Hopes for Cabozantinib NICE recommendation

Kidney Cancer UK is very disappointed to hear that at the midpoint of the Single Technology Appraisal (STA) of cabozantinib, NICE is considering NOT recommending its use within the NHS in England and Wales. Having a variety of targeted therapy options is vital for patients with advanced kidney cancer; providing hope and extra months and years of life. Different patients respond positively to different medicines. Providing a variety of therapeutic options should also help patients find a medicine that works for them. Adding cabozantinib to the second, third, fourth-line treatment options and beyond provides an option that could work really well for some patients; making kidney cancer a chronic disease rather than fatal.
An example of cabozantinib working well, is described by David Chessum, who shared his experience with us on a video for supporters of Kidney Cancer UK. Please view his video for more details. https://www.youtube.com/watch?v=9asTUb1CZRU  His experience of cabozantinib has been very positive: his quality of life has improved and he no longer has to deal with severe diarrhoea, a side-effect of his previous drug regime. Cabozantinib has given him a much better quality of life,  something we hope will be strongly considered during the NICE appraisal.
One issue that has arisen from the recently released Appraisal Consultation Document (ACD) is the lack of guidance and standardisation for doctors regarding the sequence of second-line treatments onwards. Currently axitinib, nivolumab and everolimus are recommended by NICE as second-line treatments. Sunitinib and pazopanib are recommended as first-line treatments. In reality, the treatments given as a second-line treatment and beyond are very varied: the recommended first-line drugs are often given as fifth-line drugs and some second-line drugs are rarely prescribed at all. The 2016 Kidney Cancer UK annual survey requested information about which drugs had been taken by each responder. 111 people took the survey, 34 had taken medicine for advanced kidney cancer.

• The first-line drugs were split fairly evenly between pazopanib and sunitinib, 1 person each took interleukin, everolimus (trial) and sorafenib (trial).
• 13 people went on to take a second-line drug; 7 took axitinib, 5 took either the other first-line drug (pazopanib or sunitinib), one advanced to interleukin 2.
• 7 people advanced to a third-line drug, 5 of which took nivolumab, 1 pazopanib and 1 axitinib.
• 1 person had taken a fourth-line drug, which was sunitinib (a first-line drug).
• 1 person advanced to a fifth-line drug (axitinib).

The data from our survey indicated that everolimus was not taken once as a second-line or beyond drug. Only once was it taken as a first-line treatment during part of a clinical trial. Everolimus is the drug that cabozantinib has been compared to in the METEOR clinical trial so its use is of relevance in the STA. Everolimus was previously available on the old Cancer Drug Fund and Kidney Cancer UK is pleased that everolimus (an mTOR inhibitor) has recently been recommended by NICE through its rapid appraisal scheme. Everolimus is important as it offers an alternative way of attacking kidney cancer tumour cells compared to TKI’s or immunotherapy, but we would like to ask why it is not being recommended by doctors for use on the NHS.
We certainly would welcome more research and guidelines in the area of the sequencing of second-line treatments and beyond. We understand that many doctors use the EAU (European association of urology) guidelines but there are no firm conclusions on the sequencing of drugs beyond second-line treatments.  “No firm recommendations can currently be made as to the best sequence of targeted therapy, beyond the recommendation that VEFG-targeted therapy should be used for patients with good- and intermediate-risk disease.”¹. We feel this issue should be addressed in the near future and perhaps a UK-based set of guidelines should be established, due to the variations in NICE recommendations compared to Europe drug licencing.
We sincerely hope that cabozantinib is recommended by NICE in England and Wales: the wider the choice of available drugs the better potential outcomes for patients with advanced kidney cancer. Cabozantinib has been shown to provide a tolerable range of side-effects that can benefit some patients quality of life. This is invaluable. We also envisage an era of medicine where combinations of different targeted therapies are utilised and specific medicines are given to people with appropriate genetic profiles, to produce even better survival rates; we feel that cabozantinib could be very useful in this approach. We hope that the area of multiple second-line therapies continues to evolve and expand within the UK, as it is in other countries across the world.
 

1. http://uroweb.org/wp-content/uploads/10-Renal-Cell-Carcinoma_LR.pdf