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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-tohead 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 ¼ 0.54 [95% CI ¼ 0.37-0.80], NNTB ¼ 9 [95% CI ¼ 7-22]; nintedanib OR ¼ 0.59 [95% CI ¼ 0.41-0.84], NNTB ¼ 9 [95% CI ¼ 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 ¼ 0.91 [95% CI ¼ 0.45-2.03]) or dropouts (OR ¼ 0.75 [95% CI ¼ 0.33-1.27]). Nintedanib showed an effect on dropouts, OR ¼ 1.61 (1.13-2.28) and . 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. ARTICLE HISTORY

IntroductionChronic Obstructive Pulmonary Disease (COPD) is one of the top leading causes of death and disability, and its management is focused on reducing risk factors, relieving symptoms, and preventing exacerbations. The study aim was to describe COPD prescribing patterns in Greece by using existing health administrative data for outpatients.MethodsThis is a retrospective cross-sectional study based on prescriptions collected by the largest social insurance fund, during the first and last trimester of 2012. Selection criteria were the prescription of specific active substances and a COPD diagnosis. Extracted information included active substance, strength, pharmaceutical form and number of packages prescribed, diagnosis, time of dispensing, as well as insurees’ age, gender, percentage of co-payment and social security unique number. Statistical analysis included descriptive statistics and logistic regression.Results174,357 patients received medicines for COPD during the study period. Patients were almost equally distributed between male and female, and age above 55 years was strongly correlated with COPD. Most patients received a long-acting beta agonist plus inhaled corticosteroid combination (LABA +ICS), followed by long-acting muscarinic agonist (LAMA). 63% patients belonging in the 35–54 age received LABA+ICS. LAMA was prescribed more frequently among males and was strongly correlated with COPD.ConclusionThe study provides big data analysis of Greek COPD prescribing patterns. It highlights the need for appropriate COPD classification in primary care illustrating the role of electronic prescribing in ensuring appropriate prescribing. Moreover, it indicates possible gender differences in treatment response or disease severity, and the impact of statutory co-payments on prescribing.

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.

s231 produced a statistically significant reduction over placebo in rTNSS (standardized mean difference [SMD]-0.390; 95% CI-0.476 to-0.303, p< 0.001) in both the short (less than 6 weeks) and long term (52 weeks or more). A greater improvement was also established in iTNSS (-0.360,-0.484 to-0.236, p< 0.001), rTOSS (-0.163,-0.293 to-0.033, p= 0.014), iTOSS (-0.165,-0.295 to-0.035, p= 0.013) and QoL (-0.322,-0.452 to-0.191, p< 0.001) in the short term. All effect sizes were greater than-0.5, indicating small changes according to Cohen's guidelines. The incidence of most adverse events with FFNS was similar to that with placebo, with the exception of epistaxis, which was more frequent with FFNS in both the short (FFNS 7%, placebo 4%, p= 0.004) and long term (FFNS 25%, placebo 13%, p< 0.001). ConClusions: FFNS in adults and adolescents with PAR resulted in statistically significant but not clinically relevant improvements in symptoms and QoL compared with placebo.