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New HTA Decisions in England
May 2020
Drug name
VITRAKVI® (larotrectinib)
Company
Bayer
Decision date
21/04/2020
Therapeutic area
Cancer
Therapeutic sub area
Sarcoma
Decision
Recommended with restrictions (CDF)
Indication
Larotrectinib is recommended for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children.
Decision Detail
Larotrectinib has a conditional marketing authorisation. Larotrectinib is recommended for use within the Cancer Drugs Fund only if the disease is locally advanced or metastatic or surgery could cause severe health problems, and they have no satisfactory treatment options. It is recommended only if the conditions in the managed access agreement for larotrectinib are followed.
Summary
The key clinical evidence comes from a pooled analysis of 102 patients from 3 single-arm trials. NAVIGATE is an ongoing trial for patients of 12 years and over with locally advanced or metastatic tumours with NTRK gene fusions who have had prior therapy or who would be unlikely to clinically benefit from standard care. SCOUT is an ongoing trial for children with locally advanced or metastatic solid tumours or primary central nervous system (CNS) tumours. LOXO TRK 14001 was a dose-finding study in patients with solid tumours with NTRK gene fusions. The committee considered that the evidence showed a clinically relevant overall response rate of 72% across multiple tumour types, but it noted that this may not be generalisable to the broader range of tumour types expected in NHS clinical practice. The committee concluded that the immaturity of the survival data meant that the size of larotrectinib's benefit on long-term survival could not be reliably estimated. Also, there is evidence that larotrectinib works well for some types of NTRK fusion-positive tumour, but little or no evidence for other types. The committee considered that the ICER ranges had plausible potential to be a cost-effective use of NHS resources if larotrectinib met the end-of-life criteria. However, the committee considered that there was substantial uncertainty in the survival estimates, with ICER ranges that were likely to be higher than what is considered a cost-effective use of NHS resources. Also, much uncertainty remained from modelling a population that was not generalisable to NHS clinical practice. Therefore, the committee concluded that it could not recommend larotrectinib for routine commissioning. Collecting more data would help to address some of the uncertainties in the clinical evidence. Larotrectinib has the potential to be a cost-effective use of NHS resources at its current price so it is recommended through the Cancer Drugs Fund while these data are collected.