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Volume 41 (2010)
- Issue 6 Pages 263-
- Issue 5 Pages 189-
- Issue 4 Pages 119S-
- Issue 3 Pages 81S-
- Issue 2 Pages 5S-
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Volume 41, Issue 6
Displaying 1-9 of 9 articles from this issue
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Feature Articles : Pharmacoeconomics in Japan
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Manabu AKAZAWA2010 Volume 41 Issue 6 Pages 263-264
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSDownload PDF (118K) -
Makoto KOBAYASHI2010 Volume 41 Issue 6 Pages 265-270
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSAmidst a global trend towards the introduction of health technology assessment, economic evaluation is becoming a natural process conducted side by side with safety and efficacy evaluations. Every nation faces a difficult situation with regard to healthcare resources. Pharmacoeconomics is employed based on the principle that limited healthcare resources should nonetheless be used as efficiently as possible to further improve a nation's health. The incorporation of pharmacoeconomics in Japan was introduced relatively early, but it is difficult to say that pharmacoeconomics has been actively employed in Japan since its introduction. The evaluation of new healthcare technology based on pharmacoeconomics should be fully debated in tandem with the discussion of the creation of a more sustainable health insurance system.View full abstractDownload PDF (345K) -
Hiroyuki SAKAMAKI2010 Volume 41 Issue 6 Pages 271-274
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSThe future of pharmacoeconomics in comparison with clinical research consists of collection of cost data, and the use of different outcomes measures from clinical trials. In pharmacoeconomic analysis using the data of the clinical development phase, the data that can be used for analysis have various restrictions. Pharmaceutical companies need to draw up a pharmacoeconomic research plan from the early stage of development. Moreover, creation of research guidelines is also needed based on clarification of the use of research results for health policy such as pricing.View full abstractDownload PDF (237K) -
Kojiro SHIMOZUMA, Takeru SHIROIWA2010 Volume 41 Issue 6 Pages 275-280
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSWith the decline in economic growth and increase in the aging population, rational allocation of medical resources has become more important. To construct more effective and efficient medical systems, health-related quality of life (HRQOL) is used not only for evaluating patients' HRQOL, but also for reflecting people's preference to medical resource allocation. In this review article, first we explain HRQOL, especially for cancer patients. Second we focus on the cost-effectiveness of expensive anti-cancer drugs. In addition, to support decision-making based on economic evaluation, we discuss the threshold of cost-effectiveness analysis; how the criteria on cost-effectiveness should be determined.
In the first part of this review article, we explain the concept of HRQOL, which is multi-dimensional, consisting of, for example, physical, mental and social domains. HRQOL is classified into profile and index types. The latter is mainly used for economic evaluation to calculate quality-adjusted life years (QALYs). Cost per QALY is a standard indicator to compare the efficiency of medicine or medical intervention. In the second part, we discuss the cost-effectiveness of expensive anti-cancer drugs called molecular targeting drugs. Some of them have been judged to be not cost-effective by, for example, NICE (The National Institute for Health and Clinical Excellence) in UK and other studies. We discuss how such expensive drugs should be dealt with in the context of public health insurance and taxation. Finally we propose that the threshold of cost-effective analysis should be from JPY 5.0 million to JPY 6.0 million based on our international willingness-to-pay (WTP) survey.View full abstractDownload PDF (394K) -
Shunya IKEDA, Hiroji KITAZATO, Mitsuhiko NODA, Takeo NAKAYAMA, Toshihi ...2010 Volume 41 Issue 6 Pages 281-286
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSPharmacoeconomic research utilizes a combination of various data such as clinical data, epidemiological data and cost data. Usually, they are obtained from several data sources that include claims and administrative data, medical records and published articles. Although the task of data extraction requires enormous time and cost, inconsistency among these data sometimes causes difficulty in interpreting study results.
Health care databases have been developed in several countries and have been used in health services research including pharmacoeconomic research. In Japan, several commercial and academic healthcare databases are now available. For example, the Japan Medical Data Center (JMDC) has developed the Medical Data Bank that standardizes disease names and classifications and uses an anonymous linkage system with an encryption code generated from a combination of hash values and stream ciphers. We describe an example of cost analysis of diabetes complications using the JMDC Medical Data Bank and demonstrate its usefulness in conducting pharmacoeconomic research in an efficient way.View full abstractDownload PDF (337K) -
Miwako KAMEI2010 Volume 41 Issue 6 Pages 287-290
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSInappropriate drug therapy incurs considerable additional medical costs. As an approach to addres the issue of how drug therapy can be performed appropriately, pharmacists have been required to play a more active role in drug therapy. Thus pharmacist has attracted attention as a profession that plays a role in saving medical costs. This article introduces the Asheville Project in the United States as a case study of economic evaluation focusing on pharmaceutical care by pharmacists, specifically drug treatment for outpatients. Although studies to evaluate the professional competency of pharmacists are on the rise every year, few RCT studies have included cost-effective analysis. In Japan, no economic evaluation of pharmacists' services, which has a study design with a high level of evidence, has been reported.View full abstractDownload PDF (214K)
Special Articles
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Yasunori SATO, Kengo NAGASHIMA, Chikuma HAMADA2010 Volume 41 Issue 6 Pages 291-300
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSInterindividual variation in drug response among patients is well known and poses a serious problem in medicine. The variation could be due to multiple factors including those of the host (e. g., age, genetic and environmental factors) and disease (pathophysiological phenotypes). The complex interplay of these factors may influence pharmacodynamic responses such as adverse effects and efficacy, as well as pharmacokinetic manifestations. However, at present, few biomarkers can predict responders and non-responders, and those who might experience adverse reactions for the same medication and dose. In order to realize personalized medicine, rigorous development of biomarkers is required to identify new biomarkers that may change clinical practice.
