Impact of reimbursement restriction on drug market sales under the National Health Insurance in Japan.

AIM: National health care expenditures have been increasing each year, although the Japanese government has annually revised official drug prices. Managing the health care system to pay for expensive drugs is a major concern. The reimbursement restriction, which is the only way that a drug can be implemented before market entry in Japan, is crucial for managing expenditures. Therefore, this study identifies the impact of the reimbursement restriction on drug market sales in Japan, particularly in the situation where health technology assessment or other market access regulations are not applicable before market entry. METHOD: All new drugs listed in fiscal years 2011-2019, along with their market size forecast, were identified using the materials from the Central Social Insurance Medical Council. We then calculated the percentage rate of reimbursement amounts based on the National Database of Health Insurance Claims relative to the predicted market size as a dependent variable. Using the reimbursement restriction for each drug as an independent variable, we performed descriptive and univariate analyses on each variable, followed by generalized linear mixed-effects model regression analysis. RESULTS: We identified 211 drugs. The mean rates of drugs that required physicians, facilities, and patients to meet criteria for use were 30.85% (n = 2), 31.42% (n = 2), and 72.11% (n = 6), respectively. The mean rate of drugs that required diagnostic testing was 22.99% (n = 7), which was 3.7 times lower than the rate of drugs that did not require such testing (p < .05). CONCLUSION: Our results indicate that the reimbursement restriction requiring diagnostic testing has a substantial impact on decreasing market sales. As the number of cases for each requirement is small, further study is needed to measure the impact of the other reimbursement restrictions.

Determinants of market prices for drugs under Japan's national health insurance.

AIMS: The Japanese government reimburses patients for drugs at prices specified in the Drug Price Standard (DPS) published by the National Health Insurance (NHI) scheme. It revises reimbursements for most drugs on the basis of their market prices. This study thereby identifies factors related to drugs or disease that impact market prices for drugs using the DPS list. MATERIALS AND METHODS: This study first examined the 2018 DPS list to identify all listed drugs, their prices, and their stipulated reimbursements. We then excluded from this study all the drugs for which prices are set per alternate rules. We calculated the percentage divergence between market prices and DPS prices and designated it our dependent variable. We performed descriptive and a univariate analysis on each variable and constructed multivariate regression models featuring independent variables for drug characteristics that might affect market prices. RESULTS: We identified 1,775 drugs with prices revised only by the market. We observed higher percentage divergences between DPS and market prices for drugs with generic alternatives (p < 0.001), drugs listed in the Japanese Pharmacopoeia (p < 0.001), and drugs for which at least two new drugs entered the same therapeutic category (p < 0.001). Injectable drugs exhibited a more significant and negative correlation with percentage divergences (p = 0.009) than ingestible drugs. Drugs that treat specific organs (p < 0.001), affect metabolism (p = 0.001), and those prescribed for non-therapeutic purposes (p < 0.001) display significantly higher percentage divergence than drugs affecting the nervous system and sensory organs. Divergences are less for narcotics (p < 0.001) and drugs that counter pathologic microorganisms and parasites (p = 0.004). CONCLUSIONS: Factors that elevate competition among pharmaceutical companies likely lower market prices for drugs, and the direction of prices under NHI in Japan is affected by the category of diseases a drug treats.

Epidemiological characteristics of rheumatoid arthritis in Japan: Prevalence estimates using a nationwide population-based questionnaire survey.

Objectives: To elucidate the epidemiological characteristics of patients with rheumatoid arthritis (RA) in Japan using data from the Comprehensive Survey of Living Conditions, a nationwide questionnaire survey conducted in 2016.Methods: In total, 222,365 men and 245,251 women aged ≥16 years were included in the study. RA patients were defined as those who reported 'currently receiving treatment for RA at hospitals, clinics, or a facility for Japanese traditional massage, acupuncture, moxibustion, or judo-orthopedics.' The number of RA patients was estimated from the age-specific prevalence and total Japanese population in 2016. Further, the prevalence of individuals experiencing difficulties in activities of daily living due to health problems and those with mental distress as evaluated by K6 Scale was examined.Results: The estimated number and prevalence of RA in Japan with 95% confidence interval was 822 (768-880) thousand and 0.75% (0.70-0.80%). The population peaked in the late 60s, and the prevalence continued increasing until the early 80s, regardless of sex. Compared with non-RA participants, RA patients were more likely to experience difficulties in activities and to be distressed.Conclusion: High prevalence of RA in older age and mental and physical burden among RA patients were confirmed.

Analysis of direct medical and nonmedical costs for care of rheumatoid arthritis patients using the large cohort database, IORRA.

OBJECTIVES: Our goal was to determine the annual direct medical and nonmedical costs for the care of patients with rheumatoid arthritis (RA) using data from a large cohort database in Japan. METHODS: Direct medical costs [out of pocket to hospitals and pharmacies and for complementary and alternative medicine (CAM)] and nonmedical costs (caregiving, transportation, self-help devices, house modifications) were determined for RA patients who were participants in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) studies conducted in October 2007 and April 2008. Correlations between these costs and RA disease activity, disability level, and quality of life (QOL) were assessed. RESULTS: Data were analyzed from 5,204 and 5,265 RA patients in October 2007 and April 2008, respectively. The annual direct medical costs were JPY132,000 [out of pocket to hospital (US$1 = JPY90 in 2007)], JPY84,000 (out of pocket to pharmacy), and JPY146,000 (CAM). Annual direct nonmedical costs were JPY105,000 (caregiving), JPY22,000 (transportation), JPY30,000 (self-help devices), and JPY188,000 (house modifications). Based on the utilization rate for each cost component, the annual medical and nonmedical costs for each RA patient were JPY262,136 and JPY61,441, respectively. Costs increased with increasing RA disease activity and disability level or worsening quality of life (QOL). CONCLUSIONS: Based on the IORRA database, patients with RA bear heavy economic burdens that increase as the disease is exacerbated. The results also suggest that the increase in medical and nonmedical costs may be ameliorated by the proactive control of disease activity.