Characterizing Health Outcomes in Idiopathic Pulmonary Fibrosis using US Health Claims Data.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a life-threatening interstitial lung disease (ILD). Characterizing health outcomes of IPF patients is challenging due to disease rarity. OBJECTIVE: This study aimed to identify the burden of disease in patients newly diagnosed with IPF. METHODS: Patients with ≥1 claim with an IPF diagnosis were identified from a United States healthcare insurer's database (2000-2013). Patients with other known causes of ILD or aged <40 years were excluded. Subgroups were compared based on the 2011 change in International Classification of Diseases, 9th Revision (ICD-9) definition of IPF and occurrence of IPF testing. The prevalence and incidence of preselected health conditions of clinical interest were estimated. RESULTS: Median age of newly diagnosed patients (n = 7,298) was 62 years (54.0% male). Restricting to patients with IPF diagnostic testing did not substantially affect cohort characteristics, nor did ICD-9 IPF coding change. Mean follow-up was 1.7 years; 16.8% of patients died; and a substantial proportion of patients were censored due to end of health plan enrollment (50.7%) and other causes of ILD (19.6%). The incidence of pulmonary hypertension, lung cancer, and claims-based algorithm proxy for acute respiratory worsening of unknown cause was 22.5, 17.6, and 12.6 per 1,000 person-years, respectively. CONCLUSIONS: Patients with IPF had a high disease burden with a variety of health outcomes observed, including a high rate of mortality. Database censoring due to changes in enrollment or other ILD diagnoses limited follow-up. Altering cohort entry definitions, including IPF testing or ICD-9 IPF coding change, had little impact on cohort baseline characteristics.

Assessment of Risk Evaluation and Mitigation Strategies (REMS) for varenicline (Chantix): A multistage patient survey.

PURPOSE: To evaluate the Risk Evaluation and Mitigation Strategies (REMS) for varenicline by assessing patients' understanding of the varenicline medication guide (MG) at pre-specified time points: 18 months, 3 years, and 7 years after the REMS approval. METHODS: Self-administered surveys were mailed to people who received varenicline based on a pharmacy dispensing. Survey questions assessed understanding of potential risks outlined in the MG: neuropsychiatric symptoms, skin reactions, allergic reactions, and cardiovascular risks. Crude and weighted analyses were conducted. RESULTS: The response to the survey overall was between 18% and 19%. Among responders, approximately 90% recalled receiving the MG, and at least 80% read all or part of it. At least 88% correctly identified neuropsychiatric symptoms as potential medication effects, while 41% did so for skin reactions, 53% for allergic reactions, and 82% for cardiovascular risks. Patients who read the MG had a high proportion of correct responses to the risk comprehension questions. CONCLUSIONS: A large majority of patients who were dispensed varenicline recalled receiving the MG and were able to correctly recall neuropsychiatric and cardiovascular risks in all 3 surveys. The varenicline MG may be an effective tool for patient education.

The effectiveness of varenicline medication guide for conveying safety information to patients: a REMS assessment survey.

PURPOSE: Risk Evaluation and Mitigation Strategies (REMS) include various mechanisms to enhance safe use of medications, including a patient medication guide (MG) that provides key information regarding the potential risks associated with the medication. To evaluate the effectiveness of the varenicline MG as a REMS tool for educating patients, we undertook a survey among patients who were dispensed varenicline. METHODS: Varenicline recipients within the Optum Research Database, a large U.S. administrative claims database, were invited to participate in a self-administered survey. Survey questions were general (receipt and reading of the MG) and specific regarding patient's understanding of the potential varenicline risks outlined in the MG (neuropsychiatric symptoms, skin reactions, and allergic reactions). RESULTS: From 3568 varenicline recipients invited, 640 (18%) responded, with 633 completing at least one of three risk-comprehension questions. The majority (93%) indicated receiving the MG, and 86% read all or part of it. Ninety-one percent, 41%, and 53% correctly answered at least one question on neuropsychiatric symptoms, skin reactions, and allergic reactions, respectively. A higher proportion who read the MG had correct responses to the risk-comprehension questions than those who did not read it. CONCLUSIONS: The varenicline MG was widely received and read among survey respondents, and the information conveyed was generally well understood regarding potential risk of neuropsychiatric symptoms. This study provides an assessment of the effectiveness of the varenicline MG in communicating information about potential risks associated with varenicline. This assessment method may apply to the evaluation of the effectiveness of other MGs.