NICE okays Roche rare lung cancer drug after price cut

Market Access
Roche Rituxan approval

Certain patients with untreated lung cancer have a new treatment option after NICE recommended regular NHS funding for Roche’s Alecensa (alectinib) after the manufacturer agreed to cut its price.

In a now-familiar pattern, NICE had rejected Alecensa in a first draft published in April, but agreed in a final draft that the drug should be funded in England and Wales after the Swiss pharma offered a confidential discount.

Alecensa is approved for around 5% of advanced non-small cell lung cancer (NSCLC) patients whose disease has an ALK mutation – an indication where Pfizer’s Xalkori has been standard of care for several years.

NICE calculates that at list price, and assuming most patients will be treated for around 32 months, the average cost for a course of Alecensa is £87,000.

The cost-effectiveness body also noted the significant improvement in progression-free survival (PFS) among patients taking Alecensa compared with standard of care in patients with an ALK mutation – Pfizer’s Xalkori (crizotinib).

Latest data from the phase 3 ALEX study comparing Alecensa with Xalkori show Roche’s drug more than tripled progression-free survival (PFS) compared with standard care.

PFS in patients treated with Alecensa was 34.8 months, compared with 10.9 months in patients treated with Xalkori

Further number-crunching by NICE showed that the cost per Quality Adjusted Life Year for Alecensa is between £20,000 and £30,000 compared with Xalkori – beneath the body’s cost-effectiveness threshold.

NICE also noted Alecensa can easily cross the blood-brain barrier and slow down the spread of the disease into the central nervous system.

Results from ALEX published at this month’s American Society of Clinical Oncology (ASCO) conference showed Alecensa reduced risk of tumours spreading to or growing in the CNS by 84% compared with Xalkori.

Dr Riyaz Shah, Consultant Medical Oncologist, at Maidstone and Tunbridge Wells NHS Trust, said: “This is welcome news for clinicians and patients.  ALK-positive NSCLC is a rare type of lung cancer that predominantly affects younger people, non-smokers and has a propensity to spread into the brain. Alectinib has demonstrated substantial improvements in delaying cancer growth in these patients. It has also shown significant improvements in preventing and delaying cancer spread into the brain.”

NICE’s decision applies to England, and devolved NHS organisations in Wales and Northern Ireland are now likely to follow suit and fund the drug.

The Scottish Medicines Consortium is separately reviewing Alecensa and is due to discuss it at a meeting next week.

Earlier this month NICE said that the Cancer Drugs Fund could reimburse Xalkori on an interim basis in NSCLC patients with the ROS1 mutation, which affects around 1% of patients.