The most striking example of governance issues in CED agreements is the risk-sharing agreement for interferons and glatiramers β in the treatment of multiple sclerosis in the UK. In its initial assessment, NICE refused to fund these drugs for clinical and cost-effective reasons (McCabe et al., 2010). In 2002, the government set up a CED with the four manufacturers concerned to follow a cohort of around 5000 patients in 72 centres for 10 years with the maximum cost of drug-funded medicines of £35,000/QALY. The interim analysis, which is expected after 2 years, was not published until 2009 (Boggild et al., 2009), due to patient recruitment issues. It was observed that the results were not positive, with a real benefit (measured by the expanded scale of disability status) being lower than the expected and unprocessed comparative data set. However, the authors explained that "it was too early to draw a conclusion from this initial interim analysis on the cost-effectiveness of disease-modifying treatments. Important methodological issues, including the need for additional comparative datasets, the potential bias of missing data, and the impact of the `no improvement` rule, need to be addressed, and long-term follow-up of all patients is essential to achieve meaningful outcomes" (Boggild et al., 2009). Many researchers have advocated stopping the experiment (including McCabe and, 2010; Raftery, 2010) or criticized the way the study was designed: for example, Sudlow and Counsell (2003) were highly critical of companies as co-financiers and would have preferred a completely independent study. The risks of no longer having these treatments available as part of the system and the displacement of patients to new, more expensive drugs convinced the parties involved to continue with the system, revealing disagreement within the scientific community. In addition, the scheme has been criticized (Adamski et al., 2010; Towse etal.,2012) due to delays in patient recruitment, incompleteness of the contract, doubts about the independence of the Scientific Advisory Panel, and because hospitals have not received additional funding for in-depth follow-up consultations and inadequate infrastructure, including specialized nurses. A new study was launched with a new natural history dataset and an improved profitability model (Palace etal., 2014) and results over 6 years of evidence were published in 2015 (Palace etal., 2015). 14.1.1.
Subject to clause 14.2.2, both parties agree not to bring any legal action with respect to any dispute arising out of this document that cannot be resolved by informal discussion until the procedure set out in this clause has been used. Transparency is also advocated for reporting in outcome-based agreements, particularly for EDCs conducted solely "in research", with coverage limited to patients receiving the drug as part of a clinical trial or registry (Carlson etal., 2010). The rationale for publishing the results of a results-based ITA is the public nature of the data. one. According to paragraphs (a), (b) or (d) of Article 9.1.5 – the disclosing party must: A practical problem in risk sharing is the assessment of acceptable costs that form the basis for risk sharing and the determination of risk-adjusted premium subsidies [...].