Claire Rowney, chief executive at Breast Cancer Now, said:
“This week has brought yet more heartbreak for people with a type of incurable metastatic breast cancer with a new innovative treatment combination being rejected for use across the UK.
“Inavolisib with palbociclib and fulvestrant is a clinically proven, life-extending treatment, making it incredibly disheartening that both NICE and the Scottish Medicines Consortium (SMC) have rejected it on grounds of cost-effectiveness.
“These decisions leave people living with metastatic breast cancer paying the price, being denied more precious time with their loved ones.
“Frustratingly, this rejection is not the first time we’ve seen issues with combination treatments being made available on the NHS, and its further evidence that the drug approval system is failing people with metastatic breast cancer.
“Recent changes to the system, including an increase to NICE’s cost-effectiveness threshold, have been a step in the right direction. We were thrilled to see Enhertu finally approved for use on the NHS for people with HER2-low breast cancer in September after two years of relentless campaigning alongside our charity partners METUPUK and Make 2nds Count.
“However, these changes alone do not address wider challenges in the system. We know that thanks to world-class research, promising treatments are coming through the pipeline, but we don’t currently have a system that ensures people who need them will be able to access them.
“For people living with incurable metastatic breast cancer, time is precious, and they need quick access to treatments that could extend their lives now.
“We need to see innovative solutions to the challenges in approving combination treatments, where the cost of multiple medicines makes it very difficult to come in under cost-effectiveness thresholds.
“Alongside this, it’s essential that changes are made to NICE’s severity modifier, which currently means that less money can be spent on some medicines for metastatic breast cancer than before it was introduced.
“Pharmaceutical companies must show greater flexibility when pricing new drugs, working together with NICE and NHS England to find a way forward, so that cost alone doesn’t block people from accessing life-extending treatments.
“Above all, we must never lose sight of the people at the heart of these decisions. They make a valuable contribution to society, and they deserve a system that recognises that and gives them access to treatments that could give them more precious time.
“We’re calling for urgent action from the UK government, NICE, NHS England and pharmaceutical companies, as well as their counterparts in Scotland, to get round the table and tackle the long-standing issues with the drug system that’s failing patients and tragically cutting thousands of lives short. Breast Cancer Now stands ready to work with all parties on this.
“We’re determined to keep pushing for timely and equitable access to vital treatments for everyone with breast cancer, and we won’t stop until we reach our ambition that everyone with breast cancer lives and lives well.”
ENDS
Notes to editors
NICE has published final draft guidance rejecting the use of inavolisib (Itovebi) with palbociclib and fulvestrant for people with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment
In clinical trials, this treatment combination was associated with overall survival of 34 months, compared with 27 months for people in the palbociclib and fulvestrant arm (an increase of 7 months)