Japan's Chuikyo Gives Price Approval to 12 Drugs

According to Pharma Japan, Japanese firm Takeda's angiotensin II receptor blocker Azilva (azilsartan) is likely to be the star performer among the 12 price-approved active pharmaceutical ingredients (APIs) in terms of sales, with Chuikyo forecasting that its annual turnover will peak at JPY63.7 billion (USD789.8 million) in the fifth year after its launch. Azilva's price was set using the similar-efficacy comparison method, with Japanese firm Daiichi Sankyo's Olmetec (olmesartan) used as the comparator drug. Azilva received the premium for usefulness group II (i.e. 5%), given that it has demonstrated statistical superiority over Takeda's established angiotensin II receptor blocker Blopress (candesartan).

Of the 12 APIs, the next largest in terms of sales is expected to be German firm Bayer's once-daily oral anticoagulant Xarelto (rivaroxaban), for which turnover is expected to peak at JPY41.2 billion in its 10th year. In common with Azilva, the drug's price was set using the similar-efficacy comparison method, and in this case, the comparator drug was German firm Boehringer Ingelheim's Pradaxa (dabigatran).

Five of 12 Price-Approved APIs Forecast to Achieve Annual Sales of More Than JPY10 Bil.

In total, 5 of the 12 price-approved APIs are expected to achieve annual sales in excess of JPY10 billion, with the other three being Daiichi Sankyo's monoclonal antibody Ranmark (denosumab), Japanese firm Eisai's insomnia treatment Lunesta (eszopiclone), and US pharma Merck & Co's antifungal Cancidas (caspofungin). For these three, the respective sales are expected to amount to JPY17.0 billion (in year 10), JPY11.2 billion (year 8), and JPY10.4 billion (year 5).

Ranmark—indicated for treating bone complications stemming from multiple myeloma and bone metastases from solid tumours—and Cancidas were both priced using the similar-efficacy comparison method. In the case of Ranmark, for which the comparator drug was Swiss pharma Novartis's Zometa (zoledronic acid), it was accorded a 5% premium for usefulness over the Novartis drug. Meanwhile, Cancidas, which was also given a 5% premium for usefulness, received an upward price adjustment in light of the fact that its calculated National Health Insurance price was less than 75% that of the average price in four Western countries.

Outlook and Implications

Chuikyo's new price approvals are for drugs that were approved by Japan's Ministry of Health, Labour, and Welfare (MHLW) at the beginning of the year. Other drugs that were approved at the same time include Japanese firm Astellas' restless legs syndrome treatment Regnite (gabapentin) and compatriot firm Shionogi's cancer pain product Oxifast (oxycodone; see Japan: 18 January 2012: New Approvals in Japan Include Xarelto, Ranmark, Azilva), although the source (Pharma Japan) did not provide any pricing details for these.

Marketing authorisation and pricing approval—and the high sales forecast—is particularly significant in the case of Takeda's Azilva, given that it has been earmarked as the long-term successor to Blopress, whose global sales amounted to JPY168.8 billion in the first nine months of the 2011/12 financial year (see Japan: 3 February 2012: Takeda's Q1–Q3 FY 2011/12 Results Weighed Down by Nycomed Acquisition).