Dog Owners' Perceptions of the Convenience and Value of Chewable Oclacitinib: Quantitative Survey Data from an International Survey.

Oclacitinib is an oral therapy indicated for pruritus associated with allergic or atopic dermatitis in dogs. This study sought to assess pet owners' perceptions of the relative convenience and value of the conventional film-coated formulation and the chewable formulation. A quantitative discrete-choice experimental methodology was applied, comparing (conventional, film-coated) oclacitinib versus chewable oclacitinib using unbranded treatment profiles. Initially, a qualitative interview phase with pet owners and veterinarians was conducted to develop detailed treatment profiles. Subsequently, pet owners participated in a quantitative survey. Overall, 1590 pet owners provided survey responses. Most respondents (62%) reported having experienced challenges administering tablet-based therapies to their dog(s). Half of all respondents (52%) had experience administering flavoured or chewable tablets to their dog. Comparing oclacitinib and chewable oclacitinib (with or without associated costs), the majority of the respondents preferred the chewable formulation in all regions across short-term and long-term scenarios (≥58%; all p < 0.05). The current research is one of few survey-driven studies for treatment preferences in companion animal medicine. Veterinarians may offer chewable or palatable treatment options where available, with potential positive impacts on convenience, compliance, outcomes, quality of life, and the human-animal bond.

Disutility of Cognitive Processing Speed (CPS) Impairment in the Context of Multiple Sclerosis: A Time Trade-Off (TTO) Elicitation Study.

Introduction: Cognitive impairment, especially relating to cognitive processing speed, is a major cause of disability in people with multiple sclerosis (MS). Utility values are quantitative estimates of the quality of life experienced in specific health states and are a key component of cost-effectiveness modelling. However, existing health state utility values in MS typically focus on physical ability and are generally derived using generic (not disease-specific) measures of quality of life. The objective of the current study was to generate health state utility values for levels of cognitive impairment. We used a direct utility elicitation approach called the time trade-off (TTO) methodology. Materials and Methods: Health state descriptions were created following interviews with healthcare professionals, patients, and caregivers in the United States (n=35), and with healthcare professionals in the UK (n=5). Three health states (mild, moderate, and severe impairment) were defined based upon a well-established and validated test for cognitive dysfunction called the Symbol Digit Modalities Test (SDMT) and described using qualitative interview findings. Next, interviews with members of the general public in the UK were conducted to estimate utility values for each health state using the TTO methodology. The procedure was based on the established Measurement and Valuation of Health (MVH) protocol, which generates values on a scale from 0.0 to 1.0. Results: Mean health state utility values were 0.77 ± 0.24 in "mild impairment" (SDMT 43-40), 0.57 ± 0.26 in "moderate impairment" (SDMT 39-32), and 0.34 ± 0.28 in "severe impairment" (SDMT ≤ 31). Discussion: Results indicate that the public perceives that health states of cognitive slowing (as observed in MS) are associated with a substantial reduction in affected individuals' health-related quality of life, quantified using the TTO methodology. Future economic modeling should consider how utility impacts of both cognitive and physical disability can be appropriately incorporated.

Elicitation of Health State Utility Values in Retinitis Pigmentosa by Time Trade-off in the United Kingdom.

