BACKGROUND

In Japan, biosimilars have the potential to reduce drug expenditure because their official price is lower than the price of the original products. To promote biosimilars, the Japanese government introduced a new financial incentive scheme for medical institutions to prescribe biosimilars to outpatients in April 2020. However, the impact of the incentive remains unevaluated. Hence, in this study, we conducted an interrupted time-series analysis to evaluate the impact of the incentive scheme on biosimilar prescription.

METHODS

We used the DeSC database in Japan. From this database, we included 3,348 patients who required self-injection and were prescribed insulin, human growth hormone, or etanercept. Interrupted time-series analyses were conducted by fitting Prais–Winsten linear regression models to assess the association of the financial incentive with the outcomes, namely, monthly proportions of biosimilar prescriptions between April 2019 and March 2021.

RESULTS

No significant changes were observed in the monthly proportion of biosimilar prescriptions immediately after the introduction of the incentive. The sustained effect, representing the effect of the intervention over time, was also not significant.

CONCLUSIONS

Our study suggests that the financial incentive introduced in April 2020 in Japan was not associated with an increase in biosimilar prescriptions.

This article introduces the basic concept of a novel 6-parameter model case-crossover study with active comparator design. While case-crossover study design eliminates time-invariant confounding, the 6-parameter model as a modified version also allows studying the effect of drug initiation patterns between two interacting drugs. The implementation of the case-crossover study is illustrated, including the generation of the dataset for data analysis and performing the 6-parameter model using conditional logistic regression. Potential interpretation framework is proposed using eight combinations based on three scenarios shown in the results of the 6-parameters case-crossover study design.

The Fight Retinal Blindness! Registry is a prospectively-designed registry developed in 2009 that collects international data on treatment outcomes for eye diseases including neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion. The validated and high-quality data have generated significant real-world evidence regarding clinically relevant issues, such as long-term visual outcomes, dosing regimens and practitioner variation. This paper outlines the Fight Retinal Blindness! Registry, highlighting its pros and cons, and introduces some findings from the registry.

Background: It remains unclear whether pharmacist-led educational programs in community pharmacies could increase appropriate ophthalmic visits for patients with diabetes. We assessed efficacy of pharmacist-led education on ophthalmology visits for diabetes.

Methods: We conducted a cluster randomized controlled trial at 32 community pharmacies in Japan, targeting individuals with diabetes with no ophthalmic visits over a year. Pharmacists in the intervention group received online training on diabetic retinopathy and educated patients, while the control group received a pamphlet. The primary outcome was ophthalmic visits during the follow-up period. Generalized estimating equations were performed with two adjusted models: age and sex (model 1), and additionally diabetic retinopathy factors (model 2). Key secondary outcomes were changes in behavior for ophthalmic visits and glycated hemoglobin (HbA1c) levels.

Results: Overall, 268 patients were included (133 intervention and 135 control). Participants' mean age was 60.1 years, and HbA1c level was 7.5%. Ophthalmic visits occurred in 18.8% (25/133) of the intervention and 20.7% (28/135) of the control group, yielding no significant difference (model 1, risk difference [RD] -0.03 [-0.14 to 0.08], risk ratio [RR] 0.88 (0.54 to 1.45); model 2, RD -0.07 [-0.21 to 0.08], RR 0.73 [0.41 to 1.30]). There was no significant difference between the two groups in the mean changes from baseline to 6 months in behavior for ophthalmic visits (0.07 [-0.23 to 0.37]) and HbA1c levels (-0.28 [-0.76 to 0.20]).

Conclusions: Pharmacist-led education on diabetic retinopathy did not increase ophthalmology visits or improve diabetes-related outcomes. Effective strategies to encourage ophthalmology visits are required.

Background This study aimed to evaluate the association between metformin use and the risk of cervical cancer in women with diabetes compared to dipeptidyl peptidase-4 inhibitors (DPP-4is), using a new-user active-comparator design.

Methods We analyzed data from the JMDC claims database for new users of metformin or DPP-4i between 2010–2022 who were women. Propensity score overlap-weighting was applied to adjust for differences in age, complications, comorbidities, and other anti-diabetic medications. Kaplan–Meier curves and Cox proportional hazards models were used to compare cervical cancer incidence between the metformin and DPP-4i groups.

Results A total of 31,269 eligible individuals were identified, comprising 11,466 metformin users and 19,803 DPP-4i users. Cervical cancer occurred in 11 women (34.0/100,000 person-years) from the metformin group and 34 (59.0/100,000 person-years) in the DPP-4i group. Metformin use was associated with a lower risk of cervical cancer in our unadjusted Kaplan–Meier analysis (P = 0.058), and multivariable-adjusted Cox model (hazard ratio, 0.49; 95% CI, 0.22–1.09; P = 0.082), although neither difference was statistically significant.

