EMBEDDED QUALITATIVE INTERVIEWS - GUIDANCE AND PRACTICE BY MAJOR HTA BODIES
Author(s)
Amy Wu, PharmD, MS1, Jaymin Patel2, Danny Yeh, PhD3;
1AESARA, Chapel Hill, NC, USA, 2AESARA, Associate Director - HEOR, Wake Forest, NC, USA, 3Aesara, Burlingame, CA, USA
1AESARA, Chapel Hill, NC, USA, 2AESARA, Associate Director - HEOR, Wake Forest, NC, USA, 3Aesara, Burlingame, CA, USA
OBJECTIVES: Qualitative research can reveal treatment benefits beyond conventional quantitative outcomes prioritized by health technology assessment (HTA) bodies. This review examined how HTA methods guidance incorporates qualitative research on patient experience within clinical trials and assessed whether such guidance is reflected in the use of qualitative evidence in recent HTA assessments.
METHODS: We conducted a targeted review of the most recent HTA methods guidance from major bodies (ICER, NICE, SMC, CADTH-CDA/AMC, INESSS, PBAC, G-BA, IQWiG, TLV, Medicinrådet, NoMA, HAS, ZiN, AIFA, MHLW). Keyword searches identified references to qualitative research on patient experience in trials and its intended use. To complement this, we reviewed HTA assessments from 2023 to 2025 for five drugs reported to include in trial qualitative interview data. This supplementary review was limited to HTA bodies whose guidance explicitly referenced qualitative patient experience research in trials. Public recommendation documents and, where available, sponsor submissions were examined to determine whether and how qualitative interview evidence was incorporated.
RESULTS: Recognition of qualitative research varied across guidance. Of fifteen HTA bodies reviewed, only three (NICE, CADTH-CDA/AMC, and IQWiG) explicitly referenced qualitative research on patient experience in clinical trials. Three others (SMC, INESSS, and Medicinrådet) acknowledged patient experience as a value consideration without specifying qualitative methods. Among five recently approved treatments with reported in trial interview activity, assessments conducted by NICE, CADTH-CDA/AMC, and IQWiG showed limited uptake: only one NICE submission included explicit in-trial qualitative interview evidence.
CONCLUSIONS: Qualitative interviews embedded in trials can help decision makers understand treatment benefits from the patient perspective. Few HTA bodies explicitly reference qualitative methods in their guidance, and such evidence is rarely included in recent submissions. Establishing clear pathways to plan, document, and submit qualitative findings would better integrate this evidence into HTA and support more patient centric decisions.
METHODS: We conducted a targeted review of the most recent HTA methods guidance from major bodies (ICER, NICE, SMC, CADTH-CDA/AMC, INESSS, PBAC, G-BA, IQWiG, TLV, Medicinrådet, NoMA, HAS, ZiN, AIFA, MHLW). Keyword searches identified references to qualitative research on patient experience in trials and its intended use. To complement this, we reviewed HTA assessments from 2023 to 2025 for five drugs reported to include in trial qualitative interview data. This supplementary review was limited to HTA bodies whose guidance explicitly referenced qualitative patient experience research in trials. Public recommendation documents and, where available, sponsor submissions were examined to determine whether and how qualitative interview evidence was incorporated.
RESULTS: Recognition of qualitative research varied across guidance. Of fifteen HTA bodies reviewed, only three (NICE, CADTH-CDA/AMC, and IQWiG) explicitly referenced qualitative research on patient experience in clinical trials. Three others (SMC, INESSS, and Medicinrådet) acknowledged patient experience as a value consideration without specifying qualitative methods. Among five recently approved treatments with reported in trial interview activity, assessments conducted by NICE, CADTH-CDA/AMC, and IQWiG showed limited uptake: only one NICE submission included explicit in-trial qualitative interview evidence.
CONCLUSIONS: Qualitative interviews embedded in trials can help decision makers understand treatment benefits from the patient perspective. Few HTA bodies explicitly reference qualitative methods in their guidance, and such evidence is rarely included in recent submissions. Establishing clear pathways to plan, document, and submit qualitative findings would better integrate this evidence into HTA and support more patient centric decisions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR113
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas