Frances Logan, policy and public affairs lead, Scotland, at Breast Cancer Now, says:
"Ahead of Metastatic Breast Cancer Awareness Day tomorrow, it’s deeply disappointing that today’s decision from the Scottish Medicines Consortium’s (SMC) means some people living with this devastating disease will be denied access to a life-extending treatment.
“Inavolisib with palbociclib and fulvestrant is an innovative treatment that could give people living with incurable breast cancer in Scotland more time to live and make memories with their loved ones.
"This decision highlights the challenges faced in getting combination treatments approved on cost-effectiveness grounds. But patients shouldn't bear the brunt of the impact of how these treatments are assessed.
"We're calling for urgent action from the SMC, the Scottish Government and pharmaceutical companies to overcome the barriers to approving combination therapies and ensure that life-extending drugs reach the patients who need them. Breast Cancer Now stands ready to work with them on this.
"We're also deeply concerned that the genomic testing needed to identify patients eligible for this treatment is still not routinely available across Scotland. This lack of testing is already blocking access to other, recently approved treatments, such as capivasertib and elacestrant. The Scottish Government must act now to put this testing in place.”
Inavolisib with palbociclib and fulvestrant is licensed by the MHRA for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
This treatment is used at first line (as soon as someone is diagnosed with metastatic disease) and it requires patients to have a specific genetic mutation in their tumour.
The median overall survival data for inavolisib with palbociclib and fulvestrant was 34.0 months, compared with 27.0 months for people in the palbociclib and fulvestrant arm. The invavolisib based treatment also showed a consistent improvement in median progression free survival of 17.2 months vs 7.3 months.