Introduction: Retinitis pigmentosa (RP) is an inherited retinal pathology associated with "night blindness" and progressive loss of peripheral vision, in some cases leading to complete blindness. Health state utility values are required for activities such as modelling disease burden or the cost-effectiveness of new interventions. The current study aimed to generate utility values for health states of varying levels of functional vision in RP, with members of the general public in the UK. Methods: Five health states were defined according to standard clinical measures of visual ability. Health state descriptions were developed following interviews with patients with RP in the UK (n=5). Further interviews were conducted for confirmation with healthcare professionals with specific experience of managing patients with RP in the UK (n=2). Interviews with members of the general public in the UK were conducted to value health states. A time trade-off (TTO) process based on the established Measurement and Valuation of Health (MVH) protocol was used. Due to the ongoing COVID-19 pandemic, all interviews were web-enabled and conducted 1:1 by a trained moderator. Results: In total, n=110 TTO interviews were conducted with members of the UK general public. Mean TTO utility values followed the logical and expected order, with increasing visual impairment leading to decreased utility. Mean values varied between 0.78 ± 0.20 ("moderate impairment"), and 0.33 ± 0.26 ("hand motion" to "no light perception"). Supplementary visual analogue scale (VAS) scores also followed the logical and expected order: mean VAS values varied between 47.95 ± 15.38 ("moderate impairment") and 17.22 ± 12.49 in ("hand motion" to "no light perception"). Discussion: These data suggest that individuals living with RP have substantially impaired quality of life. Utility values for RP have been elicited here using a method and sample that is suitable for economic modelling and health technology assessment purposes.

Disutility of injectable therapies in obesity and type 2 diabetes mellitus: general population preferences in the UK, Canada, and China.

INTRODUCTION: Once-daily and once-weekly injectable glucagon-like peptide-1 receptor agonist therapies (GLP-1 RAs) are established in obesity and type 2 diabetes mellitus (T2DM). In T2DM, both once-daily and once-weekly insulin are expected to be available. This study elicited utilities associated with these treatment regimens from members of the general public in the UK, Canada, and China, to quantify administration-related disutility of more-frequent injectable treatment, and allow economic modelling. METHODS: Two anchor states (no pharmacological treatment), and seven treatment states (daily oral tablet and generic injectable regimens of variable frequency), with identical outcomes were tested A broadly representative sample of the general public in each country participated (excluding individuals with diabetes or pharmacologically treated obesity). An adapted Measurement and Valuation of Health protocol was administered 1:1 in web-enabled interviews by trained moderators: visual analogue scale (VAS) as a "warm-up", and time trade-off (TTO) using a 20-year time horizon for utility elicitation. RESULTS: A total of 310 individuals participated. The average disutility of once-daily versus once-weekly GLP-1 RA was - 0.048 in obesity and - 0.033 in T2DM; the corresponding average disutility for insulin was - 0.064. Disutilities were substantially greater in China, relative to UK and Canada. DISCUSSION: Within obesity and T2DM, more-frequent treatment health states had lower utility. Scores by VAS also followed a logical order. The generated utility values are suitable for use in modelling injectable therapy regimens in obesity and T2DM, due to the use of generic descriptions and assumption of equal efficacy. Future research could examine the reasons for greater administration-related disutility in China.

Preference for Type 2 Diabetes Therapies in the United States: A Discrete Choice Experiment.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a chronic condition associated with substantial clinical and economic burden. As multiple therapeutic options are available, patient preferences on treatment characteristics are key in T2DM therapeutic decision-making. This study aimed to determine the preferences of US patients with T2DM for therapies recommended for first pharmacologic intensification after metformin. METHODS: As part of a discrete choice experiment, an online survey was designed using literature review and qualitative interview findings. Eligibility was met by US patients with T2DM who were aged 18 years or older with an HbA1c ≥ 6.5%. Anonymized therapy profiles were created from six antidiabetic therapies including oral and injectable semaglutide, dulaglutide, empagliflozin, sitagliptin, and thiazolidinediones. RESULTS: Eligible patients (n = 500) had a mean HbA1c of 7.4%, and a mean BMI of 32.0 kg/m2, the majority of which (72.2%) were injectable-naïve. The treatment characteristic with greatest importance was mode and frequency of administration (35.5%), followed by body weight change (29.2%), cardiovascular event risk (19.1%), hypoglycemic event risk (9.9%), and HbA1c change (6.5%). An oral semaglutide-like profile was preferred by 91.9-70.1% of respondents depending on the comparator agent, and preference was significant in each comparison (p < 0.05); an injectable semaglutide-like profile was preferred by 89.3-55.7% of respondents in each comparison depending on the comparator agent. CONCLUSION: Patients with T2DM in the USA are significantly more likely to prefer oral or injectable semaglutide-like profiles over those of key comparators from the glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and thiazolidinedione classes.

