Potential cost-savings from the use of the biosimilars in Slovakia

Objectives: To analyse the market shares of biosimilars in Slovakia and to calculate the potential cost-savings from the use of biosimilars in Slovakia based on two different data sources. Methods: National reimbursement lists from the Czech Republic, Hungary, Poland and Slovakia were used for analyzing the availability of biosimilars with public funding. In addition, the reimbursement dossiers of biosimilars, the justifications of reimbursement decisions by the Slovak Ministry of Health, and final reimbursement decrees, which are published on the webpage of the Slovak Ministry of Health, were utilized for this study. Reimbursement decisions regarding biosimilars by the Slovak Ministry of Health from 2006 to August 2019 were considered and the detailed utilization of biosimilars in 2018 was analyzed based on data from the State Institute for Drug Control. The study was validated based on data from the Slovak National Health Information Center. Results: Fifty four biosimilars were approved by the European Medicines Agency (EMA) in August 2019. Of the total group of licensed biosimilars on the market, 29 biosimilars (54%) were available in the Czech Republic, 28 biosimilars (52%) were available in Poland, and 27 biosimilars (50%) were available in Hungary and 24 biosimilars (44%) were available in Slovakia. Our analysis, based on the data provided by distributors of medicinal products to the State Institute for Drug Control, revealed that the health fund in Slovakia could have saved 35 to 50 million euros per year if biosimilars with marketing authorisations had been available on the Slovak market. The calculations assumed a 25-35% price decrease against the original biological medical products, and that there would be no increase in the utilization of biosimilars in Slovakia. Conclusions: To achieve significant improvement in patient access to biosimilars in Slovakia, a top-down approach establishing targets and quotas for the procurement of biosimilars should be applied

Cost-Utility Analysis of Heberprot-P as an Add-on Therapy to Good Wound Care for Patients in Slovakia with Advanced Diabetic Foot Ulcer

Objectives: To explore whether Heberprot-P (an epidermal growth factor) is a cost-effective option for the treatment of advanced diabetic foot ulcer as an add-on therapy to good wound care (GWC) in Slovakia from the perspective of health care payers. Methods: A Markov model was constructed to compare the costs and effects of Heberprot-P plus GWC to those of GWC alone from the perspective of health care payers. The 52-week clinical trial period was extended to five- and 10-year time horizons. Transition probabilities were calculated based on a previous clinical trial of Heberprot, utility values were derived from the scientific literature, and cost vectors were collected from the General Health Insurance Fund database in Slovakia. A one-way deterministic sensitivity analysis was employed to explore the influence of uncertainty for each input parameter on the incremental cost-effectiveness ratio (ICER). Results: Based on the ICER threshold of €30,030 per quality-adjusted life year (QALY) recommended by the Slovak Ministry of Health, Heberprot-P therapy plus GWC is not a cost-effective alternative to GWC alone over a 10-year time horizon. The ICER increases if a longer time horizon is applied, as the incremental costs are similar, but the aggregated utility gain from avoided amputation is lower. Based on the sensitivity analysis, the utility multiplier for the health state “no ulcer after small amputation” had the most impact on the ICER; however, the model was robust to changes in all input parameters. Conclusions: Heberprot-P, as an add-on therapy to GWC in the treatment of advanced diabetic foot ulcer, is not a cost-effective alternative to GWC alone. However, if the unit cost of Heberprot-P were to be reduced to <€273, its ICER would be <€30,030

Reinitiation and Subsequent Discontinuation of Antiplatelet Treatment in Nonpersistent Older Patients with Peripheral Arterial Disease

The successful treatment of peripheral arterial disease (PAD) depends on adequate adherence to medications including antiplatelet agents. The aims of this study were (a) to identify the proportion of nonpersistent patients who reinitiated antiplatelet therapy and how many of them discontinued therapy after reinitiation, and (b) to identify patient- and medication-related characteristics associated with the likelihood of reinitiation and discontinuation among reinitiators. The analysis of reinitiation was conducted on 3032 nonpersistent users of antiplatelet agents aged >= 65 years, with PAD newly diagnosed in 2012. Discontinuation (i.e., a treatment gap of >= 6 months without antiplatelet medication prescription) was analysed in 2006 reinitiating patients. To identify factors associated with the likelihood of reinitiation and discontinuation, Cox regression with time-dependent covariates was used. Reinitiation was recorded in 2006 (66.2%) of 3032 patients who had discontinued antiplatelet medication. Among these 2006 reinitiators, 1078 (53.7%) patients discontinued antiplatelet therapy again. Ischemic stroke and myocardial infarction during non-persistence and bronchial asthma/chronic obstructive pulmonary disease were associated with an increased likelihood of reinitiation. University education was associated with discontinuation among reinitiators. Factors associated with the probability of reinitiation and discontinuation in reinitiators make it possible to identify older PAD patients in whom "stop-starting" behaviour may be expected

