The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Ipsen’s Cabometyx (cabozantinib) for patients with differentiated thyroid cancer (DTC) who have either not responded to or are unsuitable for radioactive iodine therapy.
NICE noted that Cabometyx has been shown to increase how long patients have before the disease gets worse, but said it is not clear if it increases how long people live, meaning cost-effectiveness estimates are ‘unclear’.
The drug was approved for this indication last year, and NICE outlined that the recommendation is not intended to affect treatment with Cabometyx that had already started.
DTC is the most common form of thyroid cancer, accounting for around 90% to 95% of all diagnosed cases. More women than men are diagnosed with the condition, but the proportions of men and women are similar for patients with metastatic disease.
Treatment typically involves surgery, with radioactive iodine sometimes used to destroy any remaining cancerous cells. However, between 5% and 15% of patients have DTC that does not respond to the therapy.
The main evidence for Cabometyx came from the phase 3 COSMIC-311 trial, in which the drug plus supportive care was associated with a significant improvement in progression-free survival compared with placebo plus supportive care.
However, there was no statistically significant difference in overall survival between the two treatment arms, and NICE said patients were not followed up for long enough.
Responding to NICE’s decision, Guy Oliver, general manager at Ipsen UK and Ireland, said: “This preliminary decision by NICE is disappointing for all those living with DTC in England and Wales. Treatment options are extremely limited for people living with DTC and we believe cabozantinib addressed a significant unmet need in this patient population.
“The decision is also surprising due to the fact that cabozantinib fell within NICE’s cost-effectiveness range, especially as it was acknowledged by the NICE committee that there is an unmet need in England and Wales for an effective second-line treatment.”
Oliver added that the company will be “responding to the NICE consultation and [remains] committed to working collaboratively with NICE and the NHS to achieve a positive outcome for people living with DTC”.
The preliminary recommendation is now open for comment, with a final decision expected later this year.