Burden of Male Hypogonadism and Major Comorbidities, and the Clinical, Economic, and Humanistic Benefits of Testosterone Therapy: A Narrative Review.

Male hypogonadism and major comorbidities such as type 2 diabetes mellitus, obesity, cardiovascular disease, and osteoporosis appear closely connected, forming a vicious cycle that leads to further hypogonadism. This narrative review provides a comprehensive overview of the current literature on the overall burden of male hypogonadism alongside related comorbidities, and how this may be alleviated through testosterone therapy. Observational and clinical data demonstrate that the interaction of male hypogonadism and its related comorbidities is associated with increased mortality, cardiovascular event risk and reduced quality of life. Evidence from epidemiological and registry-based studies shows that this clinical and humanistic burden translates to increased economic burden on health-care systems, through increased physician visits, medical claims, and drug costs. Male hypogonadism can be managed with testosterone therapy, which is intended to normalize testosterone concentrations and thereby reduce both hypogonadism symptoms and risk of comorbidities. Clinical and observational data suggest that in males with hypogonadism, testosterone therapy rapidly and sustainably improves glycemia, reduces risk of progression to diabetes, leads to significantly reduced waist circumference and fat mass, while providing significant positive effects on cardiovascular event risk and bone density. Significant and sustained improvement in patient-reported erectile function, urinary function, and aging male symptoms have also been shown. Economic evaluations have estimated that reduced comorbidity risk following testosterone therapy may lead to cost-savings, with one study estimating yearly inpatient savings of £3732 for treating comorbidities after intervention. A major unmet need exists in the area of male hypogonadism, particularly related to common comorbidities. Options for treatment include testosterone therapy, which has been shown to alleviate the clinical, economic, and humanistic burden associated with these conditions. As the prevalence of male hypogonadism is likely to increase globally, and this condition may be currently underdiagnosed, cost-saving testosterone therapies should be increasingly considered to manage hypogonadism.

Preference for Oral and Injectable GLP-1 RA Therapy Profiles in Japanese Patients with Type 2 Diabetes: A Discrete Choice Experiment.

INTRODUCTION: Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) approved to date are administered by injection; therefore, patient perceptions of an oral GLP-1 RA are unknown. This discrete choice experiment explored preferences for (unbranded) oral and injectable GLP-1 RA profiles among Japanese patients with type 2 diabetes (T2D). METHODS: An online survey was designed using literature review and qualitative interview findings, and administered to Japanese patients with T2D and HbA1c ≥ 7.0% receiving oral antiglycaemic medication (with no experience of injectable antiglycaemic medication). Therapy profiles were created using Japanese head-to-head trial data for orally administered semaglutide (7 mg and 14 mg), injectable dulaglutide (0.75 mg), and injectable liraglutide (0.9 mg). Profiles were not labelled. Choice tasks tested preference between hypothetical profiles, preference between profiles with actual trial data, and willingness to initiate treatment. Relative importance of attributes was determined using conditional logit regression. RESULTS: A total of 500 respondents were analysed: mean age 61.2 years; 93.8% male; mean HbA1c 7.6%; 78.2% with HbA1c ≥ 7.0 to < 8%; 89% with HbA1c above personal target. Mean BMI was 25.4 kg/m2; 49% had obesity (≥ 25 kg/m2). The treatment attribute with greatest importance was mode and frequency of administration (49.1%), followed by nausea risk (30.8%), weight change (11.3%), and HbA1c change (8.8%). Oral semaglutide 7 and 14 mg-like profiles were both preferred: the 7 mg-like profile was preferred over dulaglutide (by 91.0% of respondents) and liraglutide (by 89.4%); the 14 mg-like profile was preferred over dulaglutide (by 88.2%) and liraglutide (by 94.4%). Willingness to initiate treatment was also higher for orally administered semaglutide-like profiles: 62.4% with 7 mg and 64.0% with 14 mg, versus 13.6% and 11.0% with injectable GLP-1 RA-like profiles. Subgroup results were generally consistent with the overall sample. CONCLUSION: Japanese patients with T2D appear to prefer oral GLP-1 RA profiles over injectable GLP-1 RA profiles, and administration appears to be the most important factor in this decision. This highlights the unmet need for an effective and orally administered GLP-1 RA for the treatment of T2D in Japan.

