Project description:BackgroundRituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings.MethodsThis non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient's first year of treatment (11 rituximab sessions).ResultsMean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27-58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1-5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53-91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1-5.5 eight-hour days.ConclusionsCompared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units.Trial registrationClinicalTrials.gov NCT01200758.

Project description:BackgroundMost endocrinologists encounter patients who are dissatisfied with their current hypothyroidism therapy and request combination therapy with either liothyronine (LT3) or thyroid extract.MethodsA survey of American Thyroid Association members was conducted in 2017. Respondents were presented with 13 scenarios describing patients with hypothyroidism and were asked to choose among six therapeutic options. The index patient was satisfied taking levothyroxine (LT4) therapy. Twelve variations introduced parameters that potentially provide reasons for considering combination therapy (presence of symptoms, low serum triiodothyronine concentration, documentation of deiodinase polymorphisms). Therapeutic options included (i) continuing LT4, (ii) increasing LT4, (iii) adding LT3 to a reduced LT4 dose, (iv) adding LT3 to the current LT4 dose, (v) replacing LT4 with thyroid extract, and (vi) replacing LT4 with LT3. Repeated-measures logistic regression analysis was performed to examine both the prescribing of LT4 (options i and ii) versus all other therapies and the choice of continuing LT4 (option i) versus either increasing LT4 (option ii), adding LT3 (options iii and iv), or replacing LT4 with thyroid extract or LT3 (options v and vi).ResultsOf the 389 survey respondents, 363 physicians prescribed therapy for hypothyroidism. For the index patient, 98% of physicians continued current LT4 therapy. However, as the patient scenario incorporated other patient characteristics, physicians opted to increase LT4 dose or prescribe other therapies. The tendency to prescribe alternative therapies was powerfully increased by patient symptoms (odds ratio = 25.6 [confidence interval 9-73], p < 0.0001). Older age and the presence of a comorbidity reduced the likelihood that an alternative therapy was prescribed (p = 0.0002 and <0.0001, respectively). All other characteristics, except athyreotic status, patient sex, and body mass index, significantly increased the likelihood that alternative therapies would be prescribed in multivariate analyses (p < 0.0001).ConclusionsEven with the acknowledged limitations of survey methodology, this analysis appears to show a marked increase in the willingness of physicians to prescribe combination therapy in specific circumstances. If current prescribing patterns do incorporate the use of therapies other than LT4, there is a critical need for more research into the benefits and risks of these therapies.

Project description:BackgroundGranisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Palonosetron is administered intravenously and is indicated for CINV prevention in acute and delayed phases after the use of moderately emetogenic chemotherapy (MEC) and in the acute phase after highly emetogenic chemotherapy (HEC). No data are available regarding the impact of SC granisetron on the cost of unscheduled hydration compared with other antiemetic drugs, specifically the older-generation palonosetron.ObjectiveTo compare the costs of unscheduled hydration associated with breakthrough CINV after SC granisetron versus palonosetron administration in patients receiving MEC or HEC.MethodsThis retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. A cost-of-care analysis for SC granisetron and palonosetron was based on the maximum per-unit Medicare reimbursement amounts for the use of unscheduled hydration, administration of rescue antiemetic drugs, laboratory tests, and patient office evaluations.ResultsA total of 182 patient records were evaluated, 91 for patients receiving SC granisetron and 91 receiving palonosetron. The mean per-patient cost of care related to unscheduled hydration in patients receiving HEC or MEC was significantly lower with SC granisetron ($296) than palonosetron ($837; P <.0001), including subset analysis of patients requiring additional care (SC granisetron [$691], N = 39; palonosetron [$1058], N = 72; P = .0260). The mean hydration costs per patient receiving HEC or MEC were lower with SC granisetron ($62) than with palonosetron ($253; P <.0001). The hydration costs per patient receiving only HEC were lower with SC granisetron ($66) than palonosetron ($280; P <.0001). The per-patient costs were lower when SC granisetron was administered than when palonosetron was administered as part of the antiemetic regimen, except for the cost of rescue antiemetic drug in patients receiving MEC. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3).ConclusionThe use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events.

Project description:BackgroundWith progress being made in the treatment of psoriasis, a variety of clinical research and treatment options are being pursued. This study used a discrete choice experiment (DCE) to estimate treatment characteristic preferences for both patients and physicians in Japan. Subgroup analysis was also applied in order to examine differences within the range of patients and within the range of physicians.MethodsThe DCE was developed with the input of clinical experts in the treatment of psoriasis to ensure inclusion of the most relevant attributes at appropriate levels in a way that is understandable to both physicians and patients. The study was conducted on parallel samples of Japanese physicians (n = 161) and Japanese psoriasis patients (n = 306) through an online panel. For each sample, a conditional logit statistical model and subgroup analysis were then performed to estimate respondent preferences for treatment attributes.ResultsThe overall findings are that better treatment efficacy as measured by proportion of patients achieving 90% reduction in the Psoriasis Area and Severity Index score (PASI 90), lower risk of adverse events and the availability of a bio-holiday are important decision factors for both patients and physicians. Low injection frequency is less of a priority for both samples. Also, while both groups demonstrate a preference to receive the treatment injections at a clinic by a healthcare professional rather than self-injection at home, this is more pronounced for the patient sample. The physician sample shows considerably more emphasis on the type of injection, though both samples prefer subcutaneous injections to intravenous injections.ImplicationsThis study reveals the importance of addressing both clinical effectiveness and process factors in systemic, non-topical psoriasis treatments to gain acceptance by both physicians and patients. As well as efficacy (as measured by PASI 90), which remains a consistent priority in treatment, administration and development of new treatments should also consider process factors such as the mode of administration and possibility for a bio-holiday.

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Insights into the choice between intravenous infusion and subcutaneous injection: physician and patient characteristics driving treatment in SLE.

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Insights into the choice between intravenous infusion and subcutaneous injection: physician and patient characteristics driving treatment in SLE.

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