Economic Evaluation of a Nonmedical Financial Assistance Program on Missed Treatment Appointments Among Adults With Cancer.

PURPOSE: We retrospectively evaluated the clinical and economic impact of a program providing nonmedical financial assistance on missed treatment appointments among patients receiving cancer treatment at a large, Southeastern public hospital system. MATERIALS AND METHODS: We used patient electronic health records, program records, and cancer registry data to examine the impact of the program on rates of missed (or no-show) radiation therapy and infusion chemotherapy/immunotherapy appointments in the 180 days after treatment initiation. We used propensity weighting to estimate the effect of the program, stratified by treatment appointment type (radiation therapy, infusion chemotherapy/immunotherapy). We developed a decision tree-based economic model to conduct a cost-consequence analysis from the health system perspective in a hypothetical cohort over a 6-month time horizon. RESULTS: Of 1,347 patients receiving radiation therapy between 2015 and 2019, 53% (n = 715) had ≥1 no-shows and 28% (n = 378) received program assistance. Receipt of any assistance was associated with a 2.1 percentage point (95% CI, 0.6 to 3.5) decrease in the proportion of no-shows, corresponding to a 51% decrease in the overall mean no-show proportion. Under the current funding model, the program is estimated to save the health system $153 in US dollars per missed appointment averted, relative to not providing nonmedical financial assistance. Of the 1,641 patients receiving infusion chemotherapy/immunotherapy, 33% (n = 541) received program assistance, and only 14% (n = 223) had ≥1 no-shows. The financial assistance program did not have a significant effect on no-show proportions among infusion visits. CONCLUSION: This study used a novel approach to retrospectively evaluate a nonmedical financial assistance program for patients undergoing active cancer treatment. Findings support investment in programs that address patients' nonmedical financial needs, particularly for those undergoing intensive radiation therapy.

Core functions of a financial navigation intervention: An in-depth assessment of the Lessening the Impact of Financial Toxicity (LIFT) intervention to inform adaptation and scale-up in diverse oncology care settings.

Background: Lessening the Impact of Financial Toxicity (LIFT) is an intervention designed to address financial toxicity (FT) and improve cancer care access and outcomes through financial navigation (FN). FN identifies patients at risk for FT, assesses eligibility for financial support, and develops strategies to cope with those costs. LIFT successfully reduced FT and improved care access in a preliminary study among patients with high levels of FT in a single large academic cancer center. Adapting LIFT requires distinguishing between core functions (components that are key to its implementation and effectiveness) and forms (specific activities that carry out core functions). Our objective was to complete the first stage of adaptation, identifying LIFT core functions. Methods: We reviewed LIFT's protocol and internal standard-operating procedures. We then conducted 45-90 min in-depth interviews, using Kirk's method of identifying core functions, with key LIFT staff (N = 8), including the principal investigators. Interviews focused on participant roles and intervention implementation. Recorded interviews were transcribed verbatim. Using ATLAS.ti and a codebook based on the Model for Adaptation Design and Impact, we coded interview transcripts. Through thematic analysis, we then identified themes related to LIFT's intervention and implementation core functions. Two report back sessions with interview participants were incorporated to further refine themes. Results: Six intervention core functions (i.e., what makes LIFT effective) and five implementation core functions (i.e., what facilitated LIFT's implementation) were identified to be sufficient to reduce FT. Intervention core functions included systematically cataloging knowledge and tracking patient-specific information related to eligibility criteria for FT relief. Repeat contacts between the financial navigator and participant created an ongoing relationship, removing common barriers to accessing resources. Implementation core functions included having engaged sites with the resources and willingness necessary to implement FN. Developing navigators' capabilities to implement LIFT-through training, an established case management system, and connections to peer navigators-were also identified as implementation core functions. Conclusion: This study adds to the growing evidence on FN by characterizing intervention and implementation core functions, a critical step toward promoting LIFT's implementation and effectiveness.

Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development.

