The National Institute for Health and Care Excellence (NICE) has reversed an earlier decision and decided to approve the “breakthrough treatment” atezolizumab after a bigger NHS discount was given.
Advanced triple negative breast cancer accounts for 15–20% of breast cancer cases but its aggressive nature means it causes 25% of deaths.
Atezolizumab is the first immunotherapy that specifically targets triple negative breast cancer where tumours have PD-L1 expression of 1% or more. It is given in combination with the chemotherapy drug nab-paclitaxel to patients who have not previously had chemotherapy whose cancer has metastasised and where surgery is not possible.
It is administered by fortnightly injection and blocks activity of the PD-L1 protein.
In new draft guidance, NICE said evidence suggests the new treatment improves overall survival by around 9.5 months and increases time before disease worsening by around 2.5 months compared with standard chemotherapy.
The list price for a 7.5 month course of atezolizumab treatment is £39,981.
NICE said Roche updated its economic model before offering a larger discount in a deal with NHS England & NHS Improvement.
It is estimated that 600 of the 2000 people in England with triple negative breast cancer would be eligible for the new drug.
Director of the NICE Centre for Health Technology Evaluation, Meindert Boysen, said in a news release: “We are pleased to have been able to work with the company to resolve the issues identified by the committee in our previous draft guidance.”
He added: “Atezolizumab is considered to be a breakthrough treatment in an area where there are currently few options.”
Seven Month Delay
“It is fantastic news,” Breast Cancer Now Chief Executive Baroness Delyth Morgan said in a statement, adding that the new treatment “signals a landmark advance in care”.
However, she criticised the delayed decision: “It is really concerning that drawn-out negotiations have resulted in a 7-month delay in this immunotherapy reaching all patients that could benefit.”
Final NICE guidance is expected in June and Wales and Northern Ireland usually mirror these decisions.
The Scottish Medicines Consortium hasn't yet issued a decision on atezolizumab. Its new drug decisions are on hold due to COVID-19.