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
Draft Guidance on Coverage with Evidence Development Released by CMS
A few of the more noteworthy provisions in the Draft CED Guidance include the following:
- CMS is proposing to no longer use the coverage with appropriateness determination (CAD) but instead, to reflect the fact that recent CED national coverage determinations (NCDs) have “all been designed around research questions.” CMS will use CED only in connection with the conduct of research (i.e., pursuant to its authority under section 1862(a)(1)(E) of the Social Security Act).
- CMS indicates that it will consider applying CED not only to new technologies for which there is an insufficient evidence base, but also for existing technologies where “new research or evolving scientific thought raises important questions about the clinical usefulness, and thus the medical necessity,” of such technologies.
- CMS provides specific guidance on how CED studies should be designed, including that the principal purpose is to test whether the item or service “meaningfully improves health outcomes of patients who are represented by the enrolled subjects”; the study protocol specifies the method and timing of public release of results on all pre-specified outcomes; and the study protocol explicitly discusses subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies.
- CMS indicates that CED ends when the CED studies are completed and explicitly states that, under CED, “there is a potential period of noncoverage between the end of the study and the agency’s review of the scientific results.” However, the agency indicates a willingness to attempt to avoid such coverage gaps.
- CMS declined to establish formalized evidentiary criteria for CED as urged by commenters and recommended by MEDCAC.
- CMS states that is expects that results of all CED approved studies will be analyzed and published in peer reviewed clinical journals.
CMS will accept public comment on the Draft CED Guidance until January 28, 2013.
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