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Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.
The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.
This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.
by Féline E. V. Scheijmans, Roosmarijn van der Wal, Margot L. Zomers, Johannes J. M. van Delden, W. Ludo van der Pol, Ghislaine J. M. W. van Thiel
ObjectivesSolidarity-based healthcare systems are being challenged by the incremental costs of new and expensive medicines for cancer and rare diseases. To regulate reimbursement of such drugs, the Dutch government introduced a policy instrument known as the Coverage Lock (CL) in 2015. Little is known about the public opinion regarding such policy instruments and their consequences, i.e., reimbursement of some, but not all, expensive medicines. We aimed to identify the preferences of Dutch citizens regarding the reimbursement of expensive medicines, and to investigate the views of the public on the use of the CL as a healthcare policy instrument and their input for improvement.
MethodsWeb-based survey of a representative sample of 1999 Dutch citizens aged 18 years and older (panel of research company Kantar Public). Potential respondents were approached via e-mail. Several policy measures, real-life cases and statements related to the CL were presented in the survey to respondents. Their responses were analysed by tabulating descriptive statistics (proportions and percentages).
Results1179 individuals (response rate 59%) filled in the questionnaire. Although a majority considered the CL policy unjustified, they preferred it to the alternative policy measures that were presented. In four real-life case descriptions of patients in need of expensive medicines, respondents most often indicated effectiveness, lack of availability of alternative treatment and improved quality of life due to treatment as reasons for a positive reimbursement decision. An unfavourable cost-benefit ratio was their main reason to be against reimbursement. Some argued that withholding reimbursement was a way of informing manufacturers that extremely high prices are unacceptable.
ConclusionThere is public support for patients in need of expensive medicine. Many respondents supported the CL as a reimbursement policy. However, there is a wish to optimize the interpretation of the assessment criteria and the weight these are attributed in decision making about reimbursement of expensive innovative medicine for patients.
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