Background: Clinical practice guidelines for the treatment of idiopathic pulmonary fibrosis (IPF) currently recommend pirfenidone and nintedanib. However, there is a lack of evidence from head-to-head comparisons. Objectives: To perform a systematic review and network meta-analysis (NMA) to access the efficacy and tolerability of two new treatments for IPF, pirfenidone and nintedanib. Methods: Randomized controlled trials (RCTs) selection (CENTRAL, MEDLINE, Embase), data extraction, risk of bias analysis and GRADE assessment were carried out by two authors separately. Direct estimates were calculated using standard pairwise meta-analysis. A Bayesian mixed treatment comparison approach for NMA estimates, with 95% confidence intervals (CI), was used to compare the treatments, calculating odds ratios (OR) and number needed to treat (NNTB) or harm (NNTH). Results: The NMA on 10 randomized controlled trials showed that each drug had a positive effect on percentage of forced vital capacity (FVC) decline ≥10% (pirfenidone OR 0.54 [95% CI 0.37-0.80], NNTB 9 [95% CI 7-22]; nintedanib OR 0.59 [95% CI 0.41-0.84], NNTB 9 [95% CI 6-23]), but no significant differences were noted when comparing pirfenidone and nintedanib with respect to acute exacerbations, mortality and serious adverse events (FVC decline OR 0.91 [95% CI 0.45-2.03]) or dropouts (OR 0.75 [95% CI 0.33-1.27]). Nintedanib showed an effect on dropouts OR 1.61 (1.13-2.28) and NNTH 14 (8-61). Conclusions: Based on RCTs of 12 month duration in patients with IPF a positive effect on FVC decline was noted for both treatments and on dropouts for nintedanib, but no significant differences were noted between treatments.

BACKGROUND: In Greece, due to the ongoing economic crisis a number of measures aiming at rationalising expenditure implemented. A new e-prescribing system, under a unified healthcare fund was the main pillar of these reforms focus on monitoring and auditing prescribing patterns.OBJECTIVE: Main objective of this study was to document the Greek experience with the new national e-prescribing system.METHODS: We analyse the dispensed prescriptions over the period 2013-2014, stratified into four levels: therapeutic subgroup, patent status, physician's specialty and geographical region.RESULTS: Data analysis offered a comprehensive insight into pharmaceutical expenditure over the timeframe and revealed discrepancies regarding composition of spending, brand-generic substitution within certain therapeutic subgroups, physicians’ prescribing behaviour based on medical specialty, therapeutic subgroup as well as regional per capita measures.CONCLUSIONS: E-prescribing system is a valuable tool providing sound information to health policymakers in order to monitor and rationalize pharmaceutical expenditure, in value and volume terms.

Objectives: The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Methods: Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. Results: The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures—such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting—have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Conclusions: Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Objectives: To assess the health technology assessment (HTA) process in Greece from its establishment in 2018 until 2023 in terms of timeliness and productivity. Methods: Data were collected from the HTA Committee’s database and other publicly available sources. The overall study timeframe was divided into three periods: (i) July 2018–January 2020, (ii) January 2020–July 2021, and (iii) July 2021–February 2023. Results: During the study period, a total of 1,157 applications for medicinal products (MPs) (including 219 new active substances (NAS) and orphans) were submitted to the HTA Committee. The number of HTA recommendations increased from 60 (first period) to 641 (third period), while the backlog of MPs pending HTA and price negotiations decreased from 89 and 106 (January 2020) to 8 and 44 (February 2023), respectively. The median time intervals for all application types decreased significantly over time. In February 2023, the median time for clinical data assessment of NAS (excluding orphans) almost halved from 207 days in the first period to 114 days; median times for NAS and orphans from regulatory approval to HTA application were 420 and 457 days, and from HTA application to reimbursement 228 and 417 days, respectively. Conclusions: The performance of the HTA process in Greece improved significantly over time, with increased MP appraisals, backlog reduction, and decreased timelines. Delays in reimbursement of NAS were mainly caused by the long gap between regulatory approval and HTA application. Overall, HTA review times in Greece are now on par with that of well-established European HTA systems.