Reimbursement recommendations for cancer drugs supported by phase II evidence in Canada

  • Y.Y.R. Li University of Toronto
  • H. Mai Canadian Agency for Drugs and Technologies in Health
  • M.E. Trudeau Canadian Agency for Drugs and Technologies in Health, Sunnybrook Odette Cancer Centre
  • N. Mittmann Canadian Agency for Drugs and Technologies in Health, Sunnybrook Research Institute
  • K. Chiasson Canadian Agency for Drugs and Technologies in Health
  • K.K.W. Chan Canadian Agency for Drugs and Technologies in Health, Sunnybrook Odette Cancer Centre
  • M.C. Cheung Canadian Agency for Drugs and Technologies in Health, Sunnybrook Odette Cancer Centre
Keywords: phase II, Reimbursement, Canada, pCODR, CADTH

Abstract

Background Phase ii data are increasingly being used as primary evidence for public reimbursement for oncologic drugs. We compared the frequency of reimbursement recommendations for phase ii and phase iii submissions and assessed for variables associated with a positive or conditional recommendation.

Methods We identified submissions made to the pan-Canadian Oncology Drug Review’s Expert Review Commit­tee (perc), of the Canadian Agency for Drugs and Technologies in Health, July 2011 to July 2019, that were supported only by phase ii data. We identified variables within the perc’s deliberative framework, including clinical and eco­nomic factors, associated with the final reimbursement recommendation. We conducted a multivariable analysis with logistic regression for these variables: feasibility of phase iii study, hematologic indication, and unmet need.

Results We identified 139 submissions with a perc final recommendation. In 27 instances (19%), the submission had only phase ii evidence, and a positive recommendation was issued for 63% of them (the positive recommendation rate was 82% for submissions with phase iii evidence). Clinical benefit (p < 0.001), unmet need (p = 0.047), and patient alignment (p = 0.015) were associated with a positive recommendation. If a future phase iii study was deemed feasible for submissions with only phase ii evidence, then in univariable (p = 0.040) and multivariable analysis (p = 0.024), the perc was less likely to recommend reimbursement (odds ratio: 0.132).

Conclusions Although more than half the oncologic submissions with phase ii data were recommended for pub­lic reimbursement, compared with submissions having phase iii data, they were less likely to be recommended. A positive or conditional recommendation was more likely if clinical benefit and alignment with patient values was demonstrated. The perc was less likely to recommend reimbursement for submissions with phase ii evidence if a phase iii trial was deemed possible.


Author Biographies

Y.Y.R. Li, University of Toronto

Department of Medicine

M.E. Trudeau, Canadian Agency for Drugs and Technologies in Health, Sunnybrook Odette Cancer Centre

Division of Medical Oncology

N. Mittmann, Canadian Agency for Drugs and Technologies in Health, Sunnybrook Research Institute

Department of Pharmacology and Toxicology, Institute for Health Policy Management and Evaluation

K.K.W. Chan, Canadian Agency for Drugs and Technologies in Health, Sunnybrook Odette Cancer Centre

Division of Medical Oncology

M.C. Cheung, Canadian Agency for Drugs and Technologies in Health, Sunnybrook Odette Cancer Centre

Division of Medical Oncology

Published
2020-06-22
How to Cite
Li, Y., Mai, H., Trudeau, M., Mittmann, N., Chiasson, K., Chan, K., & Cheung, M. (2020). Reimbursement recommendations for cancer drugs supported by phase II evidence in Canada. Current Oncology, 27(5). https://doi.org/10.3747/co.27.6489
Section
Integrative Oncology