):54. doi:10.1186/s12962-022-00389-6.

7. Tricco AC, Langlois EV, Straus SE, editores. Rapid reviews to strengthen health policy and systems: a practical guide. Geneva: World Health Organization; 2017.

8. Langlois EV, Straus SE, Antony J, King VJ, Tricco AC. Using rapid reviews to strengthen health policy and systems and progress towards universal health coverage. BMJ Glob Health. 2019;4(1):e001178. doi:10.1136/bmjgh-2018-001178.

9. Khangura S, Konnyu K, Cushman R, Grimshaw J, Moher D. Rapid review: an emerging approach to evidence synthesis in health technology assessment. Int J Technol Assess Health Care. 2014;30(1):20-27. doi:10.1017/S0266462313000664.

10. European Network for Health Technology Assessment. HTA Core Model® version 3.0. Copenhagen: EUnetHTA; 2016.

11. National Institute for Health and Care Excellence. Medical technologies evaluation programme methods guide. London: NICE; 2017.

12. Ciani O, Wilcher B, Blankart CR, Hatz M, Rupel VP, Erker RS, et al. Health technology assessment of medical devices: a survey of non-European union agencies. Int J Technol Assess Health Care. 2015;31(3):154-165. doi:10.1017/S0266462315000185.

13. European Commission. Methods for Health Technology Assessment of Medical Devices: a European Perspective (MedtecHTA) [Internet]. Brussels: Community Research and Development Information Service; 2015 [citado 2026 Jun 01]. Disponible en: https://cordis.europa.eu/project/id/305694/reporting

14. Instituto de Evaluación de Tecnologías en Salud e Investigación. Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N.° 111-IETSI-ESSALUD-2021 y anexo: metodología Ad Hoc para evaluar solicitudes de tecnologías sanitarias [Internet]. Lima: EsSalud; 2021 [citado 2026 Jun 01]. Disponible en: https://ietsi.essalud.gob.pe/normativas/resolucion-n-111-ietsi-essalud-2021/

15. Instituto de Evaluación de Tecnologías en Salud e Investigación. Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N.° 14-IETSI-ESSALUD-2024: aprobar el uso de la metodología para evaluar solicitudes de tecnologías sanitarias [Internet]. Lima: EsSalud; 2024 [citado 2026 Jun 01]. Disponible en: https://ietsi.essalud.gob.pe/normativas/resolucion-n14-ietsi-essalud-2024/

16. Instituto de Evaluación de Tecnologías en Salud e Investigación. Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N.° 000136-IETSI-ESSALUD-2025 [Internet]. Lima: EsSalud; 2025 [citado 2026 Jun 01]. Disponible en: https://ietsi.essalud.gob.pe/normativas/resolucion-n-136-ietsi-essalud-2025/

17. Instituto de Evaluación de Tecnologías en Salud e Investigación. Evaluaciones de tecnologías sanitarias de dispositivos médicos y equipos biomédicos [Internet]. Lima: EsSalud; 2026 [citado 2026 Jun 01]. Disponible en: https://ietsi.essalud.gob.pe/dictamenes-evaluacion-tecnologica/

18. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology statement: guidelines for reporting observational studies. PLoS Med. 2007;4(10):e296. doi:10.1371/journal.pmed.0040296.

19. Sampietro-Colom L, Lach K, Pasternack I, Wasserfallen JB, Cicchetti A, Marchetti M, et al. Guiding principles for good practices in hospital-based health technology assessment units. Int J Technol Assess Health Care. 2015;31(6):457-465. doi:10.1017/S0266462315000732.

20. Canadian Agency for Drugs and Technologies in Health. CADTH Rapid Response Reports [Internet]. Ottawa: CADTH; 2011-2021 [citado 2026 Jun 01]. Disponible en: https://www.ncbi.nlm.nih.gov/books/NBK168998/

21. Organización Panamericana de la Salud. Red de Evaluación de Tecnologías en Salud de las Américas (RedETSA) [Internet]. Washington, DC: OPS; 2026 [citado 2026 Jun 01]. Disponible en: https://redetsa.bvsalud.org/quienes-somos/

22. Pichon-Riviere A, Augustovski F, García Martí S, Alfie V, Sampietro-Colom L. The link between health technology assessment and decision making for the allocation of health resources in Latin America. Int J Technol Assess Health Care. 2020;36(2):173-178. doi:10.1017/S0266462320000057.

23. World Health Organization. Strengthening health technology assessment for medical devices and other health technologies to support universal health coverage. Geneva: World Health Organization; 2023 [citado 2026 Jun 01]. Disponible en: https://www.who.int/publications/i/item/9789240084135

Downloads

Published

2026-06-30

Issue

Section

Artículos Originales

How to Cite

Hildebrandt Pinedo, L. E., Gomez-Morillo, R., Diaz Obregón, D. Z., Vargas-Fernández, R., Apolaya-Segura, M., Li Sing, C. M. J., Soto Barba, M. M., Holguin Cordova, C. G., & Diaz-Vélez, C. (2026). Health Technology Assessment of Medical Devices Through the Ad Hoc Methodology: Experience of the Social Health Insurance in Peru. Revista Ciencia Y Tecnología Aplicada a La Salud Pública, 1(2), 38-51. https://rctsp.org.pe/index.php/rctsp/article/view/44