Conclusions Our findings did not show a statistically significant association between metformin use and cervical cancer incidence. However, this study’s limited sample size precluded definitive conclusions.

Background: Polypharmacy management represents a public health concern; however, intervention by community pharmacists remains limited. Therefore, we evaluated the effectiveness of community pharmacy-based educational intervention for improving polypharmacy management using interrupted time series analysis (ITSA).

Methods: We conducted the ITSA of an educational intervention implemented from June to September 2021 across pharmacies under Medical System Network Co., Ltd., Japan. We analyzed pharmacy claims data from April 2020 to May 2024, with no missing values. The intervention included lectures and workshops delivered via cascade training. The primary and secondary outcomes were the number of Fee for Medication Adjustment Support 2 (FMAS2) and Fee for Medication Adjustment Support 1 (FMAS1) per 100,000 patients, respectively. FMAS2 is claimed when pharmacists propose reducing medications for patients taking six or more medications from multiple institutions, and FMAS1 is claimed when the proposal leads to actual reduction.

Results: The study included 404 pharmacies with an average of 569,909 patients per month. After intervention, FMAS2 claims immediately increased by 3.82 per 100,000 people (95% confidence interval (CI): 1.23 to 6.41, p = 0.005), with no significant trend change. FMAS1 claims first increased by 1.29 per 100,000 people (95% CI: 0.49 to 2.09, p = 0.002) but decreased thereafter (95% CI: −0.298 to −0.130, p < 0.001).

Conclusions: Educational intervention increased FMAS2 and FMAS1 claims in the short term. However, the clinical impact of this intervention was small, and its long-term effectiveness is limited. Future efforts should focus on developing sustainable programs and follow-up systems.

Background: New drugs for pediatric immune thrombocytopenia have recently been developed; however, the practice patterns of the different treatments remain unclear in Japan. Methods: Using a national inpatient database, we analyzed recent trends in the treatment practice patterns of pediatric patients with immune thrombocytopenia.

Results: From 2010 to 2021, the proportion of corticosteroid use did not change from 35.2 to 33.4%, whereas the proportion of intravenous immunoglobulin increased from 66.0 to 76.2% (P trend 0.003), and rituximab, romiplostim, and eltrombopag increased from 0.2 to 0.7%, 0.0 to 1.4%, and 0.3 to 7.5%, respectively, (P trend <0.001, 0.003, and <0.001, respectively). The proportion of no-treatment decreased from 20.2 to 6.5% (P trend <0.001). None of the patients had undergone splenectomy since 2016. Intravenous immunoglobulin and corticosteroids were mostly used at 1.0 g/kg and 2.0 mg/kg per day, respectively. We compared clinical practice patterns and outcomes between the only one-treatment and no-treatment groups. Intravenous immunoglobulin tended to be used in non-academic hospitals and younger patients; however, more risk of readmissions within 6 months occurred. Second-line treatment tended to be used in academic hospitals and older patients.

Conclusions: We observed an increasing trend in intravenous immunoglobulin use and second-line treatment, no change in corticosteroid use, and a decreasing trend in no-treatment approaches, using a national inpatient database. The hospital type might have affected the practice patterns. Clinicians might have chosen the optimal treatment for pediatric patients with immune thrombocytopenia considering several factors and patient backgrounds.

Introduction: Miller Fisher syndrome (MFS) is typically associated with a benign course and spontaneous recovery. However, immunotherapies such as intravenous immunoglobulin (IVIG) and plasma exchange (PE) are often administered for this condition because of the potential for clinical deterioration. We aimed to evaluate the real-world use of immunotherapies in MFS management using a nationwide Japanese database.

Methods: We conducted a retrospective cohort study between April 2014 and March 2020 using the Japanese Diagnosis Procedure Combination database. Patient demographics and treatment modalities were described. Outcomes included length of hospital stay, in-hospital mortality, hospitalization cost, and activities of daily living defined by the Barthel index score.

Results: We identified 1,595 patients with MFS. Of these, 999 (62.6%) received immunotherapy (including IVIG for 908 [56.9%] patients, intravenous methylprednisolone for 219 [13.7%] patients, and PE for 18 [1.8%] patients). In patients with and without immunotherapy, the median length of hospital stay was 18 and 12 days, in-hospital mortality was 0.7% and 0.2%, median total hospitalization costs were ¥1,660,200 and ¥549,375, and the proportions of Barthel index score of 95–100 at discharge were 75.3% and 75.2%, respectively.

Conclusion: Our findings highlight the widespread use of immunotherapies for MFS in Japan despite its generally favorable natural course.