National Centre for Pharmacoeconomics

National Centre for
Pharmacoeconomics

NCPE Ireland

Darvadstrocel (Alofisel®) for the treatment of complex perianal fistulae in adult patients with non-active/ mildly active luminal Crohn’s Disease when fistulae have shown an inadequate response to at least one conventional or biologic therapy and should be used after conditioning of fistula.

NCPE Assessment Process Complete
Rapid review commissioned 14/06/2018
Rapid review completed 17/07/2018
Rapid Review outcome A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of darvadstrocel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by the HSE 31/07/2018
Pre-submission consultation with Applicant 18/09/2018
Submission received from Applicant 20/12/2018
Preliminary review sent to Applicant 30/05/2019
NCPE assessment re-commenced 02/07/2019
Factual accuracy send to Applicant 23/08/2019
NCPE assessment re-commenced 02/09/2019
NCPE assessment completed 23/09/2019
NCPE assessment outcome The NCPE recommends that darvadstrocel (Alofisel®) not be considered for reimbursement. Cost effectiveness of darvadstrocel (Alofisel®) for the treatment of complex perianal fistulae in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulae have shown an inadequate response to at least one conventional or biologic therapy has not been demonstrated, and therefore is not recommended for reimbursement.*

Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.