Value elements and methods of value-based pricing for drugs in Japan: a systematic review.

INTRODUCTION: Value-based pricing (VBP) can be a promising tool for optimizing drug prices. However, there is no consensus on the specific value elements and pricing method that should be used for VBP. AREAS COVERED: We performed a systematic review and narrative synthesis to investigate the value elements and pricing method for VBP. The main inclusion criterion was that value elements, VBP method, and estimated prices for actual drugs were reported. We performed a search in MEDLINE and ICHUSHI Web. Eight articles met the selection criteria. Four studies adopted the cost-effectiveness analysis (CEA) approach and the others used different approaches. The CEA approach included the value elements of productivity, value of hope, real option value, disease severity, insurance value in addition to costs and quality-adjusted life years. The other approaches used efficacy, toxicity, novelty, rarity, research and development costs, prognosis, population health burden, unmet needs, and effectiveness. Each study used individual methods to quantify these broader value elements. EXPERT OPINION: Both conventional and broader value elements are used for VBP. To allow VBP to be widely applied to various diseases, a simple, versatile method is preferable. Further research is needed to establish VBP method which enables to incorporate broader values.

Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan.

We investigated impacts of increased generic drug use on spontaneous adverse event reports (SAERs), because SAERs have been a major source of data for drug safety assessment at the postmarket stage. Reporting proportion of SAERs for the generic drugs was consistently and significantly lower than that for the original branded drugs. The reporting proportion targeting for 55 active product ingredients, which had the longest follow-up period after generic drug marketed, gradually decreased for the original branded drugs and increased for the generic drugs. However, these transitions did not parallel the changes in market share over the same period. These results suggest that the reporting proportion of SAERs for generic drugs may not keep pace with growth in market share. When generic drugs account for the majority of market share, utilization of multiple sources of information and data, in addition to SAERs, may be a key to assuring drug safety at the postmarket stage.

Transepidermal water loss in cats: comparison of three differently clipped sites to assess the influence of hair coat on transepidermal water loss values.

BACKGROUND: The measurement of transepidermal water loss (TEWL) is one of the parameters that can be used to assess skin barrier function. The variability and reliability of TEWL measurements in dogs have been controversial, and the hair coat has been considered as one of the factors that may cause variation of TEWL values. HYPOTHESIS/OBJECTIVES: The aims of the study were to establish a suitable procedure for measuring feline TEWL, to evaluate the influence of hair coat on TEWL measurements and to assess variations of TEWL at different anatomical sites. METHODS: Transepidermal water loss was measured using a closed-chamber evaporimeter, the VapoMeter(®). We compared three adjacent sites in the groin area of 10 clinically normal, domestic short hair cats. One site was unclipped, the second was trimmed with scissors and the third was shaved using electric clippers. Values of TEWL were obtained for 48 h after trimming with scissors and clippers. Five sites were clipped (upper back, lumbar back, lateral thigh, axillae and groin), and the TEWL was measured. RESULTS: The mean and SD of TEWL values of the clipper-trimmed site were the smallest, followed in order by the site trimmed with scissors and the unclipped site. The TEWL values were statistically constant in the clipper-trimmed site, while the values in the unclipped sites were not. There was no statistically significant difference in TEWL values between all of the anatomical sites except for the axillae. CONCLUSIONS AND CLINICAL IMPORTANCE: Hair clipping of sites with electric clippers is recommended for TEWL measurement in cats.