Real-world effectiveness and tolerability of small-cell lung cancer (SCLC) treatments: A systematic literature review (SLR).

OBJECTIVES: SCLC makes up approximately 15% of all lung carcinomas and is characterized by relatively aggressive spread and poorer prognosis compared to other lung cancers. Treatment options are limited, and their efficacy in randomized trials is poor, whilst outcomes in clinical practice remain unclear. The aim of this study was to assess the real-world effectiveness and tolerability of SCLC treatments. METHODS: An SLR was conducted across nine databases accessed through OVID, capturing observational, non-randomized studies published between 01/2006-11/2018. In total, 554 abstracts were retrieved and systematically screened for eligibility. The eligible publications included effectiveness and tolerability data from adult SCLC patients (at any line of therapy). Additional grey literature searches were conducted. RESULTS: Forty-three publications were included in this review-data from first-line therapies were captured most often (n = 32), while data from second (n = 14) and third line (n = 7) and beyond (n = 7) were less frequent. The publications reported primarily on chemotherapy/radiotherapy. The majority of publications lacked robustness and only 14/43 conducted statistical analyses or controlled for bias. Median OS for the largest SCLC populations were 9.6 months at first line (n = 23,535) and 4.9 months at second line (n = 254) for treatment with chemotherapy, and 4.7 months at third line (n = 120) for predominantly platinum-based chemotherapy or cyclophosphamide/adriamycin/vincristine. Hematologic toxicities (such as neutropenia, thrombocytopenia and anemia) were the most frequently reported TRAEs (n = 9). CONCLUSIONS: Real-world treatment effectiveness and tolerability data were fragmented and inconsistently reported, and available publications were primarily of poor quality and lacked statistical analyses. This SLR showed limited treatment options and poor OS in SCLC, with no treatment option being clearly superior. TRAEs additionally increased the burden of this already challenging disease. Recent data suggest real-world outcomes are even poorer that those reported in clinical trials, and that novel therapies are needed to offer new treatment options for patients.

The Economic Burden of Small Cell Lung Cancer: A Systematic Review of the Literature.

BACKGROUND: Small cell lung cancer (SCLC), the most aggressive form of lung carcinoma, represents approximately 15% of all lung cancers; however, the economic and healthcare burden of SCLC is not well-defined. OBJECTIVE: The aim of this study was to explore the impact of SCLC on healthcare costs through a systematic literature review (SLR). METHODS: Using the OVID search engine, the SLR was conducted in PubMed, MEDLINE In-Process, EMBASE, EconLIT and the National Health Service Economic Evaluation Database (NHS EED). Searches were limited to studies published between January 2005 and 24 February 2016, and excluded preclinical studies. Additional internet-based searches were conducted. In total, 229 abstracts were retrieved and systematically screened for eligibility, with 17 publications retained. RESULTS: The majority of publications provided data on limited and extensive disease of SCLC. The reported burden was categorised as direct costs and indirect costs, with the majority of the publications (n = 16) reporting on direct costs and one reporting on both direct and indirect costs. The only indirect costs reported for SCLC were lost productivity (premature mortality costs) and caregiver burden. Chemotherapy, diagnostic costs and treatment costs were identified as significant costs when managing SCLC patients, including the associated treatment costs such as hospitalisation, nurse visits, emergency room visits, follow-up appointments and outpatient care. CONCLUSIONS: SCLC and its treatment have a substantial impact on costs. The scarcity and heterogeneity of economic cost data negated meaningful cost comparison, highlighting the need for further research. Capturing the economic burden of SCLC may help patients and clinicians make informed treatment choices and improve SCLC management.