In this review, we first introduce how biomarkers may be used as targets and the difference between prognostic and predictive markers. Next, we focus on confirmatory clinical trial designs for biomarker development and introduce their application in actual studies. Finally, we introduce exploratory statistical screening techniques for detecting biomarkers in phase I and pharmacokinetics studies.View full abstractDownload PDF (423K)
Original
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Norie NAKAHARA, Akira WAKAMATSU, Ryutaro SHIMAMURA, Shigeru NOHDA, Shu ...2010 Volume 41 Issue 6 Pages 301-308
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSAmbrisentan is a novel, selective endothelin type A receptor antagonist that has been developed for the treatment of pulmonary arterial hypertension (PAH). The present paper reports the pharmacokinetics (PK) and safety of ambrisentan tablets when administered as single oral dose in healthy Japanese subjects and as repeated oral doses in Japanese PAH patients. When a single dose of ambrisentan was administered orally to healthy Japanese subjects under fasted conditions at three dose levels of 2.5, 5 and 10 mg, absorption was rapid, and maximum plasma concentrations, Cmax, were reached in 2-2.5 hours. The Cmax were 179±32 (SD), 362±43 and 767±91 ng/mL, and the AUC0→∞ were 1439±373, 2945±609 and 6894±1613 ng·hr/mL, following 2.5, 5 and 10 mg doses, respectively. Ambrisentan exposure increased in an approximately linear fashion with dose. A single oral dose of ambrisentan 10 mg was administered in fasted and fed states to assess the influence of food intake on the systemic absorption of this drug. Compared to the fasted state, Cmax was reduced by approximately 17% following administration with food. However, there were no changes in AUC0→48, tmax or t1/2. The fraction of parent drug excreted into the urine up to 96 and 120 hours after dosing was less than 4.0% at the three dose levels. The safety and tolerability of ambrisentan was confirmed following single oral administrations under fasted and fed conditions of 2.5, 5 and 10 mg ambrisentan to healthy Japanese subjects.
Japanese PAH patients taking ambrisentan 5 mg once daily for 12 weeks were also studied. Cmax and AUC0→24 at steady state were 674±197 ng/mL and 8337±4715 ng·hr/mL, respectively. Systemic ambrisentan exposure in PAH patients was higher than that in healthy subjects.View full abstractDownload PDF (117K) -
Hiroko INO, Shigeru NOHDA, Shuji MIKI, Katsutoshi HARA, Toshiyasu HIRA ...2010 Volume 41 Issue 6 Pages 309-315
Published: 2010
Released on J-STAGE: March 02, 2011
JOURNAL FREE ACCESSLevocetirizine hydrochloride is the R-enantiomer of the racemic compound cetirizine hydrochloride, and has been found to be a novel antihistaminic agent for the treatment of allergic rhinitis, urticaria, eczema, dermatitis, prurigo and dermal pruritus.
The objective of the present study was to investigate the pharmacokinetics of levocetirizine, when administered as the R-enantiomer (levocetirizine hydrochloride 5 mg and 10 mg) or as the racemic compound (cetirizine hydrochloride 10 mg) in healthy Japanese male volunteers.
The plasma concentration profiles of levocetirizine were similar following administration of cetirizine hydrochloride at a dose of 10 mg and levocetirizine hydrochloride at a dose of 5 mg in twenty Japanese healthy male subjects. Equivalent exposure of levocetirizine was obtained by administering levocetirizine hydrochloride at half the dose of cetirizine hydrochloride.
When single oral doses of 5 mg and 10 mg of levocetirizine hydrochloride were administered to 20 healthy Japanese adult male subjects under fasting conditions, the absorption of levocetirizine from the gastrointestinal tract was fast. The tmax values were 0.75-1 hour and the terminal phase half-lives were 7.3-7.6 hours, and did not change depending on the dose level. The exposure of levocetirizine increased with dose.
No adverse events were reported following administration of single oral doses of 5 mg and 10 mg of levocetirizine hydrochloride and 10 mg of cetirizine hydrochloride under fasting conditions, confirming the safety and tolerability of levocetirizine.View full abstractDownload PDF (359K)
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