BackgroundBipolar disorder type I (BD-I) is a chronic condition characterized by mania episodes followed by syndromic recovery periods, usually permeated by depressive symptoma-tology and recurring acute manic episodes. It requires long-term pharmacological treatment; thus, it is critical to understand the patterns of drug therapy use and medication compliance to better plan health care policies and needs. This systematic literature review aims to study these data among patients with BD-I in the USA, focusing on medications to treat mania.MethodsArticles published in the last 10 years to October 2016 were searched on MEDLINE and Embase. Studies on patterns of drug therapy, concordance of prescription with clinical practice guidelines, and adherence and persistence with pharmacological treatments for BD-I in the USA under observational conditions, with focus on treatments for mania, were selected.ResultsTreatment prevalence for BD-I is low in the USA, with the most current study showing a 46% 12-month rate. There is a lack of studies addressing the use of long-acting injectable (LAI) antipsychotics. Second-generation antipsychotics (SGAs) have been used by nearly all patients receiving oral antipsychotics since the 2000s. However, 30%–60% of individuals with BD do not receive appropriate treatment, and adherence to oral therapies is poor, with medication possession ratios ≥80% seen in only approximately 60% of patients. For persistence rates, results suggest that treatment duration is short for a condition with recommendation for at least 6 months of maintenance therapy. Literature indicates that LAI SGAs may be related to better adherence and persistence.ConclusionThere is a need for studies addressing specifically patterns of therapy and adherence to pharmacological treatment in BD-I patients in the USA to better understand the value of current standards, and an urgent need to improve the rates of adherence and persistence to BD-I pharmacotherapy and to increase the understanding of LAI SGAs’ potential to address this issue.
A825oncologic products within Latin America (LA) in comparison to a developed market (Canada). Methods: A panel of opinion leaders and policy-makers from Brazil, Colombia, Argentina, Mexico, and Canada was convened to understand current challenges in health care, patient access, and reimbursement of high-cost oncologic products with a focus on NSCLC. Results: In LA, patient access to biomarker testing in all cancers is limited, except for common biomarkers like HER2 in breast cancer. In Canada, there is no uniform coverage across provinces for diagnostic testing. In LA, there is an inconsistent and varied level of prioritization in public and private markets amongst various cancers (e.g. breast) for which access to highcost oncologic agents is more likely. Specifically, NSCLC is not prioritized because of its perceived association with smoking and "poor prognosis". It is unlikely in LA for expensive medications to be included in the standard benefit packages, and the review process can be lengthy for those that are included. Some patients may get access to some medications through filing a judicial claim against the government for individual drug cost reimbursement. Although various LA countries are witnessing evolution in some form, unlike in Canada, HTA does not have a substantial influence on payer decision-making on drug coverage. There was a consensus for enrolling more patients in clinical trials, development of regional/local clinical guidelines, and generating real-world and cost-effectiveness evidence to potentially improve reimbursement and shorten time to access to medications. ConClusions: Access to high-cost oncologic medications could be potentially improved through increased patient participation in clinical trials, generation of relevant guidelines and robust cost-effectiveness and evidence-based analyses, and implementation of risk-sharing agreements requiring innovative cancer care models.
2039 to EUR 9346, depending on care required, more costly than SREs without hospitalization (n= 165). These SREs had median costs of EUR 200 to EUR 1912, depending on care required. ConClusions: The impact of SREs on total costs could justify policy aimed at actively preventing SREs, e.g. with radionuclide therapy, possibly resulting in better quality of life and cost-reduction. Treatment of prostate cancer with bone metastases is not very costly compared to lung-and breast cancer with similar metastases. However, novel therapeutic options may dramatically increase treatment costs in the near future and proper head-to-head cost-effectiveness studies of all treatment modalities are therefore necessary. PCN72
were extracted alongside whether the priority status, pre-or post-NOC pCODR submission, and if the drug was a first submission or line extension. Statistical comparisons were made using Student's t-test. RESULTS: 32 pCODR reports were extracted with an average of 203 days between pCODR submission to recommendation, with a wide variation between different drugs (range: 119-329 days, median: 198). There was no significant variation in the average time required for pCODR decision-making based on priority status (prioritisation granted: 232 days, [n= 3]; prioritisation not granted: 202 days, [n= 29]; p= 0.17). There was also no significant variation in time required for line extensions versus first submissions (line extension: 197 days, [n= 9]; first submissions: 205 days, [n= 23]; p= 0.34). pCODR decision-making time did also not significantly vary between those submitted prior-versus post-regulatory approval (pre-NOC: 213 days, [n= 18]; post-NOC: 191 days, [n= 14]; p= 0.26). CONCLUSIONS: Although there are some wide variations in the time required for pCODR to issue recommendations between different drugs, this did not correlate with prioritisation status, whether the drug was a first submission or line extension, or if a submission was made pre-or post-NOC in a statistically significant manner. However, the small sample sizes may have precluded finding statistical significances. Further research is needed to define the key factors underlying this variation. PCN157 ImPaCt of federal regulatIoN oN aCCess to oral ChemotheraPy (oC) aNd hormoNal theraPy (ht) IN
Objectives: To estimate long-term clinical outcomes of using rilpivirine/tenofovir/emtricitabine (single tablet regimen) in treatment of naïve patients with HIV-1 RNA< 100 000 copies/ml in the Russian Federation. MethOds: The mathematical model was developed in Microsoft Office 2013. The time horizon was 5 years. The model included two submodels: Markov's model and tree-decision model. The following outcome measures were used in present study: Number of deaths, Years of life lost, Number of hospitalizations. All calculations were based on results of published clinical, epidemiological and social researches. Data for patients with HIV was obtained from prior epidemiological studies that had been provided in the Russian Federation. Results: The number of deaths on rilpivirine/tenofovir/emtricitabine scheme (single tablet regimen) was 12% and 15% less, the number of YLL was 9% and 12% less and Number of hospitalizations was 19,91% and 19,88% less than on the schemes efavirenz + tenofovir/ emtricitabin (multi-pill regimen) and lopinavir + tenofovir/ emtricitabin (multi-pill regimen), respectively. cOnclusiOns: Results obtained with present model showed that treatment naïve patients with HIV-1 RNA< 100 000 copies/ml using rilpivirine/tenofovir/emtricitabine scheme (single tablet regimen) can be associated with better long-term outcomes compared to alternative multi-pill schemes.
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