Seven-valent pneumococcal conjugate vaccine (PCV7) was introduced to Sweden in 2009 and replaced by pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) or 13-valent PCV (PCV13) from late 2009. A retrospective cohort study assessed the impact of PCVs on otitis media/acute otitis media (OM) in children aged ≤5 years (NCT02742753) living in Skåne (PCV7 then PHiD-CV) or Västra Götalandsregionen (PCV7 then PCV13) between 2005 and 2013 using linked regional and national databases. Time-series analyses described differences between pre-PCV and post-PCV eras. Adjusted age-period-cohort (APC) predictive models estimated vaccine effectiveness and OM incidence ratios between PCV cohorts. Time-to-first OM diagnosis was estimated in ≤2 year-olds by survival analysis using a Cox proportional hazards model. Descriptive interrupted time-series analyses showed OM incidence in ≤2 year-olds declined by 42% (Skåne) and 25% (Västra Götalandsregionen) after PHiD-CV/PCV13, respectively, versus pre-PCV, but baseline OM incidence and duration of PCV7 use differed between regions. In adjusted APC models, OM incidence decreased after PHiD-CV by 9.9% (95% confidence interval [CI]: 4.4; 15.1, p < .001) and PCV13 by 2.3% (95%CI: −3.2; 7.6, p = .401) compared with pre-PCV. Both PHiD-CV and PCV13 decreased the risk of first OM diagnosis: hazard ratio (95%CI) for PHiD-CV relative to pre-PCV 0.67 (0.65; 0.69); 0.87 (0.85; 0.89) for PCV13 relative to pre-PCV; p < .001 for both comparisons. Within the limitations of this study conducted in two large Swedish regions, descriptive time-series analyses showed that OM incidence rates declined following the introduction of PHiD-CV and PCV13; however, this reduction only reached statistical significance for PHiD-CV in the adjusted APC models.

In Sweden, the 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in 2009 and replaced by the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) or the 13valent PCV (PCV13) from late 2009. We assessed the impact of PCVs on rates of antibiotic prescribing, tympanostomy tube placement (TTP), and healthcare resource utilization and direct costs of physiciandiagnosed otitis media/acute otitis media (OM) in children ≤2 years of age living in Skåne (PCV7 then PHiD-CV) or Västra Götalandsregionen (VGR; PCV7 then PCV13). Retrospective cohort study using linked patient-level data from national and regional (Skåne and VGR) healthcare databases in Sweden from July 1, 2005, to December 31, 2013 (NCT02742753). Descriptive time-series analyses showed antibiotic prescriptions and TTP incidence declined after PHiD-CV/PCV13 introduction versus the pre-PCV period. The annualized mean frequencies of antibiotic use, primary care visits, outpatient visits, TTP and myringotomy procedures all decreased after PHiD-CV/PCV13 compared with pre-PCV cohorts. Annualized mean total OM-associated healthcare costs decreased in the PCV7 versus pre-PCV cohorts by 20.0% in Skåne and 10.2% in VGR, and further declined in the PHiD-CV and PCV13 cohorts (20.7% and 15.3%, respectively, relative to the PCV7 cohort), although the duration of PCV7 use differed between regions. Decreases in adjusted annualized cost ratios between cohorts per child susceptible to OM were statistically significant after PCV7 introduction and again with either PHiD-CV or PCV13 introduction in both regions. Following sequential PCV introduction, OM-related healthcare utilization and associated costs decreased in the study regions in Sweden.

