A new once-a-day tablet that treats advanced breast cancer is to be rolled out on the NHS, with about 1,100 patients in England set to benefit.
The final guidance on elacestrant by the National Institute for Health and Care Excellence (Nice) comes after it provisionally rejected the drug in October.
The charity Breast Cancer Now welcomed the news but said it remains “deeply concerned that the system is not working in getting all secondary breast cancer drugs to the people who so badly need them”.
Elacestrant, also known as Korserdu and made by Menarini Stemline, is used to treat a specific kind of cancer – oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer with an activating ESR1 mutation.
The committee understood that patients living with advanced breast cancer prioritise treatments that extend life, support quality of life, and delay the need for chemotherapy, while being safe and tolerable
It is recommended for patients whose cancer has worsened after at least a year of treatment with hormone therapy and CDK4/6 inhibitor, a drug that targets certain proteins on cancer cells to disrupt their growth.
Genetic testing for the ESR1 mutation will be required to determine who is eligible.
Helen Knight, director of medicines evaluation at Nice, said: “The committee heard from the clinical and patient experts that people whose advanced breast cancer has an ESR1 mutation tend to have worse survival than people whose cancer doesn’t have this mutation.
“Disease progression also tends to be faster for breast cancer with an ESR1 mutation.
“The committee understood that patients living with advanced breast cancer prioritise treatments that extend life, support quality of life, and delay the need for chemotherapy, while being safe and tolerable.
“Elacestrant is a promising new treatment with the potential to address these priorities. We’re therefore pleased to be able to recommend it as a good use of NHS resources and value for money for taxpayers.”
It comes after draft guidance published by Nice in October said it would not recommend elacestrant for use on the health service.
However, the NHS spending watchdog said it was “ready to work with” manufacturer Menarini Stemline to address “uncertainty in evidence” surrounding the medication.
Because elacestrant has been approved for people with a particular gene mutation, additional testing will be needed to work out who will be eligible to receive it. It is vital that this testing is put in place quickly to avoid any delays in access
Rick Coope, general manager at Menarini Stemline UK, added: “This outcome is a reflection of the strong collaboration and support from the breast cancer community and the willingness of Nice to work closely with Menarini Stemline to reach a decision that enables eligible people to have access to elacestrant.
“We are incredibly proud to reach this milestone for people living with locally advanced and metastatic breast cancer, a disease where timely access to new treatment options is of the utmost importance.
“Now our focus is to work closely with stakeholders across the healthcare system to ensure that potentially eligible patients can access testing for ESR1 mutations without delay.”
Claire Rowney, chief executive of Breast Cancer Now, said: “It’s fantastic news that elacestrant has been approved for use on the NHS in England, providing for the first time a targeted treatment specifically for certain people with ER-positive, HER2-negative incurable secondary breast cancer with an ESR1 mutation.
“Following its provisional rejection in October, crucially today’s decision means elacestrant will bring eligible patients hope of more precious time before their condition progresses to do the things that matter most to them, compared to treatments currently available.
“Because elacestrant has been approved for people with a particular gene mutation, additional testing will be needed to work out who will be eligible to receive it. It is vital that this testing is put in place quickly to avoid any delays in access.
“Today’s news is extremely welcome, but we remain deeply concerned that the system is not working in getting all secondary breast cancer drugs to the people who so badly need them.
“We remain tireless in our efforts to ensure every person with secondary breast cancer can access the vital treatments that they both so desperately need and deserve.”
Ms Rowney also said it is “crucial” that the drug is submitted to the Scottish Medicines Consortium (SMC) “so that the opportunity can be seized to make it available to everyone who needs it across the UK”.
