Advice
NICE is unable to make a recommendation about the use in the NHS of tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies. This is because Novartis has confirmed that it does not intend to make an evidence submission for the appraisal. Novartis has agreed with NICE and NHS England that a guidance update would not be a productive use of resources. Novartis considers that changes to treatment and reimbursement mean that the submission would not be viable within what NICE considers a cost-effective use of NHS resources.
NICE and the company have considered all the options for producing guidance on tisagenlecleucel for this indication. The decision to terminate this appraisal has not been taken lightly. NICE is disappointed that the committee and stakeholders will not have the opportunity to fully review the new evidence collected.
For data collected when this technology was in the Cancer Drugs Fund (NICE's technology appraisal guidance 567), see the National Disease Registration Service's data review on tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma. Data from the Novartis JULIET clinical trial will be published on the NICE website when available.
Information
If NHS organisations wish to consider tisagenlecleucel for this indication, they should follow the advice on rational local decision making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when there is no NICE guidance.
People already having tisagenlecleucel for this indication through the Cancer Drugs Fund can continue. For those people, it will be funded by the company until they and their NHS clinician consider it appropriate to stop.
ISBN: 978-1-4731-5611-1