On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
MEDCAC Discusses Future of Coverage with Evidence Development
In 2006, CMS issued a guidance document describing use of CED. In November 2011, CMS withdrew that guidance document from its website and requested comments on implementation of CED through the national coverage determination (NCD) or other avenues under Part A and Part B; potential impact of CED on the Medicare program and its beneficiaries; and suggested approach to CED to maximize benefit to Medicare beneficiaries. The Administration’s “National Bioeconomy Blueprint,” released in April 2012, explained that CMS plans to “implement the next phase of CED by better defining the parameters and guidance for CED so it can be used more widely and effectively as a driver of innovation.”
The MEDCAC meeting’s agenda focused on discussion of evidentiary thresholds for invoking or terminating CED. Nine public speakers and four invited guest speakers addressed a series of questions about definition of an evidentiary threshold. Although the panel struggled to define “evidentiary threshold,” the panel members agreed that such a threshold should be defined before applying CED to an item or service, and that application of the threshold could be affected by numerous factors, such as the safety profile of the technology, the severity of disease being treated, the availability of alternative treatments, off-label use of the technology, and whether the item or service is diagnostic or therapeutic. The panel members also agreed with the public speakers that CMS’s use of CED must be transparent and predictable, and should involve extensive stakeholder input.
CMS staff indicated that the agency will issued a revised draft of the guidance document on CED.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017