Predictability of Clinical Value Assessment in New Drug Price Calculation

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  • TAKAYAMA Akane
    北里大学大学院薬学研究科 臨床医学 (医薬開発学)
  • NARUKAWA Mamoru
    北里大学大学院薬学研究科 臨床医学 (医薬開発学)

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  • 新薬の薬価算定における有用性加算および営業利益率の加算的補正の予見性
  • シンヤク ノ ヤッカ サンテイ ニ オケル ユウヨウセイ カサン オヨビ エイギョウ リエキリツ ノ カサンテキ ホセイ ノ ヨケンセイ

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Abstract

A retrospective study to review the listed new drugs that obtained premiums under the drug price calculation was conducted and the factors which affect the assessment for premiums and upward adjustment were investigated. Four hundred and sixty four drugs were listed in the NHI price list from October 2004 to December 2014. The NHI drug price was calculated by the similar efficacy comparison method for 285 drugs (61.4%), while 135 drugs (29.1%) were calculated by the cost accounting method. Of the 285 drugs assessed by the similar efficacy comparison method, 89 (31.2%) received premiums for usefulness. Of the 135 drugs priced by the cost accounting method, the operating profit percentage of 33 drugs (24.4%) was adjusted upward. The drugs with a new mechanism of action had more chance to get premiums for usefulness than the other drugs (p<0.0001). Furthermore, the drugs with clinical trial results which demonstrated its superiority to an active control drug had more chance to get premiums for usefulness than those which showed non-inferiority to an active control drug (p=0.0013) and those which demonstrated superiority to a placebo control (p=0.0046). Similarly, compared with the drugs for which only single-armed clinical trial (s) was conducted, the drugs for which a clinical trial with an active control was conducted were likely to be adjusted the operating profit percentage upward (p=0.0021). The range of premium rates varied widely.

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