The Inclusion of Qualitative Patient Experience Data in HTA and Reimbursement Dossiers: A Review of Templates From Eight HTA Bodies
Author(s)
Montserrat Casamayor, MSc, PhD, MD1, Sangeetha C.P., MSc2, Inga Gruß, PhD3, Michael Kostikas, MSc4, Martin Paczkowski, MSc5, Marieke Krol, BA, MBA, MSc, PhD6.
1IQVIA, Barcelona, Spain, 2IQVIA, Bangalore, India, 3Patient Centered Solutions, IQVIA, Ann Arbor, MI, USA, 4IQVIA, Amsterdam, Netherlands, 5Patient Centered Solutions, IQVIA, Durham, FL, USA, 6Senior Principal Patient Centered Solutions, IQVIA, AMSTERDAM, Netherlands.
1IQVIA, Barcelona, Spain, 2IQVIA, Bangalore, India, 3Patient Centered Solutions, IQVIA, Ann Arbor, MI, USA, 4IQVIA, Amsterdam, Netherlands, 5Patient Centered Solutions, IQVIA, Durham, FL, USA, 6Senior Principal Patient Centered Solutions, IQVIA, AMSTERDAM, Netherlands.
OBJECTIVES: The importance of incorporating patient experience data (PED) in drug development and the increasing role of qualitative evidence in the regulatory approval processes are generally acknowledged. However, HTA agencies/reimbursement organizations currently do not require the inclusion of PED generated through interviews or other qualitative methods. This study explored if and how findings from qualitative patient studies could be integrated into HTA/reimbursement dossier templates from eight different HTA bodies.
METHODS: Templates and guidance from the following HTA agencies were included in the review: G-BA (Germany), Greek HTA Committee (Greece), HAS (France) NICE (England), SMC (Scotland), ZiN (Netherlands), JCA (multiple EU member states) and AMCP (US). Each template/guidance was assessed i) whether qualitative evidence was explicitly requested, ii) whether it allowed for the inclusion of qualitative evidence, and iii) in which sections qualitative evidence could be presented.
RESULTS: None of the investigated reimbursement guidance and template documents specifically request the inclusion of qualitative evidence from patient interviews. However, all templates allow for its inclusion. Qualitative PED is best suited for sections describing the disease including symptoms, impacts, unmet needs, disease treatment, real-world evidence, and benefit-risk considerations. The JCA template is most rigid in its structure and was foremost focused on clinical and registry data. It permits the use of PED to inform the burden of the target condition and support the clinical validity of Clinical Outcome Assessment instruments used in registrational trials.
CONCLUSIONS: Although qualitative PED is not specifically requested and seems not to be explicitly considered in HTA/reimbursement dossiers, there are opportunities to integrate it in country specific HTA and reimbursement dossiers or JCA submission dossiers. By doing so, the patient voice can be better reflected in the market access process.
METHODS: Templates and guidance from the following HTA agencies were included in the review: G-BA (Germany), Greek HTA Committee (Greece), HAS (France) NICE (England), SMC (Scotland), ZiN (Netherlands), JCA (multiple EU member states) and AMCP (US). Each template/guidance was assessed i) whether qualitative evidence was explicitly requested, ii) whether it allowed for the inclusion of qualitative evidence, and iii) in which sections qualitative evidence could be presented.
RESULTS: None of the investigated reimbursement guidance and template documents specifically request the inclusion of qualitative evidence from patient interviews. However, all templates allow for its inclusion. Qualitative PED is best suited for sections describing the disease including symptoms, impacts, unmet needs, disease treatment, real-world evidence, and benefit-risk considerations. The JCA template is most rigid in its structure and was foremost focused on clinical and registry data. It permits the use of PED to inform the burden of the target condition and support the clinical validity of Clinical Outcome Assessment instruments used in registrational trials.
CONCLUSIONS: Although qualitative PED is not specifically requested and seems not to be explicitly considered in HTA/reimbursement dossiers, there are opportunities to integrate it in country specific HTA and reimbursement dossiers or JCA submission dossiers. By doing so, the patient voice can be better reflected in the market access process.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR234
Topic
Health Technology Assessment, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas