The National Institute for Health and Care Excellence (NICE) has given its backing for EUSA Pharma’s drug Fotivda (tivozanib) as a first-line treatment for advanced renal cell carcinoma (RCC). RCC is the most common form of kidney cancer, making up 80% of cases.
The UK cost-effectiveness watchdog made its decision following a successful Phase III trial evaluating the efficacy of Fotivda comparative to Bayer’s Nexavar (sorafenib). The trial, known as TiVO-1, enrolled patients with recurrent RCC who had failed at least two previous regimes. Participants either received tivozanib or sorafenib in a randomised selection. The primary endpoint was to examine the progression-free survival of patients on each treatment. Secondary endpoints included monitoring overall survival, response rate and tolerability.
The study found that patients treated with EUSA’s drug experienced a progression-free survival of 11.9 months in comparison to Nexavar’s 9.1 month period. Additionally, only 14% of patients on Fotivda required a dose reduction due to undesirable side effects, compared to 43% of those on Nexavar.
“We are very pleased that NICE are recommending the use of Fotivda for the first-line treatment of advanced renal cell carcinoma,” said EUSA Pharma CEO Lee Morley.
“Fotivda has the potential to become an important new first-line therapy and the recommendation by NICE is a great achievement for the EUSA team delivering on their mission to improve the lives of those patients suffering from cancer.”
EUSA licensed Fotivda from Aveo Pharmaceuticals in 2015. Though it received European approval in advanced renal cell carcinoma, it failed to gain approval from the US Food and Drug Administration (FDA) in 2013. However, following the results of the TiVO-3 study, Aveo Oncology is looking to refile the case.
The decision for which drugs and treatments should be provided on the NHS in England and Wales falls to NICE. Recommendations are based on a review of clinical and economic evidence. The former examines how well the treatment works, while the latter looks at treatment efficiency in relation to its cost to the NHS.
Decisions are partially based on the number of quality-adjusted life years (QALY) a drug provides, a theoretical unit representing one year in perfect health. The cost of using the drug for one year is measured against how much a patient’s life can be extended and improved through its use. Generally, treatments costing under £20,000 per QALY are likely to be considered cost-effective, while those costing between £20,000 and £30,000 would require a stronger case for consideration. When comparing different treatments, NICE calculates the cost difference and divides it by the difference in effect – known as an incremental cost effectiveness ratio (ICER).
The system has, however, received some criticism over its inability to encompass differences in perceptions of medical benefit. A study conducted by the European Consortium in Healthcare Outcomes in January 2013 concluded that the system should be scrapped, saying that the value of treatment could not be determined through a formula.