Type of Clinical Evidence and Its Impact on Price Reductions for Oncology Drugs: A Review of Reimbursement Submissions in Canada

Speaker(s)

Balijepalli C1, Gullapalli L1, Yan K1, Sharma A2, Druyts E1, Rawson N3
1Pharmalytics Group, Vancouver, BC, Canada, 2Independent Consultant, Boston, MA, USA, 3Canadian Health Policy Institute, Toronto, ON, Canada

OBJECTIVES: We reviewed oncology drug submissions made to Canada’s Drug Agency (CDA) to understand the relationship between type of clinical evidence submitted by sponsors, their impact on price reductions recommended, as well as on the length of negotiations.

METHODS: We used our proprietary tool, [hta]DataMine, that captures data from published reimbursement recommendation reports from CDA for oncology pharmaceuticals and gene therapies for recommendations issued between January 2022 and April 2024. Length of negotiation was calculated using data obtained from the pan Canadian Pharmaceutical Alliance (pCPA).

RESULTS: Overall, 64/73 submissions reviewed were recommended for reimbursement. Of the 64 recommended submissions, 46 had phase 3 data, 8 had phase 2 data, 4 had phase 1 data, and 11 had phase 1/2 data. For the submissions with phase 3 data, 17/41 (41%) reported a price reduction of ≥70% for recommendation. For submissions with phase 2, phase 1, phase 1/2 data, the proportion of assessments that reported a price reduction of ≥70% for recommendation were 86% (6/7), 100% (3/3), and 88% (15/18), respectively. For the submissions that included evidence from only single-arm trials, 21/22 (96%) assessments reported a price reduction of ≥70% for recommendation. For the recommended submissions completing negotiations, the median length of negotiations were 3.8 months, 4.9 months, 4.4 months and 5.1 months, respectively, for submissions with phase 3, phase 2, phase 1/2, and phase 1 data.

CONCLUSIONS: This review found that oncology drug submissions with single-arm and phase 1 or 2 data received higher price reduction recommendations. From the limited pCPA data available for these submissions, it appears that length of negotiation was slightly longer for submissions with single-arm and phase 1 or 2 data.

Code

HTA172

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Pricing Policy & Schemes, Reimbursement & Access Policy, Value Frameworks & Dossier Format

Disease

Biologics & Biosimilars, Drugs, Oncology