GSK is starting a study to test the cost-effectiveness of its RSV vaccine in Spanish adults.

GSK has launched the Efficacy of Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Adults in Spain study1, which aims to evaluate the effectiveness of vaccinating adults aged ≥60 years with adjuvanted RSV vaccine by adapting a Markov model that estimates the incremental cost-effectiveness ratio ( ICER) immunization strategies versus no vaccination. The analysis was carried out from the perspective of the National Health System (NHS), so only direct health care costs were considered. The study was presented at the congress of the Spanish Association of Vaccinologists (AEV), which took place in Malaga from 24 to 26 October.

The study can consider a five-year time horizon due to new data on the efficacy of a single dose of adjuvanted RSV vaccine in older adults demonstrating sustained efficacy over at least three full RSV seasons (assuming proportional losses in efficacy from this period in the model). moment), presented at the CHEST Congress, held October 6-9 last year.

The base case results showed that the ICER for vaccinating adults aged ≥60 years (12,845,910 inhabitants) with RSVPreF3 OA is €17,062 per QALY gained. Likewise, this ratio was seen to improve even further in populations at higher risk, such as older people (ICER 15,502, 15,911 and 15,424 €/QALY for ≥65, ≥70 and ≥75 years, respectively) or people with concomitant diseases. (populations with COPD, asthma, diabetes or cardiovascular disease) who would benefit most from vaccination, showing an ICER of €8,139/QALY. This ratio also improved when the indirect impact of RSV infections was considered from a societal perspective (ICER: €15,855/QALY)1. In addition, the main results were supported by a probabilistic sensitivity analysis showing that 99% of simulations would be below the willingness-to-pay threshold of €25,000/QALY1. Therefore, given this theoretical threshold, vaccination of individuals aged ≥60 years with an adjuvanted RSV vaccine would be an effective strategy for SNS in the prevention of lower respiratory tract diseases (LRTD) caused by RSV in Spain.

Pulmonologist Felipe Villar, Deputy Head of the Pulmonology Service at the Jiménez Díaz Foundation University Hospital and one of the authors of the analysiscomments on this: “The results observed in this study demonstrate the effectiveness of adjuvanted RSV vaccine, particularly in those populations that would benefit most from vaccination as they are at greater risk of developing severe disease, such as adults over 70 years of age and populations with COPD , asthma, diabetes or heart disease. These results may help guide decisions on the future development of the national adult immunization schedule, ensuring effective implementation in the national health system, especially for adults and patients with chronic respiratory diseases. are particularly vulnerable to infections with this virus, and where this vaccination should be a priority.”.

First RSV vaccine with three seasons of data

GSK announced at this year’s CHEST conference, hosted by the American College of Chest Physicians, new data from the phase III AReSVi-006 study evaluating the effectiveness of a single dose of the GSK RSV vaccine in adults over 60 years of age in reducing the risk of developing RSV. -associated lower respiratory tract diseases (LRTIs) and severe LRTIs during three RSV2 seasons. These results make the GSK RSV vaccine the only one that currently has three seasons of surveillance data.

The study shows that after a single dose of the GSK RSV vaccine, the cumulative effectiveness against RSV over three seasons was clinically significant at 69.1% against RSV ETRI (97.5% CI, 55.8-78.9 48 of 12,468 against 215 out of 12,498). ), 72.3% compared with severe RSV RTRI (95% CI, 51.3–85.2; 75 of 12,498) and 71.1% compared with RSV ETRI in patients with at least one comorbidity of interest† (95% CI, 55.2–82.0 25 of 5014 vs. 116 of 4951) compared with placebo and without seasonality as a covariate in the statistical analysis.

These results include effectiveness against various RSV subtypes in older adults (70-79 years), in those with certain underlying medical conditions, and in cases where medical attention is required. Because RSV can aggravate underlying disease and potentially lead to hospitalization, the cumulative effectiveness of RSV over three seasons could have a significant health impact and offer healthcare providers flexibility in administering the vaccine year-round. The clinical development program will continue to evaluate long-term follow-up to provide information on the optimal timing of possible revaccination.