Practical Challenges of Implementing a New Patient-Reported Outcome (PRO) in Oncology Under the German Pharmaceutical Market Restructuring Act (AMNOG) - Results From a Qualitative Focus Group Study

Author(s)

Pauge S1, Surmann B2, Zueger A3, Richter L4, Mathies V5, Mehlis K3, Ernst T5, Greiner W2, Menold N4, Winkler E3
1School of Public Health, Bielefeld University, Bielefeld, NW, Germany, 2School of Public Health, Bielefeld University, Bielefeld, Germany, 3National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany, 4Faculty of Arts, Humanities and Social Science, Dresden University, Dresden, Germany, 5Hematology and Internal Oncology, University Jena, Jena, Germany

Presentation Documents

OBJECTIVES:

Cancer as a chronic disease with lifelong individual consequences requires PROs to capture potential side effects beyond clinical endpoints. However, PROs are still not exhaustively considered in health technology assessment (HTA), even though studies indicate that e.g. financial effects correlates with health-related quality of life (HRQoL) or mortality. PROs to comprehensively measure financial effects of cancer are currently under development. We aim to analyse the conditions, needs and challenges for the implementation of a new oncological PRO under the German AMNOG from a regulatory perspective.

METHODS:

A semi-structured focus group with n=6 representatives from four German HTA and payer authorities was conducted. An interview guideline was developed in advance. Transcripts were analysed using qualitative content analysis.

RESULTS:

PROs play a role almost exclusively in the measurement of HRQoL under AMNOG in line with the German law (SGB V). HRQoL data is less often considered to determine an additional benefit in oncology since data are either not available or of minor quality. To develop a new PRO, five categories need to be considered: “objectivity”, “applicability”, “conceptuality”, “methodological quality” and “regulatory conditions”. The development is challenged by the objectifiability of a subjectively perceived phenomena. Generic PROs are hampered by the chronic nature of cancer with different stages and severity of illness challenging the time horizon and degree of specialisation of the instrument. PROs need to be subsumed under HRQoL as a patient-relevant outcome. Further mentioned application could be in economic evaluations, which might get a practical impact in the AMNOG in the future.

CONCLUSIONS:

The integration of new PROs under AMNOG is presently limited by legal regulations. Profound evidence about the construct needs to be gathered beforehand using validated instruments to illustrate the relevance for patients. Further integration of PROs under AMNOG beyond HRQoL should be discussed, e.g. by considering productivity losses in economic evaluations.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Code

HTA152

Topic

Health Technology Assessment, Methodological & Statistical Research, Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods, Systems & Structure, Value Frameworks & Dossier Format

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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