The predominant driver of bioanalysis in supporting drug development is the intended use of the data. Ligand-binding assays (LBA) are widely used for the analysis of protein biotherapeutics and target ligands (L) to support pharmacokinetics/pharmacodynamics (PK/PD) and safety assessments. For monoclonal antibody drugs (mAb), in particular, which non-covalently bind to L, multiple forms of mAb and L can exist in vivo, including free mAb, free L, and mono- and/or bivalent complexes of mAb and L. Given the complexity of the dynamic binding equilibrium occurring in the body after dosing and multiple sources of perturbation of the equilibrium during bioanalysis, it is clear that ex vivo quantification of the forms of interest (free, bound, or total mAb and L) may differ from the actual ones in vivo. LBA reagents and assay formats can be designed in principle to measure the total or free forms of mAb and L. However, confirmation of the forms being measured under the specified conditions can be technically challenging. The assay forms and issues must be clearly communicated and understood appropriately by all stakeholders as the program proceeds through the development process. This paper focuses on monoclonal antibody biotherapeutics and their circulatory L that are either secreted as soluble forms or shed from membrane receptors. It presents an investigation into the theoretical and practical considerations for total/free analyte assessment to increase awareness in the scientific community and offer bioanalytical approaches to provide appropriate PK/PD information required at specific phases of drug development.

Preclinical safety evaluation of AAV2-sFLT01- a gene therapy for age-related macular degeneration.

AAV2-sFLT01 is a vector that expresses a modified soluble Flt1 receptor designed to neutralize the proangiogenic activities of vascular endothelial growth factor (VEGF) for treatment of age-related macular degeneration (AMD) via an intravitreal injection. Owing to minimal data available for the intravitreal route of administration for adeno-associated virus (AAV), we initiated a 12-month safety study of AAV2-sFLT01 administered intravitreally at doses of 2.4 × 10(9) vector genomes (vg) and 2.4 × 10(10) vg to cynomolgus monkeys. Expression of sFlt01 protein peaked at ~1-month postadministration and remained relatively constant for the remainder of the study. Electroretinograms, fluorescein angiograms, and tonometry were assessed every 3 months, with no test article-related findings observed in any group. Indirect ophthalmoscopy and slit lamp exams performed monthly revealed a mild to moderate but self-resolving vitreal inflammation in the high-dose group only, which follow-up studies suggest was directed against the AAV2 capsid. Histological evaluation revealed no structural changes in any part of the eye and occasional inflammatory cells in the trabecular meshwork, vitreous and retina in the high-dose group. Biodistribution analysis in rats and monkeys found only trace amounts of vector outside the injected eye. In summary, these studies found AAV2-sFLT01 to be well-tolerated, localized, and capable of long-term expression.

Herbal remedies for psoriasis: what are our patients taking?

The objective of this study was to review and explore the top 15 currently used and the historically used herbal remedies in the treatment of psoriasis. Articles, press releases, message boards, product marketing sites, and patient education lines through the National Library of Medicine (www.pubmed.gov), National Psoriasis Foundation (www.psoriasis.org), Google (www.google. com), and Yahoo (www.yahoo.com) were reviewed. Despite widespread use of complementary and alternative medications, specifically herbals, there is limited scientific data regarding their benefits and interactions. Studies on the efficacy and side effect profiles of these remedies are needed. Additionally, both providers and patients need to be cognizant of both potential benefit distortion and adulteration of the herbal products.

Trichophyton tonsurans associated tinea corporis infection with the development of Majocchi's granuloma in a renal transplant patient.

Trichophyton tonsurans is an uncommon cause of tinea corporis, and an even more uncommon cause of Majocchi's granuloma. We report a patient who developed tinea corporis with Majocchi's granuloma from T. tonsurans infection. Immunocompromised hosts are predisposed to develop cutaneous fungal infections, as was the case with this patient. Majocchi's granuloma is a rare complication with immunosuppression, but is significant to consider when a fungal infection is suspected because it may require more aggressive therapy.

Spray-on tanning.

The modern formulation of dihydroxyacetone (DHA), the only sunless tanning solution approved by the Food and Drug Administration (FDA), is combined with bronzers and moisturizers to deliver a cosmetically acceptable skin color and a natural-looking tan without ultraviolet (UV) exposure. Spray-on tanning products, which deliver this formulation evenly to achieve a full body tan, may be applied in a tanning booth, airbrushed on by a technician, or sprayed on at home, and they appear to offer a generally safe alternative for patients who seek a suntanned appearance.