lenvatinib and pembrolizumab

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Generic Name:
lenvatinib and pembrolizumab
Project Status:
Complete
Therapeutic Area:
advanced or metastatic renal cell carcinoma
Manufacturer:
Eisai Limited
Brand Name:
Lenvima and Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0268-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Lenvatinib, in combination with pembrolizumab, for the treatment of adult patients with advanced or metastatic RCC with no prior systemic therapy for metastatic RCC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Lenvatinib, in combination with pembrolizumab, for the treatment of adult patients with advanced or metastatic RCC with no prior systemic therapy for metastatic RCC.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open 18-Oct-21
Call for patient/clinician input closed 09-Dec-21
Clarification:

- Patient input submission received from CanCertainty and Kidney Cancer Canada (KCC)

Submission received 15-Nov-21
Submission accepted  
Review initiated 30-Nov-21
Draft CADTH review report(s) provided to sponsor for comment 01-Mar-22
Deadline for sponsors comments 10-Mar-22
CADTH review report(s) and responses to comments provided to sponsor 01-Apr-22
Expert committee meeting (initial) 13-Apr-22
Draft recommendation issued to sponsor 17-May-22
Clarification:

- pERC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation posted for stakeholder feedback 26-May-22
End of feedback period 09-June-22
Transmission de la recommandation définitive au promoteur et aux régimes d'assurance 23-Jun-22
Final recommendation posted 12-Jul-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 08-Jul-22
CADTH review report(s) posted 11-Oct-22