Analyzing the Benefits from New NHI Drug Pricing System in Japan: Factor Decomposition and Simulation

Wakutsu, Naohiko; Nakamura, Hiroshi

doi:10.4091/iken.25.205

Cited by 4 publications

(5 citation statements)

References 10 publications

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“…Notably, two of the four CML drugs (nilotinib and dasa-tinib) and all three of the NET drugs (sunitinib, everolimus, and streptozocin) received premium rewards in their drug pricing in 2018; this is referred to as "Drug Price Premiums for Promoting the Creation of New Drugs and the Elimination of Off-label Drug Use", and indicates that higher drug prices can be set for rare cancer drugs compared with those for other common cancers. Wakutsu et al reported that the benefits brought by this premium reward system were considered to be sufficient to encourage pharmaceutical companies to engage in clinical development, in that research and development costs can be recovered at an early stage [36]. However, Wakutsu et al also stressed that such benefits can be limited, especially for orphan drugs, and suggested that financial support is strongly needed in this disease area to deliver new drugs efficiently [36].…”

Section: Discussionmentioning

confidence: 99%

“…Wakutsu et al reported that the benefits brought by this premium reward system were considered to be sufficient to encourage pharmaceutical companies to engage in clinical development, in that research and development costs can be recovered at an early stage [36]. However, Wakutsu et al also stressed that such benefits can be limited, especially for orphan drugs, and suggested that financial support is strongly needed in this disease area to deliver new drugs efficiently [36]. In Japan, drug prices are set by the government and revised every other year.…”

Section: Discussionmentioning

confidence: 99%

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Can Rare Cancer Drugs Expect Sales in Japan?: A Prescription Pattern Analysis of Drugs for Chronic Myelogenous Leukemia and Neuroendocrine Tumor

Shibata

Noguchi²,

Matsushita³

et al. 2019

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Despite high unmet medical needs, investment in rare cancer drug development has stagnated, likely because the potential market for such drugs is small. In this context, we hypothesized that rare cancer drugs could achieve a higher sales margin. A dataset was created from publicly available information obtained from the IQVIA Solutions Japan K.K. Pharmaceutical Market database on the website of the Pharmaceuticals and Medical Devices Agency/Ministry of Health, Labour and Welfare of Japan. The total amount of sales and prescription volumes between 2010 and 2016 for drugs whose indications include chronic myelogenous leukemia (CML) and neuroendocrine tumor (NET) were investigated. Regarding drugs for CML, the sales and prescription volumes of imatinib have been decreasing every year, whereas those of dasatinib and nilotinib have been increasing. Regarding drugs for NET, the sales and prescription volumes of sunitinib, everolimus, and streptozocin have been increasing every year. The present study revealed two sales models for the development of rare cancer drugs. First, sales amounts can be assured if clinical positioning with other existing drugs is sufficiently clear. Second, obtaining a label for rare cancers can stimulate drug development for more common cancers. These findings suggest that rare cancer drugs can offer high market value and profit potential; thus, to meet high unmet medical needs, clinical development programs for the development of rare cancer drugs should be promoted. https://doi.org/10.21423/jrs-v07shibata

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Can Rare Cancer Drugs Expect Sales in Japan?: A Prescription Pattern Analysis of Drugs for Chronic Myelogenous Leukemia and Neuroendocrine Tumor

Shibata

Noguchi²,

Matsushita³

et al. 2019

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“…A nonlinear relationship between sales and R&D intensity was reported based on an analysis of European companies [18]. In this context, the price maintenance premium in Japan was reported to be an effective way to promote R&D, with the premium rates of this system being approximately 10 percent of those under a comparative method [116], as described in Section 1.2, and accelerating the development of new drugs that can meet high medical needs, such as oncologic and neurological agents [116,94,95,117].…”

Section: Effects Of Price Control Strategies On Pharmaceuticalmentioning

confidence: 99%

Japanese Pharmaceutical Industry: Recent Perspectives and Areas for Further Research

Shibata

Ozaki

Suzuki

2020

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The Japanese pharmaceutical market is one of the largest in the world. The Japanese government has increasingly been trying to control rising health care costs, and as a result, pharmaceutical companies are expecting that fewer opportunities will be available to command a higher price based on higher levels of innovation; this will likely lead to decreased interest in research and development (R&D) activities. With this background, the purpose of this article is to review current perspectives for R&D by the Japanese pharmaceutical industry, and to discuss the limitations and challenges for further research from the regulatory science and management perspectives. Given the substantial amount of evidence of regulatory science and management perspectives from the pharmaceutical industry outside of Japan and the limited amount of evidence from inside of Japan, it is important to review perspectives focusing on the Japanese pharmaceutical industry in comparison with those from other countries to understand the complexities of the Japanese pharmaceutical market, as well as the limitations and challenges associated with increasing productivity. https://doi.org/10.21423/jrs-v08shoyo

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“…The ''NHI Drug Price Premium for Promoting the Creation of New Drugs and the Elimination of Offlabel Use'' is a price addition within the Japanese NHI drug pricing system. [19][20][21] This price addition is targeted at medicines whose price divergence rates (ratio of delivery price to official price) are lower than average (across all medicines). The medicines for which such a price addition are received are targeted for a special price reduction by the government in the drug price revision after the first generic medicine enters the market.…”

Section: Analysis Of Sales After Generic Entrymentioning

confidence: 99%

Impact of generic entry to off-patent branded medicines in Japanese pharmaceutical market

Fukumoto

Suzuki

2017

Journal of Generic Medicines

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The Japanese pharmaceutical market is known for having a relatively low market penetration of generic medicines. However, the velocity of generic penetration varies among medicines. Looking at current sales and share of off-patent branded medicines and generic medicines in Japanese pharmaceutical market, our main aim is to identify the factors associated with sales reductions of off-patent medicines and price competition caused by generic entry in the Japanese pharmaceutical market. We showed as one result that an increase in the number of generic maker entries significantly increases both price competition and sales reductions of off-patent branded medicines. As a second factor of note, we found that being subject to ''NHI Drug Price Premium for Promoting the Creation of New Drugs and the Elimination of Off-label Use'' before generic entry is related to maintaining sales of off-patent branded medicines after generic entry. The importance of generic medicines is increasing in association with the hypertrophy of health care expenditures in Japan. Efficient polices and corporate strategies reflecting market principles are strongly needed. Detailed results of this study on what determines whether sales and prices of off-patent medicines significantly decrease after generic entry in the Japanese pharmaceutical market should be useful for this purpose.

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Analyzing the Benefits from New NHI Drug Pricing System in Japan: Factor Decomposition and Simulation

Cited by 4 publications

References 10 publications

Can Rare Cancer Drugs Expect Sales in Japan?: A Prescription Pattern Analysis of Drugs for Chronic Myelogenous Leukemia and Neuroendocrine Tumor

Can Rare Cancer Drugs Expect Sales in Japan?: A Prescription Pattern Analysis of Drugs for Chronic Myelogenous Leukemia and Neuroendocrine Tumor

Japanese Pharmaceutical Industry: Recent Perspectives and Areas for Further Research

Impact of generic entry to off-patent branded medicines in Japanese pharmaceutical market

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