Data from: Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis
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https://datadryad.org/dataset/doi:10.5061/dryad.tv138
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Objectives Investigate if the recommendations by the Common Drug Review
(CDR) and the pan-Canadian Oncology Drug Review (pCODR) to provincial,
territorial and federal drug plans about whether to list non-oncology and
oncology drug-indication combinations on their formularies are associated
with whether the drug-indication combination was approved via the standard
evidence pathway or the Notice of Compliance with conditions (NOC/c –
limited evidence) pathway. Design Cohort study. Data sources Web sites of
the CDR and pCODR up to the end of March 31, 2017; journal articles
evaluating drugs approved through the NOC/c pathway, the Notice of
Compliance database, the Notice of Compliance with conditions web site and
the Summary Basis of Decision website. Interventions Recommendations by
the CDR and pCODR. Primary and secondary outcome measures Analysis of the
percent of drugs receiving positive listing recommendations from CDR and
pCODR depending on the pathway used to approve the drug. Results There
were 310 recommendations for drug-indication combinations from the CDR and
79 from the pCODR. There was a statistically significant difference in the
number of drug-indication combinations that received a list versus do not
list recommendation from the CDR for those approved through the standard
pathway compared to those approved through the NOC/c pathway (p = 0.0407).
A similar analysis for recommendations from the pCODR was not
statistically significant. Conclusion For non-oncology drug-indication
combinations, the type of review appears to influence the recommendation
regarding listing on public formularies. This difference may reflect the
level of evidence about the efficacy and safety of the drug-indication at
the time the recommendation was made.
提供机构:
Dryad
创建时间:
2017-09-26



