NICE backs funding for Roche's lung cancer drug after price cut

NICE has recommended NHS funding for Roche’s Rozlytrek (entrectinib) as a treatment option for advanced non-small cell lung cancer with a rare mutation in final draft guidance. 

The cost-effectiveness body said in final draft guidance that it had recommended Rozlytrek for ROS-1 positive, advanced non-small cell lung cancer for patients not previously treated with an ROS1 inhibitor. 

NICE had previously rejected Rozlytrek in this indication in January saying it was too expensive, but said it remained open for further discussions. 

In a pattern commonly seen with cancer drugs, NICE has decided to recommend Rozlytrek after Roche offered a commercially confidential discount on the drug’s list price of £5,160 for 30 days’ supply. 

ROS1 is a rare mutation found in fewer than 2% of NSCLC cases. Currently there is a lack of treatments for ROS1-positive NSCLC, especially for people whose lung cancer has spread to the brain. 

NICE already agreed interim funding for Pfizer’s Xalkori (crizotinib), which can also be used to treat ROS1 lung cancer, through the Cancer Drugs Fund. 

Roche presented data from 3 clinical trials, which show that treatment with Rozlytrek is effective at shrinking tumours. 

Data showed it slowed spread of the disease with a median of 16.8 months without progression, including patients who have developed brain tumours. 

NICE said Rozlytrek meets its criteria to be considered a life-extending, end-of-life treatment. Evidence suggests that the treatment could be expected to extend life by more than three months compared to pemetrexed with platinum chemotherapy, which is a common treatment for NSCLC. 

This gave NICE more leeway on cost and raising the upper limit above the standard £30,000 per QALY threshold.

Factoring the discount, Rozlytrek costs up to £42,500 per QALY, according to NICE's estimates, which are around double those provided by the manufacturer but below the £50,000 cut-off for end-of-life therapies.

Rozlytrek is set for approval in the EU during the next few weeks after a positive opinion from the European Medicines Agency’s CHMP. It is estimated that this treatment will be made available to around 412 people in England.  

Karen Lightning-Jones, head of personalised healthcare and strategic partnerships, Roche Products Limited said: “Today's news follows many years of dedication and hard work by our scientists and the wider scientific community.  

“It represents an important milestone for patients who previously had limited treatment options for ROS1+ NSCLC, a rare form of lung cancer.”