Non-Persistence With Antiplatelet Medications Among Older Patients With Peripheral Arterial Disease

Introduction: Antiplatelet therapy needs to be administered life-long in patients with peripheral arterial disease (PAD). Our study was aimed at 1) the analysis of non-persistence with antiplatelet medication in older PAD patients and 2) identification of patient- and medication-related characteristics associated with non-persistence.Methods: The study data was retrieved from the database of the General Health Insurance Company. The study cohort of 9,178 patients aged >= 65 years and treated with antiplatelet medications was selected from 21,433 patients in whom PAD was newly diagnosed between 01/2012 and 12/2012. Patients with a 6 months treatment gap without antiplatelet medication prescription were classified as non-persistent. Characteristics associated with non-persistence were identified using the Cox regression.Results: At the end of the 5 years follow-up, 3,032 (33.0%) patients were non-persistent. Age, history of ischemic stroke or myocardial infarction, clopidogrel or combination of aspirin with clopidogrel used at the index date, higher co-payment, general practitioner as index prescriber and higher overall number of medications were associated with persistence, whereas female sex, atrial fibrillation, anxiety disorders, bronchial asthma/chronic obstructive pulmonary disease, being a new antiplatelet medication user (therapy initiated in association with PAD diagnosis), and use of anticoagulants or antiarrhythmic agents were associated with non-persistence.Conclusion: In patients with an increased probability of non-persistence, an increased attention should be paid to improvement of persistence.</p

Adherence to Antiplatelet Medications among Persistent and Non-Persistent Older Patients with Peripheral Arterial Disease

Secondary prevention of peripheral arterial disease (PAD) includes administration of antiplatelet agents, and adherence to medication is a requirement for an effective treatment. The aim of this study was to analyse adherence measured using the proportion of days covered (PDC) index separately in persistent and non-persistent patients, and to identify patient- and medication-related characteristics associated with non-adherence in these patient groups. The study cohort of 9178 patients aged >= 65 years in whom PAD was diagnosed in 1/-12/2012 included 6146 persistent and 3032 non-persistent patients. Non-adherence was identified as PDC < 80%. Characteristics associated with non-adherence were determined using the binary logistic regression model. In the group of persistent patients, 15.3% of subjects were identified as non-adherent, while among non-persistent patients, 26.9% of subjects were non-adherent to antiplatelet medication. Administration of dual antiplatelet therapy (aspirin and clopidogrel) and a general practitioner as index prescriber were associated with adherence in both patient groups. Our study revealed a relatively high proportion of adherent patients not only in the group of persistent patients but also in the group of non-persistent patients before discontinuation. These results indicate that most non-persistent PAD patients discontinue antiplatelet treatment rapidly after a certain period of adherence

Non-Adherence to Statin Treatment in Older Patients with Peripheral Arterial Disease Depending on Persistence Status

The effectiveness of statins in secondary prevention of peripheral arterial disease (PAD) largely depends on patients' adherence to treatment. The aims of our study were: (a) to analyze non-adherence during the whole follow-up in persistent patients, and only during persistence for non-persistent patients; (b) to identify factors associated with non-adherence separately among persistent and non-persistent patients. A cohort of 8330 statin users aged >= 65 years, in whom PAD was newly diagnosed between January 2012-December 2012, included 5353 patients persistent with statin treatment, and 2977 subjects who became non-persistent during the 5-year follow-up. Non-adherence was defined using the proportion of days covered <80%. Patient- and statin-related characteristics associated with non-adherence were identified with binary logistic regression. A significantly higher proportion of non-adherent patients was found among non-persistent patients compared to persistent subjects (43.6% vs. 29.6%; p < 0.001). Associated with non-adherence in both persistent and non-persistent patients was high intensity statin treatment, while in non-persistent patients, it was employment and increasing number of medications. In patients with a poor adherence during their persistent period, an increased risk for discontinuation may be expected. However, there is also non-adherence among persistent patients. There are differences in factors associated with non-adherence depending on patients' persistence

Adherence to Antiplatelet Medications among Persistent and Non-Persistent Older Patients with Peripheral Arterial Disease