IntroductionSickle cell disease (SCD) describes a group of inherited disorders of hemoglobin. Globally, SCD occurs in approximately 300,000-400,000 births annually and is most prevalent in malaria-endemic countries. However, migration has impacted the epidemiology of SCD but data on the matter are scarce. The objective of this study was to describe the epidemiology, treatment uptake, and economic burden of SCD in Sweden, a country with substantial immigration over the last decades.MethodsThis nationwide retrospective observational registry cohort study identified patients with SCD from 2001 to 2018 and followed them from 2006 to 2018. Using data from high-quality population-based Swedish registers, we estimated prevalence, treatment uptake, and SCD-related health care resource use, sick leave and disability pension.ResultsBetween 2006 and 2018 the number of patients with SCD increased from 504 to 670; inpatient hospital stays and outpatient visits increased by 200% and 300%, respectively. Patients with pain crises had approximately twice the number of inpatient episodes and outpatient visit per year, and had higher productivity losses compared to patients without crises.ConclusionIn an era of emerging treatments for SCD, we have, to the best of our knowledge, for the first time comprehensively described epidemiological and economic aspects of SCD in a country where the disease is still rare and not well recognized by the healthcare system.

provision of diagnostic services at the drugstores (p<0,05, c2-test) were established. The highest PC quality (51% -high, medium and low, 49% -unsatisfactory) was estimated for dispense of OTC-drugs. The PC quality of prescription drugs assistance and diagnostic services were unsatisfactory. The PC quality during dispense of OTC-drugs was significantly correlated with undergraduate study on OTC-drugs PC (rOTC1 ¼ 0.76) and professional development on the issues of PC during the postgraduate training of pharmacists (rOTC2 ¼ 0.65). CONCLUSIONS: Overall PC quality in Ukraine is compromised significantly by the fact that national PC system is focused mostly on OTC-drugs whereas appropriate assistance during dispense of prescription drugs and the provision of diagnostic services is lacking. The opportunity to address this issue in pharmacy educational programs as well as regulatory guidelines should be carefully considered.

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BACKGROUND Sickle cell disease (SCD) is an autosomal recessive disorder characterized by abnormal hemoglobin. SCD causes hemolytic anemia, vaso-occlusion leading to vaso-occlusive crises (VOC) and contributing to organ damage and early death. SCD is most prevalent in sub-Saharan Africa and the Middle East, but also countries such as Brazil, India and US, have comparatively high frequencies of SCD. Global migration has contributed to a greater geographical spread. The prevalence of SCD in Sweden is unknown. OBJECTIVE The primary objectives of this study were to estimate the 1-year prevalence of SCD and SCD-associated resource use in Sweden. Secondary objectives were to estimate birth incidence, treatment patterns and survival. PATIENTS Patients with an ICD-10 diagnosis code for SCD (any D57 [excluding D57.3, sickle cell trait]) were identified from the Swedish Patient Registry (between January 1 st 2001 and June 30 th 2018). Patients were assessed for 1-year prevalence and resource use per calendar year for a follow-up period of 13 years (2006-2018). METHODS Patients were considered prevalent from birth or immigration to death or emigration. Resource use from specialized care, including all events recorded in the registry with any D57 as the main diagnosis was assessed in the follow up period 2006-2018 as number of outpatient visits and inpatient stays. Costs for this hospital resource use were estimated through remuneration amounts based on diagnosis related groups. Data on sick leave days and days with disability pension due to SCD in patients in working age (18-65 years) were retrieved from the Swedish Social Security Agency and costed with the mean salary in Sweden, plus social security contributions. Costs are reported in 2019 Swedish Krona (SEK, ≈$ 0.1). RESULTS One-year prevalence of all SCD diagnosis increased from 504 patients (5.53 per 100,000 population) in 2006 to 670 patients (6.55 per 100,000 population) in 2018. The 1-year prevalence of SCD patients ever recorded with an ICD-10 code for SCD with VOC (D57.0) increased from 139 patients (1.53 per 100,000 population) in 2006 to 260 patients (2.54 per 100,000 population) in 2018. The proportion of prevalent patients that were born in Sweden decreased over the years, from approximately 55% in the beginning of the study period to 45% in the end of the study period. The mean and median age of the SCD population decreased over the study period. Individuals with SCD and VOC were, on average younger than the other SCD (D57) subgroups. Birth incidence was captured by calendar year 2006-2018 and was highest in 2007 with 15 children born with SCD. For Swedish-born children with SCD during the patient identification time (n=123), the mean time to identification in the registers was 2.6 years (SD 2.7, range 0-16 years). Hospital outpatient visits and inpatient stays with SCD (all events with D57 recorded) as main diagnosis increased from 57 to 189, and 250 to 1,003, respectively, over the years 2006-2018. This corresponded to costs of inpatient care increasing from 1.4 million (M) SEK in 2006 to 7.3 M SEK in 2018 and costs of outpatient visits increasing from 0.9 M SEK in 2006 to 4.6 M SEK in 2018. The vast majority of costs were incurred in individuals ever recorded with a SCD with VOC diagnosis (D57.0). The most frequent hospital treatment was blood transfusion, with 8-11% of patients receiving transfusion in each year studied, especially common in SCD and VOC diagnosis. The prescribed treatment with the highest increase of uptake over the study period were hydroxyurea, vitamins and paracetamol in all SCD. Individuals in working age had on average 2.3 days of sick leave per patient-year due to SCD (D57), and approximately 4% of these patients received disability benefits because of their SCD. During the follow-up period, the median age at death was 74 years for all SCD and 69 years for SCD with crisis, this is 7-10 years and 12-15 years less compared to the Swedish general population respectively. CONCLUSION This study demonstrates that the prevalence, hospital resource use and associated costs have increased substantially in Sweden. In an era of emerging treatments for SCD we have for the first time comprehensively described epidemiological-, disease-related and economical aspects of SCD in Sweden. Disclosures Hernlund: ICON: Current Employment. Ivergård: ICON: Current Employment. Svedbom: ICON: Current Employment. Dibbern: Novartis: Current Employment. Stenling: Novartis: Current Employment. Sjöö: Novartis: Ended employment in the past 24 months. Vertuani: Novartis: Current Employment. Glenthøj: Saniona: Research Funding; Bristol Myers Squibb: Consultancy; Agios: Consultancy; Novo Nordisk: Honoraria; Novartis: Consultancy; Alexion: Research Funding; Sanofi: Research Funding; Bluebird Bio: Consultancy.

