THE IMPACT OF INDICATION EXTENSIONS ON PHARMACEUTICAL PRICES

Author(s)

Genane C*1;Marinoni G2;Ando G2, Reinaud F1 1IHS, Paris, France, 2IHS, London, United Kingdom

OBJECTIVES: This study aims to assess the impact of an indication extension on pharmaceutical prices in 9 markets: Australia, Brazil, France, Germany, Italy, Japan, Spain, Turkey, and the United Kingdom.  METHODS: Websites of the EMA and national regulatory agencies were surveyed to indentify medicines granted an indication extension between 2007 and 2013. Eight case studies (bevacizumab, trastuzumab, sunitinib, ivabradine, telmisartan, aripiprazole, paliperidone, and omalizumab) were selected based on market share and availability across the geographies of interest. The list prices, at ex-manufacturer levels, of these eight drugs and those of the medicines belonging to their therapeutic class (at ATC level 3) were collected for the period 2007-13. Price movements for these eight medicines were compared to the price evolution within their therapeutic class over the period. RESULTS: Based on the selected case studies, there is ambivalent synchrony between indication extensions and pharmaceutical list price movements in the countries analysed. The data show that list prices tend to remain stable following an indication extension. When list prices changed subsequent to an indication extension, the movements could not directly be linked to the indication extension, as external factors such as a class trend or a wider pricing and reimbursement process (e.g. blanket price cuts) could also play a role. CONCLUSIONS: There is inconclusive evidence that indication extensions lead to list price changes in the countries analysed. Moreover, the impact of commercial agreements and discounts should be taken into account as secondary indications may be subject to separate pricing arrangements (e.g., patient access schemes). As such, the selection of the indication for the first marketing-authorisation filing (such as a high medical need, niche indication, commanding a premium price) is pivotal for the commercial success of a medicine, as its launch price seems unlikely to be reviewed following subsequent approvals in broader patient populations.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP9

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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