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The National Institute for Health and Care Excellence (NICE) has today (3 October 2019) announced its decision to provisionally reject immunotherapy drug atezolizumab (Tecentriq, Roche) with nab-paclitaxel (Abraxane) for use on the NHS in England for patients with a certain type of metastatic triple negative breast cancer.
According to NICE, this is because it has not been found to be a cost-effective use of NHS resources.
Atezolizumab is a type of immunotherapy given in combination with chemotherapy drug nab-paclitaxel. It is being considered as a first-line treatment for patients with untreated locally advanced or metastatic triple negative breast cancer, whose cancers produce the marker PD-L1. There is an accompanying test to identify the women who are PD-L1 positive and it is already tested for in other cancers, such as non-small cell lung cancer.
In March 2019, atezolizumab was made available through an Early Access to Medicines Scheme (EAMS), which provides access to unlicensed drugs that could be of benefit to patient groups where there is significantly unmet need. This scheme came to an end in September following atezolizumab receiving its marketing authorisation from the European Medicines Agency (EMA).
Evidence from a major trial (Impassion130) suggests that atezolizumab (with nab-paclitaxel) may offer up to 9.5 additional months of life on average for those with PD-L1 positive tumours, compared to nab-paclitaxel alone (which is not the standard treatment used on the NHS for this group of patients1).
The draft recommendation will be out for consultation until the 24th October, with the NICE committee meeting in November to make a final decision on the use of this treatment.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, the research and care charity, said:
“It’s extremely disappointing that there hasn’t been a way to make atezolizumab with nab-paclitaxel available, especially as the Early Access to Medicines Scheme which had made it temporarily available is no longer an option for new patients.
“This promising immunotherapy represents a significant advance in care for hundreds of patients with triple negative breast cancer. Having raised the hopes of a patient group with very few targeted treatment options to rely on, it is completely unacceptable that Roche, NICE and NHS England have been unable to find a long-term solution to make it available to all that could benefit.
“This combination has been available in NHS clinics for six months, and to now deny new patients the hope of this potentially life-extending drug is simply not good enough. Metastatic triple negative breast cancer remains one of the biggest areas of unmet need in breast cancer, and life expectancy remains heartbreakingly short.
“The evidence suggests that this immunotherapy combination could offer substantial life-extension – precious time to live and make memories with loved ones, which we know is absolutely invaluable.
“We now urge Roche, NICE and NHS England to work together to explore every possible solution, including considering additional discounts, to ensure this treatment option can return to NHS use as soon as possible. Women diagnosed with metastatic triple negative breast cancer do not have time to wait.
“Anyone affected by breast cancer can call our free Helpline on 0808 800 6000 for information and support.”
On the process that has seen a draft rejection of atezolizumab with nab-paclitaxel, Baroness Morgan added:
“This provisional rejection also shows that there is still work to do to ensure the recent changes to the NICE process enable positive outcomes to be reached more quickly.
“The move towards earlier discussions between a manufacturer and NICE on both clinical and cost issues has again failed to achieve faster progress. This example must now be considered as part of the upcoming NICE review of its methods and process.”
Notes to editors
1 The current standard treatment for this patient group is paclitaxel or docetaxel, which are both chemotherapies.
About Breast Cancer Now:
Breast Cancer Now is the UK’s first comprehensive breast cancer charity, combining world-class research and life-changing care to build a complete view of breast cancer and make faster progress for everyone affected.
Steered by research and powered by care, Breast Cancer Now’s ambition is that, by 2050, everyone who develops breast cancer will live and be supported to live well.
Breast Cancer Now funds around a third of all breast cancer research in the UK. By working with almost 340 of the brightest minds in breast cancer research, the charity is helping discover how to prevent more cases, save more lives and enable more women to live well with the disease.
The charity’s award winning information, services and courses, including Free Helpline, are there to make sure anyone diagnosed with breast cancer can get the support they need to live well with impacts of the disease. Anyone looking for support or information can call Breast Cancer Now’s free Helpline on 0808 800 6000.
Breast cancer is the UK’s most common cancer, with around 55,000 women and 370 men being diagnosed each year. An estimated 600,000 people in the UK are alive after a diagnosis of breast cancer, and one in seven women will develop the disease in their lifetime.
Despite decades of progress in research and care, around 11,500 women and 80 men still die from the disease every year in the UK, with hundreds of thousands more living with the devastating, long-term physical and emotional impacts of the disease.
Breast Cancer Now, the research and care charity, launched in October 2019, was created by the merger of specialist support and information charity Breast Cancer Care and leading research charity Breast Cancer Now.