PROMOTION OF PATIENT REPORTED OUTCOMES (PRO) LABEL CLAIMS BASED ON NON-PRIMARY ENDPOINTS

Author(s)

Gnanasakthy A1, Sadrick A2, DeMuro C3, Rahul R41Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 2Novartis Healthcare Pvy. Ltd., Andhra Pradesh, India, 3RTI Health Solutions, Research Triangle Park, NC, USA, 4PharmaVoxx, Orange, CA, USA

OBJECTIVES:   A recent review (Gnanasakthy, 2012) has shown that about 24% of New Drug Applications (NDAs) and Biologic License Applications (BLAs) approved by the Food and Drug Administration (FDA) between 2006 and 2010 had at least one patient-reported outcome (PRO) label claim, and most claims (74%) were granted for PRO endpoints that were also primary endpoints. Claims based on primary endpoints are likely to be fully promoted by the manufacturers; however, the extent to which manufacturers promote claims based on secondary PRO endpoints is unknown. The purpose of this review is to assess the extent of promotion of PRO label claims for six products with nonprimary PRO endpoints. METHODS:   All six pharmaceutical products that received PRO label claims based on nonprimary PRO endpoints between 2006 and 2008 were reviewed. Promotional documents distributed in the US by the manufacturers of these drugs between the year of launch and 2011 were identified from a PharmaVoxx database. To assess the intensity of promotional activity, circulation of these documents was calculated based on quarterly distributions. Two researchers reviewed the documents using standard criteria. Promotional activities based on nonprimary PRO endpoints claims were compared with total number of messages. Disease-awareness and management documents and all videos, CDs, and DVD were excluded. RESULTS:  Manufacturers of the six products distributed a total of 973 unique promotional documents 2998 times. Messages based on primary endpoints were distributed 1,798 times, whereas messages relating to secondary PRO endpoints were distributed 1200 times (40% of distributions), and varied between products (4% to 70%). Messages relating to PROs were targeted mostly at patients and consumers (65%) and physicians and health care professionals (34%). CONCLUSIONS: Promotion of PRO messages based on nonprimary endpoints is much lower than those based on primary endpoints, indicating that manufacturers do not always optimize the potential of PRO messages.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

PIH54

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Pediatrics, Reproductive and Sexual Health, Respiratory-Related Disorders

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