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