Secondary prevention of peripheral arterial disease (PAD) includes administration of antiplatelet agents, and adherence to medication is a requirement for an effective treatment. The aim of this study was to analyse adherence measured using the proportion of days covered (PDC) index separately in persistent and non-persistent patients, and to identify patient- and medication-related characteristics associated with non-adherence in these patient groups. The study cohort of 9178 patients aged &ge; 65 years in whom PAD was diagnosed in 1/&ndash;12/2012 included 6146 persistent and 3032 non-persistent patients. Non-adherence was identified as PDC &lt; 80%. Characteristics associated with non-adherence were determined using the binary logistic regression model. In the group of persistent patients, 15.3% of subjects were identified as non-adherent, while among non-persistent patients, 26.9% of subjects were non-adherent to antiplatelet medication. Administration of dual antiplatelet therapy (aspirin and clopidogrel) and a general practitioner as index prescriber were associated with adherence in both patient groups. Our study revealed a relatively high proportion of adherent patients not only in the group of persistent patients but also in the group of non-persistent patients before discontinuation. These results indicate that most non-persistent PAD patients discontinue antiplatelet treatment rapidly after a certain period of adherence

Histamine Intolerance—The More We Know the Less We Know. A Review

The intake of food may be an initiator of adverse reactions. Food intolerance is an abnormal non-immunological response of the organism to the ingestion of food or its components in a dosage normally tolerated. Despite the fact that food intolerance is spread throughout the world, its diagnosing is still difficult. Histamine intolerance (HIT) is the term for that type of food intolerance which includes a set of undesirable reactions as a result of accumulated or ingested histamine. Manifestations may be caused by various pathophysiological mechanisms or a combination of them. The problem with a “diagnosis” of HIT is precisely the inconstancy and variety of the manifestations in the same individual following similar stimuli. The diagnosing of HIT therefore requires a complex time-demanding multidisciplinary approach, including the systematic elimination of disorders with a similar manifestation of symptoms. Among therapeutic approaches, the gold standard is a low-histamine diet. A good response to such a diet is considered to be confirmation of HIT. Alongside the dietary measures, DAO supplementation supporting the degradation of ingested histamine may be considered as subsidiary treatment for individuals with intestinal DAO deficiency. If antihistamines are indicated, the treatment should be conscious and time-limited, while 2nd or 3rd generation of H1 antihistamines should take precedence

Findings from the Indonesian family life survey on patterns and factors associated with multimorbidity

Abstract The prevalence of multimorbidity tends to increase with age, but it is now also reported in the middle-aged population, which has a negative impact on healthcare systems and health outcomes. This study aims to analyze the patterns and factors associated with multimorbidity in Indonesia. This national cross-sectional population-based survey used publicly available data from the Indonesian Family Life Survey (IFLS-5) for 2014 among middle-aged (40–59 years old) and elderly (≥ 60 years old) respondents. Information on all chronic diseases was assessed using a self-reported questionnaire. Sociodemographic and health-related behavioral factors were obtained from self-reported data. Binary logistic regression analysis was used to identify the factors associated with multimorbidity. Adjusted odds ratios (AORs) with 95% confidence intervals (CIs) were reported. The study recruited 11,867 respondents. The prevalence of multimorbidity was 18.6% (95% CI 17.9–19.3) with which 15.6% among middle age (95% CI 14.95–16.25) and 24.9% among the elderly (95% CI 24.12–25.68). Hypertension was the most commonly reported disease (23.2%) in all combinations of multimorbidity and among all age groups. Socio-demographic factors: elderly (AOR: 1.66; 95% CI 1.46–1.89), female (AOR: 1.42; 95% CI 1.20–1.69), living in the urban area (AOR: 1.22; 95% CI 1.09–1.38), higher educational level (AOR: 2.49; 95% CI 1.91–3.26), unemployed (AOR: 1.63; 95% CI 1.44–1.84), and higher economic level (AOR: 1.41; 95% CI 1.18–1.68) were associated with multimorbidity. Poor health behavior factors: being former smokers (AOR: 2.03; 95% CI 1.65–2.51) and obesity (AOR: 1.53; 95% CI 1.35–1.75) were also associated with multimorbidity. The prevalence of multimorbidity in the middle-aged and elderly population in Indonesia is relatively high, particularly in populations with poor health behaviors. Therefore, healthcare professionals should integrate more patient-specific factors when designing and implementing tailored interventions to manage multimorbidity in Indonesia