THE REAL IMPACT OF QUALITY OF LIFE (QOL) ENDPOINTS ON MARKET ACCESS DECISIONS ACROSS MARKETS – A CASE STUDY OF ONCOLOGY PRODUCTS

Author(s)

Gardiner RB1, Sealey S1, Edathodu A1, Mukku SR2
1Access Partnership, London, UK, 2The Access Partnership, London, UK

OBJECTIVES: Recent approvals of targeted oncology therapies have resulted in increased patient survival, and potential comorbidities. Subsequently, a greater emphasis has been placed on QoL, and PRO endpoints. However, the impact of QoL instruments on market access of new oncology products remains unclear. This research aims at understanding the true relevance of QoL endpoints in payer decision making METHODS: The research was conducted through in-depth secondary research and interviews with payers in 6 countries including the US, Germany, France, Spain, Italy, and Sweden. RESULTS: In the markets studied, QoL data is a requirement to be submitted for reimbursement; however, it is not a key determinant of reimbursement or pricing decisions at a national level. Some countries like Italy and Spain view QoL data as being important at a regional and local level for inclusion in formularies and guidelines. Furthermore, payers suggest that QoL is considered only in a qualitative sense based on the safety profile of a drug, and do not consider the instruments used to measure it. For example, in France, although the expectation is that a disease-specific QoL instrument is submitted for review by the Transparency Commission, this data will not contribute towards an ASMR determination. Meanwhile, in Sweden, the TLV requires the use of only generic instruments such as EQ-5D that are validated to be used in cost/QALY calculations, unlike disease specific instruments. CONCLUSIONS: Contrary to the increasing academic interest in QoL and PRO endpoints, these have not yet translated into playing a significant role in payer decision making for new oncology products. Currently, QoL instruments are used in oncology clinical trials as standard protocol. However, differentiating one drug over another through an improvement demonstrated using QoL instruments does not yet directly translate to an advantage from a market access point of view for that drug.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PCN154

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Oncology

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