Incidence and cost of stroke and hemorrhage in patients diagnosed with atrial fibrillation in France.

BACKGROUND: Stroke represents a major complication of atrial fibrillation (AF). The current anticoagulation options for stroke prevention increase hemorrhage risk. The objective of the study was to estimate the incidence and costs of hospitalization for stroke and hemorrhage in patients with AF who are eligible for stroke prevention. METHODS: Patients hospitalized for AF were identified from the French National hospital database (Programme Médicalisé des Systèmes d'Information) and a calculated stroke risk score (congestive heart failure, hypertension [blood pressure consistently >140/90 mm Hg], age ≥75 years, diabetes mellitus, and previous stroke, transient ischemic attack [CHADS2]). Adult patients eligible for stroke prevention (CHADS2 >0) were enrolled. The incidence of hospitalization for stroke and hemorrhage was calculated over a 2-year period. Costs of acute care were determined using diagnosis related groups (DRGs) and corresponding National Hospital Tariffs. Rehabilitation costs were analyzed for patients with strokes and classified by stroke severity. RESULTS: Sixty-one thousand five hundred eighty-two patients were identified with a mean age of 75.0 ± 11.0 years and a mean CHADS2 score of 1.90 ± 0.99. The 24-month cumulative incidence of any stroke was 32.1 cases/1,000 patients with AF (ischemic, 60%; hemorrhagic, 24%; unspecified, 16%), and that of hemorrhage was 53.1 cases/1,000 patients with AF (gastrointestinal, 26%; intracranial, 5%; other, 69%). The mean costs of ischemic and hemorrhagic strokes were €4,848 and €7,183 (mild), €10,909 and €14,298 (moderate), €29,065 and €29,701 (severe), and €6,035 and €4,590 (fatal), respectively. The mean costs of hemorrhage by type were €3,601 (gastrointestinal), €7,331 (intracranial), €3,941 (other major), and €2,552 (nonmajor). CONCLUSIONS: The incidence and cost of hospitalization for hemorrhage should be considered in the global burden of AF. These data should be useful for pharmacoeconomic evaluation of new oral anticoagulant medications. Such real-world studies may be relevant for monitoring mid- to long-term morbidity and mortality in the AF population.

Forecasting the potential impact of cell and gene therapies in France: projecting product launches and patients treated.

Objective: To evaluate the potential impact of cell and gene therapies (CGTs) in France by forecasting the number of patients that will be treated with CGTs over the period 2023-2030 by therapeutic area and region. Methods: A review of CGTs in clinical development and related disease epidemiology was conducted to forecast the number of CGT launches and patient population between 2023 and 2030. The number of expected launches was identified by filtering the clinical development pipeline with estimated time to launch and probability of success values from Project ALPHA. Disease prevalence and incidence in France were combined with projected adoption rates derived from historical data to forecast the patient population to be treated. Results: Up to 44 new CGTs are forecasted to launch in France in the period 2023-2030, which translates into more than 69,400 newly treated patients in 2030. Leading indications in terms of newly treated patients per year include cardiovascular disease, hematological cancers and solid tumors with 27,300, 15,200 and 13,000 newly treated patients in 2030, respectively. Discussion: The forecast suggests that the future landscape of CGTs will undergo a shift, moving from CGTs targeting (ultra) rare diseases to more prevalent diseases. In France, this will likely pose organizational challenges hindering patient access to these transformative therapies. Further research and planning around network organization and patient distribution are needed to assess and improve the readiness of the French healthcare system for ensuring access for this growing number of patients to be treated with CGTs.