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Manabu Akazawa,1 Takahiro Sato,2 Nozomi Ebata,2 Michael LoPresti,3 Ryosuke Nishi3 1Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Kiyose, Tokyo, Japan; 2Medical Affairs, Rare Disease, Pfizer Japan Inc, Shibuya-ku, Tokyo, Japan; 3Value & Access, INTAGE Healthcare Inc., Chiyoda-ku, Tokyo, JapanCorrespondence: Takahiro Sato, Pfizer Japan Inc, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan, Tel +81 90-2935-0848, Email takahiro.sato@pfizer.comBackground: About one-third of caregivers of pediatric or adolescent growth hormone deficiency (pGHD) patients in Japan have reported poor treatment adherence. However, few studies have examined factors related to adherence for that group.Objective: The aim of this study is to consider factors related to poor adherence to daily treatment among caregivers of pGHD patients in Japan.Methods: A cross-sectional survey was conducted among caregivers of pGHD patients in Japan. Caregivers were asked about demographic and treatment characteristics, health literacy, treatment satisfaction, opinions about treatment, and treatment adherence. Health literacy was assessed using the 14-item health literacy scale (HLS-14). Adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). Statistical association with adherence was considered using Chi-square and Student’s t–testing. An exploratory factor analysis (EFA) and K-means cluster analysis was conducted to consider the influence of treatment satisfaction and opinions concerning treatment on adherence.Results: Responses were collected from 112 caregivers. The caregiver’s age being 30– 39 years old, the primary caregiver being male, the primary caregiver being employed, and low functional health literacy for the caregiver were associated with poor adherence. Patients being pre-elementary school age was also associated with poor adherence. Low satisfaction with drug treatment and/or their device and communication with healthcare

Manabu Akazawa,1 Daisuke Shima,2 Takahiro Sato,2 Emi Shoji,2 Michael LoPresti,3 Ryosuke Nishi3 1Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan; 2Medical Affairs, Rare Disease, Pfizer Japan Inc, Tokyo, Japan; 3Market Access, INTAGE Healthcare Inc, Tokyo, JapanCorrespondence: Takahiro Sato, Medical Affairs, Rare Disease, Pfizer Japan Inc, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan, Tel +81 90-2935-0848, Email takahiro.sato@pfizer.comBackground: Poor adherence to daily human growth hormone (hGH) treatment has been shown to be associated with poor clinical outcomes for growth hormone deficiency (GHD) patients. However, few studies have examined the perception of adherence to hGH treatment among both physicians and caregivers in Japan.Objective: The aim of this study is to examine the perception of adherence for daily hGH treatment among physicians and caregivers of pediatric and adolescent patients treated with GH in Japan. Moreover, we explore reasons for skipping treatment and the potential impact of a once-weekly treatment on adherence.Methods: A cross-sectional survey was conducted in Japan among physicians that prescribe daily hGH treatment and caregivers that have administered daily hGH treatment to children/adolescents for 3 months or longer. The Morisky Medication Adherence Scale (MMAS-8) was used to gauge perceived adherence for both physician and caregiver groups. Caregivers were also questioned regarding reasons for missing injections. Moreover, both groups were asked about the impact of a once-weekly treatment on adherence.Results: Responses were collected from 123 physicians and 112 caregivers. Physicians reported that 18.1% of patients have poor adherence based on the MMAS-8 instrument. In contrast, 32.1% of the caregivers reported poor adherence. “Simply forgetting”, “Patient refused/resisted”, and being “Busy with school activities, etc” were the most commonly selected reasons by caregivers

Manabu Akazawa,1 Wataru Mimura,1 Kanae Togo,2 Nozomi Ebata,3 Noriko Harada,4 Haruka Murano,5 Lucy Abraham,6 Koichi Fujii31Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan; 2Corporate Affairs, Health & Value, Pfizer Japan Inc., Tokyo, Japan; 3Medical Affairs, Pfizer Japan Inc., Tokyo, Japan; 4Clinical Research, Pfizer R&D Japan G.K., Tokyo, Japan; 5Clinical Research Professionals, Clinical Study Support Inc., Nagoya, Japan; 6Patient & Health Impact, Pfizer Ltd., Surrey, UKPurpose: Musculoskeletal diseases, including osteoarthritis (OA) and low back pain (LBP), are the leading causes of years lived with disability, and are associated with lowered quality-of-life, lost productivity, and increased healthcare costs. However, information publicly available regarding the Japanese real-world usage of prescription medications is limited. This study aimed to describe the clinical characteristics of patients with OA and chronic LBP (CLBP), and to investigate the patterns of medications and opioid use in Japanese real-world settings.Materials and methods: A retrospective study was conducted using a Japanese administrative claims database between 2013 and 2017. The outcomes were patient characteristics and prescription medications, and they were evaluated separately for OA and CLBP.Results: The mean age of 118,996 patients with OA and 256,402 patients with CLBP was 68.8±13.1 years and 64.8±16.4 years, respectively. Approximately 90% of patients with OA and CLBP were prescribed non-steroidal anti-inflammatory drugs (NSAIDs). Other prescriptions included hyaluronate injection (35.6%), acetaminophen (21.4%), and steroid injection (20.0%) in patients with OA, and pregabalin (39.0%) and acetaminophen (22.4%) in patients with CLBP. Weak opioids were prescribed to 10.7% and 20.6% of patients with OA and CLBP, respectively. The prescription of COX-2 inhibitors (OA: +6.5%; CLBP: +6.7%) and acetaminophen (OA: +16.4

