The National Institute for Health and Care Excellence (NICE) has recommended the use of olaparib (Lynparza) for BRCA-mutated early breast cancer and hormone-relapsed metastatic prostate cancer following what it described as "ground-breaking" deals with manufacturer AstraZeneca.
In final draft guidance, NICE said that NHS England (NHSE) had negotiated commercial arrangements that enabled it to recommend the drug as a cost-effective option on the NHS. The deals "have paved the way for hundreds to benefit", NICE said.
Today's decision reverses an earlier provisional recommendation against recommending olaparib for breast cancer following chemotherapy. The news was greeted by charity Breast Cancer Now as "fantastic news". The Institute of Cancer Research (ICR) in London hailed the ruling as "life-changing".
Olaparib can now be offered for adjuvant treatment of high-risk HER2-negative, BRCA-positive early breast cancer after chemotherapy. NICE said that evidence from the OlympiA clinical trial showed that giving olaparib after chemotherapy for BRCA-mutant, HER2-negative early breast cancer reduced the relative risk of the disease returning within 4 years by nearly a third.
Invasive Disease-Free Survival Extended
More people taking olaparib were alive and free of the disease at 4 years compared with those in the placebo group, with invasive disease-free survival of 82.7% versus 75.4%, respectively, and more people were alive overall: 89.8% compared with 86.4%. The decision was estimated to make an additional 300 people of the 450 in England affected by this type of breast cancer eligible for treatment.
Baroness Delyth Morgan, chief executive at Breast Cancer Now, described the proclamation as "fantastic news" and olaparib as "a ground-breaking and potentially life-saving treatment".
She said:"Around 5-10% of women with breast cancer carry an inherited altered gene of which the BRCA 1 and 2 genes are the most common. Sadly, some people with high-risk, HER2 negative primary breast cancer with an altered BRCA gene – often known as the 'Jolie gene' – may see their cancer return following treatment.
"Crucially, olaparib can reduce the risk of people's cancer returning or progressing to incurable secondary breast cancer and stop people dying from this devastating disease."
Approval Also Granted in Advanced Prostate Cancer
NICE also revised its position on olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations, a decision estimated to affect around 500 men who will now be eligible for olaparib treatment.
Indirect comparisons showed that olaparib could increase how long men lived irrespective of whether they had previously been treated with taxanes. NHSE said that olaparib could extend survival by an average of 6 months – from 12-18 months.
Clinical trials led by Johann De Bono, professor in experimental cancer medicine at the ICR and consultant medical oncologist at the Royal Marsden NHS Foundation Trust, showed that olaparib could block prostate cancer growth, improve survival, and delay disease progression.
"Olaparib is a precision medicine which extends the lives of men with advanced prostate cancer who have mutations in their BRCA genes. It is tremendously exciting to see the NHS in England and Wales make olaparib available to men suffering from these diseases. Olaparib is an important example of how understanding the underlying genetics of patients, and their tumours' genomics, can be used to design highly targeted precision medicines," he said.
"For patients with advanced prostate cancer and mutations in BRCA1 or BRCA2, these recommendations will be life changing – giving men another treatment option and precious extra time with their families, without the debilitating side effects we see with chemotherapy," Prof De Bono added.
Chiara De Biase, director of support & influencing at Prostate Cancer UK, said: "Not only is this fantastic news for men with advanced prostate cancer, but it is also a landmark moment for prostate cancer treatment.
"This is the first targeted treatment of its kind to be approved for the disease and it finally moves us away from the old 'one size fits all' approach to prostate cancer treatment."
'Value for Money' for Taxpayers
Announcing the decisions, Helen Knight, director of medicines evaluation at NICE, recognised the value of the drug: "We know how important it is for people with these types of cancer to have more treatment options that enable them to maintain or improve their quality of life. For people with this type of early breast cancer, being able to have a targeted treatment after surgery and chemotherapy will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease. For people with advanced prostate cancer it can also mean delaying chemotherapy and its associated side effects and allowing them to have more time with their families and loved ones.
"We are, therefore, delighted that NHS England and the company have been able to reach agreement on this ground-breaking deal enabling NICE to recommend olaparib for routine NHS use and good value for money for taxpayers."
Professor Peter Johnson, national clinical director for cancer, described olaparib as a "cutting-edge cancer treatment" and the deal as showcasing "the power of the NHS to agree deals for the latest medicines and treatments at affordable prices for taxpayers".
He said: "This is an important development for hundreds with early breast cancer or advanced prostate cancer that has progressed after other types of treatment, offering both sets of patients a vital new option to treat their cancer."
The ICR said that the "keenly awaited" judgement on "this pioneering treatment" offered "the chance of longer, healthier lives for thousands of patients". A spokesperson said: "The ICR believes that more flexible approaches to pricing drugs for different indications will play a vital role in efforts to enhance access to new medicines on the NHS."
Culmination of a 'Scientific Journey' that Started 25 Years Ago
Andrew Tutt, professor of breast oncology at the ICR and King's College London, who led the early research that resulted in the development of olaparib and was lead principal investigator of the OlympiA trial, said: "This is an amazing moment in a long scientific journey – starting with the discovery of the BRCA1 and BRCA2 genes more than 25 years ago, to ICR scientists identifying how to target a weakness in these cancers 10 years later, all the way through to the completion of the phase III clinical trials which led to today’s recommendations.
"It is immensely satisfying to know this work will now allow patients within the NHS to join the many thousands of patients globally whose lives are transformed by this work."
ICR Chief Executive Professor Kristian Helin added to that sentiment: "Olaparib is a true example of how outstanding scientific research improves lives. More than 25 years of research at the ICR into understanding the underlying cause of these inherited cancers – involving partnerships between academia, industry and charities across the world to deliver clinical trials – has led us to a cutting-edge treatment which exploits the very mutation that caused the cancer."
Olaparib is a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor that can be taken orally. Its list price is £2,317.50 per 56-pack of 150-mg tablets (excluding VAT), but the company has agreed a confidential commercial arrangement to make olaparib available to the NHS at a discount. The NHS will offer olaparib for the two new indications straight away through funding from the Cancer Drugs Fund.
NICE expects to publish final guidance on olaparib for breast cancer and prostate cancer in May 2023.