ASSESSING THE IMPACT OF PATIENT-REPORTED OUTCOMES AND HEALTH ECONOMIC BENEFIT CLAIMS ON THE MARKET VALUE OF ONCOLOGIC PHARMACEUTICALS

Author(s)

Miller JD*1;Ruiz KM1;Gagnon DD2;Foley KA1;Varker HV1, Lenhart GM1 1Truven Health Analytics, Cambridge, MA, USA, 2Truven Health Analytics, Santa Barbara, CA, USA

OBJECTIVES: To evaluate the impact that patient-reported outcomes (PRO) and health economic (HE) benefit claims made in product labels and in published literature have on market value of oncologic pharmaceuticals in the US. METHODS: A target list of 13 advanced/metastatic cancers and 32 drugs with labeled indications for them were combined into 37 unique “drug-indication pairs.” Drugs were antineoplastic agents with FDA approval ≤ 2009. PRO claims in US and EMA labels were identified through a commercial research database. PRO and HE claims made in published literature were identified through review of abstracts published 2000-2010. Economic data (i.e., market size and market share in 2010) for drug-indication pairs were extracted from MarketScan® claims databases. Data were compiled into an analytic file and one primary and four secondary regression models were specified, adjusting for relative drug safety and efficacy. The dependant variable in each model represented dollar-value market share in 2010 of each drug in its cancer indication. RESULTS: Results indicate that PRO claims in US product labels are associated with positive increases in market value of oncologic pharmaceuticals. Presence of a label PRO claim was associated with 66% increase in market share—about the same economic impact conferred by superior drug efficacy. Results were not statistically significant in the model for US labels alone (p<0.18), but were significant when combining US and EMA labels (p<0.03). No significant association was found between PRO and HE claims made in published literature and market value of oncologic pharmaceuticals. CONCLUSIONS: Our analysis fills gaps in understanding the economic value of PRO and HE benefit claims for oncologic pharmaceuticals and sets precedence for undertaking similar studies in oncology and other disease areas. Results reinforce that industry should carefully evaluate potential positive returns for investing in inclusion of PRO and HE endpoints in clinical trials.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PCN113

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Oncology

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