Manabu Akazawa,1 Ataru Igarashi,2 Nozomi Ebata,3 Tatsunori Murata,4 Shigeki Zeniya,4 Yuri Haga,5 Kazutaka Nozawa,3 Koichi Fujii,3 Toshihiko Taguchi6 1Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan; 2Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; 3Medical Affairs, Pfizer Japan Inc., Tokyo, Japan; 4CRECON Medical Assessment Inc., Tokyo, Japan; 5Clinical Research Division, Clinical Study Support, Inc., Nagoya, Japan; 6Yamaguchi Rosai Hospital, Yamaguchi, JapanCorrespondence: Nozomi EbataMedical Affairs, Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589 JapanTel +81 3 80 3393 0745Fax +81 3 5309 9198Email nozomi.ebata@pfizer.comPurpose: To evaluate the cost-effectiveness of pregabalin versus other analgesics among patients with chronic cervical pain with neuropathic components during routine clinical practice in Japan.Patients and methods: The analysis considered patients with chronic cervical pain with a neuropathic pain component (radiating pain to the upper limb) and who were treated with pregabalin with or without other analgesics (pregabalin-containing treatments) or other analgesics alone (usual care) for 8 weeks. Other analgesics included non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, antidepressants, and antiepileptic drugs. A Markov cohort simulation model was constructed to estimate costs and effectiveness (in terms of quality-adjusted life-years, QALYs) of each treatment over a 12-month time horizon. In the model, patients transitioned among three states of pain severity (no/mild, moderate, and severe). Data were derived from a previous observational study (pregabalin-containing treatments, n = 138; usual care, n = 211). Cost inputs included medical costs and productivity losses. QALYs were calculated using the EuroQol five-dimensional, five-level questionnaire. The cost-effectiveness was evaluated using incremental cost-effectiv

Ataru Igarashi,1 Manabu Akazawa,2 Tatsunori Murata,3 Toshihiko Taguchi,4 Alesia Sadosky,5 Nozomi Ebata,6 Richard Willke,5 Koichi Fujii,6 Jim Doherty,5 Makoto Kobayashi3 1Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; 2Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan; 3CRECON Medical Assessment Inc., Tokyo, Japan; 4Department of Orthopaedic Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan; 5Pfizer Inc., New York, NY, USA; 6Pfizer Japan, Inc., Tokyo, Japan Objective: To assess the cost-effectiveness of pregabalin for the treatment of chronic low back pain with accompanying neuropathic pain (CLBP-NeP) from the health care payer and societal perspectives. Methods: The cost-effectiveness of pregabalin versus usual care for treatment of CLBP-NeP was evaluated over a 12-month time horizon using the incremental cost-effectiveness ratio (ICER). Quality-adjusted life years (QALYs), derived from the five-dimension, five-level EuroQol (EQ-5D-5L) questionnaire, was the measure of effectiveness. Medical costs and productivity losses were both calculated. Expected costs and outcomes were estimated via cohort simulation using a state-transition model, which mimics pain state transitions among mild, moderate, and severe pain. Distributions of pain severity were obtained from an 8-week noninterventional study. Health care resource consumption for estimation of direct medical costs for pain severity levels was derived from a physician survey. The ICER per additional QALY gained was calculated and sensitivity analyses were performed to evaluate the robustness of the assumptions across a range of values. Results: Direct medical costs and hospitalization costs were both lower in the pregabalin arm compared with usual care. The estimated ICERs in the base case scenarios were approximately ¥2,025,000 and ¥1,435,000 per QALY

Izumi Sato,1 Manabu Akazawa21Department of Epidemiology and Statistics, Graduate School of Medicine, The University of Tokyo Tokyo, Japan; 2Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, JapanBackground: The concomitant use of multiple medications by elderly patients with hypertension is a relatively common and growing phenomenon in Japan. This has been attributed to several factors, including treatment guidelines recommending prescription of multiple medications and a continuing increase in the elderly population with multiple comorbidities.Objective: This study was aimed at investigating the association between polypharmacy, defined as the concomitant use of five or more medications, and risk of adverse drug reaction (ADR) in elderly Japanese hypertensive patients to examine the hypothesis that risk of ADR increases with the administration of an increasing number of co-medications.Methods: Using a retrospective cohort design, the data regarding all hypertensive patients aged 65 years or older were extracted from the Risk/Benefit Assessment of Drugs – Analysis and Response Council antihypertensive medication database. The data were reviewed for classification of patients into one of three groups according to drug use at the initiation of therapy – a monotherapy group composed of patients who had taken the investigated drug only, a co-medication group composed of patients who had taken the investigated drug and a maximum of three other medications, and a polypharmacy group composed of patients who had taken the investigated drug and four or more other medications – and determination of the number of ADR events experienced. Estimated rate ratios (RRs) and 95% confidence intervals (CIs) were calculated using a Poisson regression model adjusted for drug category and patient age and sex. Various sensitivity analyses were performed to confirm the robustness of the study findings.Results: Of 61,661 elder