ABSTRACT
In this latest update, we look at recent developments in market access including the pricing agreement of Libmeldy® by the Beneluxa Initiative, the financial impact of managed entry agreements in Italy and the restructuring of Agenzia Italiana del Farmaco (AIFA). We also highlight the collaboration between FINOSE and the New Expensive Drug (NED) section of the Nordic Pharmaceutical Forum.
ABSTRACT
In this latest update, we explore some of the key updates in market access over recent months including the UK's voluntary scheme for branded medicines pricing, access and growth (VPAG), the first drugs funded by the Innovative Medicines Fund in the UK and the Direct Access Scheme in France, and, finally, the new Institute for Clinical and Economic Review (ICER) value assessment framework in the USA.
Subject(s)
Academies and Institutes , Biomedical Technology , Humans , Cost-Benefit Analysis , FranceABSTRACT
In this latest update, we explore the Inflation Reduction Act (IRA) enacted by the US Congress in August 2022, with the Centers for Medicare and Medicaid Services (CMS) recently releasing the list of the first ten drugs it will negotiate prices on. We also cover the consequences of price controls and rigid value assessment in Germany which have led to the withdrawal of a number of medicines. It will be important to see how the IRA balances cost-saving with holistic value assessment, incentives for innovation and patient access to treatment.
Subject(s)
Economic Competition , Medicare , Aged , Humans , United States , Germany , Drug CostsABSTRACT
Chronic lymphocytic leukemia patients with mutated immunoglobulin heavy-chain genes (IGHV-M), particularly those lacking poor-risk genomic lesions, often respond well to chemoimmunotherapy (CIT). DNA methylation profiling can subdivide early-stage patients into naive B-cell-like CLL (n-CLL), memory B-cell-like CLL (m-CLL), and intermediate CLL (i-CLL), with differing times to first treatment and overall survival. However, whether DNA methylation can identify patients destined to respond favorably to CIT has not been ascertained. We classified treatment-naive patients (n = 605) from 3 UK chemo and CIT clinical trials into the 3 epigenetic subgroups, using pyrosequencing and microarray analysis, and performed expansive survival analysis. The n-CLL, i-CLL, and m-CLL signatures were found in 80% (n = 245/305), 17% (53/305), and 2% (7/305) of IGHV-unmutated (IGHV-U) cases, respectively, and in 9%, (19/216), 50% (108/216), and 41% (89/216) of IGHV-M cases, respectively. Multivariate Cox proportional analysis identified m-CLL as an independent prognostic factor for overall survival (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.24-0.87; P = .018) in CLL4, and for progression-free survival (HR, 0.25; 95% CI, 0.10-0.57; P = .002) in ARCTIC and ADMIRE patients. The analysis of epigenetic subgroups in patients entered into 3 first-line UK CLL trials identifies m-CLL as an independent marker of prolonged survival and may aid in the identification of patients destined to demonstrate prolonged survival after CIT.
Subject(s)
DNA Methylation , Gene Expression Regulation, Leukemic , Leukemia, Lymphocytic, Chronic, B-Cell/diagnosis , Leukemia, Lymphocytic, Chronic, B-Cell/genetics , Adult , Aged , Aged, 80 and over , Chromosome Aberrations , Computational Biology/methods , Epigenesis, Genetic , Epigenomics/methods , Female , Gene Expression Profiling , Humans , Immunoglobulin Heavy Chains/genetics , Leukemia, Lymphocytic, Chronic, B-Cell/mortality , Leukemia, Lymphocytic, Chronic, B-Cell/therapy , Male , Middle Aged , Mutation , Neoplasm Staging , Prognosis , Proportional Hazards ModelsABSTRACT
Although mentioned in the UK pandemic plan, essential service providers were not among the priority groups. They may be important targets of future influenza pandemic vaccination campaigns. Therefore, we conducted a cross-sectional survey among 380 employees from West Midlands police headquarters and 15 operational command units in the West Midlands Area during December 2009-February 2010 to identify factors affecting intention to accept the pandemic influenza A (H1N1) vaccine. One hundred and ninety nine (52.4%) employees completed the questionnaire. 39.7% were willing to accept the vaccine. The most common reasons for intention to accept were worry about catching Swine Flu (n = 42, 53.2%) and about infecting others (n = 40, 50.6%). The most common reason for declination was worry about side effects (n = 45, 57.0%). The most important factor predicting vaccine uptake was previous receipt of seasonal vaccine (OR 7.9 (95% CI 3.4, 18.5)). Employees aged <40 years, males, current smokers, and those who perceived a greater threat and severity of swine flu were also more likely to agree to the vaccine. The findings of this study could be used to improve future pandemic immunization strategies. Targeted education programs should be used to address misconceptions; the single most important factor which might lead to a large improvement in uptake is to allay concern about side effects.
