Evicenter
P&T meetings

Imlifidase

Kidney transplantation in highly sensitized patients

Manufacturer
Hansa Biopharma
Regulatory submission
BLA submitted December 2025
85 sources

Section 5 of 6

Economic information and modeling report

13 evidence topics · 5 sources

Modeling overview

Summary

The Irish lifetime cost-effectiveness model projected lower costs and more QALYs than dialysis, while its separate five-year budget analysis projected additional expenditure. The Irish conference poster reported lower costs and additional QALYs in 94.5% of model simulations, but identified the absence of utility data specific to highly sensitized patients with ESRD.

Scotland's acceptance was conditional on a Patient Access Scheme arrangement. France assigned CAV III for clinical added value, but its economic assessment did not establish cost-effectiveness because of major uncertainty and a methodological reservation. These findings concern different jurisdictions and assessment frameworks.

Budget impact model

Approach and framework

Perspective and time frame

Assessment commissioner and budget horizon
CharacteristicQuoted record
Assessment commissioner“Health Service Executive (HSE)”
Budget horizon“5 year”

Epidemiology and eligible population inputs

Eligible population and annual transplantation assumptions
InputQuoted value
Eligible patients estimated by clinical experts“20”
Annual imlifidase-enabled transplants“4 to 5”

Cost assumptions

Repeat dosing and average drug costs
InputQuoted value
Patients receiving a second dose“6.5%”
Mean drug cost before rebate, excluding VAT“€331,183”
Mean drug cost after rebate, excluding VAT“€303,032”

Model outcomes

Drug expenditure and overall healthcare expenditure
Outcome categoryQuoted outcome
Drug expenditure“gross drug budget impact”
Overall healthcare expenditure“net budget impact”

Results

Base case
Five-year Irish budget impact
OutcomeQuoted amount
Gross drug expenditure“€8,721,695”
Net total expenditure, including other healthcare costs and dialysis offsets“€5,376,092”
Scenario analyses

No evidence found.

Budget impact model discussion

Summary

The five-year estimate remains an additional cost after dialysis offsets. Inputs include 20 eligible patients, four to five transplants annually, and a 6.5% second-dose rate. The model uses Irish prices and rebates. Its lifetime cost-effectiveness result should not be interpreted as a five-year budget saving.