Tumour-agnostic drugs ‘game-changing’, says NICE as it rejects one from Bayer

The UK’s cost-effectiveness agency has said it can’t recommend Bayer’s tumour-agnostic drug Vitrakvi for routine use on the NHS because it is too expensive.

Despite that decision, NICE says there’s little doubt that ‘histology independent’ drugs like Vitrakvi (larotrectinib) – which treat cancer based on the presence of a genetic mutation rather than its location in the body – have the potential to be ‘game changing’ treatments for cancer.

Vitrakvi is being reviewed by NICE for advanced neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumours in adults and children with no other treatment options. It was approved by the EMA for this indication last September, becoming the first drug of this type in the European market.

NICE’s decision is another blow for Bayer, coming shortly after its German equivalent IQWiG said the data with Vitrakvi was too early and it had not been proven to provide any additional benefit over comparator drugs.

Unusually, NICE’s statement suggests that it may look more favourably on a rival histology independent therapy – Roche’s Rozlytrek (entrectinib) – which is under regulatory review by the EMA for NTRK fusion cancers in patients over 12.

Rozlytrek “could become the first histology independent treatment to be available to patients, provided it receives its marketing authorisation,” it says. Roche’s drug has already been approved for NTRK fusion cancers in the US and Japan, as well as in the US for ROS1-positive metastatic non-small cell lung cancer (NSCLC).

NHS national director of commissioning John Stewart has also taken a swipe at Bayer, saying: “It is disappointing that Bayer has not yet been willing to price larotrectinib at a level which represents value for the NHS and the taxpayer.”

“In the meantime, preparation continues for the introduction of this next generation of therapies, including constructive conversations with Roche on a commercial deal for entrectinib,” he added.

NTRK fusion cancer is rare, affecting no more than a few thousand patients across Europe annually, and occurs across a range of tumour types including sarcomas as well as brain, kidney and thyroid cancers.

NICE estimates there are around 600-700 people with this type of cancer in the UK, and only a proportion of these will be eligible for treatment. Use of these drugs will be reliant on patients receiving genetic testing for NTRK gene fusions in order to identify those who will benefit from the drug.

Last year, NHS England said it would prioritise tumour agnostic cancer drugs in the same way that it has CAR-T cell therapies for cancer. Central to those plans is a new NHS Genomic Medicine Service, which will test ten samples from thousands of solid tumours per year once it is fully established.

“These cutting-edge therapies target rare genetic mutations, so the clinical evidence is usually based on extremely small sample sizes, requiring novel approaches to testing them in clinical trials,” said Meindert Boysen, director of NICE’s centre for health technology evaluation.

He suggested that as additional data on their benefits will have to be collected it is most likely that these drugs will be included in the Cancer Drugs Fund (CDF).

In an emailed statement, Bayer said it was disappointed by the decision, but that it was not surprised as “NICE methods are not yet appropriate for appraising histology independent products.”

“We will continue to consult with NICE and hope that going forward a positive NICE appraisal will be granted,” it added.

“We believe that long-term funding in England and Wales should be available for larotrectinib in this hard to treat group of patients where no other satisfactory treatment options are available.”