THE COMMERCIAL EFFECTS OF REFORMULATIONS OF EXISTING DRUGS

Author(s)

Sepulveda B1, Vincent L2, White C11Quintiles, Hawthorne, NY, USA, 2Quintiles Global Consulting, Hawthorne, NY, USA

OBJECTIVES: Given the high cost of creating a complete NME, it is not surprising that sixty percent of NDAs submitted to the FDA during the 1990s were for drugs based on an existing molecule (FDA, 2004). These products generally use three strategies for life cycle management (LCM): chemical reformulation, new drug combinations, or delivery reformulation, often resulting in an enhanced efficacy, safety, and compliance profile due to improved potency, tolerability, and duration of action. The objective of this study is to investigate the commercial effect of these LCM strategies. METHODS: Retail sales and prescription volume (TRx) of well-known reformulations (venlafaxine to desvenlafaxine, citalopram to escitalopram, trazodone extended-release, and paroxetine controlled-release) and reformulated combinations (esomeprazole / naproxen and fluticasone / salmeterol) were analyzed. Annual sales and TRx data were obtained since 2002 using SDI VONA.  RESULTS: Interestingly, the two branded combination products analyzed had significant increases in TRx and in sales (p<0.05) annually after the patent expiration of their original components, which showed significant annual decreases in sales and TRx (p<0.05).  The four reformulated products showed smaller changes than the combination products sales and TRx increases in the new branded products.  Similarly, the utilization and sales decreases of the original components were smaller in the reformulated products than in the combinations.  CONCLUSIONS: Given the higher cost of branded drugs, their unfavorable tier placement by payers with respect to their generic counterparts and the increased pressure to reduce drug spending, it may not be surprising that reformulated generic products still enjoy sustained utilization.  However, the premium for combination products that may increase patient adherence has not deterred utilization according to the present findings.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PHP31

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Prescribing Behavior

Disease

Multiple Diseases

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