RESUMEN
Nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) is an advanced form of liver disease that can lead to significant morbidity and mortality primarily due to hepatic complications including fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure, as well as cardiovascular disease. As the development of NASH/MASH is closely linked to cardiometabolic risk factors such as obesity and type 2 diabetes mellitus, its prevalence is increasing along with the prevalence of those conditions. Identifying at-risk patients or those early in the disease process is essential to optimizing care and may prevent future complications. Current treatment options include disease-modifying interventions, off-label use of US Food and Drug Administration (FDA)-approved medications for comorbid conditions, and resmetirom, the recently first-ever FDA-approved medication specifically for use in NASH/MASH. There is also considerable continued activity in related drug development research with several other potential emerging treatments. With the increasing prevalence of NASH/MASH and emerging treatments, it is important for managed care organizations (MCOs) to be prepared to assist in patient care and implement equitable treatment management. Understanding patient perspectives and their experience with NASH/MASH provides insights for MCOs such as the need for education of both health care providers and patients to encourage early diagnosis and for enhancing access to individualized care including resources and support. Additionally, MCOs can consider potential management strategies for new and emerging treatments.
Asunto(s)
Accesibilidad a los Servicios de Salud , Enfermedad del Hígado Graso no Alcohólico , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Programas Controlados de Atención en Salud , Enfermedad del Hígado Graso no Alcohólico/tratamiento farmacológico , Enfermedad del Hígado Graso no Alcohólico/terapia , Prevalencia , Estados Unidos/epidemiologíaRESUMEN
Chronic graft-vs-host disease (cGVHD) is a common complication and a major cause of morbidity and mortality following allogeneic hematopoietic cell transplantation. It is primarily characterized by chronic inflammation and fibrosis involving multiple organs. Firstline treatment with steroids with or without calcineurin inhibitors for cGVHD is well established; however, a significant number of patients develop steroid-refractory/resistant cGVHD (SR-cGVHD). Subsequent treatment for SR-cGVHD varies widely, but recent advances include the approval of several medications specifically for this indication, offering new opportunities to improve the prognosis in this challenging-to-treat condition. Ongoing research in preemptive and treatment strategies, such as combinations with newer and better-tolerated agents, may inform future management of SR-cGVHD. DISCLOSURES: This supplement was written by Bridget Flavin, PharmD, Founder, Connected Content, Ltd. Connected Content, Ltd. received payment from AMC Media Group for the preparation of this manuscript. Flavin is also an adjunct associate professor at the University of Florida College of Pharmacy. This supplement was funded by Kadmon Pharmaceuticals, LLC.
Asunto(s)
Enfermedad Injerto contra Huésped , Trasplante de Células Madre Hematopoyéticas , Humanos , Enfermedad Injerto contra Huésped/tratamiento farmacológico , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Esteroides/uso terapéutico , Pronóstico , Flavinas/uso terapéuticoRESUMEN
INTRODUCTION: The University of Florida College of Pharmacy, Department of Pharmaceutical Outcomes and Policy hosted a seminar 6-7 March 2021, on the quality of pharmaceutical products in the United States. This meeting report summarizes the topics presented at the seminar and highlights the expert opinions offered by the presenters. AREAS COVERED: The seminar, held virtually due to the COVID-19 pandemic, included slide presentations and faculty-moderated panel discussions from experts in the field. These experts from regulatory, academic, and private sectors discussed bioequivalence standards, existing and emerging efforts to promote quality in brand and generic manufacturing, as well as market-based solutions throughout the drug supply chain. EXPERT OPINION: The time spent understanding bioequivalence standards during the seminar felt especially important and relevant in our current pandemic environment, given the present need to have confidence in the science of drug development and to advocate for the safety of pharmaceuticals. Also an important point to emphasize from the seminar, was that every stakeholder along the drug supply chain has a responsibility to do their part to maintain its quality. And those in attendance, many of whom were students of healthcare sciences, were encouraged to be leaders in their fields and develop strategies to advance innovative improvements.
Asunto(s)
Industria Farmacéutica/normas , Medicamentos Genéricos/normas , Legislación de Medicamentos , Preparaciones Farmacéuticas/normas , COVID-19 , Industria Farmacéutica/legislación & jurisprudencia , Humanos , Control de Calidad , SARS-CoV-2 , Equivalencia Terapéutica , Estados UnidosRESUMEN
BACKGROUND: Health plans may achieve cost savings by limiting the daily average consumption (DACON) of certain medications and encouraging members and prescribers to select lower cost dosing options. Various strengths of a given medication may be similarly priced per unit; therefore, a single unit of a higher-strength medication may cost less than multiple lower-strength units that provide the same dose. For instance, a single 10 mg tablet may cost less than two 5 mg tablets. OBJECTIVE: To measure the economic impact of implementing DACON limits for selected medications. METHODS: RegenceRx prescription claims data for the top 200 brand and select generic medications from the first quarter of 2011 were searched for DACON limit opportunities. DACON limits were placed on medications that were available in multiple strengths that were similar in cost, and at least one strength was double another (e.g., 5 mg and 10 mg).Phase 1 of the program occurred in December 2011 and consisted of messaging to dispensing pharmacies (either electronic or direct contact). In Phase 2 (effective January 1, 2012), the claims system was coded to prevent payment for prescription claims in quantities exceeding DACON limits ( greater than 1.9 tablets/day). During this phase, dispensing pharmacists received electronic messaging at the point of service recommending a transition to the least costly dosing option. If the dispensing pharmacist determined transition was not clinically appropriate, the pharmacy was able to contact RegenceRx customer service for an override.Impact was determined by analyzing prescription claims for the selected medications for the 3 months following implementation of DACON limits (January-March 2012). Specific measurements analyzed included number of claims not paid because of exceeding DACON limits, health plan administrative burden, and cost avoidance. RESULTS: DACON limits were placed on 41 medications for commercial lines of business and 35 medications for Medicare Part D lines of business, based on the medication selection criteria (DACON limits were not placed on classes of clinical concern for Medicare Part D). A total of 5,100 claims across both commercial and Medicare Part D lines of business for January to March 2012 were impacted by implementation of DACON limits at the point of service. Duloxetine, niacin CR, and generic temazepam were responsible for more than 60% of the DACON limit claims volume. Implementing DACON limits resulted in a total cost avoidance of approximately $730,000 across both commercial and Medicare Part D lines of business for January to March 2012. Duloxetine, niacin CR, and aripiprazole were responsible for nearly 60% of the total aggregate cost avoidance. After adjustment for health plan administrative costs, the total cost avoidance was just under $720,000. CONCLUSION: Implementing DACON limits on selected medications provided a cost avoidance of approximately $720,000 over a 3-month period with limited interruption to patient access and relatively low administrative burden. This reduction could result in annualized savings of nearly $3 million.