NEW DRUGS IN NON-SMALL CELL LUNG CANCER- DISPARITIES IN REQUIREMENTS FOR POST-LAUNCH REAL-WORD EVIDENCE IN EUROPE

Author(s)

Floyd D, Langham J
PHMR Ltd, London, UK

OBJECTIVES: To determine country-specific requirements for real-world evidence (RWE) in Europe to support ongoing market access for new drugs to treat non-small cell lung cancer (NSCLC). Several new classes of drugs for NSCLC are coming to market and there is likely to be much competition. RWE is expected to play an important part in differentiating the new products and their most suitable target patient populations. METHODS: We reviewed published health technology assessments (HTAs) and reimbursement agency web sites to determine data sources for, or guidance on, RWE in France, Germany, Italy, The Netherlands, Spain, Sweden and the UK. In addition, we performed a pragmatic review of peer-reviewed literature to identify types of NSCLC RWE being published, and collected the views of market access specialists on RWE requirements among country representatives of a global pharmaceutical company. RESULTS: Publicly-available guidance on NSCLC RWE data collection by HTA and reimbursement authorities is currently lacking. Likewise, data sources are highly limited in number and scope and there were no publications featuring feasible registries. Market access specialists highlighted five categories of RWE data types. All countries expressed a requirement for patient characteristics, treatment patterns and effectiveness. Resource use and quality of life were considered supportive but not essential. No current registries are able to meet these requirements. CONCLUSIONS: Formal guidance on RWE requirements in NSCLC in Europe is lacking and there is a need for registries to capture the range of data types highlighted by market access specialists to obtain and maintain market access. Given the level of development in the NSCLC field, and the number of likely new market entrants, manufacturers with new or developmental drugs need to help establish an infrastructure for collecting NSCLC RWE in Europe.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN37

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Oncology

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