Exact(3)
Interventions in the malignant disease and immunosuppression disease category (specifically oncologics) accounted for the majority of NICE submissions, with an acceptance rate slightly lower than the average across all disease areas.
8 It has also been suggested that patient group submissions, the number of randomized trials, and the number of systematic reviews supporting NICE submissions can positively affect the appraisal outcome.
Experience with NICE submissions is that the use of such vignettes describing health and other benefits is open to manipulation and carries less weight than one based on patient-reported outcomes [ 7].
Similar(57)
All three agencies considered the same direct phase III clinical trial (AFFIRM), but the NICE submission included two additional phase II studies.
Warren and colleagues (2004) assessed the economic evaluation presented with the original NICE submission of insulin glargine and published revised cost-effectiveness figures.
The systematic review identified 1,551 potentially relevant studies, of which 29 publications, including 2 Clinical Study Reports (CSRs), 1 NICE submission and 4 abstracts, were identified to be relevant.
This model demonstrated significant benefits for insulin glargine and the incremental cost effectiveness was found to be similar to that presented in the original NICE submission, thus reaffirming the overall value for money of insulin glargine and the significant health benefits that it provides.
"We have a very nice number of submissions," Ms. Towner said, adding, "We see the value in each and every submission".
NICE only accepts submissions including commercial-in-confidence data in exceptional cases after prior authorization and expects that all information on the methodology of a given study be in the public domain.
NICE also received industry submissions including economic modelling by the manufacturer, and these were reviewed by the assessment group.
This framework for developing costs of clinical events utilizing reference data provides some degree of standardization; however, it is binding only for submissions to NICE, and does not necessarily apply to independent economic evaluations that may ultimately influence decision-making.
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