Dataset Information

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis.

ABSTRACT:

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

Websites of the CDR and pCODR up to the end of 31 March 2017; journal articles evaluating drugs approved through the NOC/c pathway, the NOC database, the NOC/c website 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 with 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.

SUBMITTER: Lexchin J

PROVIDER: S-EPMC5665246 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis.

Lexchin Joel J

BMJ open 20171022 10

<h4>Objectives</h4>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.<h4>Design</h4>Cohort study.<h4> ...[more]

PMID: 29061631

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Project description:BackgroundDrugs are the fastest growing cost in the Canadian health care system, owing to the increasing number of high-cost drugs. The objective of this study was to examine the characteristics of high-drug-cost beneficiaries of public drug plans across Canada relative to other beneficiaries.MethodsWe conducted a cross-sectional study among public drug plan beneficiaries residing in all provinces except Quebec. We used the Canadian Institute for Health Information's National Prescription Drug Utilization Information System to identify all drugs dispensed to beneficiaries of public drug programs in 2016/17. We stratified the cohort into 2 groups: high-drug-cost beneficiaries (top 5% of beneficiaries based on annual costs) and other beneficiaries (remaining 95%). For each group, we reported total drug costs, prevalence of high-cost claims (> $1000), median number of drugs, proportion of beneficiaries aged 65 or more, the 10 most costly reimbursed medications and the 10 medications most commonly reimbursed. We reported estimates overall and by province.ResultsHigh-drug-cost beneficiaries accounted for nearly half (46.5%) of annual spending, with an average annual spend of $14 610 per beneficiary, compared to $1570 among other beneficiaries. The median number of drugs dispensed was higher among high-drug-cost beneficiaries than among other beneficiaries (13 [interquartile range (IQR) 7-19] v. 8 [IQR 4-13]), and a much larger proportion of high-drug-cost beneficiaries than other beneficiaries received at least 1 high-cost claim (40.9% v. 0.6%). Long-term medications were the most commonly used medications for both groups, whereas biologics and antivirals were the most costly medications for high-drug-cost beneficiaries.InterpretationHigh-drug-cost beneficiaries were characterized by the use of expensive medications and polypharmacy relative to other beneficiaries. Interventions and policies to help reduce spending need to consider both of these factors.

Project description:ObjectiveTo evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades.DesignCohort study.SettingFDA approved novel therapeutics between 1987 and 2014.PopulationPublicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review.Main outcome measuresLogistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not.ResultsThe FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction).ConclusionsIn the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative.

Dataset Information

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis.

Objectives

Design

Data sources

Interventions

Primary and secondary outcome measures

Results

Conclusion

Publications

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis.

Similar Datasets

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