Objectives: To assess the publicly available French health-economic opinions, an exhaustive retrospective analysis was conducted on Incremental Cost-Effectiveness Ratios (ICERs) and methodological objections delivered by the HAS. MethOds: An electronic database was built to extract and analyze all health-economic relevant information from the publicly available opinions published by the HAS/CEESP (Comité d'Evaluation Economique et Santé Publique) on their website. This database was structured based on the following items: structural choices, results, sensitivity analysis, cost-effectiveness ratio and methodological objections. Our analysis was performed from December, 2014 (published date of the first economic opinion) until June 8th, 2016. A hypothetical threshold of 50,000 euros per Quality Adjusted Life Year gained (€ /QALY) was used for the ICER analysis cut-off. Results: Currently, 18 health-economic opinions have been published in which: 16 studies express results in cost per QALY. Among these studies, 4 were completely invalidated, leading to the exclusion of the corresponding ICERs. These exclusions were due to various reasons such as: lack of uncertainty investigation, wrong comparator and weakness of input data. From a collective perspective, the ICERs ranged from 5,866€ /QALY up to 191,661€ /QALY. Half of them (6/12) were below the hypothetical threshold of 50,000 € /QALY. cOnclusiOns: From this wide spread of ICERs, it clearly indicates that at this stage, no threshold could be deducted for France. 6 drugs reported an ICER superior to 50,000€ /QALY, and finally access to the reimbursement system. Two products did not obtain the reimbursement in France with ICERs inferior to 30,000€ /QALY (respectively 24,413€ /QALY and 29,797€ /QALY), due to unsatisfactory safety data. To conclude, the willingness to pay of the French Health Care system is not limited by any threshold. The health-economic appraisal on the methodology plays an important role in the pricing negotiations.