Alpelisib becomes 100th fast tracked NHS cancer drug

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Alpelisib – a life-extending drug for patients with advanced breast cancer – has become the 100th fast-tracked cancer drug on the NHS and will benefit thousands of cancer patients yearly.

Around 3,000 patients with a specific type of secondary breast cancer will have access to alpelisib each year, which will be used in combination with a hormone therapy known as fulvestrant. This drug combination will effectively target the gene that causes rapidly growing tumours.

The NHS Cancer Drugs Fund

Alpelisib is the 100th fast-tracked cancer drug under the NHS Cancer Drugs Fund (CDF), which has provided cancer drugs to over 80,000 UK patients in the last five years alone. The CDF represents a £340 million funding pot to allow early access to life-saving, cutting-edge cancer treatments on the NHS.

The initiative also ensures that vital data is collected by the drug manufacturers, which NICE can then utilise to support their final recommendations for NHS use. This new process has resulted in patients in England receiving around one-third of cancer drugs early compared to the European average.

What is alpelisib?

The drug combination of alpelisib and fulvestrant combats breast cancer by inhibiting a rogue gene’s ability to allow cancer cells to survive and spread. A study demonstrated that around 50% of patients who received the treatment did not see their cancer progress for six months.

Alpelisib was developed by the pharmaceutical company Novartis and is one of a range of precision cancer treatments the NHS is rolling out that target tumours based on their DNA mutation.

John Stewart, NHS National Director for Specialised Commissioning, said: “In just over five years, more than 80,000 people have benefitted from earlier access to a range of cancer drugs, with people in England having access to nearly one-third more cancer drugs compared to the European average, and this latest innovative new treatment will help up to 3,000 more to live a better quality of life.

“This life-extending breast cancer treatment is the 100th to be rapidly made available to NHS patients thanks to the Cancer Drugs Fund, and will help people with secondary breast cancer to live longer.”

Before clinicians prescribe alpelisib, they will take a small tissue sample from the patient’s tumour, which will be sent to an NHS Genomic Laboratory Hub to undergo a new genomic test to identify and treat the tumour.

If the test identifies a mutation in the specific gene called PIK3CA, then alpelisib could be offered to patients who have not responded to other treatments. Additionally, a blood test could be employed to identify circulating tumour DNA that can illuminate the mutation causing cancer.

Moreover, breast cancer patients who have previously been treated with an endocrine and CDK4/6 inhibitor could benefit from this treatment due to the MHRA extending the license for the drug in December 2021.

Professor Dame Sue Hill, Chief Scientific Officer for England and the Senior Responsible Officer for NHS Genomics, commented: “This is another powerful example of how genomic testing is supporting access to precision medicine for individuals living with cancer and allowing them to access more effective treatments on the NHS. Genomics is helping to revolutionise cancer care, and the NHS Genomic Medicine Service is leading the way in delivering the latest genomic technologies to deliver better outcomes for patients.”

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The NHS Long Term Plan

The NHS Long Term Plan enables cancer patients to access life-saving treatments early. In addition to the £340 million CDF, the NHS launched a new £340m Innovative Medicines Fund in June, meaning £680m has been invested into getting cancer and non-cancer treatments to those who need them most as quickly as possible.

Steve Barclay, the Health and Social Care Secretary, said: “These new drugs will benefit over 1,000 cancer patients across the country, offering them more precious moments with their loved ones and a better quality of life. We are constantly monitoring the most promising treatments. The incredible work of the Cancer Drugs Fund has now provided early access to 100 cancer treatments for more than 80,000 patients since 2016 and is a pioneer for innovation.”

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, commented: “It’s absolutely fantastic news that following a provisional rejection in March, alpelisib with fulvestrant has now been recommended by NICE for routine use on the NHS, bringing hope to thousands of patients living with a particular type of incurable secondary breast cancer.

“This will be the first targeted treatment option available for certain patients with a PIK3CA mutation which is estimated to be found in around 30-40% of oestrogen receptor positive, HER2 negative breast cancers. Importantly, clinical evidence suggests that alpelisib with fulvestrant is more effective than the current standard treatment option – everolimus with exemestane – and is another step in delaying chemotherapy for patients, which can be associated with grueling side effects.”

Marie-Andrée Gamache, Country President, Novartis Innovative Medicines UK and Ireland, concluded: “We know an advanced breast cancer diagnosis is devastating for patients and their loved ones, so we’re delighted that alpelisib has been approved as a treatment via the NHS in England and Wales.

“As part of our ongoing commitment to the breast cancer community, we have secured a broader licence with the MHRA and worked closely with NICE on this appraisal to provide access to as many eligible patients as quickly as possible. We welcome the systems in place to make alpelisib available immediately through interim funding from the Cancer Drugs Fund, and will continue to partner with the NHS and the entire healthcare system to identify new innovations that improve the quality of life for people with cancer.”

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