Abstract
The objective of this study was to identify key value drivers to achieve pricing premiums through the similar efficacy comparator pricing method for innovative products in Japan. We analysed all products that were priced by the Central Social Insurance Medical Council (Chuikyo) using the similar efficacy comparator pricing method (I) from January 2010 to March 2014. Where relevant, the pricing premium and premium criteria met within each category were analysed in detail. Of 102 products assessed, 36 products (35%) were granted pricing premiums, which ranged from 5-50%. The most common premium category was utility (69%), followed by paediatric use (19%) and marketability (17%). Four products fell into two categories and were granted both pricing premiums. Of the seven orphan drugs assessed, six gained a 10% marketability (I) premium, while one achieved marketability (II) with only a 5% premium, as the orphan indication was not its main indication. Paediatric-use premiums ranged from 5-10%, with higher premiums dependent on unmet need and availability of similar therapies. 5-15% utility (II) premiums were achieved by products with improved MOA, efficacy, safety or therapeutic method. Only two products, fingolimod and telaprevir, were designated as utility (I) innovations, which qualified them for pricing premiums of 35-60%. Fingolimod was the first oral therapy approved to treat relapsing forms of multiple sclerosis. Its novel MOA, improved administration and efficacy, as well as an orphan indication, secured fingolimod a 50% pricing premium. Similarly, telaprevir was also valued by Chuikyo for its novel MOA and significant clinical improvement over the standard of care, resulting in a 40% pricing premium. Clinical benefit and unmet need are the main value drivers for premium pricing in Japan. To achieve >20% pricing premium, a product needs to meet at least two utility premium criteria to be categorized to utility (I).
Published Version
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