Real-world evidence of improved healthcare utilization in patients with schizophrenia or schizoaffective disorder after early treatment of paliperidone palmitate once-monthly treatment in Hong Kong

Background: Antipsychotics are commonly used in dementia patients but have potential risks that often outweigh clinical benefits. Limited studies have assessed the healthcare utilization and medical costs associated with antipsychotic use, especially those focused on cumulative days of use.Objectives: To examine clinical and economic burdens associated with different cumulative days of antipsychotic use in older adults with dementia in the United States.Methods: This study used Medicare Current Beneficiary Survey (2015–2017). Older (≥65 years) Medicare beneficiaries with dementia, without concurrent schizophrenia, bipolar disorder, Huntingon’s disease, or Tourette’s syndrome were included. Antipsychotic use was measured using Medicare Part D prescription events. Healthcare utilization was measured as inpatient services, outpatient services, and emergency room (ER) visits. Total medical costs were classified as Medicare and out-of-pocket costs. The logistic regression, negative binomial regression, and generalized linear model with a log link and gamma distribution were used to examine factors, healthcare utilization, and medical costs. Survey sampling weights were applied to generate national estimates.Results: Among older adults with dementia, 13.18% used antipsychotics. Factors associated with antipsychotic use were being Hispanic (OR: 2.90; 95% CI: 1.45, 5.78), widowed (OR: 3.52; 95% CI: 1.46, 8.48), and single (OR: 3.25; 95% CI: 1.53, 6.87). Compared to non-users, antipsychotic use was associated with higher inpatient visits (IRR: 2.11; 95% CI 1.53, 2.90), ER visits (IRR: 1.61; 95% CI: 1.21, 2.13), total costs (β: 0.53; 95% CI: 0.36, 0.71), Medicare costs (β: 0.49; 95% CI 0.26, 0.72), and out-of-pocket costs (β: 0.66; 95% CI: 0.35, 0.97). With the increase in cumulative days of antipsychotic use, the magnitude of clinical and economic burdens was decreased.Conclusion: The significant clinical and economic burdens associated with antipsychotic use, especially with short-term use, provide real-world evidence to inform clinical practice on deprescribing antipsychotics among community-dwelling geriatric dementia patients.

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FRI0728 Osteoarthritis and gout: real-world evidence evaluating patient characteristics, treatment patterns, and healthcare utilization

10.1136/annrheumdis-2017-eular.5030 ◽

2017 ◽

Author(s):

S Krasnokutsky Samuels ◽

M Pillinger ◽

S Kabadi ◽

DC Taylor ◽

R Morlock

Keyword(s):

Healthcare Utilization ◽

Real World ◽

Patient Characteristics ◽

Treatment Patterns ◽

Real World Evidence

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A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00342-4 ◽

2021 ◽

Author(s):

Neal E. Storm ◽

Wen Chang ◽

Tzu-Chieh Lin ◽

Jeff L. Lange ◽

Brian Bradbury ◽

...

Keyword(s):

Clinical Trial ◽

Hong Kong ◽

Clinical Practice ◽

Real World ◽

Controlled Trial ◽

Real World Evidence ◽

Study Results ◽

Global Clinical Trial ◽

Clinical Trial Program

AbstractOn June 23, 2020, Prolia® (denosumab) was approved by the National Medical Products Administration (NMPA) in the People’s Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures. Its brand name in Chinese is 普罗力, a transliteration from the English name “Prolia”, which has an implied meaning of “to give strength to everyone”— a suitable name for a potent anti-resorptive therapy. The approval was supported by a novel marketing authorization application (MAA) that included data from Prolia’s global clinical trial program establishing favorable efficacy and safety, augmented by results from a real-world evidence (RWE) study confirming the effectiveness and safety of Prolia in clinical practice within Taiwan and Hong Kong. Key constructs for this registration-quality RWE study included the fit-for-purpose assessment of data quality, methodology and quantitative assessment of potential biases, good practices of study conduct, and reproducibility of results. Using data from clinical practice in Taiwan and Hong Kong to evaluate the benefits versus risks of Prolia treatment in ethnic Chinese women with postmenopausal osteoporosis, the RWE study results for effectiveness were comparable to efficacy demonstrated in the global clinical trial program and results for safety were consistent with the incidence observed in global post-marketing safety studies. While RWE is often used to monitor postmarket safety of drug products, support health insurance coverage decisions, and inform clinicians on real-world use of medicines, it has not been widely used to support regulatory approval for new medicines in lieu of clinical bridging studies in countries where such studies are required. Well-conducted registrational RWE studies can play a pivotal role in complementing the totality of evidence presented in an MAA. The benefits of such an approach include avoiding the collection of additional placebo-controlled trial data in populations where adequate ethnic characterization of efficacy, effectiveness, and safety may already exist from postmarketing sources, and accelerate access for patients to innovative medicines in important regions. Here, we describe a regulatory case study of a novel MAA incorporating RWE that provided important evidence to confirm the benefit:risk of a new drug and facilitated a label expansion to a new patient population.

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